AETNA BETTER HEALTH® · tramadol and codeine, as either single or combination products. Policy...

AETNA BETTER HEALTH® Prior Authorization guideline for Narcotic Analgesic Utilization

Policy applies to all formulary and non-formulary schedules II –V opioid narcotics, including tramadol and codeine, as either single or combination products. Policy applies to all formulations (e.g. oral, topical, and parenteral formulations).

Members under the age of 18 with a diagnosis of active cancer, sickle cell anemia with crisis, neonatal abstinence syndrome or receiving palliative care/hospice will be exempt from prior authorization for formulary agents.

Members 18 years of age or older with a diagnosis of active cancer or sickle cell with crisis or receiving palliative/hospice care will be exempt from prior authorization for formulary agents.

Preferred Opioid Analgesics

Acetaminophen-Codeine #2 TABLET 300-15 MG Oral

Acetaminophen-Codeine #3 Tablet 300-30 MG Oral

Acetaminophen-Codeine #4 Tablet 300-60 MG Oral

Acetaminophen-Codeine SOLUTION 120-12 MG/5ML Oral Butalbital-APAP-Caff-Cod CAPSULE 50-300-40-30 MG ORAL Butalbital-APAP-Caff-Cod CAPSULE 50-325-40-30 MG ORAL Butalbital-ASA-Caff-Codeine CAPSULE 50-325-40-30 MG ORAL Codeine Sulfate TABLET 15 MG ORAL

Codeine Sulfate TABLET 30 MG ORAL

Codeine Sulfate TABLET 60 MG ORAL

FentaNYL Citrate Lozenge on a Handle 1200 MCG Buccal FentaNYL Citrate Lozenge on a Handle 1600 MCG Buccal FentaNYL Citrate Lozenge on a Handle 200 MCG Buccal

FentaNYL Citrate Lozenge on a Handle 400 MCG Buccal

Methadone HCl CONCENTRATE 10 MG/ML Oral

Methadone HCl SOLUTION 10 MG/5ML ORAL

Methadone HCl SOLUTION 5 MG/5ML ORAL

Methadone HCl Tablet 10 MG Oral

Methadone HCl Tablet 5 MG Oral

Methadone HCl TABLET SOLUBLE 40 MG ORAL

Morphine Sulfate (Concentrate) Solution 10 MG/0.5ML Oral Morphine Sulfate ER Tablet Extended Release 100 MG Oral Morphine Sulfate ER Tablet Extended Release 15 MG Oral Morphine Sulfate ER Tablet Extended Release 200 MG Oral Morphine Sulfate ER Tablet Extended Release 30 MG Oral Morphine Sulfate ER Tablet Extended Release 60 MG Oral Morphine Sulfate SOLUTION 10 MG/5ML Oral

Morphine Sulfate SOLUTION 20 MG/5ML Oral

Last Review: 11/2017 Previous PARP Approval: 1/2018

Current PARP Approval: 8/2018



FentaNYL Patch 72 Hour 100 MCG/HR Transdermal





Hydrocodone-Acetaminophen SOLUTION 7.5-325 MG/15ML Oral Hydrocodone-Acetaminophen Tablet 10-325 MG Oral

Hydrocodone-Acetaminophen Tablet 2.5-325 MG Oral

Hydrocodone-Acetaminophen Tablet 5-325 MG Oral

Hydrocodone-Acetaminophen Tablet 7.5-325 MG Oral

Hydrocodone-Homatropine SYRUP 5-1.5 MG/5ML Oral

Hydrocodone-Homatropine TABLET 5-1.5 MG Oral

Hydrocodone-Ibuprofen TABLET 10-200 MG Oral

Hydrocodone-Ibuprofen TABLET 5-200 MG Oral

Hydrocodone-Ibuprofen TABLET 7.5-200 MG Oral

Hydromet SYRUP 5-1.5 MG/5ML ORAL

HYDROmorphone HCl PF Solution 10 MG/ML Injection

HYDROmorphone HCl PF Solution 50 MG/5ML Injection

HYDROmorphone HCl PF Solution 500 MG/50ML Injection HYDROmorphone HCl Solution 2 MG/ML Injection

HYDROmorphone HCl SUPPOSITORY 3 MG Rectal

HYDROmorphone HCl Tablet 2 MG Oral

Morphine Sulfate SUPPOSITORY 10 MG Rectal




Morphine Sulfate TABLET 15 MG ORAL

Morphine Sulfate TABLET 30 MG ORAL

OxyCODONE HCl SOLUTION 5 MG/5ML Oral

OxyCODONE HCl TABLET 10 MG Oral



OxyCODONE HCl Tablet 30 MG Oral

OxyCODONE HCl Tablet 5 MG Oral

Oxycodone-Acetaminophen Tablet 10-325 MG Oral

Oxycodone-Acetaminophen TABLET 2.5-325 MG Oral

Oxycodone-Acetaminophen Tablet 5-325 MG Oral

Oxycodone-Acetaminophen Tablet 7.5-325 MG Oral

Oxycodone-Aspirin TABLET 4.8355-325 MG Oral

OxyMORphone HCl ER Tablet Extended Release 12 Hour 10 MG Oral OxyMORphone HCl ER Tablet Extended Release 12 Hour 15 MG Oral OxyMORphone HCl ER Tablet Extended Release 12 Hour 20 MG Oral OxyMORphone HCl ER Tablet Extended Release 12 Hour 30 MG Oral OxyMORphone HCl ER Tablet Extended Release 12 Hour 40 MG Oral OxyMORphone HCl ER Tablet Extended Release 12 Hour 5 MG Oral OxyMORphone HCl ER Tablet Extended Release 12 Hour 7.5 MG Oral



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HYDROmorphone HCl Tablet 4 MG Oral

HYDROmorphone HCl TABLET 8 MG Oral

Pentazocine-Naloxone HCl TABLET 50-0.5 MG Oral

Promethazine VC/Codeine SYRUP 6.25-5-10 MG/5ML ORAL Promethazine-Codeine Syrup 6.25-10 MG/5ML Oral

TraMADol HCl Tablet 50 MG Oral

Tramadol-Acetaminophen Tablet 37.5-325 MG Oral

Coverage Policy

• Short-acting opiate containing medications (with and without acetaminophen, aspirin, and ibuprofen, pentazocine and tramadol) will be limited to a 5 day supply without prior authorization for members 21 years old or older and to a 3-day supply without prior authorization for members under age 21.

• Long-Acting opiate containing medications require prior authorization before the original fill.

• Prior authorization is always required for non-formulary opioids.

• Prior authorization is required for doses exceeding 50 MME per day (Morphine Milligram Equivalent).



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Authorization guidelines

CRITERIA FOR SHORT-ACTING OPIOIDS

Initial Review

A. Documentation of one of the following exemptions: a) Request is for a formulary agent

and b) Member is < 18 years old with a diagnosis of active cancer, sickle cell anemia with crisis,

neonatal abstinence syndrome or receiving palliative care/hospice and drug not does not contain codeine or tramadol or

c) Member is ≥ 18 years with a diagnosis of active cancer or sickle cell with crisis or receiving palliative/hospice care

OR B. Request is for either of the following:

a) More than a 5-day supply for members ≥ 21 years old or a 3-day supply for members < 21 years old or

b) Less than a 5-day supply for members ≥ 21 years old or a 3-day supply for members <21 years old at a dose of 50 MME/day or greater

AND C. Documentation of moderate or severe pain and the associated diagnosis

AND D. Documentation of rationale for use of a short acting opioid for more than 5 days for members ≥ 21

years old or for more than 3 days for members < 21 years old and the anticipated duration of therapy AND

E. Member was recently assessed for use of an opioid (within the past 60 days) AND

F. Documentation of therapeutic failure, contraindication, or intolerance to non-pharmacological and non-opioid therapies (e.g. acetaminophen, non-steroidal anti-inflammatory agents (NSAIDSs)) AND

G. Member or parent/guardian has been educated on the potential adverse effects AND

H. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary AND

I. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database AND



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J. Member has a pain management agreement on file AND

K. If member is under 18 years of age, short acting opioid does not contain codeine or tramadol AND

L. Prescriber has counseled member on the use of naloxone (or has already prescribed naloxone) for members with any of the following risk factors for opioid-related harm:

a) opioid doses ≥ 50 MME per dayb) history of overdose c) history of SUD (substance use disorder d) concurrent benzodiazepine use

AND M. Member has baseline urine drug screen (UDS)* that is consistent with prescribed controlled

substances and will have ongoing UDS at the following frequency: a) UDS every 3-12 months for members on opioid doses < 50 MME per day b) UDS every 3-6 months for members on opioid doses ≥ 50 MME per day

*Note: Includes testing for licit and illicit drugs with the potential for abuse; must include specific testing for oxycodone, fentanyl, tramadol, and carisoprodol

AND N. If request is for ≥ 50 Morphine Milligram Equivalents (MME) per day, documentation of the

following: a) Medication is prescribed by an appropriate specialist or in consultation with an

appropriate specialist b) Pain is inadequately controlled at lower dosage

AND O. If request is for a transmucosal fentanyl product, documentation of the all of following:

a) Member has a diagnosis of cancer b) Member is opioid tolerant (defined as taking at least morphine 60 mg/day, transdermal

fentanyl 25 mcg/h, oxycodone 30 mg/day, oral hydromorphone 8 mg/day, or an equi-analgesic dose of another opioid for one (1) week or longer)

c) The prescriber is an American Board of Medical Specialties (ABMS) Certified Oncologist or Pain Specialist

d) Trial and failure, contraindication or inadequate response to a preferred agent AND

P. If request is for nasal butorphanol, documentation of all of the following: a) Member has a diagnosis of migraine b) Member is managed by a neurologist or pain medication specialist c) Trial and failure, contraindication or inadequate response to triptans for acute treatment of

migraine attacks d) Trial and failure, contraindication or inadequate response to two (2) of the following

preventative therapies: 1) Beta blockers



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2) Calcium channel blockers 3) Anticonvulsants 4) Selective serotonin reuptake inhibitor (SSRI) Antidepressants 5) Tri-cyclic antidepressants 6) Non-steroidal anti-inflammatories (NSAIDs)

AND Q. If member is on concurrent buprenorphine or naltrexone for extended-release injectable suspension

(Vivitrol), documentation of all of the following: a) Both of the prescriptions are written by the same prescriber or, if written by different

prescribers, all prescribers are aware of the other prescription(s) b) The member has an acute need for therapy with a short acting opioid and the other therapy

will be suspended during the treatment for acute pain AND

R. If there is therapeutic duplication with another short acting opioid, documentation of the following: a) The member is being titrated to, or tapered from, a drug in the same class

or b) There is supporting peer-reviewed literature or national treatment guidelines for the

concomitant use AND

S. If request is for a non-preferred short acting opioid, there’s documentation of trial and failure, contraindication, or inadequate response to a preferred agent

Requests for Renewals

A. Documentation of improvement in pain control and level of functioning while on the requested agent AND

B. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary AND

C. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database AND

D. Prescriber has counseled member on the use of naloxone or has already prescribed naloxone for members with any of the following risk factors for opioid-related harm:

a) opioid doses ≥ 50 MME per dayb) history of overdose c) history of SUD (substance use disorder d) concurrent benzodiazepine use

AND E. Documentation of one of the following:



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a) If member is taking <50 Morphine Milligram Equivalents (MME) per day: A urine drug screen (UDS)* is performed every 3-12 months and is consistent with prescribed controlled substances

b) If member taking ≥ 50 MME per day: Member has a UDS every 3-6 months that is consistent with prescribed controlled substances




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CRITERIA FOR LONG-ACTING OPIOIDS

Initiation of Therapy

A. Documentation of one of the following exemptions: a) Request is for a formulary agent AND b) Member is < 18 years old with a diagnosis of active cancer, sickle cell anemia with crisis,

neonatal abstinence syndrome or receiving palliative care/hospice or

c) Member is ≥ 18 years with a diagnosis of active cancer or sickle cell with crisis or receiving palliative/hospice care

OR B. Documentation of moderate or severe pain and the associated diagnosis/rationale for use

AND C. Documentation of anticipated duration of therapy

AND D. Member or parent/guardian has been educated on the potential adverse effects

AND E. Prescriber has counseled member on the use of naloxone or has already prescribed naloxone for

members with any of the following risk factors for opioid-related harm: a) opioid doses ≥ 50 MME per dayb) history of overdose c) history of SUD (substance use disorder d) concurrent benzodiazepine use

AND F. Member has baseline urine drug screen (UDS)* that is consistent with prescribed controlled

substances and will have ongoing UDS at the following frequency: a) UDS every 3-12 months for members on opioid doses < 50 MME per day b) UDS every 3-6 months for members on opioid doses ≥ 50 MME per day


AND G. Documentation of therapeutic failure, contraindication, or intolerance to non-pharmacological and

non-opioid analgesics (e.g. acetaminophen, non-steroidal anti-inflammatory agents (NSAIDSs)) AND

H. Member is opioid tolerant* and previously received a trial of short-acting opioids

Note: *opioid tolerance is defined as taking at least morphine 60 mg/day, transdermal fentanyl 25 mcg/hour, oxycodone 30 mg/day, oral hydromorphone 8 mg/day or an equi-analgesic dose of

another opioid for one week or longer AND



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I. Prescribed dosing regimen is FDA-approved or supported by nationally recognized compendia and standards of care AND

J. Member was recently assessed for use of an opioid (within the past 60 days) AND

K. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary AND

L. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database AND

M. Member has a pain management agreement on file AND

N. In addition, a) if request is for Oxymorphone ER or for a non-preferred long-acting opioid: documentation

of trial and failure, contraindication, or inadequate response to at least 2 weeks of TWO formulary long-acting opioids (i.e., fentanyl patch, morphine sulfate ER, methadone)

b) if request is for Nucynta ER for the treatment of diabetic peripheral neuropathy: 1) Trial and failure, contraindication or inadequate response to duloxetine AND

tramadol AND at least ONE additional formulary medication (i.e., gabapentin, amitriptyline, nortriptyline, or topical capsaicin)

2) Trial of formulary agents were for at least 4 weeks and at maximum tolerated doses

Requests for Renewals

A. Documentation of improvement in pain control and level of functioning while on the requested agent AND

B. Member is not taking a benzodiazepine, unless the benzodiazepine or opioid is being tapered or concomitant use is determined medically necessary AND

C. Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database AND

D. Prescriber has counseled member on the use of naloxone or has already prescribed naloxone for members with any of the following risk factors for opioid-related harm:

a) opioid doses ≥ 50 MME per dayb) history of overdose c) history of SUD (substance use disorderd) concurrent benzodiazepine use

AND



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E. Documentation of one of the following: a) If member is taking <50 Morphine Milligram Equivalents (MME) per day: A urine drug screen

(UDS)* is performed every 3-12 months and is consistent with prescribed controlled substances

b) If member taking ≥ 50 MME per day: Member has a UDS every 3-6 months that is consistent with prescribed controlled substances


Authorization and Limitations

Members with a diagnosis of active cancer, sickle cell with crisis or neonatal abstinence syndrome, or is receiving palliative care or hospice services will be granted one year authorizations.

Initial Length: Lesser of the duration requested or 6 months.

Extended Approval: Lesser of the duration requested or 1 year.

A partial approval may be considered when there is documentation of the following: a. Member has no current valid authorization b. Information available indicates that the member has been chronically taking opioids (covered by

Aetna or another payer) and would be at risk for withdrawal if treatment were abruptly discontinued/interrupted

c. The requested opioid treatment is determined to be not medically necessary or inappropriate and would otherwise be denied, but a tapering regimen should be undertaken to safely discontinue opioid treatment.

d. The member is currently expected to be without or have less than 7 days’ supply of medication on hand based on claim history or provider supplied information

e. The requested prior authorization request does not meet the criteria outlined in this guideline for full Initial Approval or Extend Approval (outlined below) due to missing or incomplete information.

f. Duration of the partial approval is at the discretion of the medical director based on the information supplied, not to exceed 3 months.

Medically Necessary — A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards:

The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability.

The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability.



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The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age.

Determination of Medical Necessity for covered care and services, whether made on a Prior Authorization, Concurrent Review, Retrospective Review, or exception basis, must be documented in writing.

The determination is based on medical information provided by the Member, the Member’s family/caretaker and the Primary Care Practitioner, as well as any other Providers, programs, agencies that have evaluated the Member.

All such determinations must be made by qualified and trained Health Care Providers. A Health Care Provider who makes such determinations of Medical Necessity is not considered to be providing a health care service under this Agreement.

References:

1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated October, 2013.

2. National Institute for Health and Care Excellence (NICE). Neuropathic pain - pharmacological management. The pharmacological management of neuropathic pain in adults in non-specialist settings. London (UK): National Institute for Health and Care Excellence (NICE); . (Clinical guideline; no. 173). Updated February 2017

3. Xtampza ER (oxycodone hydrochloride) extended-release capsule package insert. Cincinnati OH: Patheon Pharmaceuticals. April 2016

4. Butrans (buprenorphine transdermal system) package insert. Stamford, CT: Purdue Pharma L.P Updated June 2014

5. Nucynta (tapentadol extended-release oral tablets) package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc. Updated December 2016

6. Xartemis XR (acetaminophen; oxycodone) extended-release tablets. Hazelwood MO: Mallinckrodt Brand Pharmaceuticals, Inc. Updated March 2014

7. Kirschner N, Ginsburg J, Sulmasy LS for the Health and Public Policy Committee of the American College of Physicians. Prescription Drug Abuse: Executive Summary of a Policy Position Paper from the American College of Physicians. Annals of Internal Medicine 2014;160(3):198-200.

8. FDA News Release: FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics; September 10, 2013. Available at http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm367726.htm.

9. Belbuca (buprenorphine) buccal film package insert. Endo Pharmaceuticals Inc Updated October 2015

10. Embeda (morphine; naltrexone) package insert. New York, NY: Pfizer, Inc June 2009



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http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm367726.htm

http://www.clinicalpharmacology.com

11. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1

12. Pennsylvania Guidelines on the Use of Opioids to Treat Chronic Noncancer Pain. Accessed January 31, 2017,http://www.health.pa.gov/My%20Health/Diseases%20and%20Conditions/MP/opioids/Do cuments/PAGuidelinesonOpioids.pdf

Last Review: 11/2017Previous PARP Approval: 1/2018


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http://dx.doi.org/10.15585/mmwr.rr6501e1

http://www.health.pa.gov/My%20Health/Diseases%20and%20Conditions/MP/opioids/Documents/PAGuidelinesonOpioids.pdf

http://www.health.pa.gov/My%20Health/Diseases%20and%20Conditions/MP/opioids/Documents/PAGuidelinesonOpioids.pdf

AETNA BETTER HEALTH® · tramadol and codeine, as either single or combination products. Policy...

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