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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: NSAID-Proton Pump Inhibitor combination

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C diclofenac sodium              
C diclofenac potassium              
C diflunisal              
C etodolac              
C fenoprofen              
C ibuprofen (>200 mg)              
C flurbiprofen              
C ketoprofen              
C meloxicam              
C naproxen sodium (>220mg)              
C naproxen/naproxen EC              
C sulindac              
C salsalate              
C choline magnesium trisalicylate              
NC Prevacid® NapraPAC  (Prevacid® NapraPAC)   X       X  
Note: Criteria for oral NSAIDs are discussed in Pharmacy Clinical Policy Bulletin: NSAIDs-Nonsteroidal Anti-inflammatory Agents; AND criteria for oral PPIs are discussed in Pharmacy Clincial Policy Bulletin: Proton Pump Inhibitors (PPIs)


Policy:

  1. Precertification Criteria

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

    A.    A documented:

    • Age greater than 60 OR
    • Concomitant use of chronic oral (systemic) corticosteroid therapy OR
    • History of ulcer disease or GI bleed OR
    • History of significant GI disease requiring therapy with an H2 receptor antagonist (cimetidine/Tagamet®, famotidine/Pepcid®, nizatidine/Axid®, ranitidine/ Zantac®) or a proton pump inhibitor (AcipHex®, Nexium®, omeprazole/Prilosec®, Prevacid®, Protonix®)
  2. Medical Exception Criteria

    3. Prevacid NapraPAC 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 Prevacid NapraPAC to be medically necessary for those members who meet ALL of the following criteria:

    A.    A documented:

    • Age greater than 60 OR
    • Concomitant use of chronic oral (systemic) corticosteroid therapy OR
    • History of ulcer disease or GI bleed OR
    • History of significant GI disease requiring therapy with an H2 receptor antagonist (cimetidine/Tagamet®, famotidine/Pepcid®, nizatidine/Axid®, ranitidine/ Zantac®) or a proton pump inhibitor (AcipHex®, Nexium®, omeprazole/Prilosec®, Prevacid®, Protonix®)

     AND

     B.   A documented:

    • Contraindication to one covered generic alternative agent indicated for the member's condition OR
    • Intolerance to one covered generic alternative agent indicated for the member's condition OR
    • Allergy to one covered generic alternative agent indicated for the member's condition OR
    • Failure of an adequate trial of one month of one covered generic alternative agent indicated for the member's condition
* 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:
  1. 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.
  2. Bloom BJ.  New drug therapies for the pediatric rheumatic diseases.  Current Opinion in Rheumatology.  2001;13:410-4.
  3. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines.  Guidelines for the Management of Rheumatoid Arthritis.  Arthritis and Rheumatism. 1996;39:713-22.
  4. 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.
  5. Kaplan B, Swain RA. NSAIDs are there any differences?  Arch Fam Med. 1993;2:1167-74.
  6. Willkens RF.  The selection of nonsteroidal antiinflammatory drug in there a difference?  The Journal of Rheumatology 1992;19:9-12.
  7. Skeith KJ, Wright M, Davis P.  Differences in NSAID tolerability profiles: Fact or fiction?  Drug Safety 1994; 10(3):183-95.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Roth SH. NSAID gastropathy; a new understanding. Arch Intern Med. 1996;156:1623-28.
  13. 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.
  14. 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.
  15. 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.
  16. Anon.  Drugs for Pain.  Med Lett Drugs Ther.  2000;42:74.
  17. Creamer P, Osteoarthritis Pain and Its Treatment, Current Opinion in Rheumatology 2000;12:450-455.
  18. 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.
  19. 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.
  20. Spencer-Green, G and E.  Nonsteroidal Therapy of Rheumatoid Arthritis and Osteoarthritis:  How Physicians Manage Treatment Failures, J Rheumatol, 1998;25:2088-93.
  21. 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.
  22. 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.
  23. Scottish intercollegiate Guidelines Network, (SIGN), Management of Early Rheumatoid Arthritis, December 2000, 1-45.
  24. Yuan Y, Hunt RH.  Assessment of the safety of selective cyclo-oxygenase-2 inhibitors: where are we in 2003?  Inflammopharmacology. 2003;11:337-54.
  25. Warner TK, Mitchell JA.  Cyclooxygenases: new forms, new inhibitors, and lessons form the clinic.  FASEB J.  2004;18:790-804.
  26. Meagher EA.  Balancing gastroprotection and cardioprotection with selective cyclo-oxygenase-2 inhibitors.  Drug Safety.  2003;26:913-24.
  27. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  28. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  29. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  30. Prevacid Naprapac Package Insert.  TAP Pharmaceuticals, Lake Forest, IL  November, 2003.
  31. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  32. 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.
  33. 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.

September 28, 2006
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