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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Proton pump inhibitors (PPIs) are effective for the treatment of a variety of acid-related disorders including peptic ulcer disease, treatment and prevention of gastroduodenal ulcers associated with NSAIDs, gastroesophageal reflux disease and its complications (e.g. esophageal strictures, Barrett’s Esophagus), laryngopharangeal reflux, Zollinger-Ellison Syndrome, and eradication of Helicobacter pylori.
PPIs exert their pharmacologic effect by inhibiting H-K-ATPase, and enzyme present in the parietal cells of the stomach that is necessary for hydrogen ion transport into the gastric lumen (the final step in gastric acid secretion). Although the currently available PPIs differ in their bioavailability, peak plasma levels, and routes of excreation, it is unknown whether these differences have any clinical significance.
The American Gastroenterological Association (AGA) Institute’s 2008 Technical Review and Medical Position Statement on the Management of Gastroesophageal Reflux Disease strongly recommend “antisecretory drugs for the treatment of patients with esophageal gastroesophageal reflux disease (GERD) syndromes (healing esophagitis, symptomatic relief, and maintaining healing of esophagitis). In these uses, PPIs are more effective than histamine-2 receptor antagonists (H2RAs), which are more effective than placebo.” Long-term use of PPIs is recommended for patients with esophagitis once they have proven clinically effective. Also recommended with fair evidence is twice-daily PPI therapy for patients with an esophageal syndrome with an inadequate symptom response to once-daily therapy and once-or twice-daily PPIs for patients with a suspected extra-esophageal GERD syndrome (laryngitis, asthma) with a concomitant esophageal GERD syndrome. This review also concludes that “there is no major difference in efficacy among the currently available PPIs (esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole).”
PPIs provide the most rapid symptomatic relief and heal esophagitis in the highest percentage of patients with GERD of any of the available medical treatments. The PPIs may be considered therapeutically interchangeable because of their comparable pharmacologic properties, clinical efficacy and safety profiles. Consistent results of clinical trials in patients with duodenal ulcers, gastric ulcers, GERD, hypersecretory conditions, and other acid-related disorders strongly suggest that there is a class effect of PPIs for these disorders, although differences in dosage formulations and drug interactions may occasionally influence choice of PPI in individual cases.
A prospective pharmacoepidemiologic cohort study evaluated the incidence of hospital-acquired pneumonia in patients exposed and unexposed to acid-suppressive medication (n=63,878); hospital-acquired pneumonia occurred in 2219 admissions (3.5%). The unadjusted incidence of hospital-acquired pneumonia was higher in the group exposed to acid suppressive medication than in the unexposed group (4.9% vs 2.0%; odds ratio [OR], 2.6 95% CI, 2.3-2.8). The adjusted OR of hospital-acquired pneumonia in the group exposed to acid suppressive medication was 1.3 (95% CI, 1.1-1.4). A population-based cohort study examined the association between the use of acid suppressive drugs and the occurrence of community acquired pneumonia (CAP; n=364,683). The incidence rates of pneumonia in non-acid suppressive drug users and acid suppressive drug users were 0.6 and 2.45 per 100 person-years, respectively. The adjusted relative risk for pneumonia among persons currently using PPIs compared with those who stopped using PPIs was 1.89 (95% CI, 1.36-2.62).
The interaction of PPIs and clopidogrel is believed to be due to decreased CYP2C19 conversion of clopidogrel to the active metabolite. Omeprazole has been implicated in the interaction due to the moderate inhibition of CYP2C19. Avoid using omeprazole concomitantly or 12 hours apart with clopidogrel. Consider using another acid-reducing agent with less CYP2C19 inhibitory activity. A higher dose regimen of clopidogrel concomitantly administered with omeprazole increases antiplatelet response; an appropriate dose regimen has not been established. For details of clopidogrel-PPI drug interactions, please see Prime Therapeutics Formulary Chapter 13.4A.
In February 2012 the FDA issued a safety warning to healthcare professionals as well as patients that PPIs may be associated with increased risk of C diff associated diarrhea (CDAD).
Except for infection, most adverse outcomes associated with PPIs occurred among patients who received long-term therapy. Minimizing the duration of therapy by reviewing periodically a patient’s need for acid-suppressive therapy could reduce the risk of adverse outcomes.
FDA APPROVED INDICATIONS AND DOSAGE
Dosing: All available proton pump inhibitors (PPIs) are available as delayed release products except for omeprazole/sodium bicarbonate (Zegerid). Dosing of PPIs is once daily for most conditions per the prescribing information. More frequent daily dosing may be used in pathologic hypersecretory conditions (Zollinger-Ellison) and Helicobacter pylori (H. pylori) eradication.
Maximum Daily Dosage
Therapeutic Drug Class Limit
Previous use of samples or vouchers/coupons will not be considered for authorization.
The intent of the PPI generic first program is to encourage the use of cost-effective preferred generic PPIs prior to the use of brand PPIs and high cost generic PPIs. Brand name and generic (Nexium/esomeprazole & Dexilant) PPIs will be paid at the same amount as generic omeprazole, if any one of the following is met:
Generic Zegerid will be covered if the following is met:
POLICY EXCEPTIONSProton Pump Inhibitor generic first program is not required for Federal Employee Program (FEP) and State Health Plan members.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
01/01/2014: New policy added.
08/14/2015: Code Reference section updated for ICD-10.
10/27/2015: Policy section updated to state: Previous use of samples or vouchers/coupons will not be considered for authorization.
04/01/2016: Policy description updated to add generics rabeprazole and esomeprazole to the table regarding Maximum Daily Dosage. First policy statement revised to state that the intent of the PPI generic first program is to encourage the use of cost-effective preferred generic PPIs prior to the use of brand PPIs and high cost generic PPIs. Added generic esomeprazole to the first policy statement. Added policy statement that generic Zegerid will be covered if certain criteria are met. Investigative definition updated in policy guidelines section.
05/31/2016: Policy number added.
08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
SOURCE(S)1. Dexilant prescribing information. Takeda Pharmaceuticals America, Inc. May 2012.
2. Prevacid prescribing information. Takeda Pharmaceuticals, Inc. May 2012.
3. Nexium prescribing information. AstraZeneca LP. January 2012.
4. Prilosec prescribing information. AstraZeneca LP. January 2012.
5. Protonix prescribing information. Wyeth Pharmaceuticals Inc. May 2012.
6. Aciphex prescribing information. Eisai Co, Ltd. May 2012.
7. Zegerid prescribing information. Santarus, Inc. April 2012.
8. Chapter review 7.4C Proton pump inhibitors. Prime Therapeutics.2012.
9. American Gastroenterological Association Institute Technical Review on the Management of Gastroesophageal Reflux Disease. Gastroenterol. 2008;135:1392-1413.
10. Kahrilas PJ, Shaheen NJ, Vaezi MF, et al. American Gastroenterological Association Institute Medical Position Statement on the Management of Gastroesophageal Reflux Disease. Gastroenterol. 2008;135:1383-91.
11. DeVault KR, Castell DO, et al. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005;100:190-200.
12. DeleteOregon Health Resources Commission Subcommittee Report on PPIs: Update #2 April 2004. Accessed at: http://www.oregon.gov/DAS/OHPPR/ORRX/docs/PPI/HRC_Reports/PPI_Update_FINAL_4-27-04.pdf. Accessed March 2010.
13. DeleteVHA/DoD Clinical Practice Guideline for the Management of Adults with Gastroesophageal Reflux Disease in Primary Care Practice. 3/12/2003.
14. Klok RM, Postma MJ, van Hout BA, et al. Meta-analysis: comparing the efficacy of proton pump inhibitors in short term use. Aliment Pharmacol Ther. 2003;17:1237.
15. Vakil N, Fennerty MB. Direct comparative trials of the efficacy of proton pump inhibitors in the management of gastroesophageal reflux disease and peptic ulcer disease. Aliment Pharmacol Ther. 2003;18:559-568.
16. Oregon Health Resources Commission Subcommittee Report on PPIs: Update #4. July 2006. http://www.oregon.gov/OHPPR/HRC/docs/HRC.Reports/PPI.7.2006.Update4.pdf. Accessed March 2010.
17. Plavix prescribing information. Sanofi Aventis. November 2009.
18. Herzig SJ, Howell MD, Ngo LH, Marcantonia ER. Acid-suppressive medication use and the risk for hospital acquired pneumonia. JAMA. 2009; 301(20):2120-2128.
19. Laheij RJF, Sturkenboom MCJM, Hassing R-J, et al. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004 292: 1955-1960.
20. Yang Yu-Xiao, Metz DC. Safety of proton pump inhibitor exposure. Gastroenterology. 2010 139: 115-1127.
21. FIRST–Omeprazole package insert. CutisPharma, Inc. December 2011.
22. FIRST-Lansoprazole package insert. CutisPharma, Inc. December 2011.
23. FDA. Drug Safety Communication: C Diff associated diarrhea can be associated with stomach acid drugs known as PPIs. February 8, 2012. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm290510.htm#hcp. Accessed April 2012.
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.