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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Proton Pump Inhibitors (PPI's)

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C Prevacid®  (lansoprazole)   X X        
C Prevacid® I.V.  (lansoprazole)   X          
C Protonix®  (pantoprazole)   X X        
C Protonix® I.V.  (pantoprazole)   X          
NC AcipHex®  (rabeprazole)   X X   X X  
NC Nexium®  (esomeprazole)   X X   X X  
NC Nexium® I.V.  (esomeprazole)   X     X X  
NC omeprazole   X X   X X  
NC Prilosec®  (omeprazole)   X X   X X  
NC Zegerid®  (omeprazole IR capsule and oral suspension)   X X   X X  


Policy:

  1. Precertification Criteria

    2. A AND B

    Under some plans, including plans that use an open or closed formulary, AcipHex, Nexium, Nexium IV, omeprazole, Prevacid, Prevacid IV, Prilosec, Protonix, Protonix IV and Zegerid are subject to precertification.   If precertification requirements apply Aetna considers AcipHex, Nexium, Nexium IV, omeprazole, Prevacid, Prevacid IV, Prilosec, Protonix, Protonix IV and Zegerid to be medically necessary for those members who meet the following precertification criteria:

    A.   Documented diagnosis listed below:

    Duodenal ulcer - active ulcer OR maintenance of healed ulcer (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
    Gastric ulcer - active benign (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); maintenance
    Gastrojejunal ulcer - active; maintenance
    NSAID-induced gastric ulcer - healing (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); risk reduction for recurrence
    Peptic ulcer disease (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
    Stress ulcer/surgical prophylaxis
    Barrett's esophagus
    Crohn's disease
    Erosive esophagitis - active, maintenance, healed
    Gastric residual reduction
    Gastrointestinal bleed
    GERD - moderate to severe with symptoms (treatment, maintenance, screening)
    H. pylori, treatment
    Hypersecretory conditions, including Zollinger-Ellison Syndrome
    Laryngopharyngeal reflux
    Post transplant and/or MD is a transplant specialist

    B.   Quantity limits:   According to the manufacturer, the oral proton pump inhibitors can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below.  A quantity of each drug will be considered medically necessary as indicated in the table below if member fulfills criteria A above.

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits

    AcipHex

    		 20 mg/Once Daily 20 mg Up to 30 tablets in 30 days

    Nexium

    		 40 mg/Once Daily 20 mg, 40 mg Up to 30 capsules in 30 days

    omeprazole

    		 40 mg/Once Daily 10 mg, 20 mg Up to 30 capsules in 30 days

    Prevacid

    		 30 mg/Once Daily 15 mg, 30 mg Up to 30 capsules, Solutabs, or packets in 30 days

    Prilosec

    		 40 mg/Once Daily 10 mg, 20 mg, 40 mg Up to 30 capsules in 30 days

    Protonix

    		 40 mg/Once Daily 20 mg, 40 mg Up to 30 tablets in 30 days

    Zegerid capsules

    		 40 mg/Once Daily 20 mg, 40 mg Up to 30 capsules in 30 days
    Zegerid packets 40 mg/Once daily 20 mg, 40 mg Up to 30 packets in 30 days


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

    • Member has a diagnosis of a pathological hypersecretory condition OR
    • Member is being treated for Barrett's esophagus OR
    • Member is being treated for laryngopharyngeal reflux OR
    • Member is being treated for a GI bleed (3-month duration) OR
    • Member is being treated for eradication of H. pylori (triple therapy only; 30 day duration) OR
    • Member is Post transplant and/or MD is a transplant specialist OR
    • Member is a child <11 years of age who is being treated for gastroesophagela reflux disease (GERD) or erosive esophagitis and remains symptomatic after 2 or more weeks of once-daily proton pump inhibitor - Prevacid, omeprazole, Prilosec only OR
    • Member has gastroesophageal reflux disease (GERD) and meets ALL the following criteria:
      a. Member has nocturnal acid breakthrough on once-daily proton pump inhibitor
      AND
      b. Member has tried and failed an adequate trial of two weeks of a H2 receptor antagonist (cimetidine, famotidine, nizatadine, ranitidine; prescription or non-prescription) given as an evening dose while also on a PPI daily.

    NOTE:  Aetna does NOT consider prescription PPIs to be medically necessary for members with the following indications (when NOT in combination with a diagnosis listed under A above):

    Dyspepsia
    Gastritis or duodenitis
    Gastroparesis
    Gastric bypass surgery
    Hiatal hernia
    Schatzki's ring (esophagogastric ring)



  2. Step Therapy Criteria

    3. Under some plans, including plans that use an open or closed formulary, AcipHex, Nexium, Nexium IV, omeprazole, Prilosec, and Zegerid are subject to step-therapy.  Aetna considers AcipHex, Nexium, Nexium IV, omeprazole, Prilosec and Zegerid to be medically necessary for those members who meet the following step-therapy criterion:

    A documented trial of one month each of both lansoprazole (Prevacid) AND pantoprazole (Protonix) - alternatives on the Aetna Medicare 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

    4. A OR (B AND C)

    AcipHex, Nexium, Nexium IV, omeprazole, Prilosec and Zegerid 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 AcipHex, Nexium, Nexium IV, omeprazole, Prilosec and Zegerid to be medically necessary for those members who meet the following criteria:

    A. Member is <6 years of age AND is intolerant to OR has failed an adequate trial of two weeks of the preferred alternative Prevacid - For omeprazole and Prilosec ONLY.

    OR

    B.   Documented diagnosis listed below

    Duodenal ulcer - active ulcer OR maintenance of healed ulcer (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
    Gastric ulcer - active benign (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); maintenance
    Gastrojejunal ulcer - active; maintenance
    NSAID-induced gastric ulcer - healing (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); risk reduction for recurrence
    Peptic ulcer disease (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
    Stress ulcer/surgical prophylaxis
    Barrett's esophagus
    Crohn's disease
    Erosive esophagitis - active, maintenance, healed
    Gastric residual reduction
    Gastrointestinal bleed
    GERD - moderate to severe with symptoms (treatment, maintenance, screening)
    H. pylori, treatment
    Hypersecretory conditions, including Zollinger-Ellison Syndrome
    Laryngopharyngeal reflux
    Post transplant and/or MD is a transplant specialist

    AND

    C.    A documented:

    • Contraindication to the preferred alternatives lansoprazole (Prevacid) AND pantoprazole (Protonix) OR,
    • Intolerance to the preferred alternatives lansoprazole (Prevacid) AND pantoprazole (Protonix) OR
    • Allergy to the preferred alternatives lansoprazole (Prevacid) AND pantoprazole (Protonix) OR
    • Failure of an adequate trial of one month each of the preferred alternatives lansoprazole (Prevacid) AND pantoprazole (Protonix)


    NOTE:  Aetna does NOT consider prescription PPIs to be medically necessary for members with the following indications (when NOT in combination with a diagnosis listed under A above):

    Dyspepsia
    Gastritis or duodenitis
    Gastroparesis
    Gastric bypass surgery
    Hiatal hernia
    Schatzki's ring (esophagogastric ring)

     

* 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. DeVault KR, Castell DO.  Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease.  Am J Gastroenterology 1999; 94(6): 1434-1442.
  2. Castell DO, Brunton SA, Earnest DL, et al.  GERD: Management Algorithms for the Primary Care Physician and the Specialist.  Practical Gastroenterology   Feb 1999:20-44.
  3. Fennerty MB, Castell DO, Fendrick AM, et al.  The diagnosis and treatment of gastroesophageal reflux disease in a managed care environment. Arch Int Med.  1996;156:477-84.
  4. Kahrilas PF. Gastroesophageal reflux disease.  JAMA. 1996;276:983-88.
  5. Singh G, et al. Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis. Arch Int Med. 1996;156:1530-36.
  6. Bjorkman DJ. Nonsteroidal Anti-inflammatory drug induced gastrointestinal injury. Am J Med. 1996;101(supp 1A):25-32.
  7. Graham DY, et al. Duodenal and gastric ulcer prevention with misoprostol in arthritis patients taking NSAIDs. Ann Intern Med. 1993;119:257-62.
  8. Silverstein F, et al. Reduction by misoprostol of clinically detected serious gastrointestinal complications associated with nonsteroidal anti-inflammatory drug use in older patients with rheumatoid arthritis.  Ann Intern Med. 1995;123:241-9.
  9. Chiba N et al.  Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: A meta-analysis.  Gastroenterology 1997; 112(6): 1798-1810.
  10. Florent C et al.  Efficacy and safety of lansoprazole in the treatment of gastric ulcer: A multicenter study.  Eur J Gastroenterol Hepatol 1994; 6: 1135-1139.
  11. Yeomans ND et al.  A comparison of omeprazole with ranitidine for ulcers associated with non-steroidal anti-inflammatory drugs.  The ASTRONAUT study.  N Engl J Med 1998; 338: 719-726.
  12. Vivian E et al.  Efficacy and cost effectiveness of lansoprazole versus omeprazole in maintenance treatment of symptomatic gastroesophageal reflux disease.  Am J Manag Care 1999; 5: 881-886.
  13. Welage, LS, Berardi, RR, Evaluation of Omeprazole, Lansoprazole, Pantoprazole, and Rabeprazole in the Treatment of Acid-Related Disease.  J Am Pharm Assoc 40(1):52,2000.
  14. American Pharmaceutical Association, New Product Bulletin-AcipHex (rabeprazole sodium), 1999:1-13.
  15. Rehner M et al.  Comparison of pantoprazole versus omeprazole in the treatment of acute duodenal ulceration -- A multicenter study.  Aliment Pharmacol Ther 1995; 9: 411-416.
  16. Dekkers CPM, Beker JA, et al.  Comparison of rabeprazole 20 mg versus omeprazole 20 mg in the treatment of active duodenal ulcer: a European mulitcentre study.  Alimental Pharmacol Ther 1999;179-186.
  17. Cloud ML, Enas N, et al.  Rabeprazole in the treatment of acid related diseases: Results of three placebo-controlled dose-response clinical trials in duodenal ulcer, gastric ulcer, and gastroesophageal reflux disease (GERD).  Digestive Disease and Sciences 1998;43(5):993-1000.
  18. Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors: Pharmacology and rationale for use in gastrointestinal disorders.  Drugs 1998;56(3):307-335.
  19. Jaspersen, D et al. A comparison of omeprazole, lansoprazole, and pantoprazole in the maintenance treatment of severe reflux oesophagitis.  Aliment Pharmacol Ther 12:49-52, 1998.
  20. Supplement-Acid Secretory Disorders: Burning Issues and Hot Topics. Am J Gastroenterology   94(11):S1-S25, November 1999.
  21. Vivian E, et al.  Efficacy and cost effectiveness of lansoprazole versus omeprazole in maintenance treatment of symptomatic gastroesophageal reflux disease.  Am J Manag Care 1999;5:881-886.
  22. Johnston BT, Gastroesophageal reflux disease and a HAPPI quality of life.  Am J Gastroenterology   94(7):1723-1724, July 1999.
  23. Saltiel E, Proton Pump Inhibitors: A comparative review.  US Pharmacist, December 1997, HS-21-30.
  24. Corinaldesi, R et al. Pantoprazole and omeprazole in the treatment of reflux oesophagitis: a European multicenter study.  Aliment Pharmacol Ther 9:667-671, 1995.
  25. Holtz, J et al. Pantoprazole is superior to ranitidine in the treatment of acute gastric ulcer.  Scand J Gastroenterol   30(2):111-115, 1995.
  26. Armbrecht, U et al.  Treatment of reflux esophagitis of moderate and severe grade with ranitidine or pantoprazole-Comparison of 24-hour intragastric an oesophageal pH.  Aliment Pharmacol Ther   11(5):959-965, 1997.
  27. Koop, H et al. Comparative trial of pantoprazole and ranitidine in the treatment of reflux esophagitis.  J Clin Gastroenterol 20(3):192-195, 1995.
  28. van Rensburg, CJ et al.  Improved duodenal ulcer healing with pantoprazole compared with ranitidine: A multicentre study.   Eur J Gastroenterol Hepatol   6(8):739-743, 1994.
  29. Cremer, M et al.  A double-blind study of pantoprazole and ranitidine in the treatment of acute duodenal ulcer.  Dig Dis Sci 40(6):1360-1364, 1995.
  30. Katz  PO, Anderson C, Khoury R, & Castell DO.  Gastro-aesophageal reflux associated with nocturnal gastric acid breakthrough on proton pump inhibitors.  Aliment Pharmacol Ther 1998:  12:  1231-1234.
  31. Robinson, M.  Clinical Relevance and Management of 'Occasional Acid Breakthrough' on Proton Pump Inhibitor Therapy.  Pract Gastroenterol November 1999:  55 - 57.
  32. Peghini P, Castell DO, Decktor D.  Understanding Nocturnal Acid Breakthrough on Proton Pump Inhibitors.  Pract Gastroenterol May 2000:  60 - 67.
  33. Earnest D.  Symptomatic Occasional Acid Breakthrough During Proton Pump Inhibitor Therapy is Common.  Ask Your Patients.  Pract Gastroenterol February 2000:  51 - 54.
  34. Peghini PL, Katz, PO, Bracy NA, & Castell DO.  Nocturnal Recovery of Gastric Acid Secretion with Twice-Daily Dosing of Proton Pump Inhibitors.  Am J Gastroenterol   1998:  93: (5) 763 - 767.
  35. Beck IT, Champion MC, Lemire S, et al.  The Second Canadian Consensus Conference of the Management of Patients with Gastroesophageal Reflux Disease.  Can J Gastroentrerol   1997:  11 (Suppl B) 7B - 20B.
  36. Moss SF, Arnold R, Tytgat GNJ, et al.  Consensus Statement for Management of Gastroesophageal Reflux Disease.  J Clin Gastroenterol   1998: 27 (1): 6-12.
  37. Zimmermann, AE, Esomeprazole, A Novel Proton Pump Inhibitor for the Treatment of Acid Related Disorders, Formulary 2000;35:882-93.
  38. Kahrilas et al., Esomeprazole Improves Healing Symptoms Resolution as Compared with Omeprazole in Reflux Oesophagitis Patients: a Randomized Controlled Trial.  The Esomperazole Study Investigator, Aliment Pharmacol Ther 2000;14(10):1249-1258.
  39. Richter et al., abstract - Esomerprazole is Superior to Omeprazole for the Healing of Erosive Esophagitis in GERD Patients, Gastroenterology, 2000;118:A20.
  40. Vakil et al., abstract - Esomeprazole is Effective as Maintenance Therapy in GERD Patients with Healed Erosive Esophagitis (EE), Gastroenterology, 2000;118:A22.
  41. Johnson, et al., abstract - Efficacy and Safety of Esomeprazole as Maintenance Therapy in GERD Patients with Healed Erosive Esophagitis (EE), Gastroenterology 2000;118:A17.
  42. Lind et al., Esomeprazole Provides Improved Acid Control vs. Omeprazole In Patients with Symptoms of Gastro-esophageal Reflux Disease, Aliment Pharmacol Ther., 2000;14:861-867.
  43. Food and Drug Administration, Prilosec OTC (omeprazole) information page; June 20, 2003.  http://www.fda.gov/cder/drug/infopage/prilosecOTC/default.htm
  44. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006
  45. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006
  46. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  47. Prevacid Product Information. TAP Pharmaceuticals, Chicago, IL.  October 2002.
  48. AcipHex Product Information.  Eisai, Inc. Teaneck, NJ. November 2002.
  49. Protonix Product Information, Wyeth Laboratories, Philadelphia, PA.  July 2002.
  50. Prilosec Product Information.  AstraZeneca, Wayne PA.  July 2002.
  51. Nexium Product Information, AstraZeneca, Wilmington, DE,  2002.
  52. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  53. 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.
  54. 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.

July 24, 2006
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