Pharmacy Clinical Policy Bulletins Aetna Medicare Prescription Drug Plan
Subject: Analgesics - Duragesic
Status
Drug
PR-B/D
PR
PR-QL
PR-AL
ST
M EX‡
TOC§
C
APAP/butalbital/caffeine/codeine
C
acetaminophen/codeine
C
aspirin/butalbital/caffeine/codeine
C
butorphanol nasal spray
X
C
fentanyl transdermal
X
C
hydrocodone/acetaminophen
C
hydrocodone/ibuprofen
C
hydromorphone
C
methadone
C
morphine, morphine SR
C
oxycodone
C
oxycodone SR
X
C
oxycodone/acetaminophen
C
oxycodone/aspirin
C
Oxyfast® (oxycodone)
C
tramadol
C
Kadian CR®(morphine CR)
C
OxyContin CR®(oxycodone SR)
X
NC
Duragesic®(fentanyl transdermal)
X
X
Note: Criteria for OxyContin CR and oxycodone SR are discussed in Pharmacy Clinical Policy Bulletin: OxyContin CR; and Criteria for butorphanol nasal spray are discussed in the Pharmacy Clinical Policy Bulletin: Analgesics
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, Duragesic and fentanyl transdermal are subject to precertification. If precertification requirements apply Aetna considers Duragesic and fentanyl transdermal to be medically necessary for those members who meet the following precertification criteria:
A. Quantity limits:
According to the manufacturer, one Duragesic transdermal patch and fentanyl transdermal patch will supply fentanyl for absorption for 72 hours. A quantity of Duragesic or fentanyl transdermal of up to 20 patches per 30-day increments (2 patches per 3 days) will be considered medically necessary.
For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of Duragesic or fentanyl transdermal will be considered medically necessary for those members who meet ANY of the following criteria:
Member has diagnosis of cancer OR
Member is enrolled in a hospice program or meets hospice criteria OR
Duragesic prescription is written by an oncologist or pain specialist OR
Member has a diagnosis of moderate to severe chronic pain AND
A formal pain evaluation has been documented AND
Other pain management regimens have been inadequate OR
Member has failed an every-72-hours regimen and requires dosing every 48 hours OR
Member requires a regimen of Duragesic or fentanyl transdermal with more than one patch every 72 hours
Medical Exception Criteria
Duragesic is currently a Not Covered Part D drug under the Aetna Medicare Prescription Drug Plan.* Therefore, it is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Duragesic to be medically necessary for those members who meet ANY of the following criteria:
A. A documented:
Contraindication to two covered narcotic analgesics (single entity or combination products) OR
Intolerance to two covered narcotic analgesics (single entity or combination products) OR
Allergy to two covered narcotic analgesics (single entity or combination products) OR
Failure of an adequate clinical trial of one week each of at least two covered narcotic analgesics (single entity or combination products)
* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.
Place of Service:
Outpatient
The above policy is based on the following references:
Jeel & Benfield. Transdermal fentanyl: a review of its pharmacologic properties and therapeutic efficacy in pain control. Drugs; January 1997.
Donner B. Zenz. Transdermal fentanyl: a new step on the therapeutic ladder. Anticancer Drugs 1995; April 6 (SUPPL 3): 39-43.
Vielvoye-Kerkmeer A, Mattern C, Uitendaal MP. Transdermal fentanyl in opioid-naïve cancer pain patients: an open trial using transdermal fentanyl for the treatment of chronic cancer pain in opioid-naïve patients and a group using codeine. J Pain Symptom Manage 2000;19:185-92.
Mystakidou K, Befon S, Tsilika E, Dardoufas K, et al. Use of TTS fentanyl as a single opioid for cancer pain relief: a safety and efficacy clinical trial in patients naïve to mild or strong opioids. Oncology. 2002;62(1):9-16.
Richards D, Simmonds M, Shelby S, et al. Once daily, rapid onset extended release morphine in patients with chronic malignant pain. Abstract #1559. Presented at the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.
Rischitelli DG, Karbowicz SH. Safety and efficacy of controlled-release oxycodone: A systematic literature review. Pharmacotherapy 2002;22(7):898-904.
Quigley C. Hydromorphone for acute and chronic pain. Cochrone Database Syst Rev. 2002;(1):CD003447.
Broomhead A, Kerr R, Tester W, O'Meara P, Maccarrone C, et al. Comparison of a once-a day sustained-release morphine formulation with standard oral morphine treatment for cancer pain. J Pain Symptom Manage 1997; 14 (2): 63-73.
Kerr R, Tester W. A patient preference study comparing two extended-release morphine sulfate formulations (once-daily Kadian versus twice-daily MS Contin) for cancer pain. Clin Drug Invest 2000; 19 (1): 25-32.
Duragesic Package Information. Janssen Pharmaceutics. Titusville, NJ. February 2001.
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med. 2003;163:2716-24.
Zahn C, Sangl J, Bierman AS, et al. Potentially inappropriate medication use in the community-dwelling elderly. JAMA. 2001;286:2823-29.
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.