Subject: Proton Pump Inhibitors (PPI's)

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

Policy:

1. Precertification Criteria

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

A.   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
Kapidex	60 mg/Once Daily	30 mg, 60 mg	Up to 30 capsules in 30 days
Nexium	40 mg/Once Daily	20 mg, 40 mg	Up to 30 capsules in 30 days
Nexium	40 mg/ Once daily	10 mg, 20 mg, 40 mg	Up to 30 packets in 30 days
omeprazole	40 mg/Once Daily	10 mg, 40 mg	Up to 30 capsules in 30 days
omeprazole	40 mg/Once Daily	20 mg	Up to 60 capsules in 30 days
lansoprazole cap delayed release, Prevacid cap or SoluTab	30 mg/Once Daily	15 mg, 30 mg	Up to 30 capsules or Solutabs in 30 days
Prilosec	40 mg/Once Daily	10 mg, 20 mg, 40 mg	Up to 30 capsules in 30 days
Prilosec oral suspension packets	20 mg (less than or equal to 16 yrs)/Once daily	2.5 mg, 10 mg	Up to 60 packets in 30 days
pantoprazole, Protonix	40 mg/Once Daily	20 mg, 40 mg	Up to 30 tablets in 30 days
Zegerid	20 mg/Once daily	20 mg, 40 mg	Up to 30 capsules or 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 [e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasia type 1 (MEN-1)] OR
• Member is being treated for Barrett's esophagus OR
• Member is being treated for laryngopharyngeal reflux OR
• Member is post transplant and/or MD is a transplant specialist 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 has gastroesophageal reflux disease (GERD) and meets ALL the following criteria:
  a) Member is currently taking once daily PPI therapy  
  b) Member has had at least 4 wks of once daily PPI therapy taken 30-60 min before a meal (any meal) 
  c) Member is experiencing acid breakthrough (uncontrolled symptoms of GERD)
  OR
• Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of multiple tablets/capsules OR need for a higher dose.



2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, AcipHex, Prilosec, and Zegerid are subject to step-therapy.  Aetna considers AcipHex, 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 two of the following: Nexium OR Prevacid OR 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

AcipHex, Kapidex, Prilosec and Zegerid are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan* and are on the Aetna Step-Therapy List.*.  Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, or that require step-therapy criteria,  unless a medical exception is granted.  Aetna considers AcipHex, Kapidex, Prilosec and Zegerid to be medically necessary for those members who meet the criteria specified below:

Nexium I.V. 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 benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Nexium I.V. to be medically necessary for those members who meet the  criteria specified below:


For Aciphex, Kapidex, Prilosec, and Zegerid

A. A documented:

• Contraindication to two of the following preferred alternatives: Nexium OR Prevacid OR  pantoprazole /Protonix OR,
• Intolerance to two of the following preferred alternatives: Nexium OR Prevacid OR pantoprazole /Protonix OR
• Allergy to two of the following preferred alternatives: Nexium OR Prevacid OR pantoprazole /Protonix OR
• Failure of an adequate trial of one month each of two of the following preferred alternatives: Nexium OR Prevacid OR pantoprazole /Protonix


For Nexium I.V.

A. Oral therapy with a preferred PPI alternative is not possible or appropriate

AND

B   A documented

• Contraindication to the preferred alternative,  Protonix I.V. OR
• Intolerance the preferred alternative, Protonix I.V. OR
• Allergy to the preferred alternative, Protonix I.V. OR
• Failure of an adequate trial of three days of the preferred alternative, Protonix I.V.
  

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Pan T, Wang Y, Guo Z, et al.  Additional bedtime H2-receptor antagonist for the control of nocturnal gastric acid breakthrough.  The Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD004275.pub2. DOI: 10.1002/14651858.CD004275.pub2.
8. Rostom A, Dube C, Wells G, et al.  Prevention of NSAID-induced gastroduodenal ulcers. The Cochrane Database of Systematic Reviews 2022, Issue 4. Art.: CD00296. DOI: 10.1002/14651858.CD002296.
9. Labenz J, Armstrong D, Lauritsen K, et al. Esomeprazole 20mg vs. pantoprazole 20mg for maintenance therapy of healed erosive oesophagitis: results from the EXPO study. Aliment Pharmacol Ther. 2005;22(9):803-11.
10. Rohss K, Lind T, Wilder-Smith C. Esomeprazole 40mg provides more effective intragastric acid control than lansoprazole 30mg, omeprazole 20mg, pantoprazole 40mg and rabeprazole 20mg in patients with GERD symptoms. Eur J Clin Pharmacol. 2004;60(8):531-9.
11. Richter JE, Fraga P, Mack M, et al. Prevention of erosive oesophagitis relapse with pantoprazole. Aliment Pharmacol Ther. 2004;20(5):567-75.
12. Gillesen A, Beil W, Modlin IM, et al.  40mg pantoprazole and 40mg esomeprazole are equivalent in the healing of esophageal lesions and relief from GERD-related symptoms. J Clin Gastroenterol. 2004;38(4):332-40.
13. Fennerty MB, Johanson JF, Hwang C, Sostek M.  Efficacy of esomeprazole 40mg vs. lansoprazole 30mg for healing moderate to severe erosive esophagitis. Aliment Pharmacol Ther. 2005;21(4):455-63.
14. Caos A, Breiter J, Perdomo C, Barth J. Long-term prevention of erosive or ulcerative GERD relapse with rabeprazole 10 or 20 mg vs. placebo: results of a 5-year study in the United States. Aliment Pharmacol Ther. 2005;22(3):193-202.
15. Bour B, Staub JL, Chousterman M, et al.  Long-term treatment of GERD patients with frequent symptomatic relapses using rabeprazole: on-demand treatment compared with continuous treatment.  Aliment Pharmacol Ther. 2005;21(7):805-12.
16. Scholten T, Dekkers CP, Schulze K, et al. On-demand therapy with pantoprazole 20 mg as effective as long-term management of reflux disease in patients with mild GERD: the ORION trial. Digestion. 2005;72(2-3);76-85.
17. Tsai HH, Chapman R, Shepherd A, et al. Esomeprazole 20 mg on-demand is more acceptable to patients than continuous lansoprazole 15 mg in the long-term maintenance of endoscopy-negative gastroesophageal reflux patients: the COMMAND study. Aliment Pharmacol Ther. 2004;20(6):657-65.
18. Scheiman JM, Yeomans ND, Talley NJ, et al. Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors. Am J Gastroenterol. 2006;101(4):701-10.
19. Conrad SA, Gabrielli A, Margolis B, et al. Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients. Crit Care Med. 2005;33(4):760-5.

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 04, 2009