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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Inflammatory Bowel Disease Agents

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C Asacol®  (mesalamine oral)     X        
C Canasa®  (mesalamine supp)     X        
C Colazal®  (balsalazide)     X        
C mesalamine enema              
C prednisolone              
C prednisone              
C sulfasalazine     X        
NC Azulfidine®  (sulfasalazine)     X     X  
NC Dipentum®  (olsalazine)     X     X  
NC Entocort EC®  (budesonide oral)           X  
NC Pentasa®  (mesalamine oral)     X     X  
NC Rowasa® enema  (mesalamine enema)           X  


Policy:

  1. Precertification Criteria

    2. Under some plans, including plans that use an open or closed formulary, Asacol, Azulfidine, Canasa, Colazal, Dipentum, Pentasa, and sulfasalazine are subject to precertification.   If precertification requirements apply Aetna considers Asacol, Azulfidine, Canasa, Colazal, Dipentum, Pentasa, and sulfasalazine to be medically necessary for those members who meet the following precertification criteria:

    A. Quantity limits:

     According to the Ulcerative Colitis Practice Guidelines from the American College Gastroenterology (ACG), these agents may be dosed up to a maximum dose as indicated below.  A quantity of each drug will be considered medically necessary as indicated in the table below.

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Asacol 4.8 grams 400 mg Up to 360 tablets in 30 days (12/day)
    Azulfidine 6 grams 500 mg Up to 360 tablets in 30 days (12/day)
    Canasa 1500 mgs 500 mg Up to 90 suppositories in 30 days (3/day)
    Canasa 1500 mgs 1000 mg Up to 60 suppositories in 30 days (2/day)
    Colazal 6.75 grams 750 mg Up to 270 capsules in 30 days (9/day)
    Dipentum 3 grams 250 mg Up to 360 capsules in 30 days (12/day)
    Pentasa 4.8 grams 250 mg Up to 600 capsules in 30 days (20/day)
    sulfasalazine 6 grams 500 mg Up to 360 tablets in 30 days (12/day)



    For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of ulcerative colitis agents will be considered medically necessary for those members who meet ANY of the following criteria:

    • Member's dose is being titrated by physician (3-month limit) OR
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.


  2. Medical Exception Criteria

    3. Azulfidine, Dipentum, Entocort EC, Pentasa and Rowasa enema 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 benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Azulfidine, Dipentum, Entocort EC, Pentasa and Rowasa enema to be medically necessary for those members who meet ANY of the following criteria:
    A. A documented

    • Contraindication to one covered alternative agent indicated for the member's condition OR
    • Intolerance to one covered alternative agent indicated for the member's condition OR
    • Allergy to one covered alternative agent indicated for the member's condition OR
    • Failure of an adequate trial of one month of one covered 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. Kornbluth A, Sachar DB. Ulcerative Colitis Practice Guideline in Adults (Update): American College of Gastroenterology, Practice Parameters Committee.  Am J Gastroenterol. 2004;99(7):1371-85.
  2. Hanauer SB and Sandborn W. Management of Crohn’s disease in adults. Am J Gastroenterol 2001;96:635-43.
  3. Sutherland LR, May GR, Shaffer EA.  Sulfasalazine revisited: a meta-analysis of 5-aminosalicylic acid in the treatment of ulcerative colitis.  Annals of Internal Medicine.  1993;118:540-9.
  4. Stein RB and Hanauer SB. Comparative tolerability of treatments for inflammatory bowel disease. Drug Safety 2000;23 (5):429-48.
  5. Munakata A, Yoshida Y, Muto T, et al. Double-blind comparative study of sulfasalazine and controlled-release mesalamine tablets in the treatment of active ulcerative colitis. J Gastroenterol 1995;30(S8:108-11.
  6. Mulder CJ, Tytgat GNJ, Weterman IT, et al. Double-blind comparison of slow-release 5-aminosalicylate and sulfasalazine in remission maintenance in ulcerative colitis. Gastroenterology 1988;95:1449-53.
  7. Steinhart AH, Hemphill D, Greenberg GR.  Sulfasalazine and mesalamine for the maintenance therapy of Crohn's disease: A meta-analysis.  American Journal of Gastroenterology.  1994;89(12):2116-24.
  8. Hanauer S, Schwartz J, Robinson M, et al. Mesalamine capsules for the treatment of active ulcerative colitis: results of a controlled trial. Am J Gastroenterol 1993;88:1188-97.
  9. Miner P, Hanauer S, Robinson M, et al. Safety and efficacy of controlled-release mesalamine for maintenance of remission in ulcerative colitis. Dig Dis Sci 1995;40:296-304.
  10. Fockens P, Mulder CJJ, Tytgat GNJ, et al. Comparison of the efficacy and safety of 1.5 compared with 3 g oral slow-release mesalamine (Pentasa) in the maintenance treatment of ulcerative colitis. Eur J Gastroenterol Hepatol 1995;7:1025-30.
  11. Bondesen S, Danish 5-ASA group. Mesalamine (Pentasa) as prophylaxis in Crohn’s disease. A multicenter, controlled trial [abstract]. Scand J Gastroenterol 1991;26(S183):68.
  12. Gendre JP, Mary JY, Florent C, et al. Oral mesalamine (Pentasa) as maintenance treatment in Crohn’s disease: a multicenter placebo controlled study [in French]. Ann Gastroenterol Hepatol 1993;29:251-6.
  13. Brignola C, Iannone P, Pasquali S, et al. Placebo-controlled trial of oral 5-ASA in relapse prevention of Crohn’s disease. Dis Dis Sci 1992;37:29-32.
  14. Sutherland LR, Martin F, Bailey RJ, et al. 5-Aminosalicylic acid (Pentasa) in the maintenance of remission of Crohn’s disease [abstract]. Gastroenterology 1995;108 Suppl:924.
  15. Hanauer SB, Krawitt EL, Robinson M, et al. Long-term management of Crohn’s disease with mesalamine capsules (Pentasa). Am J Gastroenterol 1993;88:1343-51.
  16. Singleton JW, Hanauser SB, Gitnick GL, et al. Mesalamine capsules for the treatment of active Crohn’s disease: results of a 16 week trial. Pentasa Crohn’s Disease Study Group. Gastroenterology 1993;104:1293-301.
  17. Brignola C, Cottone M, Pera A, et al. Mesalamine in the prevention of endoscopic recurrence after intestinal resection for Crohn’s disease. Italian Cooperative Study Group. Gastroenterology 1995;108:345-9.
  18. Lochs H, Mayer M, Fleig WE, et al. Prophylaxis of postoperative relapse in Crohn’s disease with mesalamine: European Cooperative Crohn’s Disease Study VI. Gastroenterology 2000;118:264-73.
  19. Marshall JK and Irvine EJ. Putting rectal 5-aminosalicylic acid in its place: the role in distal ulcerative colitis. Am J Gastroenterol 2000;95(7):1628-36.
  20. Geier DL, Miner PB. New therapeutic agents in the treatment of inflammatory bowel disease. Amercian Journal of Medicine. 1992;93:199-208
  21. Drossman DA. Measuring Quality of Life in Inflammatory Bowel Disease. Pharmacoeconomics. 1994;6(6):578-80.
  22. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. N Engl J Med. 1987;317(26):1625-9.
  23. Tremaine WJ, Schroeder KW, Harrison JM, Zinsmeister AR. A randomized, double blind, placebo-controlled trial of the of the oral mesalamine (5-ASA) preparation, Asacol, in the treatment of syptomatic Chohn's colitis and ileocolitis. Journal of Clinical Gastroenterology 1994;19(4):278-82.
  24. Thompsen O, Cortot A, Jewell D, et al. A comparison of budesonide and mesalamine for active Crohn’s disease. N Engl J Med 1998;339:370-4
  25. De Vos M. Clinical pharmacokinetics of slow release mesalamine. Clin Pharmacokinet 2000;39(2):85-97.
  26. Beatie RM. Therapy of Crohn’s disease in childhood. Paediatr Drugs 2000:2(3):193-203.
  27. Clemett D and Markham A. Prolonged-Release mesalamine. A review of its therapeutic potential in ulcerative colitis and Crohn’s disease. Drugs 2000;59:929-56.
  28. Ulcerative Colitis IN The Merck Manual of Diagnosis and Therapy, Beers MH and Berkow R, Eds, Merck Research Laboratories, 1999;307-12.
  29. Prakash A and Spencer CM. Balsalazide. Drugs 1998;56(1):81-9.
  30. Cohen RD. A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis. Am J Gastroenterol 2000;95(5):1263-76.
  31. Baldassano RN and Piccoli DA. Inflammatory bowel disease in pediatric and adolescent patients. Gastroenterology Clinics. 1999;28(2):445-58.
  32. Mahmud N, Kamm MA, Dupas JL, et al. Olsalazine is not superior to placebo in maintaining remission of inactive Crohn’s colitis and ileocolitis: a double blind, parallel, randomized, multicentre study. Gut 2001;49:552-6.
  33. Green JRB, Mansfield JC, Gibson JA, et al. A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis. Aliment Pharmacol Ther 2002;16(1):61-68.
  34. Mansfield JC, Giaffer MH, Cann PA, et al. A double-blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis. Aliment Pharmacol Ther 2002;16(1):69-77.
  35. Green JR, Lobo AJ, Holdwsorth CD, Leicester RJ, Gibson JA, Kerr GD et al. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. Gastroenterology 1998; 114(1):15-22.
  36. Green JR, Gibson JA, Kerr GD, Swarbrick ET, Lobo AJ, Holdsworth CD et al. Maintenance of remission of ulcerative colitis: a comparison between balsalazide 3 g daily and mesalazine 1.2 g daily over 12 months. Aliment Pharmacol Ther 1998; 12:1207-16.
  37. Levine DS, Pruitt R, Riff D, et al. A multi-center, double-blind dose-response trial of Colazide (balsalazide disodium) and Asacol (mesalamine) formild-moderately active ulcerative colitis. Gastroenterology. 1997;112(suppl 4):A1026.
  38. Pruitt R, Hanson J, Safdi M, et al. Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute ulcerative colitis. Gastroenterology. 2000;118(4,Pt 1):A756.
  39. Kruis W, for the German Colazide Study Group. A comparison of two different doses of balasalazide and one dose of mesalazine in chronic treatment of ulcerative colitis. Gastroenterology. 1998; 114 (4, pt 2): A4151.
  40. Pruitt R, Hanson J, Safdi M, Wruble L, et al. Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of actue  mild-to-moderate ulcerative colitis. Am J Gastroenterol 2002:;97:12:3078-86.
  41. Levine DS, Riff DS, Pruitt R, et al. A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis. Am J Gastroenterol 2002;97(6):1398-1407.
  42. Michetti P, Peppercorn MA. Inflammatory bowel disease: Medical therapy of specific clinical presentations. Gastroenterology Clinics June 1999. 28(2):353-370.
  43. Ghosh S, Shand A, Ferguson A. Ulcerative colitis. British Medical Journal. 2000. 320:1119-1123.
  44. Brown MO. Inflammatory bowel disease. Primary Care: Clinics in Office Practice March 1999. 26(1):141-170.
  45. Thompsen O, Cortot A, Jewell D, et al. A comparison of budesonide and mesalamine for active Crohn's disease. N Engl J Med 1998;339:370-4
  46. Rutgeerts P, Lofberg R, Malchow H, et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med 1994;331:842-5
  47. Cortot A, Colombel JF, Rutgeerts P, et al. Switch from systemic steroids to budesonide in steroid dependent patients with inactive Crohn's disease. Gut 2001;48:186-90.
  48. Papi C, Luchetti R, Gili L, et al. Budesonide in the treatment of Crohn's disease: a meta-analysis. Aliment Pharmacol Ther 2000;14:1419-28.
  49. Kendhal P, Zachos M, Holmes JL, and Griffiths AM. Controlled ileal release budesonide in pediatric Crohn disease: Efficacy and effect on growth. J Pediatr Gastroenterol Nutr 2001;33:75-80.
  50. Campieri M, Ferguson A, Doe W, et al. Oral budesonide is an effective as oral prednisolone in active Crohn's disease. Gut 1997;41:209-14.
  51. Bar-Meir S, Chowers Y, Lavy A, et al. Budesonide versus prednisone in the treatment of active Crohn's disease. Gastroenterology 1998;115:835-40.
  52. Entocort Product Information. AstraZeneca LP, Wilmington, DE. October 2001.
  53. Pentasa Product Information. Roberts Pharmaceuticals, Eatontown, NJ. June 1999.
  54. Dipentum Product Information. Pharmacia, Kalamazoo, MI. July 1999.
  55. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  56. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  57. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  58. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  59. 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.
  60. 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.

December 8, 2006
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