(INCLUDES A MANUFACTURER INDIGENT …includes a directory of pharmaceutical manufacturer indigent...

102d Congress COMMITTEE PRINT T.2d Session 102-117

PRESCRIPTION DRUG PROGRAMSFOR OLDER AMERICANS

(INCLUDES A DIRECTORY OF PHARMACEUTICALMANUFACTURER INDIGENT PATIENT PROGRAMS)

A STAFF REPORT

OF THE

SPECIAL COMMITTEE ON AGINGUNITED STATES SENATE

NOVEMBER 1992.

Serial No. 102-S

This document has been printed for information purposes. It does notrepresent either findings or recommendations formally adopted by thiscommittee

U.S. GOVERNMENT PRINTING OFFICE

59-585 WASHINGTON : 1992

For sale by the U.S. Government Printing Office

Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0-16-039545-3

SPECIAL COMMITTEE ON AGING

DAVID PRYOR, Arkansas, ChairmanJOHN GLENN, OhioBILL BRADLEY, New JerseyJ. BENNETT JOHNSTON, LouisianaJOHN B. BREAUX, LouisianaRICHARD SHELBY, AlabamaHARRY REID, NevadaBOB GRAHAM, FloridaHERB KOHL, WisconsinTERRY SANFORD, North CarolinaJOCELYN BIRCH BURDICK, North Dakota

WILLIAM S. COHEN, MaineLARRY PRESSLER, South DakotaCHARLES E. GRASSLEY, IowaALAN K. SIMPSON, WyomingJAMES M. JEFFORDS, VermontJOHN McCAIN, ArizonaDAVE DURENBERGER, MinnesotaLARRY CRAIG, IdahoCONRAD BURNS, MontanaARLEN SPECTER, Pennsylvania

PORTIA PORTER MFrELMAN, Staff DirectorCRusToPman C. JENNINGS, Deputy Staff Director

MARY BERRY GERWIN, Minority Staff Director/Chief Counsel

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PREFACE

Taking prescription medications is often a matter oflife and death for millions of older Americans. .The un-fortunate truth, however, is that many older Americansare unable to buy the drugs that they need to sustainlife because they are simply just too expensive. For thatreason, many older Americans do not take their medica-tions correctly, or do not take them at all. The purposeof this report is to update the Congress and the Ameri-can people about the impact of rising drug costs onolder Americans, and analyze the extent to whichpublic and private insurance programs meet the need ofproviding drugs to this population group.

Unfortunately, there . is little encouraging news toreport. Unlike hospital and physician services, there islittle adequate public or private health insurance cover-age for prescription drugs. Medicare-the primaryhealth insurance program for older Americans--doesnot cover the cost of outpatient drugs. Medicaid, thehealth insurance program for the poor, provides somedrug coverage for the poorest of the poor, but leaves toomany other poor older Americans exposed to potentiallycatastrophic prescription drug costs. Medigap plans,which can be purchased to supplement Medicare's in-surance protections, generally offer inadequate prescrip-tion drug coverage. This assumes that an elderly personcan even afford to buy a Medigap policy..

The bottom line is that, because of the prescriptiondrug insurance void, the overwhelming majority ofolder Americans' prescription drug costs are paid out-of-pocket. That is why almost 5 million older Americans inthe United States today say that they make toughchoices between paying for food or their medications.

The relative lack of prescription drug insurance forolder Americans has been significantly compounded by12 years of unrelenting pharmaceutical manufacturerprescription drug price increases. Year after year since1980, drug price increases have added a profound

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burden to millions of older Americans who are alreadystaggering under the weight of paying for other necessi-ties of life such as food, heat, and rent.

Although the drug industry contends that pharma-ceutical price inflation is slowing down, recent datafrom the Bureau of Labor Statistics do not support thisassertion. During the period between June 1991 andJune 1992, while overall inflation at the manufacturers'level increased 1.5 percent, pharmaceutical price infla-tion at the manufacturers' level increased more thanfour times this rate-6.3 percent. These eye-openingdata make it more important than ever to bring thecost of pharmaceuticals under control as soon as possi-ble.

Unfortunately, the drug manufacturing industry inthe United States has done little to make drugs moreaffordable and accessible to poor and indigent popula-tions in particular. Drugs can be the most cost effectiveform of treatment for a particular illness, but if theyare unaffordable, they cannot help.

Many drug companies have developed programs thatmake drugs free of charge to poor and other vulnerablepopulations of Americans that cannot afford them.However, these programs are currently being used byonly a small number of Americans that could truly ben-efit from. them. In addition, the programs often requirelong waiting times for indigent patients to receive theirfree medications from drug manufacturers.

This report contains a directory of the indigent pa-tient programs that many pharmaceutical manufactur-ers currently have in operation. However, an analysis ofthese programs leads to the conclusion that substantialchanges need to be made in order to make them moreaccessible and practical for use by indigent patients andtheir physicians.

During the current and upcoming debate on healthcare reform, it will be imperative for the Congress toaddress the very important issues of access to and costsof prescription medications. If these issues are not ade-quately addressed, many Americans of all ages--espe-cially older Americans-will have to continue to choose

V

between life-saving medications and the many othervital necessities of life.

Sincerely,DAVID PRYOR,

Chairman.WIMAM COHEN,

Ranking Republican Member.

CONTENTS

Page

P reface................................................................................................ . IIIPharmaceutical Manufacturer Indigent Patient Programs...... 1

A . O verview ............................................................................... 1B. General Findings About the Indigent Patient Pro-

gram s.................................................................................... 2C. How To Use This Directory ................................................. 6D. Recommendations To Improve Pharmaceutical Manu-

facturer Indigent Patient Programs............................... 8E. PMA Response to Prescription Drug Access and Af-

fordability Crisis..................................... ............... 9Alphabetical Listing of Drugs Covered Under Indigent Pa-

tient Program s ................................................................................ 11

APPENDIX

Directory of Pharmaceutical Manufacturer Indigent PatientP rogram s ......................................................................................... . 19

TABiES

1-Price Increases for Major Prescription Drugs Taken byOlder Am ericans, 1986-91............................................................ 94

2-Major Brand Name Prescription Drugs Coming OffPatent, 1992-95 .............................................................................. 95

3-Cost of New Drugs Skyrocketing...................... 974-Description of Benefits Provided Under State-based Phar-

maceutical Assistance Programs for Older Americans.......... 985-Contacts for State-based Pharmaceutical Assistance Pro-

grams for Older Americans ......................................................... 1006-Patient Assistance Programs for HIV-Related Therapies ... 103

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Pharmaceutical Manufacturer Indigent PatientPrograms

A. OVERVIEW

To increase access to drugs for indigent patients, anumber of pharmaceutical manufacturers have devel-oped programs to help make medications more availablefree of charge. The programs are commonly referred toas "indigent patient. programs." It is laudable thatpharmaceutical manufacturers have, for several years,voluntarily offered programs to assist some of the poor-est Americans obtain life-saving medications. However,the limited scope of these programs, the small numberof recipients, the cumbersome distribution system, andthe minimal level of awareness among indigent patientsindicate that these drug company programs may not befulfilling their mission. In the final analysis, these pro-grams are certainly not substitutes for affordable pre-scription drugs or prescription drug insurance.

The level of awareness of these manufacturers' pro-grams appears to be minimal among older Americansand the agencies that have been established to providesocial services to this population group. That is becausethe programs are usually promoted to the physicianthrough word-of-mouth by the local sales representativeof the pharmaceutical manufacturer, and are rarelypromoted to the indigent patients who need them themost. As a result, only a very small number of indigentpatients are benefitting from the programs at this time.

To make older Americans and other indigent vulnera-ble populations more aware of these programs, the U.S.Senate Special Committee on Aging surveyed pharma-ceutical manufacturers for information about their indi-gent patient programs. Information from each manufac-turer that responded to the survey is included in the Di-rectory which is part of this report. The manufacturersand their programs are listed in alphabetical order bymanufacturer.

While the level of awareness of these. programs cer-tainly needs to be increased, it is encouraging to notethat almost all major, brand name pharmaceutical man-ufacturers reported that they have programs that pro-vide prescription drugs free of charge to indigent pa-tients. Based on an analysis of the programs reported tothe Committee by the manufacturers, recommendationson improvements that can be made to these programsare suggested at the end of this section.

B. GENERAL FINDINGS ABOUT THE INDIGENTPATIENT PROGRAMS

Many manufacturers provided prompt and detailedresponses to the Committee's survey. However, therewere a significant number of manufacturers that werevery reluctant to provide. detailed information to theCommittee about their programs. The nature and struc-ture of pharmaceutical manufacturer indigent patientprograms differ from program to program. However, itis possible to make some generalizations about howthese programs have been operating, and whether theyare meeting their goal of providing indigent patientaccess to needed medications.

DRUGS COVERED UNDER THE PROGRAMS

The drug companies that responded to the survey re-ported that they generally make all their prescriptionproducts available free of charge to indigent patientsthrough these programs. In general, some drug manu-facturers reported that they have well-defined, well-structured indigent patient programs, while other man-ufacturers reported that they have programs that makedrugs available to indigent patients on an informal adhoc basis through the request of the physician. The pro-grams generally do not make controlled substancesavailable, such as narcotic drugs. Some companies haveestablished special programs for certain drugs that maybe very expensive or that treat particular populations,such as cancer or AIDS patients. A 'special listing ofAIDS drugs programs is provided in the Appendix.

Many of the companies reported that part of their ef-forts to serve indigent patients involve the distributionof free drug samples to physicians. Companies reportthat physicians, in turn, distribute some of these sam-

ples to indigent patients. Unfortunately, the use ofpharmaceutical samples to treat indigent patients is notan acceptable substitute for an effective indigent pa-tient program. Pharmaceutical samples are not alwaysavailable in physicians' offices at the time of the indi-gent patient's visit. In addition, the samples of the drugdistributed to the patient on the initial visit may not beavailable when the patient returns for subsequentvisits. The patient may then have to be switched to adifferent drug.

Because many indigent patients see multiple physi-cians or pharmacists, or receive care in a busy clinic oremergency room, samples may not always be available,or the samples that were dispensed may not be properlyrecorded on the patient's chart. This makes it muchmore difficult to track a patient's drug therapy. In thefinal analysis, drug samples are primarily expensivemarketing tools for pharmaceutical manufacturers, andare not a substitute for an indigent patient programthat provides a full course of therapy for the patient'scondition at the time of need.

PATIENT ELIGIBILITY

Many of the programs simply require that the physi-cian determine that the patient is indigent and cannotafford the drugs prescribed. Some programs require thephysician to write a letter to the company stating thatthe patient is indigent, and include a prescription forthe products requested. Other programs, especially forthose drugs that are expensive, require either the physi-cian or patient to enroll in a program, or qualify for aprogram by meeting certain income and asset criteria.Some companies have established toll-free numbers thatpatients and physicians can call to enroll in these pro-grams.

Many of the programs require that the patient be in-eligible for private health insurance, third-party cover-age, Medicaid or Medicare before they qualify for an in-digent patient program. Unfortunately, as was de-scribed in the first section of this report, while some in-digent patients--especially older and disabled Ameri-cans-may qualify for Medicare, outpatient prescriptiondrugs are not covered under Medicare. Therefore, itwould be unfair to deny indigent patients access to any

of these programs simply because they qualify for Medi-care. Of course, because of their financial status, mostindigent patients would be unlikely to purchase supple-mental insurance coverage that would cover the cost ofoutpatient prescription drugs. However, if an indigentpatient has some form of health care insurance thatdoes not cover prescription drugs, that patient should beeligible to receive drugs under a drug manufacturer'sindigent patient program.

A few programs require that the physician treat thepatient as indigent before the drug manufacturer willprovide the drugs free of charge to that patient. That is,the -physician is also required to waive his or her fee fortreating the indigent patient. These programs, however,indicate that they usually. honor the physician's deter-mination that the patient is indigent even if the physi-cian does not waive his-or her fee.

How THE INDIGENT PATIENT OBTAINS THE DRUGS

Most of the programs require that the physicianmake initial contact with the company, either directlyor through the local sales representative, to obtain thedrugs for the indigent patient. The drugs are then deliv-ered to the physicians' office, where they are distributedto the patient. In some cases, injectable drugs and hos-pital-only drugs are delivered to the hospital if they areadministered in that setting to a patient that is unin-sured.

Even if there is increased awareness of indigent pa-tient programs among patients and health care profes-sionals, the mechanism by which almost every companydelivers drugs to the indigent patient is through thephysician's office. Unfortunately, this does not allow pa-tients to get their drugs in a timely manner. This distri-bution system significantly reduces the goal of provid-ing access to drugs. to indigent patients which the com-panies say that they are committed to doing. It maytake several weeks to get the drugs to the patientthrough the physician. In addition, indigent patientsmay not have a regular physician if they are receivingcare through clinics or emergency rooms. In these cases,patients may never receive their medications.

A better way to provide prescription drugs to an indi-gent patient is to have them dispensed to the -patient by

a pharmacist. Such an approach would allow the pa-tient to receive the drug in a timely fashion. It wouldalso help the pharmacist monitor the patient's drugtherapy if the indigent patient is seeing multiple physi-cians and taking multiple medications. Pharmaceuticalmanufacturers should then reimburse the pharmacistfor the cost of the product and a dispensing fee, as atleast two drug manufacturers do in their indigent pa-tient programs.

NUMBER OF PATIENTS COVERED

In general, the data reported by the companies aboutthe number of indigent Americans that are participat-ing in these programs lead to the conclusion that only asmall number of Americans that qualify for these pro-grams are actually taking advantage of them. This maybe the case for many reasons. First, indigent patientsmay often receive care in emergency rooms or other fa-cilities in which they see multiple physicians. Thus, thefragmented care that they receive oftentimes does notallow them to establish a professional relationship witha health professional who can provide continuity ofcare. Many of the physicians may therefore be unawareof the patient's financial situation, or the patient's drughistory.

Second, many indigent patients themselves are un-aware that these programs exist, and do not ask physi-cians or pharmacists about them. Even if patients doknow about these programs, many may feel uncomfort-able asking for "free drugs," and may feel too "proud"to admit that they are unable to afford their drugs.

Finally, drug manufacturers need to do a much betterjob of promoting these programs to the public at large-including the medical and pharmacy profession-andimproving the operation of these programs. to makethem more accessible and practical for patients. A pri-mary target for publicizing these programs should becommunity-based health clinics, organizations such asArea Agencies on Aging, and other home-care agencies,that provide services to older Americans. Oftentimes,caregivers of older Americans are the first ones to rec-ognize that drugs are not taken properly because olderAmericans do not know how to take them, or becausethey cannot afford to take the drugs as prescribed.

. C. HOW TO USE THIS DIRECTORY.As noted, the various drug manufacturers that re-

sponded to the survey are listed in alphabetical order. Ifyou know the manufacturer of -the drug or drugs thatare being taken, simply locate the manufacturer in thissection for more information about that company's indi-gent patient program. If you do not know the' name ofthe company that makes the drug, then check the list-ing that follows for the drug that you are taking, andthe name of the company will be identified. This listidentifies by BRAND NAME the major drugs of themanufacturers that responded to the survey.

NoTE TO PATIENTS

Most of the indigent patient programs listed in thisbooklet ask that the physician make initial contact withthe company to obtain the drugs that the physician hasdetermined necessary. In some cases, physicians are re-quired to complete forms to enroll patients in the pro-gram. In other cases, the physician simply has to con-tact the local sales representative of the drug companyto order the medications.

If you believe that you qualify for one of the pro-grams listed in the directory, then speak with your phy-sician. If you are eligible for the program, in most cases,the company will send the drugs to your physician, andyou will have to then obtain them from the physician.

Please note that this directory includes programs ofalmost all the major brand name pharmaceutical manu-facturers; however, some manufacturers may not belisted. If you are taking a drug which does not appearon this list, please talk to your physician about whetheror not the drug is covered under an indigent patientprogram. Drug companies that did not respond to thissurvey may have indigent patient programs that willmake your drugs available free of charge. The physiciancan contact that company's local sales representative tofind out if the company has such a program.

NOTE TO PHYSICIANS

Most of the pharmaceutical companies' indigent pa-tient programs allow the physician to determine wheth-er a patient is eligible for the program. However, thisvaries from company to company. In most cases, it is up

to the physician to make initial contact with the compa-ny for a patient. This contact can be made eitherthrough the phone or FAX number provided for eachcompany, or by contacting the company's local salesrepresentative.

Many older Americans are often reluctant to tell phy-sicians that they cannot afford the medications thathave been prescribed for them, or the patient only real-izes that they cannot afford the drug until after theytry to have the prescription filled at the pharmacy. Phy-sicians are encouraged to work with the local pharma-cist to identify patients who cannot afford their drugs,and direct them to an indigent patient program. Physi-cians are also encouraged to remain as up-to-date aspossible about the cost of the various drugs and courseof comparative drug therapy within the same therapeu-tic class, and for the generic versions of these drugs.Pharmacists can serve as a source of information aboutprices for generic and brand name drugs.

NoTE TO PHARMACISTS

Pharmacists are often in a unique position to identifypatients who are unable to afford their medications.Often times, patients will be reluctant to tell physiciansthat they cannot afford their drugs, or they do not knowhow much they cost until they attempt to have the pre-scription filled at the pharmacy. Pharmacists shouldlook for the "warning signs" that patients are unable toafford their medications, such as "splitting" the quanti-ty ordered on the prescription, breaking tablets in halfto stretch the quantity of the prescription, or not re-turning for refills on time.

Pharmacists should ask the local drug company salesrepresentatives for more information about the pro-grams, or ask for forms for each pharmaceutical manu-facturers indigent patient program, and keep them onfile. Pharmacists should also become proactive in in-forming physicians about which of their patients maybe having trouble paying for medications. Local phar-macists are also a good source of information for physi-cians on the cost of various drugs in the same therapeu-tic categories, as well as the cost of their generic ver-sions. Pharmacists should help sensitize physicians to

the cost- of various medications, especially new drugsthat are coming to market..

D. RECOMMENDATIONS TO IMPROVE PHARMA-CEUTICAL MANUFACTURER INDIGENT PA-TIENT PROGRAMS

Based on the information collected by the SenateAging Committee on pharmaceutical manufacturers'current indigent patient programs, it is now clear thatonly a small percentage of indigent patients that qual-ify appear to be taking advantage of these programs.

. Drug manufacturers have developed these indigentpatient programs to enhance and expand prescriptiondrug access to indigent patients. In order to meet thiscommitment, drug- manufacturers should take steps topublicize and restructure their programs. The followingsuggested changes could reduce administrative burdenson physicians and pharmacists, and enhance the.abilityof indigent patients to obtain their needed medicationsin a timely fashion.

RECOMMENDATION 1: -In order to provide drugs toindigent patients in a timely fashion, the pharmaceuti-cal industry should consider developing a standard pre-scribing form or "prescription blank" for indigent pa-tients. These forms would be completed by the physi-cian and then taken by the patient to the local pharma-cy where the prescription can be filled by the patient'spharmacist. As an alteinative, a' physician's regularprescription blank could be stamped with some phraseor coding, indicating that the patient is eligible for oneof these programs. Either approach would:

(a) Reduce the waiting time for the patient to re-ceive the full quantity of their prescription, and en-hazice patient compliance with the regimen pre-scribed.

(b) Reduce the burden on the physician to makecontact with the company and' complete unneces-sary paperwork:

(c) Provide the indigent patient with the benefitof talking to the pharmacist about medications..

RECOMMENDATION 2: The pharmaceutical indus-:try should assemble a panel of representatives from themedical and pharmacy communities and elderly advoca-cy- groups to- identify ways to reform current indigent

patient programs, and explore mechanisms to dissemi-nate information about these programs. This panelshould then publish--on an annual basis-a directory ofthose companies that have indigent patient programs,and the specifics about each company's program.

RECOMMENDATION 3: The pharmaceutical indus-try has stated that it will develop a toll-free numberthat physicians can call for information about each indi-vidual company's indigent patient programs. It has alsostated that it will notify major physician groups aboutthe availability of this number. In addition to physiciangroups, notification of this number should be made toother health care professions, such as pharmacy andnursing. Also, access to this toll-free number should beprovided to organizations and agencies that are involvedin providing social services to indigent older Americans,such as Area Agencies on Aging, and advocacy groupsrepresenting older Americans.

E. PMA RESPONSE TO PRESCRIPTION DRUG- ACCESS AND AFFORDABILITY CRISIS

In a press statement dated May 12, 1992, the Pharma-ceutical Manufacturer's Association (PMA) indicated itssupport for various approaches that would make pre-scription drugs more available to indigent populations.In its press telease, the PMA stated that it had decidedto establish a "pilot program to make it simpler forphysicians to obtain information. on existing andplanned company programs to provide prescriptionmedicines to indigent patients." The release also indi-cated that the PMA would be developing a directory ofdrug manufacturer indigent patient programs andwould be establishing a toll-free hotline that physicianscan call to obtain up-to-date information about drugcompany indigent patient programs.

PMA made its Directory of Prescription Drug Indi-gent Programs available shortly before the release ofthis report. PMA indicated that physicians can obtainup-to-date information about individual manufacturers'indigent patient programs by calling the following toll-free hotline:

1-800-PMA-INFO

The number for calls made within the Washington,DC area is 202-393-5200. Unlike this directory however,the PMA directory does not always identify the drugsmanufactured by individual companies. This criticalomission makes it difficult for patients to know whethera drug that they are taking is covered under an indi-gent patient program.

The press release also indicated that the PMA recent-ly sent a letter to Senator Lloyd Bentsen (D-TX), Chair-man of the Senate Finance Committee. The letter en-dorsed the inclusion of a prescription drug benefit inone or more insurance plans which private insurerswould be required to provide under Senator Bentsen.'shealth care reform bill S. 1872, "The Better Access toAffordable Health Care Act of 1992". While such an en-dorsement is worth noting, this position of the PMAfalls far short of what is required to insure affordableaccess to prescription drugs for all Americans. The As-sociation has not yet said publicly whether it would sup-port the inclusion of a prescription drug benefit in anexpanded publicly funded health care program for thepoor and uninsured, or in the Medicare program. (ThePMA ultimately endorsed the inclusion of an outpatientprescription drug benefit in the Medicare CatastrophicCoverage Act (MCCA) of 1988.) Furthermore, the PMAhas yet to detail its own plans for containing the cost ofpharmaceuticals under either public or private insur-ance programs that cover prescription drugs.

It is difficult to envision how meaningful access toprescription drugs can be achieved without insuringthat both privately insured and publicly insured Ameri-cans have access to affordable and reasonably pricedprescription drug products. The PMA should work close-ly with the Congress to develop meaningful and practi-cal cost containment approaches for pharmaceuticals toassure that any publicly funded drug benefit is finan-cially sound.

ALPHABETICAL LISTING OF DRUG

This section identifies the name of medications fre-quently prescribed for older Americans and the manu-facturers of the drugs which are covered under an indi-gent patient program listed in this report. If a drug thatyou take is NOT listed here, it still may be providedunder an indigent patient program; it is suggested thatyour physician call the company to determine if it iscovered under a program. If the manufacturer of a.par-ticular drug is not listed in this directory, it is suggestedthat the patient or physician call the company directlyto determine if the company has an indigent patientprogram. Drug Manufacturer telephone numbers can befound in the Physician's Desk Reference.

Drug Manufacturer

A

A ci-Jel................................................... O rthoActivase ................................................ GenentechActimmune .................. GenentechAdriamycin PFS.................................. AdriaAdrucil .................................................. A driaAldactazide................... SearleAldactone ............................................. SearleAldomet .................... MerckAlupent ..................... BoehringerAnaprox ................................................ SyntexAnsaid................................................... U pjohnAntivert .................... Pfizer # 1Anusol HC ................... Parke-DavisApresoline ................... Ciba-GeigyAralen .................................................. Sanofi-W inthropArtane................................................... LederleAtrovent .................... BoehringerA xid....................................................... Eli LillyAugmentin .................. SmithKlineAZT (Retrovir) ................ Burroughs-Wellcome

Drug Manufacturer

B

Bactrim ................................................. Hoffman-LaRocheBactrim DS.................. Hoffman-LaRocheBactroban ................... SmithKlineBeconase............................................... GlaxoBeconase AQ ........................................ GlaxoBetagan ..................... AllerganBICNU .................................................. Bristol-M yers #3Blenoxane............................................. Bristol-Myers # 3Bleph-10 ................................................ A llerganBlephamide .................. AllerganBucladin-S I ................... /StuartBuSpar .................................................. Bristol-M yers # 1

C

Calan .................................................... SearleCalan SR ............................................... SearleCapoten ..................... Bristol-Myers #2Capozide................................................ Bristol-M yers #2Carafate .................... Marion Merrell DowCardene................................................. SyntexCardizem............................................... Marion Merrell DowCardizem CD ................. Marion Merrell DowCardizem SR ................. Marion Merrell DowCardura................................................. PfizerCatapres................................................ BoehringerCeclor .................................................... Eli LillyCEENU ................................................. Bristol-M yers #3Ceftin..................................................... G laxoCefzil...................................................... Bristol-M yers # 1Ceredase................................................ Genzym eCipro..................................................... M ilesClinoril.................................................. M erckClozaril................................................. SandozCogentin................................................ M erckCompazine ................... SmithKlineCordarone ................... Wyeth-AyerstCorgard ................................................. Bristol-M yers # 2Corzide .................................................. Bristol-M yers # 3Coumadin ................... DuPont-MerckCyclospasmol...................... Wyeth-AyerstCytotec.................................................. SearleCytovene .................... SyntexCytoxan ..................... Bristol-Myers #3

13

Drug Manufacturer

D

Dalmane . Hoffman-LaRocheDanocrine . Sanofi-WinthropDantrium . Norwich-EatonDesyrel.................................................. Bristol-Myers #1Diabinese .............................................. Pfizer # 1Diamox.................................................. LederleDienestrol....................................... OrthoDiflucan ................................................ Pfizer # 2Dilantin..................... Parke-DavisDiprolene ................... Schering-PloughDiprosone.............................................. Schering-PloughDolobid ................................................. MerckDuricef .................................................. Bristol-Myers # 1Dyazide ................................................. SmithKline # 1Dymelor .................... Eli Lilly

E

E-Mycin................................................ UpjohnEfudex (Fluorouracil Injection)........ Hoffman-LaRocheEldepryl......................................I......... SandozEminase .................... SmithKline #2Epogen .................................................. AmgenErgamisol ................... Janssen # 2Erycette .................... OrthoEstrace .................................................. Bristol-Myers #1Eulexin.................................................. Schering-Plough

F

Flexeril ................................................. M erckFloxin .................................................... O rthoFM L..................................................... .. A llerganFolex...................................................... A driaFulvicin*................................................. Schering-Plough

G

Gastrocrom........................................... FisonsGlucotrol............................................... Pfizer # 1

H

H alcion.................................................. U pjohnH aldol.................................................... M cN eilHismanal .................... Janssen # 1H M S ...................................................... A llergan

Drug Manufacturer

I

Idam ycin ............................................... AdriaIfex......................................................... Bristol-M yers # 3Im uran .................................................. Burroughs-W ellcom eIndocin ..................................................Insulin Products.. ...............................Interferon-A Recombinant ......Intron-A ...................Isoptin ...................................................Isordil....................................................

K

K -Lyte ...................................................K eflex....................................................Kerlone.................................................Kinesed ....................Klonopin ..... ..........................K lotrix...................................................

L

Lanoxin ....................Leucovorin Calcium............................Leukine............................................Librium .................................................Limbritol ...................Lindane Lotion/Shampoo..................Lioresal .................................................Lithobid ................................................Lo/Ovral........................L opid .....................................................Lopressor .......................Lotrimin ...............................................Lotrisone...............................................Loxapine ...............................................Lyophilized Cytoxan ...........Lysodren ......... ........................

MerckEli LillyHoffman-LaRocheSchering-PloughKnollWyeth-Ayerst

Bristol-Myers # 1Eli LillySearleICI/StuartHoffman-LaRocheBristol-Myers # 1

Burroughs-WellcomeLederleImmunexHoffman-LaRocheHoffman-LaRocheReed and CarnickCiba-GeigyCiba-GeigyWyeth-AyerstParke DavisCiba-GeigySchering-PloughSchering-PloughLederleBristol-Myers # 3Bristol-Myers #3

Macrodantin ................. Norwich-EatonMaxzide................................................. LederleMeclan .................................................. OrthoMedrol................................................... UpjohnMegace.................................................. Bristol-Myers 4Mesnex.................................................. Bristol-Myers 4Metrodin .................... Ares-SeronoMicronase ............................................. Upjohn

Drug Manufacturer

Drug Manufacturer

Minipress . Pfizer # 1Minizide . Pfizer # 1Minocin. LederleM onistat ............................................... OrthoMonistat Derm .................................... OrthoMonopril . Bristol-Myers #3M otrin ................................................... U pjohnMyambutol........................................... LederleMycostatin............................................ Bristol-Myers # 1

N

Naphcon-A .................. AllerganNaprosyn .............................................. SyntexNasalide................................................ SyntexNatalins RX ................. Bristol-Myers # 1Nebupent .............................................. FujisawaN eosar ................................................... A driaNeupogen.............................................. AmgenNicorette ............................................... Marion Merrell DowNimotop .................... MilesN itrodisc ............................................... SearleNizoral .................................................. Janssen # 1Nolvadex............................................... ICI/StuartNordette................................................ Wyeth-AyerstNormodyne................... Schering-PloughN orpace................................................. SearleNorpace CR.......................................... SearleNoroxin................................................. MerckNorplant System .............. Wyeth-Ayerst

0Oculinium .............................................O ptim ine...............................................O rinase..................................................O rtho-Dienestrol .................................O rudis ...................................................O vcon ....................................................

AllerganSchering-PloughUpjohnOrthoWyeth-AyerstBristol-Myers #1

Pancrease ............................................. McNeilParafon Forte ...................................... McNeilParaplatin ................... Bristol-Myers #3Parlodel .................... SandozPavabid ................................................. Marion Merrell DowPepcid .................................................... M erckPeriactin ............................................... M erck

Drug Manufacturer

Drug Manufacturer

Persa-Gel .............................................. OrthoPersantine ................... BoehringerPilogan.................................................. A llerganPlatinol ..................... Bristol-Myers #3Plendil........................ MerckPonstel .................... Parke-DavisPravochol.............................................. Bristol-Myers #2Premarin .................... Wyeth-AyerstPrilosec................................................. M erckPrinivil.................................................. M erckProcan ...................... Parke-DavisProcan SR............................................. Parke-DavisProcardia ................... Pizer # 1Procardia XL ................. Pfizer # 1Procrit ...................... Ortho-BiotechnologyProkine ................................................. Hoechst-RousselPronestyl SR ................. Bristol-Myers #2Propine ..................... AllerganProstat .................................................. O rtho ,Protropin... ................. GenentechProventil.............................................. Schering-PloughProvera ................................................. U pjohnProzac.................................................... Eli LillyPyridium ............................................... Parke-Davis

QQuestran .................... Bristol-Myers #2Quinamm.............................................. Marion Merrell Dow

R

Relafen.................................................. Sm ithKlineRheumatrex ................. LederleRocaltrol .................... Hoffman-LaRocheRocephin .................... Hoffman-LaRocheRythm ol................................................ K noll

SSandimmune........................................ SandozSandoglobulin ................ SandozSandostatin .................. SandozSantyl.................................................... .K nollSectral ..................... Wyeth-AyerstSeptra DS ................... Burroughs-WellcomeSeldane ................................................. Marion Merrell DowSeldane D ................... Marion Merrell DowSinemet................................................. Du Pont-M erck

Drug Manufacturer

Sinemet CR .......................................... Du Pont-MerckSorbitrate ............................................. ICI/StuartSpectazole ................... OrthoSporanox............................................... Janssen # 1Sultrin...............................................:... O rthoSurvanta.................... AbbottSymmetrel ................... Du Pont-MerckSynalar................................................. SyntexSynem ol................................................ SyntexSynthroid.............................................. Boots

T

Tagamet................................................ SmithKlineTarabine............................................... A driaTenormin II................... /StuartTenoretic............................................... ICI/StuartTerazol.................................................. O rthoTheraCys .................... Connaught LabsTim olol.................................................. M erckTim optic................................................ M erckTofranil........................... Ciba-GeigyTolectin ................................................. M cN eilTrandate............................................... GlaxoTridesilon Cream ................................ MilesTriostat ..................... SmithKlineTriphasil .................... Wyeth-Ayerst

X

Xanax.................................................... U pjohn

V

Vagistat .................... Bristol-Myers #1Valium.................................................. Hoffman-LaRocheV asocar................................................. M cN eilVasodilan.............................................. Bristol-Myers #2V asoretic............................................... M erckV asotec.................................................. M erckVepesid ................................................. Bristol-Myers #3V erelan................................................. LederleVidex..................................................... Bristol-M yers # 4Vincasar.................... AdriaVoltaren................................................ Ciba-Geigy

wWellcovorin .................. Burroughs-WellcomeWinstrol .................... Sanofi-Winthrop

Drug Manufacturer

Wytensin .................... Wyeth-Ayerst

zZantac ......................Zarontin ................................................Zestril....................................................Zestoretic ...................Zithrom ax.............................................Zoloft ......................................................Zostrix ...................................................Zovirax..................................................Zyloprim ...................

GlaxoParke-DavisICI/StuartICI/StuartPfizer # 1Pfizer # 1KnollBurroughs-WellcomeBurroughs-Wellcome

.APPENDIX

Directory of Pharmaceutical ManufacturerIndigent Patient Programs

ABBOTT LABORATORIES/ROSS LABORATORIES

(Pharmaceutical Products Division)

CONTACT FOR THE PROGRAM:

Survanta LifelineMedical Technology Hotlines555 13th Street NW Suite 7EWashington, DC 20004-11091-800-922-3255202-637-6690 (FAX)

PROGRAM CHARACTERISTICS

(a) The pharmaceutical products which are covered:The product covered under this program is Survanta.

Abbott has other pharmaceutical products, but did notindicate whether these are covered under an indigentpatient program.

(b) The quantity of the product which can' be obtained atany one time:

A complete course of therapy is covered (usually 1 to4 vials), which depends on the patient's condition.

(c) The patient eligibility criteria that have to be met:The patient cannot have public or private insurance

coverage, or HMO coverage.

(19)

(d) To whom the products are sent for distribution to thepatient:

The hospitals are reimbursed for product used forqualifying patients.

(e) The specific forms that have to be completed, if any,to be enrolled in the program, and from whom theforms are obtained:

Hospitals are sent the enrollment form after callingthe Survanta Lifeline, 1-800-922-3255.(f) How refills for the products are obtained:

The product is an acute-use hospital product; there-fore, refills are extremely unlikely.

(g) Restrictions on the use of the program:Must be used on qualifying patients, consistent with

approved labeling.

(h) Any copayments or cost-sharing that the company re-quires from the patient:

None.

NUMBER OF PATIENTS SERVED BY THE PROGRAM

Immediately following FDA approval of the drug, 13hospitals enrolled in the program. Abbott did not pro-vide data concerning the number of patients that bene-fited from the program.

ADDITIONAL COMMENTS

The company indicated that it is in the process of de-veloping an indigent patient program for Biaxin (Clar-ithromycin). However, at the time of publication of thisdirectory, the program was not yet in effect. The compa-ny had established the Clarithromycin InformationLine, 1-800-688-9118.

Under the proposed program, the drug would beavailable for an initial supply of 90 days of treatment.Additional quantities would be available upon comple-tion by a physician of a case report form and financialrequalification form. In order to qualify, the programwould require that the patient have an annual incomeof less than $25,000, be a single person, have no depend-ents, have no insurance coverage, be ineligible for Med-

icaid, or have applied, but not yet enrolled in the StateMedicaid program.

ADRIA LABORATORIES, INC.CONTACT FOR THE PROGRAM:

Adria Laboratories Patient Assistance ProgramP.O. Box 16529Columbus, OH 43215-6529614-764-8100614-764-8102 (FAX)


(a) The pharmaceutical products which are covered:The company reported that the following products are

covered by this program: Adriamycin PFS, Adrucil,Folex, Idamycin, Neosar, Tarabine, and Vincasar.

,(b) The quantity of the product which can be obtained atany one time:

Two months' supply.

(c) The patient eligibility criteria that have to be met:Physician must certify that patient is unable to afford

the cost of the drug, and is unable to obtain assistanceelsewhere.


Physician.


An initial request letter must be received -from thetreating physician containing the following information:patient's name, drug requested, intended dose and treit-ment schedule, primary diagnosis, and a statement thatthe patient cannot afford drug requested and cannotobtain reimbursement elsewhere. A serial-numberedone-page application form is sent to the physician.

(fi) How refills for the products are obtained:Submission of certificate form.

(g) Restrictions on the use of the program:1. Program is available to patients of physicians who

purchase Adria oncology products; 2. Intended use ofthe product must be within the scope of the packageinsert; 3. Drugs are to be used only within the UnitedStates.(h) Any copayments or cost-sharing that the company re-

quires from the patient:None required of the patient. However, Adria re-

quests that the treating physitfan provide his'or herservices for administration of the drug at no charge tothe patient.


The company estimates that the program servesabout 700 people each year, but could not provide anyadditional data.

ALLERGAN PRESCRIPTION PHARMACEUTICALSCONTACT FOR THE PROGRAM:

Judy McGee1-800-347-4500 Ext. 6219714-955-6976 (FAX)


(a) The pharmaceutical products which are covered:All Allergan prescription products are covered, which

include Naphcon A, Propine, FML, HMS, Pilogan, Beta-gun, Bleph-10, and Blephamide(b) The quantity of the product which can be obtained at

any one time:Course of therapy, up to a maximum of 6 months'

supply.(c) The patient eligibility criteria that have to be met:

Eligibility criteria is at the physician's discretion.(d) To whom the products are sent for distribution to the

patient:Products are distributed to prescribing physician via

prescription request.


No formal enrollment is required.

(/ How refills for the products are obtained:Refills can be obtained from the prescribing physi-

cian's office.

(g) Restrictions on the use of the program:Eligibility criteria inatthe physician's request.


None.


The company does not require any formal enrollment,and could not supply any information about the numberof patients enrolled in its program.

ADDITIONAL COMMENTS SUPPLIED BY THE PROGRAM

Allergan also has a program that supplies Oculinum(Botulinum Toxin Type A) free of charge to patientsthat meet certain eligibility criteria. Eligibility formsare to be completed by the physician and patient (1page each) and are obtained by contacting Lloyd Glennor Brian Visconti at the Allergan office in Irvine, CA(714-752-4500, FAX: 714-752-4214). To be eligible, thepatient must have income of $12,000 or less for a one ortwo person household, $19,000 or less for three or moreperson household, and no insurance of any type. Theproduct is sent to the physician for distribution to thepatient.

AMGEN, INC.CONTACT FOR THE PROGRAM:

Amgen Safety Net ProgramsMedical Technology Hotlines1-800-272-9376(637-6688: Washington, DC)


(a) The pharmaceutical products which are covered:Both of the company's currently marketed products

are covered under this program: Epogen and Neupogen.

(b) Amgen has two programs:An Uninsured Patient Program and a Variable Cap

Program.Uninsured Patient Program

1. Covers anemic patients on dialysis receivingEpogen who:

* Have an annual gross family income of less than$25,000; and* Have no, and are ineligible for, health insurancefor dialysis or for Epogen (except for State kidneyprograms, county or charitable funds).

Amgen provides free replacement product.2. Covers patients receiving Neupogen for a medically

appropriate application who:* Have an annual gross family income of less than$25,000; and* Have no, and are ineligible for, medical insur-ance.

Amgen provides free replacement product.

Variable Cap Program

1. Covers anemic patients on dialysis receivingEpogen who:

* Have an annual gross family income of less than$50,000;* May have medical insurance; and* Incur significant financial liabilities for Epogenrelative to income.

After the patient's documented financial liabil-ities for Epogen exceed a percentage of the patient'sgross family income, Amgen provides free replace-ment product.

Patient's financial liabilities for Epogen arecapped at a level which varies with patients'annual gross family income.

2. Covers patients receiving Neupogen for a medicallyappropriate application who:

* Have an annual gross family income of less than$50,000;* May have medical insurance; and* Incur significant financial liabilities for Neupo-gen relative to income.

After the patient's documented financial liabil-ities for Neupogen exceed a percentage of the pa-tient's gross family income, Amgen provides free re-placement product.

Patients' financial liabilities for Neupogen arecapped at a level which varies with patients'annual gross family income.

Quantities Provided: Generally, 1 month's supply ofEpogen and one treatment cycle of Neupogen are pro-vided per shipment at the health care provider's re-quest.

Additional Requirements of the Safety Net Program:Patients must receive Epogen or Neupogen from quali-fied health care providers'who purchase Epogen or Neu-pogen and who enroll in the Safety Net Program byproviding the required information. Eligibility is deter-mined on a calendar-year basis, and patients must reap-ply each year if they require treatment in consecutiveyears. Special consideration may be given familiesfacing extraordinary circumstances.


The company stated that since June 1989, the Epogenprogram has helped over 530 patients, and in the first10 months since approval, the Neupogen program hashelped over 100 patients.

ARES-SERONO, INC.


Gina CellaManager, Corporate CommunicationsAres-Serono, Inc.100 Longwater CircleNorwell, MA 020611-617-982-90001-617-982-1269 (FAX)

59-585 - 92 - 2


(a) The pharmaceutical products which are covered:Metrodin (follicle stimulating hormone, urofollitro-

pin).

(b) The quantity of the product which can be obtained atany one time:

Not indicated.

(c) The patient eligibility criteria that have to be met:Patients cannot be covered for outpatient prescription

drugs under private insurance or a public program. Pa-tient may or may not be poor, but retail drug purchasewould cause hardship. Eligibility is determined by phy-sician based on company guidelines. No documentationis required.

(d) To whom the products are sent for distribution to thepatient: o

Physician.


As indicated above.(f) How refills for the products are obtained:

Not indicated.

(g) Restrictions on the use of the program:Referral must be made by the physician. The

company will be allowed follow-up survey of patientsand physicians participating in the program.(h) Any copayments or cost-sharing that the company re-

quires from the patient:None indicated.

Source: PMA 1992 Directory of Prescription Drug Indi-gent Programs.

ASTRA PHARMACEUTICALS, INC.CONTACT FOR THE PROGRAM:

Linda Braun, Research CoordinatorFAIR Program (Foscavir Assistance and Information

on Reimbursement)State and Federal Associates1-800-488-3247703-683-2239 (FAX)


(a) The pharmaceutical products which are covered:The pharmaceutical product covered under this pro-

gram is Foscavir (Foscarnet Sodium). The company didnot indicate whether its other pharmaceutical productsare covered under an indigent patient program.


One month's supply of Foscavir.

(c) The patient eligibility criteria that have to be met:Patient's income must be below $27,500 if there are

no dependents; income must be below $45,000 with de-pendents.


The physician's office, hospital pharmacy, or homehealth agency.


Forms (called the "Foscavir Patient Assistance Pro-gram Qualification Form") are obtained from the FAIRprogram analyst.

(f) How refills for the products are obtained:Physician must contact FAIR program analyst at

number above.

(g) Restrictions on the use of the program:Contact FAIR analyst for any specifics at number

listed above.


None.


The program began in October 1991. Through the endof 1991, 17 patients were covered under the program.

BOEHRINGER INGLEHEIM PHARMACEUTICALS,INC.


Sam Quy203-798-4131


(a) The pharmaceutical products which are covered:All Boehringer Ingleheim pharmaceutical products

are covered, which include Persantine, Atrovent, Alu-pent, and Catapres. Prelu-2 is a controlled substanceand not covered under an indigent patient program.(b) The quantity of the product which can be obtained at

any one time:One or 2 months' supply.

(c) The patient eligibility criteria that have to be met:Patient must be on a fixed income.


Physician.(e) The specific forms that have to be completed, if any,

to be enrolled in the program, and from whom theforms are obtained:

A letter from the patient's physician, indicating thereason and attesting to the fact that they are indigent.(Must indicate that the patient has a fixed income and/or no insurance coverage.) The company indicated thatit preferred to have a social-services recommendation.(f) How refills for the products are obtained:

A written prescription must be made for each re-quest.

(g) Restrictions on the use of the program:The company indicated that it will discontinue pro-

viding the service if the physician does not ask for eachshipment, or if the patient's situation improves.


None.NUMBER OF PATIENTS SERVED BY THE PROGRAM

The company was unable to provide data on thenumber of patients served by the program.

BOOTS PHARMACEUTICALS


T.N. ThurmanPublic AffairsBoots Pharmaceuticals300 TriState International Office CenterSuite 200Lincolnshire, IL 60069-44151-800-323-18171-708-405-7400


(a) The pharmaceutical products which are covered:Synthroid Tablets.


Not indicated.(c) The patient eligibility criteria that have to be met:

Physician must submit appropriate documentationproving patient indigence to company.


Physician.(e) The specific forms that have to be completed, if any,


None indicated.

(f) How refills for the products are obtained:Not indicated.

(g) Restrictions on the use of the program:Decisions are made by the company on a case-by-case

basis.(h) Any copayments or cost-sharing that the company re-

quires from the patient:None indicated.

Source. PMA 1992 Directory of Prescription Drug Indi-gent Programs.

BRISTOL-MYERS SQUIBB #1(General Indigent Patient Program)


Bristol-Myers SquibbIndigent Patient ProgramP.O. Box 9445McLean, VA 22102-99981-800-736-0003703-760-0049 (FAX)


(a) The pharmaceutical products which are covered:The company indicated that the following pharmaceu-

tical products are covered under this program: Duricef,Cefzil, BuSpar, Desyrel, Estrace, Ovcon-35, Ovcon-50,Natalins, Natalins RX, Vagistat-1, Mycostatin.(b) The quantity of the product which can be obtained at

any one time:Three months' supply.

(c) The patient eligibility criteria that have to be met:Physician's request.


Physician.


Forms available from the company sales representa-tive.

(f) How refills for the products are obtained:By physician prescription every 3 months.

(g) Restrictions on the use of the program:The program is not designed to reimburse hospitals

for uncompensated inpatient care. However, any physi-cian that is willing to follow a patient on an ongoingbasis in the outpatient setting may enroll in the pro-gram.


None.


The company indicates that the program served about1,440 patients in 1989, 1,760 patients in 1990, and 2,836patients in 1991.

BRISTOL-MYERS SQUIBB #2

(Cardiovascular Access Program)


Cardiovascular Access ProgramP.O. Box 9445McLean, VA 22102-99981-800-736-0003703-760-0049 (FAX)


(a) The pharmaceutical products which are covered:This program provides access to the company's cardio-

vascular products, which include Capoten, Capozide,Corgard, Klotrix, K-Lyte, Monopril, Naturetin, Pravo-chol, Pronestyl-SR, Questran Light, Rauzide, Saluron,Salutensin, Vasodilan, and Betapen-VK.


Three months' supply.

(c) The patient eligibility criteria that have to be met:First, the patient must work through an enrolled phy-

sician. Second, the patient must not be eligible for othersources of drug coverage. Third, the patient must bedeemed financially eligible, as determined by a "means"and "liquid assets" test.

(d) To whom the products are sent for distribution to thepatient:.*

Product is shipped to enrolled physicians.


Physician enrollment forms can be obtained from thecompany's sales representatives. An application formmust be completed for each individual patient. This issent to the physician after the patient calls 1-800-763-0003 and is screened for third-party coverage .eligibility.

(f) How refills for the products are obtained:When the 90-day supply of product is near an end,

the program will send a letter to the physician askingthe physician to sign a renewal card if the patient re-quires the drug for an additional 90 days. The physicianmust return the renewal card with a valid prescription.Upon receipt of a renewal prescription, the companysends the product refill to the physician. Patients mustre-apply to the program every 6 months.


for uncompensated inpatient care. However, any physi-cian that is willing to follow a patient on an ongoingbasis in the outpatient setting may enroll in the pro-gram.(h) Any copayments or cost-sharing that the company re-

quires from the patient:None.


The company indicates that the program, whichbegan in March 1992, has enrolled 6,600 physicians. Thecompany did not provide any information on thenumber of patients that have been served.


(Cancer Patient Access Program)


Bristol-Myers SquibbCancer Patient Access ProgramP.O. Box 9445McLean, VA 22102-99981-800-736-0003703-760-0049 (FAX)


(a) The pharmaceutical products which are covered:The company indicated that the following cancer

drugs are covered under this program: BICNU, CEENU,Lysodren, Mutamycin, Mycostatin Pastilles, Paraplatin,Platinol, Platinol-AQ, VePesid, Blenoxance, Cytoxan,Lyophilized Cytoxan, Ifex, Mesnex, and Megace.



(c) The patient eligibility criteria that have to be met:Physician's assessment of patient's financial need and

confirmation by local sales representative.


Physician.


Form available from company sales representative.

(f) How refills for the products are obtained:By physician prescription every 3 months.





The company indicated that the program servedabout 3,000 patients in 1989, 3,152 patients in 1990, and3,432 patients in 1991.


(Videx Assistance Program)CONTACT FOR THE PROGRAM:

Videx Temporary Assistance Program1-800-788-0123703-760-0049 (FAX)


(a) The pharmaceutical products which are covered:Videx (Didanosine).


One month's supply.(c) The patient eligibility criteria that have to be met:

The patient must not be eligible for other sources ofdrug coverage and deemed financially eligible, as deter-mined by a "means" and "liquid assets" test.(d) To whom the products are sent for distribution to the

patient:Physician.


The physician must complete a patient/physician en-rollment form, which is then sent to the physician afterthe physician or patient calls the toll-free number (1-800-788-1023) and is screened for third-party drug cov-erage eligibility.

(f) How refills for the products are obtained:Each month after the initial shipment, renewal cards

are mailed to the physician. In response, the physicianmust return a valid prescription. Upon receipt of the re-newal prescription, the company sends the next month'ssupply of Videx to the physician. The patient and thephysician must reapply to the program every 3 months.




None.


Videx was approved by the FDA in October 1991, andthrough the end of 1991, the company indicated that 75patients were served by this program.

BURROUGHS-WELLCOMECONTACT FOR THE PROGRAM:

Jonas B. DaughertyManager, Professional Information ServicesBurroughs-Wellcome Co.3030 Cornwallis RoadResearch Triangle Park, NC 27709919-248-4418919-248-0421 (FAX)1-800-722-9294 (Program Enrollment)

orBernard StreedSupervisor, Special ProjectsBurroughs-Wellcome Co.Patient Assistance ProgramP.O. Box 52035Phoenix, AZ 85072-9349602-494-8725602-996-7731, 7732 (FAX)1-800-722-9294 (Program Enrollment)


(a) The pharmaceutical products which are covered:All Burroughs-Wellcome products are covered by the

program, which include Septra, Septra DS, Lanoxin,AZT (Retrovir), Zovirax, Zyloprim, Imuran, and Wellco-vorin.(b) The quantity of the-product which can be obtained at

any one time:The products are available in a 30-day supply, with a

maximum of 90 days therapy.(c) The patient eligibility criteria that have to be met:

1. Gross monthly income must be less than 200 per-cent of Federal poverty guidelines.

2. All applications will be reviewed within establishedcriteria and on a case-by-case basis.

3. Patients must be residents of the United States.4. All alternative funding sources must be investigat-

ed.5. All required information must be provided for con-

sideration of eligibility.

6. Patients may be approved (occasionally) by excep-tion if extreme extenuating circumstances exist.


Products are provided to the patients by local phar-macist.


No forms are necessary for the original prescription;however, physicians are required to provide a complet-ed, signed application form from an enrollment pack-age. Subsequent refills are not available until the com-pleted package is received.

(f) How refills for the products are obtained:Physician request.

(g) Restrictions on the use of the program:The company has placed a $10 million annual cap on

available benefits.


None.


According to the company, over 10,000 patients havereceived free drugs through a variety of programs, in-cluding Investigational New Drug (IND) programs. Thecompany could not provide more specific data about thenumber of patients currently served by the program.

CIBA-GEIGY CORPORATION, PHARMACEUTICALSDIVISION


Jackie LaguardiaSenior Information AssistantCiba-Geigy Corporation556 Morris AvenueSummit, NJ 07901908-277-5849


(a) The pharmaceutical products which are covered:According to the company, through its Patient Sup-

port Program, Ciba-Geigy's policy is that any patientswho are unable to afford their products can receive afree supply of the drug. The company's products includeLopressor, Lioresal, Lithobid, Voltaren, Brethine, To-franil, and Apresolihe. Ritalin and Rimactane are con-trolled substances and not available under this pro-gram.(b) The quantity of the product which can be obtained at

any one time:Up to 3 months' supply.

(c) The patient eligibility criteria that have to be met:To become eligible for the Ciba-Geigy Patient Support

Program, the company requires the following:1. The physician must attest to the patient's lack

of third-party reimbursement and the financial in-ability to purchase the product.

2. The physician must complete an applicationform and include a completed prescription.

3. The completed prescription must include thepatient's name and an indication that the medica-tion will be accepted without a safety closure.

4. The medication is sent to the physician's office.5. To continue receiving the medication, the com-

pany requires a new prescription and applicationevery 3 months. There are no automatic refills.


Physician.


The form can be obtained by contacting the personlisted above or the company's sales representative.

(f) How refills for the products are obtained:After completing an application form, the physician

can obtain an initial 3 months' supply for the patient.Physician must reapply every 3 months by submitting anew application and prescription.

(g) Restrictions on the use of the program:As indicated above.


None.


According to the company, between January 1991 andMarch 1992, it had provided 1,100 patients with ap-proximately 2,300 prescriptions free of charge.

CONNAUGHT LABORATORIES, INC.CONTACT FOR THE PROGRAM:

David HuntProduct ManagerConnaught Laboratories, Inc.Route 611, P.O. Box 187Swiftwater, PA 18370-0187717-839-4617


(a) The pharmaceutical products which are covered:The company reports that the only product covered

under an indigent patient program is TheraCys (BCGlive intravesical for the treatment of carcinoma in situof the urinary bladder).


At the physician's discretion, the company providesfor a full course of therapy-the induction and mainte-nance doses-which may be as many as 11 doses (6 forinduction and 5 for maintenance).(c) The patient eligibility criteria that have to be met:

Patient cannot be insured, be ineligible for Medicareor Medicaid, and in the physician's best judgment, isunable to afford the treatment.(d) To whom the products are sent for distribution to the

patient:Physician.


The company must receive a note on physician's let-terhead confirming that the patient is unable to affordtreatment, is uninsured, and is ineligible for Medicareor Medicaid. The patient must also be diagnosed withCIS, the only approved indication for the drug.(f) How refills for the products are obtained:

Not applicable.(g) Restrictions on the use of the program:

In addition to the patient's meeting the above crite-ria, the physician must agree that the drug will not besold, traded, or used for any other purpose than to treatthe patient.


None.


Since January 1992, the company reports that 5 pa-tients have received the drug under the program.

ADDITIONAL COMMENTS PROVIDED BY THE COMPANY

The company does not have an indigent patient pro-gram for its flu vaccine because it stated virtually all

State and many county and city health departmentsoffer the vaccine to high-risk patients free of charge.

DU PONT MERCK


Du Pont Merck PharmaceuticalsBarley Mill PlazaP.O. Box 80027Wilmington, DE 19880-0027


(a) The pharmaceutical products which are covered:The company reports that all Du Pont Merck retail

oral solid pharmaceutical products are covered underthis program. These include Coumadin, Sinemet, Sine-met CR, and Symmetrel. The program does not coverthe company's controlled substances, which includesPercodan and Percocet.


Thirty days' supply.

(c) The patient eligibility criteria that have to be met:The patient must be indigent and cannot be eligible

for a Federal or State Government pharmaceutical as-sistance program.


Physician.


Physicians can request free medications by writtenrequest accompanied by a signed and dated prescriptionand a letter stating the financial status and need of thepatient. Form letters and multiple requests are not hon-ored. Samples are given to the patient at the discretionof the physician.

(f) How refills for the products are obtained:Does not provide for automatic refills, but will permit

refills with appropriate documentation from the pa-tient's physician.

(g) Restrictions on the use of the program:As stated above.

(h) Any copayments or cost sharing that the company re-quires from the patient:

None indicated by the company.NUMBER OF PATIENTS SERVED BY THE PROGRAM

The company just began its program in 1991, and wasunable to determine the number of patients that hadbeen served by the program.

FISONS PHARMACEUTICALSCONTACT FOR THE PROGRAM

Gastrocrom Patient Assistance ProgramFisons PharmaceuticalsP.O. Box 1766Rochester, NY 246031-800-234-55351-716-475-9000


(a) The pharmaceutical products which are covered:Gastrocrom (cromolyn sodium capsules).


Two months' supply of medication.

tc) The patient eligibility criteria that have to be met:Patient must have a diagnosis of mastocytosis, an

annual household income of not more than $9,000 forone or two people. An additional allowance of $1,000 perdependent child may be made up to $12,000 totalannual household income. Patient may not qualify forprescription assistance or reimbursement through pri-vate insurance or public assistance.


Physician.


Contact company or local sales representative forforms that have to be completed.

(fi) How refills for the products are obtained:New application forms are required for participation

in the program.(g) Restrictions on the use of the above program:

As indicated above.


None indicated.Source: 1992 PMA Directory of Prescription Drug Indi-gent Programs.

FUJISAWA PHARMACEUTICAL COMPANY


Richard G. WhiteNebuPent Patient Assistance ProgramFujisawa Pharmaceutical CompanyParkway North Center3 Parkway NorthDeerfield, IL 60015708-317-8638708-317-5941 (FAX)1-800-366-6323 (Reimbursement Hotline)


(a) The pharmaceutical products which are covered:NebuPent (pentamidine isethionate) .


NebuPent is made available to nonprofit clinics whoadminister the drug, rather than directly to users. The

quantity of NebuPent that is provided to eligible organi-zations is based upon the number of HIV-infected indi-viduals that the organization cares for that require as-sistance.

(c) The patient eligibility criteria that have to be met:The NebuPent Patient Assistance Program provides

the drug based on organization-specific criteria, for ad-ministration to persons who are indigent. The healthcare organization, once it receives a donation, is respon-sible for determining which of its patients qualify forassistance. Fujisawa does not set income or asset crite-ria.


All product is sent directly to the health care organi-zation; no product is sent directly to the patient.(e) The specific forms that have to be completed, if any,


A nonprofit organization interested in participatingin the program should contact Richard G. White at thenumber and address provided above. Once the companyreceives a written letter of inquiry from an organizationon the program, a questionnaire is sent to the organiza-tion. Upon receipt of the complete questionnaire, thecompany supplies a contract that:

1. Specifies the number of vials to be donated;2. States that the product will be administered as

per labeling;3. States that the product will be stored appropri-

ately; and4. Contains other provisions.

Once the contract is returned, the drug is shipped.(f) How refills for the products are obtained:

Users of the drug would deal directly with the partici-pating clinics on the mechanisms of how subsequent ad-ministrations would be scheduled. Additional donationsof NebuPent to organizations that have previously re-ceived product under the program are reviewed by Fu-jisawa on a case-by-case basis.

(g) Restrictions on the use of the program:The agreement with the providing organizations con-

tains various restrictions to assure that they are tax-exempt organizations and will utilize the drug properly.The program has no restrictions applicable to patientsother than broad eligibility requirement of indigency.(h) Any copayments or cost-sharing that the company re-



According to the company, because the program isnot "patient-specific," the company does not know howmany patients have used the 14,150 vials donated to theprogram to date.


Fujisawa operates a Reimbursement Hotline (1-800-366-6323) that informs third-party payers, physicians,patients, and other interested persons about current re-imbursement policies related to NebuPent.

GENENTECH, INC.CONTACT FOR THE PROGRAM:

Genentech Reimbursement Information ProgramMailstop # 99c/o Genentech, Inc.460 Point San Bruno BlvdS. San Francisco, CA 940801-800-879-4747

PROGRAM CHARACTERISTICS -

(a) The pharmaceutical products which are covered:The company reports that its three currently market-

ed products are covered under the program: Protropin(Human Growth Hormone), Activase (TPA, Tissue Plas-minogen Activator), and Actimmune (InterferonGamma-1b).


Company reports that quantity provided is variable.

(c) The patient eligibility criteria that have to be met:The company reports that its eligibility criteria are

variable. Generally, patients are asked to provide suffi-ciently detailed information to assure the company thatthey are uninsured and cannot afford the required pay-ments. (For Activase: If an uninsured patient has grossfamily income of $25,000 or less, the company providesreplacement product to the hospital.)

Cd) To whom the products are sent for distribution to thepatient:

The distribution point depends upon the product. Thedistribution of Activase is to hospital pharmacies. Theother two products are sent directly to the patient.

(e) The specific forms that have to be completed, if any,- to be enrolled in the program, and from whom the

forms are obtained:The company does have a form for its uninsured pa-

tient program, which can be obtained directly fromGenentech. Initial contact should be made with thecompany by the treating physician.

(f) How refills for the products are obtained:Refills are not applicable for Activase. The procedure

for obtaining continued coverage for the company'sother drugs varies with the nature of the patient's fi-nancial situation.

(g) Restrictions on the use of the program:None.


Depends upon the individual patient situation.NUMBER OF PATIENTS SERVED BY THE PROGRAM

From 1986 through 1991, the company reports that3,257 patients participated in the Human Growth Hor-mone program and 2,505 patients participated in theTPA program.

GENZYME CORPORATIONCONTACT FOR THE PROGRAM:

William AliskiDirector of ReimbursementGenzyme Corporation1 Kendall SquareCambridge, MA 02139617-252-7871617-252-7600 (FAX)


(a) The pharmaceutical products which are covered:Ceredase.


One month's supply.(c) The patient eligibility criteria that have to be met:

Individual review of each patient's application.(d) To whom the products are sent for distribution to the

patient:The product is sent directly to the physician because

this is not a self-administered drug.(e) The specific forms that have to be completed, if any,


An application form, verification of income, and awaiver of liability form.(f) How refills for the products are obtained:

The treating physician must reorder the drug.(g) Restrictions on the use of the program:

The patient must be uninsured and ineligible forpublic insurance programs.(h) Any copayments or cost-sharing that the company re-

quires from the patient:Copayments and cost-sharing depend on the income

and assets of the patient.


Because the program began in 1991, the company re-ported that it could not provide specific figures on thenumber of individuals using the program.

GLAXO, INC.CONTACT FOR THE PROGRAM:

Laura J. NewberrySupervisor, Trade CommunicationsGlaxo, Inc.P.O. Box 13438Research Triangle Park, NC 277091-800-GLAXO77919-248-7932 (FAX)


(a) The pharmaceutical products which are covered:According to the company, all Glaxo pharmaceutical

products are covered, which include Zantac, Ceftin,Ventolin, Beconase, Beconase AQ, and Trandate.(b) The quantity of the product which can be obtained at

any one time:Maximum 3 months' supply.

(c) The patient eligibility criteria that have to be met:Patient must be a private outpatient who the physi-

cian considers medically indigent and is not eligible forany other third-party reimbursement. Physician mustwaive fees for the patient.(d) To whom the products are sent for distribution to the

patient:Physician.


Glaxo Indigent Patient Program applications can beobtained by contacting 1-800-GLAXO77.

(f9 How refills for the products are obtained:Repeat requests can be accommodated upon receipt of

a signed note on the physician's letterhead or prescrip-tion blank specifying the patient's identification and thedrug required.

(g) Restrictions on the use of the program:As stated above.


None.


According to the company, approximately 2,000 newand refill prescription requests were filled in 1991. Ap-proximately 500 new and refill requests were filled inthe first quarter of 1992.

HOECHST-ROUSSEL PHARMACEUTICALS, INC.


Jannalee SmitheyTechnology Assessment Group1-800-PROKINE


(a) The pharmaceutical products which are covered:Prokine (sargramostim) is covered under the program

described here.The company indicated that it provides other prod-

ucts to indigent patients upon receipt of a prescriptionand a physician's letter certifying that the patient is in-digent. Eligibility is on a case-by-case basis. This policycovers patients who are ineligible for a third-partypayer or Medicaid. The company's other products in-clude Lasix, Trental, and Diabeta.


One course of therapy (usually 2-3 weeks).

(c) The patient eligibility criteria that have to be met:Lack of insurance or ability to pay.


Usually the hospital.


There are no forms to enroll in the program; the Re-imbursement Service number must be contacted.(f) How refills for the product are obtained:

Refills are not applicable to this product.

(g) Restrictions on the use of the program:Only two patients per physician at a single time.


None.


The company reported that about 30 patients wereenrolled in the Prokine program in 1991.

HOFFMAN-LaROCHE, INC.CONTACT FOR THE PROGRAM:

Inge ShanahanMedical Communications AssociateRoche Laboratories340 Kingsland StreetNutley, NJ 071101-800-526-6367 Teleprompter #2201-235-5624 (FAX)


(a) The pharmaceutical products which are covered:All Roche pharmaceutical products are covered by

this program, which include Valium, Librium, Limbri-tol, Dalmane, Bactrim, Bactrim 'DS, Klonopin, Efudex(Fluorouracil Injectable), Gantrisin, Gantanol, Inter-feron 2A Recombinant, Rocephin Injectable, and Rocal-trol.



(c) The patient eligibility criteria that have to be met:Eligibility limited to private practice outpatients who

are considered by the physician to be medically indigentand who are not eligible to receive Roche drugs throughany other third-party reimbursement program. Inpa-tients and those that can obtain drug reimbursementfrom other sources are not eligible. The physician's sig-nature and DEA number are required for all applica-tions, whether or not the request is for a controlled sub-stance.


Physician.


Roche Indigent Patient Program Forms are required,and are available from the Professional Services De-partment.

(f) How refills for the products are obtained:Repeat requests require an additional application, but

that application need only specify the patient identifica-tion by initials, or other identifier, the drug, and theamount required.

(g) Restrictions on the use of the program:The program is only available to private patients, not

covered by third-party insurance programs.(h) Any copayments or cost-sharing that the company re-



The company reports that approximately 2,000 pa-tients were enrolled in 1989, 3,000 patients in 1990, and5,000 patients in 1991.

ICI/STUART PHARMACEUTICALSCONTACT FOR THE PROGRAM:

Yvonne A. GrahamManager, Professional ServicesICI Pharmaceuticals GroupP.O. Box 15197Wilmington, DE 19850-5197302-886-2231


(a) The pharmaceutical products which are covered:The company reported that the following pharmaceu-

tical products are covered under this program: Nolva-dex, Zestoretic, Bucladin-S, Kinesed, Sorbitrate, Tenor-min, Tenoretic, and Zestril.


One to 3 months' supply.(c) The patient eligibility criteria that have to be met:

None indicated on the survey.


Physician.

(e) The specific forms that. have to be completed, if any,to be enrolled in the program, and from whom theforms are obtained:

Forms are obtained from the ICI PharmaceuticalsGroup Professional Services Representatives.(f) How refills for the products are obtained:

Refills are automatically given for 1 year. Reapplica-tion has to be made every 12 months.(g) Restrictions on the use of the program:

Eligibility for all available alternative programs mustfirst be considered.


None.


According to the company, about 5,000 patients wereserved in 1989, 6,000 in 1990, and 8,000 in 1991.

IMMUNEX CORPORATIONCONTACT FOR THE PROGRAM:

Michael L. KleinbergDirector of Professional ServicesImmunex Corporation206-587-0430206-343-8926 (FAX)1-800-321-4669



gram is Leukine 250 mcg. and Leukine 500 mcg.Cb) The quantity of the product which can be obtained at

any one time:One cycle.

(c) The patient eligibility criteria that have to be met:Physician must attest that the patient requires the

drug and that all the reimbursement options for the pa-tient have been tried.

Cd) To whom the products are sent for distribution to thepatient:

Physician.


A patient assistance program enrollment form is ob-tained by the physician from the company's medicalservice representative.(fi) How refills for the products are obtained:

Up to two refills may be requested by the physicianwith the initial request. Refills are sent based on cycletime. Further refills may be requested on an as neededbasis.

(g) Restrictions on the use of the program:The patient must not be entitled to any other govern-

mental program or other reimbursement.


None.


The company reported that, since March 1991, 168 pa-tients have been served by the program.

JANSSEN PHARMACEUTICA INC. # 1CONTACT FOR THE PROGRAM:

Professional Services DepartmentJanssen Pharmaceutica Inc.1125 Trenton-Harbourton RoadP.O. Box 200 Office A32000Titusville, NJ 08560-02001-800-253-3682


(a) The pharmaceutical products which are covered:Hismanal, Nizoral, Duragesic, Sporanox capsules, Al-

fenta, Sufenta, and Sublimaze.(b) The quantity of the product which can be obtained at

any one time:Varies by product, patient condition.

(c) The patient eligibility criteria that have to be met:Physician determines that patient is indigent and not

eligible for health insurance.


Physician.


Physicians may request free medications by writtenor telephone request, accompanied by a signed and

dated prescription and letter stating financial statusand need of patient.

(f) How refills for the product are obtained:Through the individual's physician.

(g) Restrictions on the use of the program:Varies by product and patient condition.


None.


The company reported that thousands of requestsfrom physicians had been honored over the past decade.It could not provide specific data on the number of pa-tients that had been served each year.

JANSSEN PHARMACEUTICA INC. # 2


Ellen McDonaldAssistant Product ManagerJanssen Pharmaceutica Inc.40 Kingsbridge RdPiscataway, NJ 08854908-524-9409908-524-9118 (FAX)



gram is Ergamisol (Levamisole HCL).(b) The quantity of the product which can be obtained at

any one time:Two months' supply.

(c) The patient eligibility criteria that have to be met:1. Less than $25,000 total annual household income.2. Can have Medicare or private insurance, but

cannot have prescription coverage.


Physician.


Physician may obtain forms from company sales rep-resentatives or by contacting the company's headquar-ters.

(f) How refills for the products are obtained:Refills are obtained from the patient's physician

every 2 months. The patient must be requalified for theprogram every 6 months.

(g) Restrictions on the use of the program:Diagnosis must be for Duke C Colon Cancer.


None.


The company reported that the program served 140patients in 1990 and 411 in 1991.

KNOLL PHARMACEUTICALSCONTACT FOR THE PROGRAM:

Knoll PharmaceuticalsIndigent Patient Program30 N. Jefferson Rd.Whippany, NJ 079811-800-526-0710


(a) The pharmaceutical products which are covered:Isoptin, Rythmol, Santyl, and Zostrix.


Not indicated.

(c) The patient eligibility criteria that have to be met:Patients can enroll in the Heart-in-harmony program

to receive educational information. Contact the localcompany sales representative, or call the patient helpline at 1-800-526-0710.(d) To whom the products are sent for distribution to the

patient:Physician.


The request must be forwarded by the physician tothe company at the address above, or given to the localcompany sales representative.

(f) How refills for the products are obtained.Not indicated.

(g) Restrictions on the use of the program:Not indicated.


None indicated.Source: PMA 1992 Directory of Prescription Drug Indi-gent Programs.

LEDERLE LABORATORIES


Jerry Johnson, Pharm.D.Director, Industry AffairsAmerican Cyanamid, Inc.One Cyanamid PlazaWayne, NJ 074701-800-526-78701-201-831-4484 (FAX)

59-585 - 92 - 3


(a) The pharmaceutical products which are covered:All Lederle pharmaceutical products are covered

under the program, which include: Diamox, Artane,Minocin, Leucovorin Calcium, Loxapine, Verelan, Rheu-matrex, Maxzide, and Myambutol.



(c) The patient eligibility criteria that have to be met:Physician has to make the request. Patients have to

be financially indigent, and not eligible for coverageunder third party insurance or Medicaid reimburse-ment.


Physician.

(e) The specific forms that have to completed, if any, tobe enrolled in the program, and from whom theforms are obtained:

A form can be obtained from the company's sales rep-resentatives.(fi) How refills for the products are obtained:

A new request must be made by the physician.(g) Restrictions on the use of the program:

The program is not designed to reimburse hospitalsfor uncompensated care. However, any physician that iswilling to follow a patient on an ongoing basis in theoutpatient setting may enroll in the program.(h) Any copayments or cost-sharing that the company re-



The company reports that 300-400 patients per monthare served through the programs, plus 240,000 throughcommunity health centers.


Lederle also have a program to distribute its antibiot-ic Suprax to indigent patients seen at community-basedclinics through the Lederle Family Health Fund. Re-quests for the product should be made to Lederle or Ad-vantus sales representatives. Physicians should be onstaff at the community health center, which should alsobe a member of the National Association of CommunityHealth Centers.

ELI LILLY AND COMPANYCONTACT FOR THE PROGRAM:

Indigent Patient Program AdministratorEli Lilly and CompanyLilly Corporate CenterDrop Code 1844Indianapolis, IN 46285317-276-2950317-276-9288 (FAX)


(a) The pharmaceutical products which are covered:The company reported that all Eli Lilly prescription

products are covered, which include Ceclor, Keflex,Prozac, Dymelor, and Axid. The company also indicatedthat it makes its insulin products available through itsindigent patient program. These insulin products in-clude NPH insulin, Regular insulin, Lente insulin, andHumulin insulin. The program does not cover controlledsubstances, which include Darvon and Darvocet prod-ucts.(b) The quantity of the product which can be obtained at

any one time:Quantities are dependent upon the product, the diag-

nosis, and the physician's instructions. Generally, onecourse of therapy is supplied for acute care products.Quantities of chronic care products are determined on acase-by-case basis in consultation with the prescribingphysician.

(c) The patient eligibility criteria that have to be met:Patient eligibility is determined on a case-by-case

basis in consultation with the prescribing physician.The intent is to provide products to individuals withlimited resources and lacking third-party assistance.(d) To whom the products are sent for distribution to the

patient:Physician.


Access to this program is qualified through consulta-tion with the prescribing physician. Patients are not re-quired to complete enrollee forms.(f) How refills for the products are obtained:

Requests for refills are evaluated in a manner similarto original requests.(g) Restrictions on the use of the program:

Controlled substances are not provided. No product isprovided for indications not approved by FDA.(h) Any copayments or cost-sharing that the company re-

quires from the patient:None.The company would not provide data on the number

of patient's that had been served by the program.

McNEIL PHARMACEUTICALCONTACT FOR THE PROGRAM:

Laura LitzenbergerSenior Medical Information SpecialistScientific AffairsMcNeil PharmaceuticalSpring House, PA 19477215-540-7803


(a) The pharmaceutical products which are covered:Pancrease, Parafon Forte DSC, Haldol, Vascor, and

Tolectin.


Varies by product, patient condition.(c) The patient eligibility criteria that have to be met:

The physician determines that patient is indigent andnot eligible for health insurance.(d) To whom the products are sent for distribution to the

patient:Physician.

(e) The specific forms that have to be completed, if any,to be ehrolled in the program, and from whom theforms are obtained

Physicians may request free medications by writtenor telephone request, accompanied by a signed anddated prescription and letter stating financial statusand need of patient.(f) How refills for the products are obtained:

Through the individual's physician.(g) Restrictions on the use of the program:

Varies by product and patient condition.(h) Any copayments or cost-sharing that the company re-




MARION MERRELL DOW, INC.CONTACT FOR THE PROGRAM:

Bill LawrenceSupervisor of Product ContributionsP.O. Box 8480Kansas City, MO 64114816-966-4250


(a) The pharmaceutical products which are covered:The company reported that all Marion Merrell Dow

pharmaceutical products are covered under this pro-gram, which include Cardizem, Cardizem CD, CardizemSR, Carafate, Pavabid, Seldane, Seldane D, Nicorette,Rifadin, Quinamm, and Lorelco.(b) The quantity of the product which can be obtained at

any one time:Three months' supply.

(c) The patient eligibility criteria that have to be met.The physician determines whether the patient is eligi-

ble for the program. The. intent of the program is toassure -access to drug products for patients that fallbelow the Federal poverty level and have no othermeans of health care coverage.(d) To whom the products are sent for distribution to the

patient:Historically, the products have been sent to the physi-

cian; however, the company reports that a revised pro-gram will include the pharmacist.


Physicians can obtain program certificates from thecompany.

(f) How refills for the products are obtained:Physician request.

(g) Restrictions on the use of the program:Indigent patients.


None.


The company reported that 15,000 requests were re-ceived and honored in 1989, 52,000 in 1990, and 105,000in 1991.

MERCK SHARP AND DOHME (HUMAN HEALTHDIVISION, U.S.)


Professional Information DepartmentMerck Human Health Division, U.S.West Point, PA 19486215-540-8627


(a) The pharmaceutical products which are covered:According to the company, generally all Merck phar-

maceutical products are covered by this program, withthe exception of injectable medicines. Merck productsinclude Mevacor, Plendil, Pepcid, Prilosec, Prinivil, Ti-moptic, Timolol, Clinoril, Flexeril, Periactin, Noroxin,Cogentin, Indocin, Aldomet, Dolobid, Vasoretic, and Va-sotec.


Requests for 3 months' supply are generally honored.(c) The patient eligibility criteria that have to be met:

The patient's physician must: provide a written state-ment of medical need; indicate the existence of financialhardship; indicate the lack of patient eligibility for pre-scription coverage from insurance or government assist-ance programs.(d) To whom the products are sent for distribution to the

patient:Physician.


No specific forms have to be completed; requestsshould be made to the contact listed above.(f) How refills for the products are obtained:

The patient's physician can make subsequent requestsfor additional medications.

(g) Restrictions on the use of the program:Multiple, simultaneous requests from one physician

cannot be considered.


None.



MILES PHARMACEUTICALSCONTACT FOR THE PROGRAM:

Professional ServicesAttention: Miles Indigent Patient Program400 Morgan AveWest Haven, CT 065161-203-937-2000


(a) The pharmaceutical products which are covered:All Miles prescription products are covered under the

program, which include: Cipro, Nimotop, and TridesilonCream.


Medication quantities and duration of support is de-termined on a case-by-case basis.

(c) The patient eligibility criteria that have to be met:Physician must certify that the patient is not eligible

for or covered by government funded reimbursement orinsurance programs for medication. Patient's income isbelow Federal poverty guidelines.


Physician.


Physician must indicate condition for which the drugis to be prescribed and certify that the drug will be usedfor indicated use only. Physician must follow patientthrough course of therapy. A signed and dated prescrip-tion with professional designation, State license, or DEAnumber must be included with the application formfrom Miles.

(9 How refills for the products are obtained:As above.

(g) Restrictions on the use of the program:As indicated above.


None indicated.Source: 1992 PMA Directory of Prescription Drug Indi-gent Programs.

NORWICH-EATON PHARMACEUTICALS (PROCTORAND GAMBLE)


R.M. Brandt, ManagerCoverage and Reimbursement607-335-2079607-335-2020 (FAX)1-800-448-4878


(a) The pharmaceutical products which are covered:The company reported that all Norwich-Eaton phar-

maceutical products are covered under this program,which include Macrodantin and Dantrium.


The quantity varies depending upon the situation, butat least a 1 month's supply can be obtained upon receiptof a physician's prescription.

(c) The patient eligibility criteria that have to be met:The company relies on the physician's appraisal of

the patient's need. The company also helps the patientidentify other sources of financial help to pay for thepatient's medications.


Physician.


None.(f9 How refills for the products are obtained:

The physician must send another prescription to thecompany.(g) Restrictions on the use of the program:

Determination of patient eligibility is made on a case-by-case basis, based on the physician's assessment of thepatient's need.


None.


The company indicated that it has not tracked re-quests, and could not provide specific information to re-spond to this question.

ORTHO BIOTECHNOLOGYCONTACT FOR THE PROGRAM:

Carol Webb, Executive DirectorHematopoietic Products908-704-5232908-526-4997 (FAX)The Ortho Financial Assistance Program1800 Robert Fulton DriveReston, VA 220911-800-447-3437 (Financial Assistance)1-800-441-1366 (Cost Sharing Program)



gram is Procrit (Epoetin-alfa).


Determined by physician, normally 4-8 weeks.

(c) The patient eligibility criteria that have to be met:1. Financial Assistance Program-Less than $35,000

annual total household income, and no other prescrip-tion drug coverage.

2. Cost-Sharing Program-The program is activatedwhen Procrit expenditures for a patient exceed $8,500for a calendar year, regardless of third-party coverage.


Physician.


A Financial Assistance Program form must be com-pleted, which can be obtained from the company's salesrepresentative or by contacting the company directly.

(f) How refills for the products are obtained:Through the patient's physician, by requalifying

every 60 days.

(g) Restrictions on the use of the program:None indicated.


None, except for cost sharing program mentionedabove.


The company reported that 200 patients were servedby the program in 1991.

ORTHO PHARMACEUTICALSCONTACT FOR THE PROGRAM:

Jerald HollemanDirector, Government AffairsICOM Development GroupJohnson & JohnsonP.O. Box 300, Route 202 SouthRaritan, NJ 08869-0602908-218-6466


(a) The pharmaceutical products which are covered:Floxin, Aci -Jel, Ortho Dienestrol Cream, Monistat

Vaginal Suppositories, Protostat tablets, Sultrin TripleSulfa Cream, Sultrin Triple Sulfa Vaginal Tablets, Ter-azol 3 Suppositories, Terazol 7 Cream, SpectazoleCream, Monistat-Derm Cream, Grifulvin V Supposito-ries, Meclan Cream, Persa-Gel, Persa-Gel W, and Ery-cette.


Varies by product, patient condition.(c) The patient eligibility criteria that have to be met:

The physician determines that patient is indigent andnot eligible for health insurance.


Physician.


Physicians may request free medications by writtenor telephone request, accompanied by a signed anddated prescription and letter stating financial statusand need of patient.

(f) How refills for the products are obtained:Through the individual's physician.

(g) Restrictions on the use of the program:Varies by product and patient condition.


None.



PARKE-DAVISCONTACT FOR THE PROGRAM:

Parke-Davis201 Tabor RoadMorris Plains, NJ 07950201-540-2000


(a) The pharmaceutical products which are covered:The company indicated that all pharmaceutical prod-

ucts except controlled substances (Centrax) are madeavailable to patients on an informal, ad hoc basisthrough their physicians.

The company's pharmaceutical products include Di-lantin, Mandelamine, Accupril, Pyridium, Lopid, Nitro-stat Sublingual, Tabron, Ponstel, Procan, Anusol HC,and Zarontin.


There are no formal limits. The quantity of the prod-uct to be distributed to indigent patients is governed byboth relevant Federal, State, and local law and the phy-sician's determination of the indigent patient's medicalneed.

(c) The patient eligibility criteria that have to be met:The program is managed on an informal, ad hoc

basis, and thus no formal criteria exist. The physician'sgood-faith determination of need is the chief restrictionon the use of the program.(d) To whom the products are sent for distribution to the

patient:Physician.


None required.(f) How refills for the products are obtained:

See (b) above.

(g) Restrictions on the use of the program:See (c) above.


None.


The company indicated that it did not keep statisticson enrollment in the program, and did not respond- inmore detail to this question.

PFIZER PHARMACEUTICALS, INC. PROGRAM # 1:

PFIZER LABS, ROERIG DIVISION, PRATTPHARMACEUTICALS


Richard VastolaManager, Professional and Consumer ProgramsPfizer, Inc.235 East 42nd StreetNew York, NY 10017212-573-3954


(a) The pharmaceutical products which are covered:All Pfizer outpatient pharmaceutical products are

covered by this program, which include Antivert,Marax, Diabinese, Cardura, Minizide, Navane, Sine-quan, Zithromax, Feldene, Procardia, Procardia XL, Vi-bramycin, Vistaril, Zoloft, Minipress, Minizide, and Glu-cotrol. (Diflucan is covered by another program de-scribed separately.)(b) The quantity of the product which can be obtained at

any one time:Up to 3 months' supply, as prescribed by the physi-

cian.(c) The patient eligibility criteria that have to be met.

Any patient that a physician is treating as indigent iseligible. Patients must not be covered by third-party in-surance or Medicaid.(d) To whom the products are sent for distribution to the

patient:Physician receives products for distribution to pa-

tient.

(e) .The specific forms that have to be completed, if any,to be enrolled in the program, and from whom theforms are obtained:

Forms are not necessary. The patient's physicianmust write a letter to Pfizer stating the need, and in-clude the written prescription for the drug.(f) How refills for the products are obtained:

Through the request of the physician.(g) Restrictions on the use of the program:

The physician must be treating the patient as indi-gent, and in a letter must indicate financial need andinability to pay on part of the patient.(h) Any copayments or cost-sharing that the company re-



According to the company, about 2,000 free courses oftherapy were provided to indigent patients from 1989through 1991. The company did not report on thenumber of patients that have been served.

ADDITIONAL COMMENTS

Pfizer also participates in the Arkansas Health CareAccess Program and the Kentucky Health Care AccessProgram. These programs make all Pfizer prescriptiondrugs available free of charge to patients that each re-spective State certifies as being below the Federal pov-erty level, without health insurance benefits, and ineli-gible for any government entitlement program. More in-formation about the programs is available from:

73

ArkansasPat KellerProgram DirectorArkansas Health Care Access FoundationP.O. Box 56248Little Rock, AR 72215501-221-30331-800-950-8233

KentuckyArch Manious, Jr.Executive Vice PresidentKentucky Health Care Access Foundation147 Market Street, Suite 200Lexington, KY 40507606-255-7442606-254-5846 (FAX)

PFIZER INC. PROGRAM #2: ROERIG DIVISION


Diflucan Patient Assistance Program1-800-869-9979


(a) The pharmaceutical products which are covered:Diflucan (Fluconazole).


Up to 3 months' supply.

(c) The patient eligibility criteria that have to be met:Patient must not have insurance or other third-party

coverage, including Medicaid.Patient must not be eligible for a State AIDS drug as-

sistance program.Patient must have an income of less than $25,000 a

year without dependents; or less than $40,000 a yearwith dependents.


Physician.

59-585 - 92 - 4


A one-page qualification form completed and submit-ted by the physician is required for enrollment. Theform can be obtained by contacting the 1-800 numberlisted above.(9 How refills for the products are obtained

Refills are obtained by the physician resubmitting aone-page qualification form.(g) Restrictions on the use of the'program:

None, beyond income and coverage limitations.(h) Any copayments or cost-sharing that the company re-



Information provided by the company indicate that1,217 patients were enrolled in the program in 1991. In1990, the year for which records were most readilyavailable, 440 courses of therapy were provided throughthe program. The number of patients served in 1990was not reported by the company.

REED AND CARNRICK/BLOCK DRUG COMPANYCONTACT FOR THE PROGRAM:

Conrad ErdtCustomer Service AssociateReed and Carnrick Pharmaceutical CompanyOneNew England AvePiscataway, NJ 08854908-981-0070908-981-1391 (FAX)


(a) The pharmaceutical products which are covered:The company indicated that all its prescription prod-

ucts are covered by the program (when accompanied bya prescription form signed by a physician), which in-clude Lindane Shampoo and Lindane Lotion. The com-

pany's nonprescription products are also covered underthe program.


One month's supply.

(c) The patient eligibility criteria that have to be met:

The company makes a determination of eligibilitybased on income information provided by the physician.


Physician.


Written request from physician to company repre-sentative or direct to company headquarters, accompa-nied by signed physician prescription form.

(f) How refills for the products are obtained:Written request by the physician, accompanied by

signed physician prescription form.

(g) Restrictions on the use of the program:As above.



According to the company, only one patient was en-rolled in the program in 1991.

SANDOZ PHARMACEUTICALS


Gilbert Honigfeld, Ph.D.Director of Scientific Affairs59 Route 10East Hanover, NJ 07936-1951201-503-8341201-503-7185 (FAX)Maria Hardin, DirectorSandoz Drug Cost Sharing Program (DCSP)P.O. Box 8923New Fairfield, CT 06812203-746-65181-800-447-6673203-746-6481 (FAX)Carol Lee-KantorDirector, Clozaril Assistance ProgramP.O. Box 8923New Fairfield, CT 06812-17831-800-937-6673203-746-6481 (FAX)


The National Organization for Rare Diseases(NORD)/Sandoz Drug Cost Share Program (DCSP) issolely administered by NORD.

(a) The pharmaceutical products which are covered:The company reported that Sandimmune, Sandoglo-

bulin, Sandostatin, Parlodel, and Eldepryl are coveredunder one program. Clozaril is covered under a differentprogram, as described below. The company did not indi-cate if it had a program for its other pharmaceuticalproducts, which include Restoril and Mellaril.(b) The quantity of the product which can be obtained at

any one time:Patient is awarded up to 1-year's worth of drug,

which is shipped in 3-month supplies via the mail-orderpharmacy utilized by the program.

Clozaril-Patient is eligible to receive up to 1-year'ssupply of the drug, dispensed only 1 week at a time, perdispensing requirements of package label.


NORD determines eligibility by medical and financialcriteria, and applies a cost share formula. The patient/applicant must demonstrate financial need above andbeyond the availability of Federal and State funds, pri-vate insurance or family resources. NORD also makesdetermination of patient eligibility for Clozaril program.


Products are sent directly to the patient via a mailorder pharmacy. For Clozaril, the drug is supplied bylocal pharmacists, and NORD reimburses the pharma-cist for the drug plus a dispensing fee. NORD also mayreimburse laboratories for weekly blood tests.


An application packet which also includes a separatephysician form is available from NORD for both thegeneral program and the Clozaril program.

(f) How refills for the products are obtained:Patient's physician must complete DCSP dosage quar-

terly updates. A new prescription must accompany phy-sician's up-date when a dosage change has occurred.

Clozaril-dispensed 1 week at a time at local pharma-cy, after laboratory check of patient's white blood cell(WBC) count, per physician's prescription.

(g) Restrictions on the use of the program:All applicants must be citizens or permanent resi-

dents of the United States. There is no income ceiling.For Clozaril, patients must apply each year to requalify.


A percentage of the costs, up to 100 percent, of an eli-gible applicant's drug therapy, is subsidized according tofinancial need. Patient is responsible for shipping andhandling costs of the drug. For Clozaril, patients mustpay for the percentage of the medication costs that theycan afford.


According to the company, the general Sandoz indi-gent patient program served 79 patients in 1989, 504 in1990, and 1,005 in 1991. The Clozaril program served1,249 patients in 1990 and the same number in 1991.

SANOFI WINTHROP PHARMACEUTICALSCONTACT FOR THE PROGRAM:

Sanofi WinthropProduct Information Department90 Park AvenueNew York, NY 10016212-907-2000


(a) The pharmaceutical products which are covered:The company indicated that all Sanofi Winthrop

pharmaceutical products are available under this pro-gram, which include Aralen, Danocrine, and Winstrol.


One unit or 1 month's supply, as required.(c) The patient eligibility criteria that have to be met:

Subject to acceptance by the company, patients canobtain medications by having their physician contactthe company to request the product, provide a writtenorder for the product, and confirm the patient's need.(d) To whom the products are sent for distribution to the

patient:Physician.


Pharmaceuticals can be obtained by contacting thelocal sales representative or calling the product infor-mation department, and providing a written prescrip-tion.

(f) How refills for the products are obtained:Specific requests must be made for additional product.

(g) Restrictions on the use of the program:Each request is handled on a case-by-case basis.


None.


According to the company, patients are handled on acase-by-case basis, and are not enrolled in a formal pro-gram. Therefore, the company did not provide any dataon the number of patients that the program served.

SCHERING-PLOUGHCONTACT FOR THE PROGRAM:

For Intron/Eulexin Products:Roger D. Graham, Jr.Marketing Manager, Oncology/BiotechService ProgramsSchering Laboratories2000 Galloping Hill RoadBuilding K-5-2 B2Kenilworth, NJ 07033

For Other Schering Products:Drug Information ServicesIndigent ProgramSchering Laboratories/Key Pharmaceuticals2000 Galloping Hill RoadBuilding K-5-1 C6Kenilworth, NJ 07033908-298-40001-800-822-7000


(a) The pharmaceutical products which are covered:Intron A-Initial supply is for 2 months; renewals

available for 4 months at a time.Eulexin-Initial supply is for 6 months; renewals

available for 6 months at a time.

Other Schering products, which include Trinalin, Lo-trimin, Lotrisone, Diprosone, Diprolene, Fulvicin, Pro-ventil, Vancenase, Normodyne, and Optimine, are pro-vided for an initial 3 months' supply, with renewalsavailable for up to 3 months at a time.(b) The quantity of the product which can be obtained at

any one time:As indicated above.

(c) The patient eligibility criteria that have to be met.Patient eligibility is determined on a case-by-case

basis, based on the internal criteria (economic status) aswell as through consultation with the prescribing physi-cian. The consultation includes a review of the specificcase as well as the availability of other means of healthcare assistance.(d) To whom the products are sent for'distribution to the

patient:Physician.


The physician either completes a request form. in thecase if Intron A and Eulexin or submits a formal writ-ten request for assistance for other Schering drugs.(f) How refills for the products are obtained:

Refills are sent directly to the physician.(g) Restrictions on the use of the program:

According to the company, the program is designed toassist those patients who are indigent and ineligible forpublic or private insurance reimbursement, and cannotafford treatment.(h) Any copayments or cost-sharing that the company re-



According to the company, 2,100 patients were en-rolled in the program in 1991. Data were not providedfor earlier years.

G.D. SEARLE AND CO.CONTACT FOR THE PROGRAM:

For health care professionals:Michael IsaacsonVice President, "Patients in Need" FoundationSearle Co.5200 Old Orchard Rd.Skokie, IL 600771-800-542-2526708-470-3831708-470-6633 (FAX)

For general information about the program:Laura LeberAssociate Director, Public Affairs708-470-6280708-470-6719 (FAX)


(a) The pharmaceutical products which are covered:The company indicated that the following pharmaceu-

tical products were covered under the program: Aldac-tazide, Aldactone, Calan, Calan SR, Cytotec, Kerlone,Nitrodisc, Norpace, Norpace CR.


Supply is based on the physician's assessment of theneeds of the patient.

(c) The patient eligibility criteria that have to be met:The program is conducted through the -physician, who.

determines the patient's eligibility based on medicaland economic need. Searle provides suggested guidelinesto the physician to consider when determining patienteligibility.


"Patients in Need" program certificates for new andrefill prescriptions are made available to the physician.The physician gives the completed certificate to the pa-tient, who takes it to the pharmacy with a prescriptionfor the Searle product. The pharmacist submits the cer-tificate to Searle, and the pharmacist is reimbursed by

the company at the pharmacy's usual and customarycharge.


The physician enrolls the patient in the programthrough the "Patients in Need" certificate. The patientdoes not have to complete any forms. Certificates areavailable from Searle medical representatives or by call-ing the toll-free number.

(f) How refills for the products are obtained:Refills can be obtained through the physician by uti-

lizing "Patients in Need" program certificates. There isno limit to the number of refills under the program, soa patient could receive a lifetime supply of medicationthrough the program.

(g) Restrictions on the use of the program:There are no time or monetary limitations on pa-

tients using the program.(h) Any copayments or cost-sharing that the company re-



Since 1987, the company reports that nearly 5 millioncertificates worth $150 million have been distributed tophysicians around the country. However, the companydid not provide, data on the number of patients thathave been served by the program.

83

SIGMA-TAU PHARMACEUTICALS


Michele McCourtCarnitor Drug Assistance ProgramAdministratorNational Organization for Rare DiseasesP.O. Box 8923New Fairfield, CT 06812-17831-800-999-6673203-746-6518203-746-6481 (FAX)Barbara J. BaconManager, Marketing OperationsSigma-Tau Pharmaceuticals200 Orchard Ridge DriveGaithersburg, MD 208781-800-447-0169301-948-1041301-948-1862 (FAX)


(a) The pharmaceutical product which is covered:Carnitor (Levocarnitine).

(b) The quantity of the product which can be obtained atany onetime:

Three months' supply, up to 1 year.

(c) The patient eligibility criteria that have to be met:The patient must have no other means for obtaining

the drug through insurance or State or Federal assist-ance, or liquid assets, and cannot afford to purchase thedrug. Must be a U.S. citizen or permanent resident.


Product is sent directly to the patient.


Applications are obtained through the NORD/Sigma-Tau Carnitor Drug Assistance program.

(f) How refills for the products are obtained:Physician sends new quarterly prescription. Voucher

for free drug is sent out quarterly.

(g) Restrictions on the use of the program:Program limited to patients who cannot afford to pur-

chase the prescribed drug and have no other means ofobtaining it.


Patient must pay for the shipping and handling of thedrug.


The company reported that the program served 10 pa-tients in 1989, 13 patients in 1990, and 18 patients in1991.

SMITHKLINE BEECHAM: PROGRAM #1CONTACT FOR THE PROGRAM:

Jan StilleySmithKline BeechamOne Franklin Plaza FP1320Philadelphia, PA 10101215-751-5760


(a) The pharmaceutical products which are covered:All SmithKline Beecham pharmaceutical products

are covered under this program, which include Taga-met, Augmentin, Relafen, Dyazide, Ridaura, Bactroban,and Compazine. Eminase and Triostat are coveredunder different programs, described in the next section.(b) The quantity of the product which can be obtained at

any one time:Up to 3 months' supply.

(c) The patient eligibility criteria that have to be met:Physicians determine which patients are eligible.


The physician makes the request of the local companysales representative. The requesting physician signs aform acknowledging receipt of the product.(e) The specific forms that have to be completed, if any,


Patients do not have to be enrolled in the program.Requesting physicians are asked to forward to a letterto the company confirming patient need and eligibility.(f) How refills for the products are obtained:

Physicians can obtain refills from the local companysales representative, and, upon delivery, sign an ac-knowledgement of receipt for another 3 months' supply.(g) Restrictions on the use of the program:

None indicated by the company.(h) Any copayments or cost-sharing that the company re-



The company indicated that it could not report thisbecause it does not collect aggregate data about the pro-gram.

SMITHKLINE BEECHAM: PROGRAM #2CONTACT FOR THE PROGRAM:

Eminase and Triostat ProgramsHelene KennedyProgram Specialist555 13th Street NW Suite 700 EastWashington, DC 20004202-508-6512202-637-6690 (FAX)


(a) The pharmaceutical products which are covered:Eminase (Antistreplase) and Triostat (Liothyronine

Sodium Injection) are covered under the programs de-scribed below.(b) The quantity of the product which can be obtained at

any one time:All Eminase and Triostat vials that the hospital uses

to treat patients who meet the program requirementswill be replaced by the company free of charge.

(c) The patient eligibility criteria that have to be met:To be eligible for this program, patients must (1) dem-

onstrate that they do not have private or public insur-ance coverage; (2) meet the program income require-ments (single patients with annual incomes of $18,000or less and married patients or those with one depend-ent are eligible if their income is $25,000 or less).


After a hospital submits a request, Eminase andTriostat replacement vials will be shipped directly tothe hospital within 30 days after the application hasbeen approved.(e) The specific forms that have to be completed, if any,


For each eligible patient, hospitals must submit aHospital Consent Form and an Application Form withany one of the following documents: a copy of the pa-tient's medical record, a copy of the patient's pharmacy

record, a copy of the patient's bill. Forms can be ob-tained from the company's sales representative or bycontacting the following:

For Eminase:Compassionate Care Programc/o Medical Technology Hotlines555 13th Street NW Suite 7EWashington, DC 200041-800-866-6273202-637-6695

For Triostat:Medical Technology HotlinesP.O. Box 7710Washington, DC 20004-77101-800-866-6273202-637-6695

(f) How refills for the products are obtained:Given the method of administration and treatment

for these drugs, refills are not applicable.

(g) Restrictions on the use of the program:None.



Since its development in 1990, 110 patients have beenenrolled in the Eminase program. The Triostat programwas just developed in 1992.

SYNTEX LABORATORIES, INC.CONTACT FOR THE PROGRAM:

Cytovene Medical Information Line:1-800-444-4200 (Syntex Provisional Assistance Pro-

gram for Cytovene)General Telephone Number to Inquire About Indigent

Patient Programs:1-800-822-8255


(a) The pharmaceutical products which are covered:The only product covered under this program is Cyto-

vene (ganciclovir sodium) 500mg sterile powder.The company indicated that it makes its other prod-

ucts available to indigent patients on an ad hoc basisthrough their physicians. The company's other productsinclude Naprosyn, Anaprox, Cardene, Synalar, Synemol,and Nasalide.(b) The quantity of the product (Cytoven) which can be

obtained at any one time:25 vials (dose depends on maintenance-vs-induction

therapy, adjusted for patient's weight).(c). The patient eligibility criteria that have to be met:

Syntex provides Cytovene free of charge when it isprescribed for an immunocompromised patient who hasbeen diagnosed as having cytomegalovirus (CMV) retini-tis, if that patient does not have the means to purchasethe drug and that patient is not eligible for any form ofthird-party reimbursement to otherwise pay for thedrug.

Specifically, the eligibility criteria for the Syntex Pro-visional Assistance Program for Cytovene are as fol-lows:

If the physician indicates that the patient has CMVretinitis and cannot afford the cost of treatment, the pa-tient is considered prequalified and an initial 25 vialsare shipped directly to the physician. In addition, a Pa-tient Eligibility Form is sent, and the treating physicianor social worker completes the necessary information toindicate that the patient has no known source of reim-bursement for Cytovene, including private or govern-ment insurance, or eligibility for other charitable

means of assistance. If the treating physician and socialworker determine the patient is "indigent" and all re-quirements for eligibility are duly documented, the pa-tient's forms are retained on file and the patient is al-lowed to continue to receive assistance. Patients, onceenrolled, will continue to receive drug unless financialor medical conditions change.(d) To whom are the products sent for distribution to the

patient:Physician.


Program structure is as outlined:(1) The physician contacts the Cytovene Informa-

tion Line and identifies a patient who has CMV ret-initis but cannot afford Cytovene; patient is prequa-lified, and Syntex Order Department is instructedto drop ship 25 vials of Cytovene immediately to thephysician, along with Eligibility Form and Requestfor Additional Product Form.

(2) When forms are completed and returned, theyare reviewed as detailed above. If the patient meetsthe criteria for financial eligibility, the patient isconsidered qualified and further drug may beshipped to the physician as requested. The frequen-cy of requests for additional supply varies, depend-ing on the dosage regimen, but usually it is on amonthly basis.

(f) How refills for the products are obtained:Once patients are deemed eligible and are enrolled in

the program, physicians complete a Request for Addi-tional Product Form. The physician's signature andDEA number are required on all forms.(g) Restrictions on the use of the program:

Patients must have a diagnosis of cytomegalovirus(CMV) retinitis and have documentation by their physi-cian or social worker indicating that the patient doesnot have the means to purchase the drug and is not eli-gible for any form of third-party reimbursement to oth-erwise pay for the drug.


None.


The company reports that 81 patients have enrolledin the Cytovene Provisional Assistance Program, and 10patients are pending eligibility approval to date.

ADDITIONAL COMMENT PROVIDED BY THE COMPANY

The company indicated that it is in the process of de-veloping an indigent patient program for Synarel, re-cently approved by the FDA for the treatment of Cen-tral Idiopathic Precocious Puberty.

UPJOHN COMPANYCONTACT FOR THE PROGRAM:

Wendell PierceNational Professional Services ManagerUpjohn Company7000 Portage RdKalamazoo, MI 49001616-323-6004616-323-6332 (FAX)


(a) The pharmaceutical products which are covered:The company reports that any Upjohn product may

be considered for the patient, which includes Ansaid,Motrin, Provera, E-Mycin, Halcion, Xanax, Medrol,Cleocin, Lincocin, Loniten, Micronase, Orinase, and To-linase.


Generally, a 3-months' supply is provided. However, aphysician can request a supply for a longer period oftime.

(c) The patient eligibility criteria that have to be met:The physician determines the patient's needs, and if

there are available insurance or other social programsto help provide medications.


Physician.


There are no forms involved in making the request.(f) How refills for the products are obtained:

Through follow-up requests by the physician to theUpjohn sales representative.(g) Restrictions on the use of the program:

None indicated.


None.


The company indicated that this data was not avail-able.

WYETH-AYERST LABORATORIESCONTACT FOR THE PROGRAM:

Roger EurbinAssociate Director, Professional ServicesWyeth-AyerstP.O. Box 8299Philadelphia, PA 19101215-971-5604


(a) The pharmaceutical products which are covered:The company indicated that various products are cov-

ered under its program. The company's products includeSectral, Cyclospasmol, Premarin, Isordil, Phenergan, Di-metapp, Orudis, Wytensin, and Cordarone. The compa-ny also makes three oral contraceptives: Triphasil, Lo/Ovral, and Nordette, which are primarily provided byfamily planning clinics. The program to provide the

Norplant System is described in the "Comments" sec-tion.


In general, 1-2 months' supply or the closet tradepackage size available is provided. For Cordarone, 1months' supply or up to two bottles of 60 tablets is pro-vided.

The number of cycles of oral contraceptives given tothe patient is determined by a health care provider orthe family planning clinic.


The patient must be medically indigent, with no formof coverage for pharmaceutical products. The familyplanning clinic determines eligibility for new and refilloral contraceptive cycles.


Physician.


No specific forms are needed; just a signed and datedprescription that includes the physician's professionaldesignation, the State license or Federal DEA number,and a brief statement affirming that the patient ismedically indigent and has no form of coverage forpharmaceutical products.

(f) How refills for the products are obtained:Same as request for original prescription.

(g) Restrictions on the use of the program:Subject to case-by-case approval.


None.

93


The company indicates that data about the programis not captured by a single source and is therefore notavailable.

COMMENTS

The company established a foundation in 1991 to pro-vide the Norplant contraceptive system. Up to 5 yearsof use can be provided. The Norplant Foundation deter-mines whether the patient is eligibl4 to receive thesystem free of charge. Contact: The Norplant Founda-tion, P.O. Box 25223, Alexandria, VA 22314, 703-706-5933.

TABLE 1-PRICE INCREASES FOR MAJOR PRESCRIPTION DRUGSTAKEN BY OLDER AMERICANS, 1986-91

AnnualDrug, Manufacturer and Average Generic Name Generic

Use , Price AvailableIncrease

Coumadin (Du PontMerck) anticoagulant.

Tylenol #3 (McNeil)painkiller.

Premarin (Wyeth-Ayerst) estrogen.

Halcion (Upjohn)sleeping pill.

Xanax (Upjohn)antianxiety.

Dilantin (Parke-Davis)antiepilepsy.

Inderal (Wyeth-Ayerst)hypertension/angina.

Nitrostat (Parke-Davis)angina.

Feldene (Pfizer)antiarthritic.

Capoten (Bristol-Myers)hypertension.

Lopressor (Ciba-Geigy)hypertension.

Procardia (Pfizer)hypertension/angina.

Tagamet (SmithKline)antiulcer.

21.4% Warfarin..............

17.0% Acetaminophenwith codeine.

17.0% Conjugatedestrogens.

15.0% Triazolam............

NO *

NO *

NO-1993

15.0% Alprazolam.......... NO-1993

14.4% Phenytoin............

14.4% Propranolol.........

14.1% Sublingualnitroglycerin.

14.0% Piroxicam............

NO *

YES

NO

NO-1992

13.2% Captopril.............. NO-1995

12.8% Metoprolol........... NO-1993

12.0% Nifedepine........... YES

11.6% Cimetidine........... NO-1994

* Generic versions of these products are no longer available be-cause of manufacturing problems, but are eventually expected toreturn to market.

Source: PRIME Institute. Minneapolis, Minnesota.

TABLE 2-MAJOR BRAND NAME PRESCRIPTION DRUGS COMINGOFF PATENT, 1992-95

1991 U.S.Month of Sales

Brand Name, Generic Name Patent (Estimat-Manufacturer and Use Expiry ed) [In

Millions)

Dolobid (Merck)[antiarthritic].

Feldene (Pfizer)[antiarthritic].

Procardia XL (Pfizer)[heart medication].

Cardizem SR (Marion)[heart medication].

Ceclor (Eli Lilly)[antibiotic].

Voltaren (Ciba-Geigy)[antiarthritic].

Lopid (Parke-Davis)[cholesterol].

Ansaid (Upjohn)[antiarthritic].

Corgard (Bristol-Myers)[heart medication].

Xanax (Upjohn)[antianxiety].

Halcion (Upjohn)[antianxiety].

Lopressor (Ciba-Geigy)[heart medication].

Naprosyn (Syntex)[antiarthritic].

Anaprox (Syntex)[antiarthritic].

1992Diflunisal............. January......

Piroxicam ............ April ...........

Nifedepine........... September..

Diltiazem............. November..

Cefaclor................ December...

1993Diclofenac............ January......

Gemfibrozil ......... January......

Flubiprofen ......... February ....

Naldolol............... September..

Alprazolam.......... October.......

Triazolam...... October.......

Metoprolol........... December...

Naproxen............. December...

Naproxensodium.

(95)

December...

$295

$808

$350

$550

$355

$350

$140

$130

$465

$100

$250

$480

$185

96

TABLE 2-MAJOR BRAND NAME PRESCRIPTION DRUGS COMINGOFF PATENT, 1992-95--Continued

1991 U.S.Month of Sales

Brand Name, Generic Name Patent (Estimat-Manufacturer and Use Expiry ed) [In

Millions]

Diabeta (Hoechst)[antidiabetic].

Seldane (Marion)[antihistamine].

Tagamet (SmithKline)[antiulcer].

Micronase (Upjohn)[antidiabetic].

Vancenase (Schering)[antiasthma].

Vanceril (Schering)[antiasthma].

Clozaril (Sandoz)[schizophrenia].

Capoten (Bristol-Myers) [heartmedication].

Zantac (Glaxo)[antiulcer].

Sandimmune (Sandoz)[transplant

rejection].

1994Glyburide ............ January......

Terfenadine......... March.........

Cimetidine........... May.............

Glyburide ............ May.............

Beclometha-sone.

Beclometha-sone.

Clozapine.............

1995Captopril..............

August........

August........

September..

August.....

Ranitidine........... December...

Cyclosporin ......... September..

$135

$530

$640

$215

$110

$50

$40

$580

$1,530

$250

Source: Generic Pharmaceutical Industry Association and C.J.Lawrence, March 23, 1992, Number 92-3.

TABLE 3-COST OF NEW DRUGS SKYROCKETING

FDADrug/Manufacturer Use Approv- Cost

al

Centoxin Antibiotic......... Pending.. $3,000-$4,000/CENTOCOR. . dose

Interleukin-2 Renal cancer ... Pending.. $4,000-$5,000/CETUS. dose

Foscavir ASTRA......... AIDS/eye 9/91......... $21,000/yearinfection

Proscar MERCK......... Prostate 6/92......... $730-$1,095/yearcancer

Sumatriptan Migraine Pending.. $65-$100/doseGLAXO. headaches (subcutaneous)

Pergamid NOVA........ Leukemia......... Pending.. $1,100/doseAredia GEIGY ............ Cancer.............. 10/91....... $900-$1,400/3 day

therapyTiclid SYNTEX........... Stroke............... 11/91....... $2.02/day

Source: American Journal of Hospital Pharmacy, January 1992.

EXPANDED DRUG COVERAGE

This manual primarily focuses on prescription drug benefts under Medicaid. Tle XX of the Social Security Act, for persons wth lowincomes and dependant children in response to a groing need for prescription drug coverage to the elderly, who consume

New Jte uand Delaware'

YearEnacted: 1977 1977 1979 1982

EligibilityCriteriaAge 65 65, None 65+

Means test S15,700s SS400 s S7,750 s to S11,000s519.250 c 510.500 C $14.950 $15.100 c

under age 65 55+ ith Fam of 10wlSS disabilily exceptions

Program,Characteristics:

Copay S5.00 3.00-5.00 05.00 10% AAC'

Rxs covered All legend Rx. MOSt Chronic Anti-infectious Rx drugs. formularyinsulin & diabetic lest illnesses Maintenance + insulin/quinine

materials. No DESI drugs Chronic Conditions

Ft, feeto Pharmacy 93.6310 3.973 53.35' $4.94'

toS6.17

Fiscal ImpactFunding 33.5% General fund General fund General fund The Nemours

66.5% Casino Revenue FoundationFund

I recipiens 214.152 14.378 17.000 17,000 (enrolled) 1991

Cost per yea? $177 S4.3 $10 53.3

Pop. over age 65: 1.069,000 164.385 560.901 80,000

Comparable MedicaidRK Data 1990:TOL Recipiens 614,073 150.623 380,255 50,580&% Recipiets 506,804 118,241 286.270 38,026Rx Expend. S186.3 S38.3 $85.8 $9.7Net Stale Cost $93.1 (50%) $14.1 (37%) $42.9 (50%) $4.8 (50%)

Mig. Rebates: Recent enactmet Tied to OBRA 9D Not yet implemented% of AMPs; Started 6/92

Not a vendor drug program. All Rx's dispensed througn Nemnours Memorial Health Clinic, Wilmington, DEMons

3 Medicaid Table 4

(98)

FOR THE ELDERLY

considerably more drugs than the average Amercan, stare health planners and legislators in nine states have developed state-fundedprograms for therr elderly citzens. Each of these programs difer somewhat and their characteristics ae listed below.

llinois Rhode islard Connectcut New York Vemnon

1984 1985 1985 1986 1987 1990

65. 65. 65+ 65. 65+ 65+

less than $14,000 513.116 s less than 59.000-15,000 s $11,600 s513.000 s household $16,395 c $13.800 s $12.000.20,000 c $15,500 c$16.200 m 16 & 516.650 c (low-moderate disabled

totally disabled 18-64 income)disabled Title II & XVI

upto 80%523 depending

56.00 $25 per month 40% of cost $10.00 on cost

AI Rx. 30- Cardiovascular Rx. Rx (selected All 'State Rx All Ak - All legend Rx,day supply antiarthritic. diagnostic insulin, needles 6 No DESI or insulin. syringes, needlesor 100 units insulin categories) syringes - No OTCNo DESI or Exp. needles & syr. DES or cosmnetics

52.75' S3.60 S1 brand S4 10' 52.75 AWP-10%55 generic (.50 generic to + $4.25

incentive fee) S3.00

Lottery General fund General fund General fund General fund + General fundfunds premiums pd/rebates

369,919 102.792 19.000 53,567 90.600 3.300 eligibles5230.9 S62.8 54.7 5284 538.8

1,829,106 1.429.000 150.547 444.000 2.340.000 66,163

1.277,428 1,144.272 163.704 271.903 2.461,537 70699859.875 896.686 102,095 198,852 1,714.055 54.3995293.4 $203.3 526.5 575.1 5524.7 $17.2

5126.1 (43%) 1101.6 (50%) 512.1 (46%) 537.5 (50%) 5262.3 (50%) 56.6 (38.6%)

528 None Not yet implemented 51.82 S4.5 None12.5%/10 11%2.5%/16%'

4 Actual Acquisition Cost Table 4Average Manufacturer Cost12 5% generic/10% brand

TABLE 5-CONTACTS FOR STATE PHARMACEUTI-CAL ASSISTANCE PROGRAMS FOR OLDERAMERICANS

CONNECTICUT

Marcia MaineSupervisor, Program Development CONNPACEConnecticut Department on Aging175 Main StreetHartford, CT 06106-1861203-566-8840203-566-8843 (FAX)

DELAWARE

W. Frank Morris, R.Ph.Director of PharmacyThe Nemours Clinic1801 Rockland RoadWilmington, DE 19803302-429-9400302-429-8499 (FAX)

ILLINOIS

Susan M. CoombeManager of PharmaceuticalsIllinois Department of RevenueP.O. Box 19021Springfield, IL 62794-9021217-782-3336217-782-4217 (FAX)1-800-624-2459 (in Illinois only)

(100)

101

MAINE

Diane HopperMedical Care CoordinatorProfessional Claims ReviewMaine Department of Human Services249 Western AvenueAugusta, ME 04333207-289-3081207-289-2675 (FAX)

MARYLAND

Leone W. Marks, R.Ph.Staff Specialist for Pharmacy ServicesMaryland Medical Care Policy Administration201 West Preston StreetBaltimore, MD 21201410-225-1459410-333-5409 (FAX)

NEW JERSEY

Wade EppsPrincipal Standards & Procedures TechnicianNew Jersey Division of Medical Assistance & Health

ServicesPharmaceutical Assistance to Aged & DisabledCN 715Trenton, NJ 08625609-588-7032609-588-7037 (FAX)

PENNSYLVANIA

Theresa V. BrownChief, Research & Development, PACE ProgramPennsylvania Department of Aging231 State StreetHarrisburg, PA 17101717-787-7313717-772-2730 (FAX)

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RHODE ISLAND

Susan L. SweetAssociate Director of Community ServicesRhode Island Department of Elderly Affairs160 Pine StreetProvidence, RI 02903401-277-6553401-277-2130 (FAX)

NEW YORK

Marilyn DesmondDeputy Director, EPICNew York State Department of Health401 Corning Tower, Empire State PlazaAlbany, NY 12237-0769518-474-3672518-474-3292 (FAX)

VERMONT

Marghi BartonVscript Program ManagerDivision of MedicaidVermont Department of Social Welfare103 S. Main StreetWaterbury, VT 05676802-241-2886802-241-2974 (FAX)

TABLE 6-PATIENT ASSISTANCE PROGRAMS FORHIV-RELATED THERAPIES

Epoetin Alpha (EPO, Procrit)MFGR: Ortho BiotechnologyCost Sharing ProgramOrtho Biotech1-800-441-1366Ortho Financial Assistance Program1-800-447-3437Procrit Line1-800-553-3851

Filgrastim (GCSF, Neupogen)MFGR: Amgen, Inc.Amgen Safety Net Program1-800-272-9376

Fluconazole (Diflucan)MFGR: Pfizer Pharmaceuticals, Roerig DivisionDiflucan Reimbursement Hotline1-800-869-9979

Ganciclovir (Cytovene)MFGR: Syntex LaboratoriesProvisional Assistance Program1-800-444-4200

Interferon Alpha 2A (Roferon)MFGR: Roche LaboratoriesRoferon-A Cost Assistance Program1-800-227-7448ONCOLINE1-800-443-6676

Interferon Alpha 2B (Intron A)MFGR: Schering-Plough Corp.Interactive Reimbursement Information Services1-800-521-7157ICON Information Network1-800-446-8766

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Pentamidine (Pentam)MFGR: Fujisawa Pharmaceutical Co.Rick White708-317-8638

Sargramostim (GMCSF Leukine)MFGR: ImmunexImmunex Reimbursement Service1-800-321-4669Leukine Product Information & Professional Service

Hotline1-800-33-GMCSF

Sargramostim (GMCSF Prokine)MFGR: Hoechst-Roussel Pharmaceuticals1-800-Prokine

Zidovudine (Retrovir)MFGR: Burroughs WellcomePatient Assistance Program1-800-722-9294

Source: Drug Topics, September 1991.

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ISBN 0-16-039545-3

90000

9780160 395451

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