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Pharmacy Clinical Policy Bulletins

Subject: NSAIDs – Nonsteroidal Anti-inflammatory Agents

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
P diclofenac sodium          
P diclofenac potassium          
P diflunisal          
P etodolac          
P fenoprofen          
P ibuprofen (>200 mg)          
P flurbiprofen          
P indomethacin/indomethacin SR          
P ketoprofen          
P ketorolac   X      
P meclofenamate          
P naproxen/naproxen EC          
P piroxicam          
P sulindac          
P salsalate          
P choline magnesium trisalicylate          
NP Anaprox® (naproxen sodium)          
NP Anaprox® DS (naproxen sodium)          
NP Ansaid® (flurbiprofen)          
NP Cataflam® (diclofenac potassium)          
NP Clinoril® (sulindac)          
NP Dolobid® (diflunisal)          
NP EC-Naprosyn® (naproxen EC)          
NP Feldene® (piroxicam)          
NP Indocin® (indomethacin)          
NP Indocin® SR (indomethacin CR)          
NP Motrin® (ibuprofen)          
NP Nalfon® (fenoprofen)          
NP Naprosyn® (naproxen)          
NP Toradol® (ketorolac)   X      
FE Arthrotec® (diclofenac sodium/ misoprostal)         X
FE Daypro® (oxaprozin)         X
FE diclofenac XR         X
FE etodolac SR         X
FE ketoprofen SR         X
FE Lodine XL® (etodolac SR)         X
FE Mobic® (meloxicam)       X X
FE nabumetone         X
FE Naprelan® (naproxen CR)       X X
FE Oruvail® (ketoprofen SR)         X
FE oxaprozin         X
FE Ponstel® (mefenamic acid)         X
FE Relafen® (nabumetone)         X
FE Tolectin® (tolmetin)         X
FE tolmetin         X
FE Voltaren XR® (diclofenac XR)         X

*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

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

      A. Quantity limits:

    According to the manufacturer, ketoroloac and Toradol can be dosed up to a maximum daily dose at the interval as indicated in the table below. A quantity of ketorolac or Toradol will be considered medically necessary as indicated in the table below:

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Toradol
    Ketorolac    		 40 mg / in divided doses daily 10 mg Up to 20 capsules in 30 days

    For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of ketorolac or Toradol 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, Mobic and Naprelan are subject to step-therapy.  Aetna considers Mobic and Naprelan to be medically necessary for those members who meet the following step-therapy criterion:

    A documented trial of two weeks each of two generic nonsteroidal anti-inflammatory agents - 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 II below.)

  3. Medical Exception Criteria

    Arthrotec, Daypro, diclofenac XR, etodolac SR, ketoprofen SR, Lodine XL, Mobic, nabumetone, Naprelan, Oruvail, oxaprozin, Ponstel, Relafen, Tolectin, tolmetin, and Voltaren XL are currently listed on the Aetna Formulary Exclusions List.* 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 Arthrotec, Daypro, diclofenac XR, etodolac SR, ketoprofen SR, Lodine XL, Mobic, nabumetone, Naprelan, Oruvail, oxaprozin, Ponstel, Relafen, Tolectin, tolmetin and Voltaren XL to be medically necessary for those members who meet the following criteria:

    1. A documented:

      • Contraindication to at least two preferred nonsteroidal anti-inflammatory agents indicated for the member’s condition OR
      • Intolerance to at least two preferred nonsteroidal anti-inflammatory agents indicated for the member’s condition OR
      • Allergy to at least two preferred nonsteroidal anti-inflammatory agents indicated for the member’s condition OR
      • Failure of an adequate trial of two weeks each of at least two preferred nonsteroidal anti-inflammatory agents indicated for the member’s condition

*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. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2005.
  2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
  3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
  4. Subcommittee on Osteoarthritis Guidelines, Recommendations for the Medical Management of Osteoarthritis of the HIP and Knee, Arthritis & Rheumatism, September 2000; Vol 43(9):1905-1915.
  5. Bloom BJ.  New drug therapies for the pediatric rheumatic diseases.  Current Opinion in Rheumatology.  2001;13:410-4.
  6. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines.  Guidelines for the Management of Rheumatoid Arthritis.  Arthritis and Rheumatism. 1996;39:713-22.
  7. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines.  Guidelines for Monitoring Drug Therapy in Rheumatoid Arthritis.  Arthritis and Rheumatism. 1996;39:723-31.
  8. Kaplan B, Swain RA. NSAIDs are there any differences?  Arch Fam Med. 1993;2:1167-74.
  9. Willkens RF.  The selection of nonsteroidal antiinflammatory drug in there a difference?  The Journal of Rheumatology 1992;19:9-12.
  10. Skeith KJ, Wright M, Davis P.  Differences in NSAID tolerability profiles: Fact or fiction?  Drug Safety 1994; 10(3):183-95.
  11. Furst DE. Are there differences among nonsteroidal antiinflammatory drugs?  Comparing acetylated salicylates, nonacetylated salicylates, and nonacetylated nonsteroidal antiinflammatory drugs.  Arthritis and Rheumatism 1994;37(1):1-9.
  12. Henry D, et al.  Variability in risk of gastrointestinal complications with individual nonsteroidal anti-inflammatory drugs: results of a collaborative meta-analysis.  BMJ. 1996;312:1563-66.
  13. Miwa LJ, Jones JK, Pathiyal A, Hatoum H.  Value of epidemiologic studies in determining the true incidence of adverse events; the nonsteroidal anti-inflammatory drug story.  Arch Intern Med. 1997;157:2129-36.
  14. Roth S et al.  Reduced risks of NSAID gastropathy (GI mucosal toxicity) with nonacetylated salicylate (salsalate): An endoscopic study. Semin Arthritis Rheum 1990;19(4 suppl 2):11-19.
  15. Roth SH. NSAID gastropathy; a new understanding. Arch Intern Med. 1996;156:1623-28.
  16. Simon LS et al.  Risk factors for serious nonsteroidal-induced gastrointestinal complications: regression analysis of the MUCOSA trial.  Fam Med. 1996;28(3):204-10.
  17. Bjorkman DJ.  Current status of nonsteroidal anti-inflammatory drug (NSAID) use in the United States: risk factors and frequency of complications.  Am J Med. 1999;107(6A):3S-8S; 8S-10S.
  18. Jackson, LM, Hawkey, CJ, COX-2 Selective Nonsteroidal Anti-inflammatory Drugs, Do They Really Offer Any Advantages, ADIS Drugs, 2000 Jun;59(6):1207-1216.
  19. Anon.  Drugs for Pain.  Med Lett Drugs Ther.  2000;42:74.
  20. Creamer P, Osteoarthritis Pain and Its Treatment, Current Opinion in Rheumatology 2000;12:450-455.
  21. Feldman, M, McMahon, AT, Do Cyclooxygenase-2 Inhibitors Provide Benefits Similar to Those of Traditional Nonsteroidal Anti-Inflammatory Drugs, with Less Gastrointestinal Toxicity, Ann Intern Med. 2000;132:132-143.
  22. Lanes, SF, et al., Resource Utilization and Cost of Care For Rheumatoid Arthritis and Osteoarthritis in a Managed Care Setting, Arthritis and Rheumatism, August 1997;40(8):1475-1481.
  23. Spencer-Green, G and E.  Nonsteroidal Therapy of Rheumatoid Arthritis and Osteoarthritis: How Physicians Manage Treatment Failures, J Rheumatol, 1998;25:2088-93.
  24. NICE Appraisal Team, on behalf of the National Institutes of Clinical Excellence, The Clinical Effectiveness and Cost Effectiveness of Celecoxib, Rofecoxib, Meloxicam and Etodolac (COX-2 Inhibitors) For Rheumatoid Arthritis and Osteoarthritis, November 1, 2000.
  25. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, Guidelines for the Management of Rheumatoid Arthritis, February 2002 Update, Arthritis & rheumatism; 46(2):328-346.
  26. Scottish intercollegiate Guidelines Network, (SIGN), Management of Early Rheumatoid Arthritis, December 2000, 1-45.
  27. Yuan Y, Hunt RH.  Assessment of the safety of selective cyclo-oxygenase-2 inhibitors: where are we in 2003?  Inflammopharmacology. 2003;11:337-54.
  28. Cheng HF, Harris RC.  Cyclooxygenases, the kidney, and hypertension.  Hypertension.  2004;43:525-30.
  29. FitzGerald GA.  Cardiovascular pharmacology of nonselective nosteroidal anti-inflammatory drugs and coxibs: clinical considerations.  Am J Cardiol. 2002;89(suppl):26D-32D.
  30. Frishman WH.  Effects of nonsteroidal anti-inflammatory drug therapy on blood pressure and peripheral edema.  Am J Cardiol. 2002;89(suppl):18D-25D.
  31. Armstrong EP, Malone DC.  The impact of nosteroidal anti-inflammatory drugs on blood pressure, with an emphasis on newer agents.  Clin Ther.  2003;25:1-18.
  32. Lawrence RC, et al., Estimates of the Prevalence of Arthritis and Selected Musculoskeletal Disorders in the United States, Arthritis & Rheumatism, May 1998;41(5):778-799.
  33. The Medical Letter, September 18, 2000, Drugs for Pain, vol. 42, page 74.
  34. Creamer P, Osteoarthritis Pain and Its Treatment, Current Opinion in Rheumatology 2000;12:450-455.
  35. Feldman, M, McMahon, AT, Do Cyclooxygenase-2 Inhibitors Provide Benefits Similar to Those of Traditional Nonsteroidal Anti-Inflammatory Drugs, with Less Gastrointestinal Toxicity, Ann Intern Med. 2000;132:132-143.
  36. Lanas, A, et al., Nitrovasodilators, Low-dose Aspirin, Other Nonsteroidal Anti-inflammatory Drugs, and the Risk of Upper Gastrointestinal Bleeding, N Engl J Med 2000;343(12):834-9.
  37. Wolfe, MM, et al, Gastrointestinal Toxicity of Nonsteroidal Anti-inflammatory Drugs, N Engl J Med;340(24):1888-1899.
  38. Mandell BF. General Tolerability and use of nonsteroidal anti-inflammatory drugs. Am J Med. 1999; 107(6A):72S-77S.
  39. Lapane, KL, The Effect of Nonsteroidal Anti-Inflammatory Drugs on the Use of Gastroprotecive Medication in People with Arthritis, Am J. Managed Care 2001; 7:402-408.
  40. Singh G, Ramey DR. NSAID induced gastrointestinal complications: the ARAMIS perspective—1997. J Rheumatol 1998; 25(S51):8-16.
  41. Wallace JL. Distribution and expression of cyclooxygenase (COX) isoenzymes, their physiological roles, and the categorization of nonsteroidal anti-inflammatory drugs (NSAIDs) Am J Med 1999; 107(6A):11S-17S.
  42. Furst DE. Pharmacology and efficacy of cyclooxygenase (COX) inhibitors. Am J Med. 1999; 107(6A):18S-26S.
  43. Rainsford KD. Profile and mechanisms of gastrointestinal and other side effects of nonsteroidal anti-inflammatory drugs (NSAIDs). Am J Med 1999; 107(6A):27S-36S.
  44. McCarthy DM. Comparative toxicity of nonsteroidal anti-inflammatory drugs. Am J Med 1999; 107(6A):37S-47S.
  45. Meagher EA.  Balancing gastroprotection and cardioprotection with selective cyclo-oxygenase-2 inhibitors.  Drug Safety.  2003;26:913-24.
  46. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  47. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  48. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  49. 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