Note: Criteria for fentanyl and Duragesic are discussed in Pharmacy Clinical Policy Bulletin: Duragesic; and Criteria for oxycodone sr and OxyContin SR are discussed in the Pharmacy Clinical Policy Bulletin: OxyContin SR
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, butorphanol nasal spray , Combunox, Darvocet-N, Darvon Compound, Demerol, meperidine, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCL, propoxyphene/aspirin/caffeine, propoxyphene napsylate/acetaminophen, Stadol NS, Talacen, Talwin NX, Trycet and Wygesic are subject to precertification. If precertification requirements apply Aetna considers butorphanol nasal spray, Combunox, Darvocet-N-100, Darvon Compound, Demerol, meperidine, meperidine/promethazine, pentazocine, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCL, propoxyphene/aspirin/caffeine, propoxyphene napsylate/acetaminophen, Stadol NS, Talacen, Talwin NX, Trycet and Wygesic to be medically necessary for those members who meet the following precertification criteria:
A. Quantity limits:
For butorphanol nasal spray and Stadol NS
Quantity limits: 2 vials/30 day supply increments
For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of butorphanol nasal spray or Stadol NS will be considered medically necessary for those members who meet the following criterion:
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
For Combunox
Quantity limits: 5 mg/400 mg - 120 tablets per 30 days
For coverage of additional tablets, member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of Combunox will be considered medically necessary for those members who meet the following criterion:
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
B. Age limits:
For Darvocet-N, Darvon Compound, Demerol, meperidine, pentazocine/acetaminophen, pentazocine/naloxone, propoxyphene HCL, propoxyphene/aspirin/caffeine, propoxyphene napsylate/acetaminophen, Talacen, Talwin NX, Trycet and Wygesic
Age limit for members greater than or equal to 65 years of age:
Member has tried and failed alternative drugs that are appropriate in the elderly to treat the condition OR
Member has been stabilized on the drug for an extended period and discontinuation or change in the drug might result in physical and/or mental impairment OR
Member is in a critical or terminal state and disruption of therapy at this point would be inappropriate AND
Member is being monitored AND
Member has no known history of emergency department visits and/or hospital admissions from use of the drug in the member
Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Bancap HC,Capital/Codeine, Combunox, Darvocet-N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet HD/Lorcet Plus, Lortab, Norco, Percocet, Percodan, Reprexain, Talacen, Trycet, Tylenol #3, Tylox, Vicodin, Vicodin ES, Vicoprofen, Xodol, and Zydone are subject to step-therapy. Aetna considers, Bancap HC, Capital/Codeine, Combunox, Darvocet-N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet HD/Lorcet Plus, Lortab, Norco, Percocet, Percodan, Reprexain, Talacen, Trycet, Tylenol #3, Tylox, Vicodin, Vicodin ES, Vicoprofen, Xodol and Zydone to be medically necessary for those members who meet the following step-therapy criterion:
A documented trial of two days of the corresponding covered generic equivalent
If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)
Medical Exception Criteria
Bancap HC, Capital/Codeine, Combunox, Darvocet N, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/Lorcet HD/Lorcet Plus, Lortab, Norco, Percocet, Percodan, Reprexain, Talacen, Trycet, Tylenol #3, Tylox, Vicodin, Vicodin ES, Vicoprofen, Xodol, and Zydone are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan* and are on the Aetna Step-Therapy List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step therapy criteria, unless a medical exception is granted. Aetna considers these to be medically necessary for those members who meet the following criteria:
A. A documented:
Contraindication to one preferred alternative agent indicated for the member's condition OR
Intolerance to one preferred alternative agent indicated for the member's condition OR
Allergy to one preferred alternative agent indicated for the member's condition OR
Failure of an adequate trial of one month of one preferred alternative agent indicated for the member's condition
Avinza, Darvon Compound, Demerol, Dilaudid inj, Dolophine, Duragesic, Maxidone, MS Contin, Oramorph SR, pentazocine/naloxone, propoxyphene HCl, propoxyphene/aspirin/caffeine, propoxyphene napsylate/APAP, Roxicet, Stadol NS, Synalgos DC, Talwin NX, Ultracet, Ultram, Ultram ER, Vicodin HP and Wygesic are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Avinza, Darvon Compound, Demerol, Dilaudid inj, Dolophine, Duragesic, Maxidone, MS Contin, Oramorph SR, pentazocine/naloxone, propoxyphene Hcl, propoxyphene/aspirin/caffeine, propoxyphene napsylate/APAP, Roxicet, Stadol NS, Synalgos DC, Talwin NX, Ultracet, Ultram, Ultram ER, Vicodin HP and Wygesic to be medically necessary for those members who meet the following criteria:
A. A documented:
Contraindication to two preferred alternative narcotic analgesics (single entity or combination products) OR
Intolerance to two preferred alternative narcotic analgesics (single entity or combination products) OR
Allergy to two preferred alternative narcotic analgesics (single entity or combination products) OR
Failure of an adequate clinical trial of two days each of at least two preferred alternative 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:
Caldwell JR, Rapoport RJ, Davis JC, et al. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open label extension trial. J Pain Symptom Management 2002;23:278-91.
Douglas MD, Garland WT, Kelly JB, et al. Efficacy of a new, once-daily, rapid-onset, extended-release morphine formulation (Morphelan) and a twice-daily morphine sulfate controlled-release formulation (MS Contin) in patients with chronic, moderate-to-severe pain [abstract #780]. Presented at the 20th Annual Scientific Meeting of the American Pain Society, Phoenix, AZ, April 19-22, 2001.
Portenoy RK, Sciberras A, Eliot L, et al. Steady-state pharmacokinetic comparison of a new, extended-release, once-daily morphine formulation, Avinza, and a twice-daily controlled-release morphine formulation in patients with chronic moderate-to-severe pain. J Pain Symptom Management 2002;23:292-300.
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.
Anon. Drugs for pain. Med Lett Drugs Ther. 1998;40(1033):79-84.
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.
Rischitelli DG, Karbowicz SH. Safety and efficacy of controlled-release oxycodone: A systematic literature review. Pharmacotherapy 2002;22(7):898-904.
American Pain Society. Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain 4th ed. Glenview, IL: American Pain Society, 1999.
Kaplan R, Parris WC-V, Citron ML, et al. Comparison on controlled-release and immediate-release oxycodone tablets inpatients with cancer pain. J Clin Oncol. 1998;16(10):3230-3237
Heiskanen T, Kalso E. Controlled-release oxycodone and morphine in cancer related pain. Pain. 1997;73:37-45.
Citron ML, Kaplan R, Parris WC-V, et al. Long-term administration of controlled-release oxycodone tablets for the treatment of cancer pain. Cancer Invest. 1998;16(8):562-571.
Mucci-LoRusso P, Berman BS, Silberstein PT, et al. Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study. Eur J Pain. 1998;2:239-249.
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.