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Pharmacy Clinical Policy Bulletins

Subject: Analgesics, Narcotics and Narcotic combinations

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
P acetaminophen /butalbital/ caffeine          
P acetaminophen/codeine          
P aspirin/butalbital/caffeine          
P Balacet (propoxyphene-n 100/APAP 325)          
P oxycodone          
P oxycodone SR   X      
P oxycodone/acetaminophen          
P oxycodone/aspirin          
P OxyFast® (oxycodone)          
P pentazocine/naloxone          
P butalbital/caffeine/codeine/ASA          
P hydrocodone/acetaminophen          
P hydrocodone/ibuprofen          
P hydromorphone          
P meperidine/promethazine          
P morphine, morphine SR          
P pentazocine/acetaminophen          
P propoxyphene HCl          
P propoxyphene/aspirin/caffeine          
P propoxyphene napsylate/APAP          
P tramadol          
P tramadol/apap          
P Kadian CR® (morphine CR)          
P Oxycontin CR® (oxycodone SR)   X      
NP Anexsia® (hydrocodone/APAP)       X X
NP Bancap-HC® (hydrocodone/APAP)       X X
NP Capitol/ Codeine® (codeine/APAP)       X X
NP Darvocet-N® (propoxyphene napsylate/APAP)       X X
NP Darvon® (propoxyphene)       X X
NP Darvon Compound® (aspirin/propoxyphene/caffeine)       X X
NP Fioricet/ Codeine® (butalbital/APAP/caffeine/codeine)       X X
NP Fiorinal/ Codeine® (butalbital/aspirin/caffeine/codeine)       X X
NP Lorcet®/ Lorcet HD®/ Lorcet Plus® (hydrocodone/APAP)       X X
NP Lortab®/Lortab elixir(hydrocodone/APAP)       X X
NP Mepergan Fortis® (meperidine/ promethazine)       X X
NP Norco® (hydrocodone/APAP)       X X
NP Panlor SS/DC (acetaminophen-caff-dihydrocod)          
NP Percodan® (oxycodone/aspirin)       X X
NP Percocet®/ (oxycodone/apap)       X X
NP Reprexain® (hydrocodone/ ibuprofen)       X X
NP Roxicet (oxycodone/ acetaminophen)       X X
NP Synalgos DC (dihydrocodeine compound)       X X
NP Talacen® (pentazocine/APAP)       X X
NP Tylenol #3® (codeine/APAP)       X X
NP Tylox® (oxycodone/APAP)       X X
NP Vicodin/Vicodin ES®/Vicodin HP® (hydrocodone/APAP)       X X
NP Vicoprofen® (hydrocodone/ ibuprofen)       X X
NP Vopac® (codeine/APAP)       X X
NP Wygesic® (propoxyphene/APAP)       X X
NP Xodol® (hydrocodone/APAP)       X X
FE Avinza® (morphine SR)         X
FE Combunox (oxycodone 5mg/ ibuprofen 400mg)   X   X X
FE Maxidone® (hydrocodone/ acetaminophen)       X X
FE Percocet®2.5/325 (oxycodone/ acetaminophen)       X X
FE Roxicet®5/500 (oxycodone/ acetaminophen)       X X
FE Trycet ® (propoxyphene-n 100/APAP 325)       X X
FE Ultracet® (tramadol/APAP)         X
FE Ultram® (tramadol)       X X
FE Zydone® (hydrocodone/APAP)       X X
Note: Criteria for OxyContin CR are discussed in the Pharmacy Clinical Policy Bulletin: Analgesics - OxyContin CR/oxycodone SR

*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy ‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to step-therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).

Important Note

This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Issues Manual can be found on the following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.

Policy

  1. Precertification Criteria

    Under some plans, including plans that use an open or closed formulary, Combunox is subject to precertification. If precertification requirements apply Aetna considers Combunox to be medically necessary for those members who meet the following precertification criteria:

    A. Quantity limits

    According to the manufacturer, Combunox can be dosed up to four times per day. A quantity of Combunox will be considered medically necessary as indicated below:

    Combunox, 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

  2. Step-Therapy Criteria

    Under some plans, including plans that use an open or closed formulary, Anexsia, Bancap HC Capitol/Codeine, Combunox, Darvocet-N, Darvon, Darvon Compound, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/HD/Plus, Lortab, Lortab elixir, Maxidone, Mepergan Fortis, Norco, Percodan, Percocet, Percocet®2.5/325, Reprexain, Roxicet, Roxicet® 5/500, Synalgos DC, Talacen, Tylenol #3, Tylox, Trycet, Ultram, Vicodin, Vicodin ES/HP, Vicoprofen, Vopac, Wygesic, Xodol, and Zydone are subject to step-therapy. Aetna considers Anexsia, Bancap HC, Capitol/Codeine, Combunox, Darvocet-N, Darvon Compound, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/HD/Plus, Lortab, Lortab elixir, Maxidone, Mepergan Fortis, Norco, Percodan, Percodan Demi, Percocet, Percocet®2.5/325 Roxicet, Roxicet® 5/500, Synalgos DC, Tylenol #3, Tylox, Ultram, Vicodin, Vicodin ES/HP, Vicoprofen, Wygesic, 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 preferred generic equivalent - alternatives on the Preferred Drug List.

    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).

  3. Medical Exception Criteria

    Anexsia, Bancap HC, Capitol/Codeine, Darvocet-N, Darvon, Darvon Compound, Fioricet/Codeine, Fiorinal/Codeine, Lorcet/HD/Plus, Lortab, Merpgan Fortis, Norco, Percodan, Percocet, Reprexain, Roxicet, Synalgos DC, Talacen, Tylenol #3, Tylox, Vicodin, Vicodin ES/HP, Vicoprofen, Vopac, Wygesic and Xodol are currently listed on the Step-Therapy List.* Therefore, these 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 them to be medically necessary for those members who meet the criteria below:

    • A documented:
      • Contraindication to the preferred generic equivalent OR
      • Intolerance to the preferred generic equivalent OR
      • Allergy to the preferred generic equivalent OR
      • Failure of an adequate clinical trial of two days each of the preferred generic equivalent.

    Combunox, Maxidone, Percocet®2.5/325, Roxicet® 5/500, Trycet, Ultram and Zydone are currently listed on the Aetna Formulary Exclusions and Step-Therapy lists.* Therefore, these drugs 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 Combunox, Maxidone, Percocet®2.5/325, Roxicet® 5/500, Trycet, Ultram and Zydone to be medically necessary for those members who meet the following criteria:

    • A documented:
      • Contraindication to a preferred generic alternative OR
      • Intolerance to a preferred generic alternative OR
      • Allergy to a preferred generic alternative OR
      • Failure of an adequate clinical trial of two days of the preferred generic alternative.

    Avinza and Ultracet are currently listed on the Aetna Formulary Exclusions List.* Therefore, Avinza and Ultracet 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 and Ultracet to be medically necessary for those members who meet the following criteria:

    • A documented:
      • Contraindication to two preferred analgesics, either narcotic analgesics (single entity or combination products) OR
      • Intolerance to two preferred analgesics, either narcotic analgesics (single entity or combination products) OR
      • Allergy to two preferred analgesics, either narcotic analgesics (single entity or combination products) OR
      • Failure of an adequate clinical trial of two days each of at least two preferred analgesics, either narcotic analgesics (single entity or combination products).

*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.

The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.

For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

Place of Service:

    Outpatient

The above policy is based on the following references:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Anon. Drugs for pain. Med Lett Drugs Ther. 1998;40(1033):79-84.
  6. Quigley C. Hydromorphone for acute and chronic pain. Cochrone Database Syst Rev. 2002;(1):CD003447.
  7. 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.
  8. 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.
  9. Rischitelli DG, Karbowicz SH. Safety and efficacy of controlled-release oxycodone: A systematic literature review. Pharmacotherapy 2002;22(7):898-904.
  10. American Pain Society. Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain 4th ed. Glenview, IL: American Pain Society, 1999.
  11. 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
  12. Heiskanen T, Kalso E. Controlled-release oxycodone and morphine in cancer related pain. Pain. 1997;73:37-45.
  13. 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.
  14. 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.
  15. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  16. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  17. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  18. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.

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.

January 1, 2006