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F5 Point-of-Care Assessment of Response to High-Cost Specialty Therapy: Real-World Experience in Outcomes-Based ContractingNathan White, CPCSal Rafanelli, RPhFred Brownfield, RPh

Learning Objectives1.)Explain the rationale and societal promise of outcomes-based contracting programs to the health care industry as a whole, and the specialty pharmaceutical industry specifically.2.)Discuss the socioeconomic and business benefits to patients, providers, payers, specialty pharmacies, and manufacturers of a response-to-therapy innovative contracting program.3.)Identify the clinical and economic considerations in designing an outcomes-based contract as well as potential outcomes, and per member per month or per member per year cost savings to a payer.4.)Describe clinical algorithms and utilization management pathways for automated non-responder risk assessment.

Continuing Pharmacy Education CreditLog-in to AMCP Learn at http://amcplearn.org/*PLEASE NOTE: USE THIS EXACT URLFollow instructions available on amcpmeetings.orgHave available:NABP e-profile IDBirth month and birthdaySession-specific attendance codeComplete and submit session evaluation no later than May 23, 2016 (5:00 PM ET)Information in CPE Monitor approximately 72 hours after submission completion

Financial Relationship DisclosuresNathan White reports-eMAX Health: Employee NucleusX Market Access: Employee (Self) Salary ; is employed by CompanySam Rafanelli reports-BiologicTx: Employee (Self) Salary Fred Brownfield reports having no financial relationships with any commercial interests during the past 12 months

AMCP Antitrust GuidelinesAMCPs policy is to comply fully and strictly with all federal and state antitrust laws.This session will be monitored for any antitrust violations and will be stopped by the session monitor if any such violation occurs.Please refer to page 5 of the final program or www.amcp.org/antitrust for more information.

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FacultyFred Brownfield, BSPharmStrategic Consultant - Innovative Contracting, Humana Pharmacy SolutionsHumana Inc.Louisville, Kentucky

Sal Rafanelli, RPhChief Operating Officer and Co-FounderBiologicTxTotowa, New Jersey

Nathan White, CPCManaging Director, Head of Market Access, eMAX Health, White Plains, New York

PRE-TEST

Demographic QuestionWhat title best describes your current position?

PayerManufacturerConsultantRetail, community or hospital pharmacistAcademicStudentOtherTEXT TO 22333320389320391320392320393320395320396320397320398320399

Should we add specialty pharmacy provider?10

Poll Title: Demographic Question: What title best describes your current position?https://www.polleverywhere.com/multiple_choice_polls/1tpELxOVHRoAFEi11

Learning Assessment Question #1Out of the following disease categories, which would benefit the most from outcomes-based contracting?

Rheumatoid arthritisNext-gen hepatitis CDiabetesMultiple sclerosisCholesterol managementOncology

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Poll Title: Learning Assessment Question #1: Out of the following disease categories, which would benefit the most from outcomes-based contracting?https://www.polleverywhere.com/multiple_choice_polls/CCTEhfgJAIhiHV713

Learning Assessment Question #2Of the following, what is the greatest challenge to implementing an outcomes-based contract?

Parties averse to financial riskCorporate structures get in the wayDifficulty in gathering and analyzing clinical dataParties dont see true value in the arrangement

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Poll Title: Learning Assessment Question #2: Of the following, what is the greatest challenge to implementing an outcomes-based contract?https://www.polleverywhere.com/multiple_choice_polls/F7bEbt4z9YjAiv515

Learning Assessment Question #3Outcomes-based contracting in the US started in what year?2001200520092015

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Poll Title: Learning Assessment Question #3: Outcomes-based contracting in the US started in what year?https://www.polleverywhere.com/multiple_choice_polls/D0NH8jCWbAkA9yh17

Learning Assessment Question #4Who has been more active in promoting movement towards an outcomes-based contracting environment?

PayersManufacturersTEXT TO 22333

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Poll Title: Learning Assessment Question #4: Who has been more active in promoting movement towards an outcomes-based contracting environment?https://www.polleverywhere.com/multiple_choice_polls/upoLTkLnusTRq7o19

BackgroundLandscape of Outcomes-based Contracting

SOURCES: http://www.ibj.com/blogs/12-the-dose/post/54074-obama-orders-hospitals-to-serve-full-meal-dealsand-sparks-a-health-care-revolution

WHY CHANGE THE STATUS QUO?

Healthcare Spending as a Percentage of GDP, 1960-2013US Trajectory 1982The overall trend in healthcare spending over the past 35 years is not sustainable.

Rest of First World

196020132%4%6%8%10%12%14%16%18%

#1: UNSUSTAINABLE COSTSInappropriate healthcare resource utilization leads to high costs and poor quality of care.SOURCES: 1Becher EC, Chassin MR. Improving the quality of healthcare: who will lead? Health Aff. 2001;20:68-81.2ASPE analysis of IMS Health NPA data from October 2009 to September 2015.

US spent an estimated $128B on non-retail prescription drugs in 2015.

$2.729 Trillion2015 Total Healthcare Spending

$457 Billion 2015 RX Spend72% Retail Misuse of healthcare resources in the US amounts to roughly 30% of all healthcare costs1

30% $2.729 Trillion2015 Total Healthcare Spending

Non-retail prescription spending represented 28% of the $457B spent on prescription drugsRX drug spending accounted for 17% of total healthcare spend ($457 billion)2

17%

28% Non-retail

#2: DISPROPORTIONATE SPENDINGIn six years, a nearly 30-point gap has arisen between retail expenditures and retail prescription units.The widening gap between RX revenues and RX volume is indicative of trends toward increasingly high-cost treatments and continuing price increases.SOURCES: 1ASPE analysis of IMS Health NPA data from October 2009 to September 2015.

#3: ACCESS BARRIERSSOURCES: 1www.express-scripts.com; www.caremark.com2http://khn.org/news/large-employers-look-to-tighten-control-of-costs-for-expensive-drugs/Barriers to novel drug access will continue to grow with PBM exclusion lists and employer-driven cost containment measures.CVS and ESI grew their formulary exclusion lists by 67% and 61% respectively from 2014 to 2016.

Localized drug managementPersonalized care managementSupply limitPrior authorizationMandatory SPP

#4: INTERNET OF THINGS (IoT)Real-time, real-world data will become easily available as the IoT grows rapidly over the next decade.

SOURCES:1http://www.wallstreetdaily.com/2016/02/10/internet-of-things-big-data-healthcare/ (infographic above)2http://www.lairdtech.com/solutions/embedded-wireless/what-connected-hospital/connected-hospital-infographic3.7 Million

97%10%Medical Devices in US2WiFi Adoption Rate in HospitalsMedical Devices Enabled With WiFI

318.9 Million (2014)5,723US Population

Improved Patient CareObjectives of eConnectivity

Facilitation of Data FlowJohn Chambers, former CEO of Cisco, predicts 500 billion connected devices by 20251.eConnected hospitals

OUTCOMES-BASED CONTRACTING IN EUROPEOutcomes guarantees have been established in European markets for more than a decade.All outcomes-based contracts in Europe involve a significant financial risk component.SOURCES:http://www.ispor.org/research_pdfs/35/pdffiles/PHP15.pdfPatient Population (or sub-population)PatientResponse DependentResponse AssumedCost-EffectivenessCash refundReplacement stockPay for consequenceLonger treatment required, drug free of chargeHigher dose required, drug free of chargePre-agreed price increasePre-agreed price decrease +/- rebatePrice adjusted +/- cash transfer variable determined by dataFailureMaximum treatment cost/patientUnit of AnalysisOutcome MeasureTerms of Settlement

ESI excludes atorvastatin Novartis ESI sacubitril/valsartan AbbVie ESI HepC BCBS patient-centered care program MERCK Cigna sitagliptin/metformin EMD Serono Cigna interferon b-1a Gilead Cigna & Catamaran HepC Amgen Harvard Pilgrim & ESI evolocumab

200520162010

OUTCOMES-BASED CONTRACTING IN THE US Sanofi Health Alliance risedronic acidOutcomes-based contracting in the US had a stalled start in 2009, and began in earnest in 2015.Amgen, AbbVie, Novartis, and Gilead have publicly announced outcomes-based contract discussions over the past 18 months.SOURCES:eMAX Health Research

Objectives and methodsPrimary Research With Payers and Manufacturers

RESEARCH OBJECTIVESeMAX Health conducted research via a web survey with manufacturers and payers.OBJECTIVE 3Pinpoint contract structures that have greatest likelihood of successOBJECTIVE 2OBJECTIVE 1Understand top reasons why outcomes-based contracts are challenging to implementUnderstand which therapeutic categories and drug classes are important for outcomes-based contracting discussionsThe principal goal is to better understand perceptions and opinions of the current outcomes-based contracting landscape.

ABOUT THE SAMPLEThe research was conducted via an internet survey with representatives from both payers and manufacturers who had a moderate to advanced topical knowledge of outcomes-based contracting.Primary Research SampleNational and regional commercial payersn = 17Pharmaceutical Manufacturersn = 29

Representatives of pharmacy benefit managers and large pharmaceutical/biotech companies represent 42% of the experts surveyed.

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ABOUT THE SAMPLEWithin the manufacturer cohort, we obtained insights from stakeholders in HEOR, field managed markets, and payer strategy; within the payer cohort, pharmacy and external relations were most prevalent.Manufacturer Rolesn=29Payer Rolesn=17Of the payers surveyed, nearly a quarter were pharmacy directors; of the manufacturers surveyed, HEOR, managed markets, and market access strategy were evenly represented.

resultsPrimary Research With Payers and Manufacturers

FAMILIARITYQuestion: How familiar are you with the topic of outcomes-based contracting?Three quarters of the screened respondents had a moderate or higher familiarity with the topic of outcomes-based contracting.

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HISTORICAL PERSPECTIVEQuestion: Has your organization implemented an outcomes-based contract in the past five years?All of the payers who participated had been involved in outcomes-based contracting in the past five year, while most in the manufacturer sample had not.YESNO

PLAYERSQuestion: Who has been more active in promoting the outcomes-based contracting movement?The majority of respondents, both payer and manufacturer, believe that payers are in the drivers seat.

n=17n=29

DISEASE AREASQuestion: Outcomes-based contracting arrangements are most promising in what disease area?No singular disease area was mentioned as significantly more important, however, oncology led slightly as an area of interest.

TYPES OF CONTRACTSQuestion: Which type of contract has the most/least potential for success?Both manufacturers and payers agree that clinical performance (or pay-for-performance) contracts have the most potential for success; while a capitated utilization model has the least potential for success.

MOSTLEASTn=46

n=17n=29n=17n=29

MANUFACTURER RISKQuestion: What level of financial risk do you expect manufacturers to take on in order to proceed with an outcomes-based contract?Not surprisingly, payers said that a manufacturer should assume a moderate level of financial risk.

EXCLUSIVITYQuestion: How likely is it that your organization would have future interest in an exclusivity outcomes-based contract?Payers leaned towards a the possibility of a future filled with exclusivity arrangements.

IMPLEMENTATION BARRIERSQuestion: Please rate each of the following implementation barriers. Although the corporate inertia exists to make outcomes-based contracting happen, technical difficulties present as the most challenging barrier to implementation.

Resistance to Financial RiskLeast ChallengingMost Challenging

Corporate StructureTechnical DifficultyLack of Corporate InertiaLack of Perceived Value

IMPLEMENTATION BARRIERSQuestion: What single barrier is most challenging to successful implementation of an outcomes-based contract? The sheer difficulty with the technical aspects of contract implementation ranks as the most challenging barrier to outcomes-based contact implementation.

IMPLEMENTATIONQuestion: What is the likelihood you will implement an outcomes-based contract over the following time periods?Payers more strongly than manufacturers that they would implement outcomes-based contracts in the near future.Six MonthsOne YearTwo YearsThree YearsVery UnlikelyVery Likely

KEY LEARNINGSOur research with payers and manufacturers on outcomes-based contracting yielded seven key learnings. Payers are largely responsible for the push towards outcomes-based contracting

Oncology, metabolic, cardiovascular, and CNS are four key disease areas of interest to payers

Clinical performance agreements are believed to have the highest likelihood of implementation success

Technical difficulties are largely responsible for implementation delays and failures

Manufacturers expected to take on some level of financial risk in an outcomes-based contract

Payers are open to the idea of formulary preference as part of an outcomes-based contract arrangement

Outcomes-based contracting should become more common in the next few years

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Case studiesConstructs of Implemented Outcomes-based Contracts

CASE STUDY #1

sitagliptin/metforminMERCKCIGNA

Disease Area: DiabetesImplemented: 2009AGREEMENT COMPONENTSGOALS/OUTCOMESCIGNA assesses the blood sugar levels (A1c lab values) for patients on any oral antidiabetic medicationsIf the A1c values, in aggregate, improve by the end of the agreement period, the discounts will decrease by a pre-agreed amountCIGNA uses claims data to determine if patients are taking the Merck drugs as prescribedBetter placement on CIGNAs formularyLower copayment versus that for other branded drugsIn 2010, CIGNA announced positive outcomes from the diabetes support program: Patients blood sugar levels were reduced by more than 5%, Individuals who participated were more likely to control their blood sugar than those who did not participate in the program87% of patients who took the Merck drugs took their medications correctly

SOURCE: http://www.ispor.org/meetings/montreal0614/presentations/IP9-AllSpeakers.pdf Type: Clinical PerformanceThe MERCK-Cigna deal is one of the few to have publicly released results of the program.

CASE STUDY #2

Interferon beta-1aEMD SERONOCIGNA

Disease Area: MSImplemented: 2011AGREEMENT COMPONENTSGOALS/OUTCOMESCIGNA tracks the percentage of hospitalizations and ER visits avoided by people using EMD Serono drugCIGNA uses medical claims in order to determine whether a relapse was the cause for hospitalization and/or ER visitsCIGNA uses 2010 as a baseline, looking at data from medical, pharmacy and lab claims, and measuring members medication-possession ratio (MPR)EMD Serono provides rebates based on adherence outcomes and relapse-free patients

Because MS eventually leads to a state of disability, CIGNA helps to delay disease progression and quick accumulation of irreversible neurological damage by improving adherenceUsing experiences in MS, CIGNA extended its monitoring strategies to other conditions through the THERACARE program

SOURCE: https://aishealth.com/archive/nspn0411-01 Type: Clinical PerformanceThe EMD Serono-Cigna deal is the only publicly acknowledged US OBC in MS.

CASE STUDY #3

evolocumabAMGENHARVARD PILGRIM

Disease Area: CVImplemented: 2015AGREEMENT COMPONENTSGOALS/OUTCOMESAmgen gained formulary preference as part of the dealHarvard Pilgrim can also receive additional rebates if utilization is above a pre-determined amountAmgen will be at risk financially if health plan members cholesterol levels arent lowered enoughThe pay-for-performance element is in addition to the discount

Compare patient low-density lipoprotein cholesterol levels to clinical trial outcomes

SOURCE: http://www.modernhealthcare.com/article/20151109/NEWS/151109899 Type: Clinical PerformanceAmgen implemented a highly innovative risk-based contract model focused on a population-health outcome.

Appropriate care MODELReal-world Example of an Outcomes-based Contracting Program

Large % of patients on specialty drugs do not respond but stay on therapy

APPROPRIATE CARE MODELAn appropriate care model identifies non-responders based on therapeutic response.The single greatest opportunity to reduce aggregate claim dollars in specialty is to identify patients that do not respond and take them off the drug.SOURCES: 1eMAX Health claims analysis2Adalimumab Full Prescribing Information3Hughes et al., Lancet Neurol 2008; 7: 13644Inappropriate Use

PROBLEM

OBJECTIVESReduce treatment days with no responseIntegrate outcomes and authorizationsEstablish funding partnership for patient monitoring46% of CIDP patients did not respond to IVIG after 24 weeks, yet 75% of patients are on treatment for more than 48 weeks1,3Adalimumab showed only a 53% response rate after 6 months2Reimbursement decisions based on actual response

Point of care drug assessment mobile appUtilization preference in exchange for price adjustment to offset monitoring costStandardized AssessmentDiscounts/Rebates Response-linked AuthorizationsSOLUTION

PROGRAM FLOWThe appropriate care model supplements current drug authorization process.At PA/re-auth, point, plan requires enrollment in program

Partner SPP conducts assessment on behalf of plan in case management system

Software flags non-respondersProgram administrator coordinates with SPP and provider to identify alternate care plans for non-respondersPlan authorization department makes ultimate coverage decision using outcomes dataProgram administrator manages the rebate between the manufacturer sponsor and healthplanProgram administrator reports on program savings to healthplan and manufacturer sponsor

CASE STUDY: APPROPRIATE CARE

IGIVDE-IDENTIFIEDDE-IDENTIFIED

Disease Area: NeurologyImplemented: N/AAGREEMENT COMPONENTSGOALS/OUTCOMESReal-time patient outcomes data monitored via point of care assessment toolAppropriate site-of-care and treatment response were monitoredNon-responders were transitioned to alternate site-of-care and/or alternate treatment Manufacturer sponsored monitoring program in exchange for formulary preference

Savings PMPM: $.2226% reduction in drug spend for treated patientsType: Appropriate CareManufacturer implemented an appropriate care model focused on identifying non-responders in exchange for formulary preference.

$111.9m$99m

BENEFITSThe primary benefit of an appropriate care model contracting model is to improve overall health outcomes by reducing inappropriate utilization of treatment, resulting in savings to the payer.Improve and simplify health outcomes for chronic disordersSimplify health outcomes monitoring for therapyReduce duration of treatment for non-responding patientsProvide medically-defensible coverage determinationReduce specialty drug spend for non-responding patientsReduce specialty drug spend by optimizing site of care

Role of specialty pharmacyHow does specialty pharmacy fit in?

ROLE OF SPECIALTY PHARMACYSpecialty and infusion pharmacies play an important role in the patient care and monitoring aspects of outcomes-based contracting programs.In the high-cost specialty area, health plans provider networks can play an important role in outcomes-based contracting

Outcomes data must be conveyed quickly and efficiently to be actionableInfusion ProvidersInfusion pharmacies administer the drug creating an opportunity to assess patient status in real-timeRelying on claims data to review drug performance only offers retrospective price adjustment, but not a change in appropriate care and coveragePhysically at the point-of-careRoutinely interact with patients

HEALTH STATUS MONITORINGSpecialty pharmacy disease programs provide opportunity for health status monitoring.Specialty pharmacy and home infusion providers develop disease programs with routine patient touch points.

Key patient status parameters under disease programs are captured at the point of care and reside in pharmacy software

Creates a unique global picture of therapeutic impact and treatment efficacyCaptures and reports clinical profile, lab data, adverse events, medication history, insurance information, and general metrics

CONTRACTING PROGRAMSSpecialty pharmacies already reside in payer networks, allowing seamless participation in contracting programs.Payer-directed patient volume provides incentives for patient monitoring and data reporting

Pharmacies can efficiently monitor patient status through data collection tools provided under a programData Collection MethodsNurse enter data into pharmacy software which can be relayed electronically to data aggregator for use by payer and prescriberPaper SurveysEfficient tools are deployed in the field for ongoing monitoring if there is minimal training and data integration requirementsSpecialty pharmacies maintain electronic medical records for its patients - data elements can be incorporated into programs to define outcomesElectronic ApplicationMedical Records

HOME INFUSION CASE STUDY

IGIVDE-IDENTIFIEDDE-IDENTIFIEDDisease Area: NeurologyImplemented: N/ACOMPONENTSBiologicTx negotiates reimbursement rates with payers to compensate for monitoring and reporting cost Manufactures offer brand preference agreements in the form of a rebate with health plans to offset the cost of monitoringManufactures may also offer discounted drug purchase agreements with pharmacies for participation in the payer programType: Appropriate CareBiologicTx participates as infusion pharmacy to deliver IGIV to patients with neurological disability.

Nurses nationally trained on the use of point-of-care application to assess patient neurological status

Pharmacy on-boards cases during prior authorization process and links the upcoming patient encounter to a nurse for monitoring Infusion pharmacy ships product along with a hard copy of disability survey as a back-up to digital application surveyInfusion nurse arrives at the home and conducts digital survey on tablet or phone through a secure URL, to assess neurological disabilityNeurological status data are relayed to the program manager in real-time and provided to the health plan to make coverage decisions

Payer perspectiveInsights From a Leader in Outcomes-based Contracting

INNOVATIVE CONTRACTING

Drug AccessReal World EvidenceReal World DataPatient Response StatisticsTherapeutic ResponseProgression Free SurvivalHospital AvoidanceLower DiscontinuationDisease CureAssess EffectivenessMeasure EndpointsShare Financial Responsibility for Failures/Successes

Total Cost of CarePharmaceutical ManufacturerHumana

RECIPE FOR SUCCESS

Keep it simpleSenior level support/buy-inBeing a captive PBMDedicated HEOR analytical support staffAligned incentives within the organizationBe willing to share in risk

INNOVATIVE CONTRACTING TYPES

ToxicityTherapeutic ResponseNew Approaches

RelapseDiscontinuation

Indication Based

Hospital Admission

Total Cost of Care

Adverse Events

WastageDuration

Progression

QualityOf Life

CHALLENGES

ASP pricing Medicaid Best Price Safe Harbor/Anti-kickback statuteWillingness of pharma to participateFinding and funding the money from pharma

CHALLENGESData limitations and privacy concernsFire wall within pharmaLimited payer participationLack of access to medical claims in PDP

LESSONS LEARNED

HPS has contracts in place for CFI, MAPD and both lines of business

Understanding the data, what we have, who owns it, where to find it

Need to have access to experts in data management and HEOR Usually an addendum to an existing rebate contract The outcome or cost associated is paid as a rebate

LESSONS LEARNED

Revenue is DIR reportablePersistency and adherence are part of the contractMost contracts are for one yearData submitted quarterly, bi-annual or annuallyBuild 120 days into submissions due to medical claim lagAverage time to execute is 6-9 months ROI is knowledge gained, not revenue produced

Post-Test

Learning Assessment Question #1Out of the following disease categories, which would benefit the most from outcomes-based contracting?

Rheumatoid arthritisNext-gen hepatitis CDiabetesMultiple sclerosisCholesterol managementOncology

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Poll Title: Learning Assessment Question #1: Out of the following disease categories which would benefit the most from outcomes-based contracting?https://www.polleverywhere.com/multiple_choice_polls/YXWg7pmHtQKacaR68

Learning Assessment Question #2Of the following, what is the greatest challenge to implementing an outcomes-based contract?

Parties averse to financial riskCorporate structures get in the wayDifficulty in gathering and analyzing clinical dataParties dont see true value in the arrangement

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Poll Title: Learning Assessment Question #2.b: Of the following, what is the greatest challenge to implementing an outcomes-based contract?https://www.polleverywhere.com/multiple_choice_polls/Tlx50m0BXDjCaCp70

Learning Assessment Question #3Outcomes-based contracting in the US started in what year?2001200520092015

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Poll Title: Learning Assessment Question #3.b: Outcomes-based contracting in the US started in what year?https://www.polleverywhere.com/multiple_choice_polls/lRSBkW8KxG7623s72

Learning Assessment Question #4Who has been more active in promoting movement towards an outcomes-based contracting environment?

PayersManufacturersTEXT TO 22333

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Poll Title: Learning Assessment Question #4.b: Who has been more active in promoting movement towards an outcomes-based contracting environment?https://www.polleverywhere.com/multiple_choice_polls/NDui6b2mdPLI1uh74

Questions?[PLACEHOLDER CODE]

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