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Proton pump inhibitor drug list selection

Selection of proton pump inhibitors (PPIs) for our drug list was influenced by similar efficacy rates and safety profiles among the agents.

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Proton pump inhibitors (PPIs) are most commonly used for prevention and treatment of gastroesophageal reflux disease (GERD). Other FDA-approved indications include treatment of erosive esophagitis, Helicobacter pylori (H. pylori) infection, active duodenal or gastric ulcers, and non-steroidal anti-inflammatory drug (NSAID)-associated ulcers.1

Summary of selected evidence for PPIs Outcome H. pylori eradication rates3 Products compared omeprazole triple therapy* vs. lansoprazole triple therapy omeprazole triple therapy vs. Aciphex triple therapy omeprazole triple therapy vs. Nexium triple therapy lansoprazole triple therapy vs. Aciphex triple therapy Results 75% vs. 76%

The PPIs are considered comparable to each other in efficacy due to similar clinical outcome improvements reported in clinical trials.

As you know, the goals of GERD therapy include2: · Controlling symptoms · Healing esophagitis · Managing or preventing complications · Maintaining GERD remission We critically evaluated studies with outcomes reflecting these goals. These outcomes, along with safety profile information and meta-analyses of PPI use in pregnancy, were the primary measures used in our Pharmacy & Therapeutics Process to select PPIs for our drug list.

78% vs. 81%

88% vs. 89%

81% vs. 86%

Conclusion: No statistically significant differences in H. pylori eradication rates were reported for omeprazole compared with lansoprazole, Aciphex or Nexium use over seven to 10 days (P-value = not significant for all comparisons). Rates were also similar for lansoprazole compared with Aciphex. Reflux esophagitis healing rates4 Nexium 40 mg vs. lansoprazole 30 mg or omeprazole 20 mg or pantoprazole 40 mg Four weeks 76% vs. 70% P-value = .0001 Eight weeks 89% vs. 85% P-value = .0001

Clinical review

Our clinical review focused on the efficacy and safety of PPIs for eradication rates of H. pylori, healing rates for reflux esophagitis and symptom control of GERD.3-11

Conclusion: Based on one meta-analysis, Nexium provides a modest benefit over lansoprazole, omeprazole or pantoprazole use in healing reflux esophagitis after four and eight weeks of therapy. The absolute risk reduction for reflux esophagitis healing rates is 4% to 6% with Nexium versus other PPIs. To heal one additional patient, 17 to 25 patients need to be treated with Nexium, instead of an alternative PPI, for four to eight weeks. Reflux esophagitis healing rates5 Dexilant 60 mg vs. lansoprazole 30 mg Study 1 Dexilant 60 mg: 85% lansoprazole 30 mg: 79% P-value < .05 Study 2 Dexilant 60 mg: 87% lansoprazole 30 mg: 85% P-value = not significant Conclusion: Use of Dexilant 60 mg shows similar or modestly-improved benefit in healing erosive esophagitis compared with lansoprazole 30 mg over eight weeks, as measured by crude rate analysis. The absolute risk reduction for reflux esophagitis healing rates is 6% with Dexilant 60 mg versus lansoprazole. Seventeen patients need to be treated with Dexilant, instead of a lansoprazole, for eight weeks to heal one additional patient. GERD symptom control6 lansoprazole 30 mg vs. Nexium 40 mg Days or nights with heartburn: 36% to 38% vs. 38% to 39% P-value = not significant

Conclusion: No statistically significant difference in GERD symptom control was reported for lansoprazole compared with Nexium use over two weeks (P-value = not significant).

*Triple therapy combines a PPI with clarithromycin and amoxicillin or metronidazole.

2 | Proton pump inhibitor drug list selection

PPIs have a good overall safety profile and are well tolerated by the majority of patients. However, overuse of these medications is a concern. Judicious use of PPIs is advised to decrease the risk of serious events potentially associated with PPI use. There are conflicting reports about several possible PPI-related safety concerns, highlighted below. Possible PPI-related safety issues Adverse event Clostridium difficile-associated disease (CDAD) Fracture risk Reports Results of case-control studies suggest an increased risk with PPI use, while other articles state there is no difference in risk.12-15 Three large database reviews and an analysis of a prospective study found an increase in osteoporosis-related fractures following one or more years of PPI therapy.16-19 A fourth database review found no increase in the risk of hip fractures in subjects without major risk factors for osteoporosis who received any PPI prescription, compared with those with no PPI prescription.20 The FDA recently issued a public health advisory regarding the drug interaction between Plavix (clopidogrel), omeprazole and Nexium. There is potential for increased risk of cardiovascular events due to CYP 2C19 inhibition by omeprazole and Nexium. CYP 2C19 converts Plavix to an active metabolite which inhibits platelet aggregation. Avoid concomitant use of these medications. The FDA does not have enough information about drug interactions between Plavix and other PPIs to advise on their concomitant use.21

Value assessment

Internal analyses revealed the most prescribed PPIs are23: · Nexium · Generic omeprazole · Prevacid The least costly PPIs for Anthem Blue Cross and Blue Shield include: · Generic lansoprazole · Nexium · Generic omeprazole · Generic pantoprazole

Tier placement

Final placement of the PPI products on our drug list was determined based on the clinical review conclusions, followed by considerations from the value assessment, to make evidencebased, informed tier placement decisions. The lower, moderate and higher tiers of our PPI coverage are outlined below. PPI coverage on the Drug List Lower member cost · lansoprazole 30 mg capsules* · omeprazole capsules* · pantoprazole tablets Moderate member cost · Nexium Higher member cost · Dexilant (formerly Kapidex) · Aciphex · Prevacid solutab · Prilosec suspension · Protonix injection & suspension · Prevpac · Zegerid*

Drug interaction with Plavix (clopidogrel)

All PPIs are rated as pregnancy category B, with the exception of omeprazole-containing products (omeprazole, Prilosec, Zegerid) and Prevpac, which are pregnancy category C. The most documented data and clinical experience during pregnancy are with use of omeprazole.22 Based on critical appraisal of the clinical data, the Clinical Review Committee determined that all PPIs are safe, effective and comparable to each other at equivalent doses. The PPIs are considered comparable in their efficacy due to similar clinical outcome improvements reported in clinical trials. These agents are also well tolerated by the majority of patients.

*Lansoprazole 15 mg capsules, omeprazole 20 mg tablets and Zegerid 20 mg/1100 mg capsules are available over the counter. Prevpac contains lansoprazole, amoxicillin and clarithromycin and is only indicated for H. pylori eradication. Zegerid contains omeprazole and sodium bicarbonate.

To learn more about our Pharmacy & Therapeutics Process, visit anthem.com and select "Providers" on the bottom right. On the Provider landing page, under Formulary click "Rx Search." Click the "Drug List Selection" tab, then scroll down and select the "How is our Drug List selection process unique?" link.

Proton pump inhibitor drug list selection | 3

References

1. Drug Facts and Comparisons® eAnswers. Available at http://www.factsandcomparisons.com Accessed on February 6, 2011. 2. Kahrilas PJ, Shaheen NJ, Vaezi MF, et al, American Gastroenterological Association (AGA) Institute Medical Position Panel. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135: 1383-91. 3. Vergara M, Vallve M, Gisbert JP, Calvet X. Meta-analysis: comparative efficacy of different proton pump inhibitors in triple therapy for Helicobacter pylori eradication. Aliment Pharmacol Ther. 2003;18:647-54. 4. Edwards SJ, Lind T, Lundell L. Systematic review: proton pump inhibitors (PPIs) for the healing of reflux oesophagitis a comparison of esomeprazole with other PPIs. Aliment Pharmacol Ther. 2006; 24:743-50. 5. Sharma P, Shaheen NJ, Perez MC, et al. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009;29:731-41. 6. Chey W, Huang B, Jackson RL. Lansoprazole and esomeprazole in symptomatic GERD. Clin Drug Invest. 2003; 23:69-84. 7. Bardhan KD, Achim A, Riddermann T, Pfaffenberger B. A clinical trial comparing pantoprazole and esomeprazole to explore the concept of achieving `complete remission' in gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2007;25:1461-9. 8. Fennerty MB, Johanson JF, Hwang C, Sostek M. Efficacy of esomeprazole 40 mg vs. lansoprazole 30 mg for healing moderate to severe erosive esophagitis. Aliment Pharmacol Ther. 2005; 21:455-63. 9. Lightdale CJ, Schmitt C, Hwang C, Hamelin B. A multicenter, randomized, double-blind, 8 week comparative trial of low dose esomeprazole (20 mg) and standard dose omeprazole (20 mg) in patients with erosive esophagitis. Dig Dis Sci. 2006; 51:852-7. 10. Mulder CJ, Dekker W, Gerretsen M. Lansoprazole 30 mg versus omeprazole 40 mg in the treatment of reflux oesophagitis grade II, III and IVa (a Dutch multicentre trial). Eur J Gastroenterol Hepatol. 1996; 8:1101-6. 11. Wang X, Fang JY, Lu R, Sun DF. A meta-analysis: comparison of esomeprazole and other proton pump inhibitors in eradicating Helicobacter pylori. Digestion. 2006;73:178-86. 12. Dial S, Delaney JA, Barkun AN, Suissa S. Use of gastric acidsuppressive agents and the risk of community-acquired Clostridium difficile-associated disease. JAMA. 2005;294:2989-95. 13. Dial S, Delaney JA, Schneider V, Suissa S. Proton pump inhibitor use and risk of community-acquired Clostridium difficileassociated disease defined by prescription for oral vancomycin therapy. CMAJ. 2006; 175:745-8. 14. Lowe DO, Mamdani MM, Kopp A, et al. Proton pump inhibitors and hospitalization for Clostridium difficile-associated disease: a population-based study. Clin Infect Dis. 2006;43:1272-6. 15. Pepin J, Saheb N, Coulombe MA, et al. Emergence of fluoroquinolones as the predominant risk factor for Clostridium difficile-associated diarrhea: a cohort study during an epidemic in Quebec. Clin Infect Dis. 2005; 41:1254. 16. Targownik LE, Lix LM, Metge CJ, Prior HJ, Leung S, Leslie WD. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ. 2008;179(4):319-26. 17. Yang YX, Lewis JD, Epstein S, Metz DC. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006;296:2947-53. 18. Vestergaard P, Rejnmark L, Mosekilde L. Proton pump inhibitors, histamine H2 receptor antagonists, and other antacid medications and the risk of fracture. Calcif Tissue Int. 2006;79:76-83. 19. Yu EW, Blackwell T, Ensrud KE, et al. Acid-suppressive medications and risk of bone loss and fracture in older adults. Calcif Tissue Int. 2008;83:251-9. 20. Kaye JA, Jick H. Proton pump inhibitor use and risk of hip fractures in patients without major risk factors. Pharmacotherapy. 2008;28:951-9. 21. Information for Healthcare Professionals: Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC). FDA Center for Drug Evaluation and Research (CDER). Available at: fda.gov. Accessed January 20, 2011. 22. Gill SK, O'Brien L, Einarson TR, Koren G. The safety of proton pump inhibitors (PPIs) in pregnancy: a meta-analysis. Am J Gastroenterol. 2009;104:1541-5. 23. Data on file. WellPoint, Inc.; 2009.

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