Developing Evidence-Based Best Practices for the Prescribing and Use of Proton Pump Inhibitors in Canada

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1 Developing Evidence-Based Best Practices for the Prescribing and Use of Proton Pump Inhibitors in Canada Presented by: Sumeet R. Singh, COMPUS April 4, 2006

2 Background COMPUS Objective: To identify and promote the implementation of evidencebased and cost-effective best practices in the prescribing and use of medicines in key therapeutic areas First project: Proton-pump inhibitors (PPIs)

3 Background Rationale: PPI prescriptions dispensed increased from 10.8 million to 12.4 million between 2003 and 2004, an increase of 15% * Rising expenditures on PPIs *Source: IMS Health Canada

4 Background Estimated total PPI retail pharmacy sales in Canada * : Millions of Dollars % increase Year * Source: IMS Health Canada

5 Background Approved Indications for PPIs in Canada: Gastroesophageal reflux disease Reflux esophagitis Barrett s esophagus Dyspepsia Peptic ulcer disease NSAID-associated ulcer Helicobacter pylori eradication Zollinger-Ellison syndrome GERD Dyspepsia PUD ZES

6 Background PPIs available in Canada: Omeprazole (Losec, Apo-omeprazole) Lansoprazole (Prevacid) Pantoprazole (Pantoloc) Esomeprazole (Nexium) Rabeprazole (Pariet) Cost: $ $4.40/day depending upon agent, brand, indication, dose

7 COMPUS Framework for Identifying Best Practices: Rationale for using CPGs and CDs: 1) Identify and summarize existing recommendations regarding Source the of recommendations use of PPIs for the based approved on available indications. evidence and clinical experience. Sources: Clinical Practice Guidelines (CPGs) and Consensus Documents (CDs) Have a significant influence on patterns of drug 2) Identify, prescribing evaluate, and and use. summarize the available clinical and economic evidence pertaining to these recommendations. Sources: CPGs and CDs, stakeholders input, literature search 3) Determine the final content and phrasing of COMPUS Best Practice Recommendations for the Prescribing and Use of PPIs: expert panel.

8 1) Identify and summarize existing recommendations regarding the use of PPIs for the approved indications. 1a) Collection of CPGs and CDs*. 1b) Extraction of recommendations on PPIs. 1c) Grouping of similar recommendations into a Synopsis of Existing Recommendations (SERs). * Stakeholders also consulted.

9 2) Identify, evaluate, and summarize the available clinical and economic evidence pertaining to these recommendations. 2a) Identification, selection, and evaluation of CPG/CD-cited evidence for each SER. 2b) Identification, selection, and evaluation of relevant new evidence (published after CPGs/CDs) from SRs and RCTs*. 2c) Identification and evaluation of relevant Canadian economic studies*. * Stakeholders also consulted.

10 1a) Collection of CPGs and CDs: Search Strategy: MEDLINE, BIOSIS Previews, EMBASE and PASCAL, PubMed, Cochrane Library and CINAHL Internet-based collections of guidelines: CMA Infobase, AHRQ's National Guidelines Clearinghouse, the NHS National Electronic Library of Health Guidelines Finder, and the Guidelines International Network web site Grey literature: selected web sites using the Google and Yahoo! search engines and specific websites of gastroenterology associations

11 1a) cont d Selection Criteria: CPGs and CDs containing recommendations on the use of PPIs for the approved indications in Canada Produced by professional groups or bodies in Canada, USA, Western Europe, Australia, and New Zealand

12 1b) Extraction of recommendations 1c) Synopsis of similar recommendations Example: Guideline 1: Canadian H. pylori Consensus Conference: All H. pylori-positive patients with duodenal or gastric ulcer should receive eradication treatment. Guideline 2: New Zealand Guidelines Group: H. pylori eradication is effective in healing peptic ulcers and also very significantly reduces ulcer recurrence (rare) and complications. Guideline 3: NICE (UK): Offer H. pylori eradication therapy to H. pylori-positive patients who have peptic ulcer disease. Synopsis of Existing Recommendations: H. pylori eradication therapy is recommended for patients diagnosed with gastric or duodenal ulcer who are infected with H. pylori.

13 2a) Identification, selection, and evaluation of CPG/CD-cited evidence for each SER. Example: Guideline 1: Canadian H. pylori Consensus Conference: All H. pyloripositive patients with duodenal or gastric ulcer should receive eradication treatment. a,b,c Guideline 2: New Zealand Guidelines Group: H. pylori eradication is effective in healing peptic ulcers and also very significantly reduces ulcer recurrence (rare) and complications. a,d,e Guideline 3: NICE (UK): Offer H. pylori eradication therapy to H. pyloripositive patients who have peptic ulcer disease. a,c,f Total evidence base for SER contains 6 studies: a, b, c, d, e, f

14 2a) cont d Selection of studies for detailed evaluation was based on a hierarchy of evidence: Systematic reviews > RCTs > Observational studies > Expert opinion

15 2a) cont d Algorithm for selecting studies for detailed assessment: All cited SRs AllRCTs for SERs with no good quality SRs cited, or having a direction of effect opposite to good quality SRs Allobservational studies for SERs with no SRs or RCTs, or having a direction of effect opposite to poor quality SRs or RCTs Expert or consensus opinion for SERs with no SRs, RCTs, or observational studies

16 2a) cont d Quality assessment of selected evidence: QA instruments: SRs: AMSTAR RCTs: Adapted SIGN50 Methodology Checklist for RCTs Observational studies: Adapted SIGN50 methodology checklist for cohort and checklist for case-control studies

17 2a) cont d Summary of selected evidence: Studies summarized according to PICO principle: Example: SER: PPIs are more effective than H 2 RAs for remission of symptoms and healing in patients with GERD. Study Type (QA) Population Intervention (I) Comparator (C) Outcome Measure Results Dir Kaplan- Machlis et al RCT (good) 268 clinically diagnosed GERD patients Ome 20mg qd for 4 weeks ran 150mg bid for 4 weeks Heartburn relief at 4 weeks 59% with ome vs. 35% with ran (p<0.001) +

18 2b) Identification of relevant new evidence: SRs and RCTs related to PPIs published 2003 onwards Same process for selecting and evaluating new evidence Selected studies were classified by the existing SERs Unclassifiable studies were referred to a clinical expert

19 2c) Identification and evaluation of relevant Canadian economic studies: Identified from the selected CPGs/ CDs, and literature search in MEDLINE, BIOSIS Previews and EMBASE Extraction of Economic Data Linking of each selected studies to the relevant SERs Assessment of Economic Studies: - Quality parameters: timeliness, type of study, outcomes, efficacy/effectiveness, cost, discounting and summary efficiency measure - Relevance parameters: population, intervention, time frame and setting

20 Results CPGs and CDs selected: 70 documents addressed PPI use for GERD, PUD, dyspepsia - 69 were identified from the literature search - 1 was identified by stakeholders - no CPGs/CDs addressed ZES Economic Studies selected: 7 studies - 5 from CPGs/CDs, - 5 from the literature search - 3 overlapped between them

21 Results Highest Level of evidence by SER: Indications Total No. of SERs No. of SERs supported by good quality SRs No. of SERs supported by good quality RCTs No. of SERs supported by poor quality RCTs or SRs No. of SERs supported only by opinion GERD Dyspepsia PUD Total

22 Results Evidence Update results Indications Selected studies Related to current SERs Related to new clinical points GERD 49 (12 SRs 37 RCTs) 49 0 Dyspepsia 5 (2 SRs 3 RCTs) 5 0 PUD 80 (19 SRs 61 RCTs) 47 (13 SRs 34 RCTs) 33 (6 SRs 27 RCTs)

23 Results COMPUS interim report: Summary of Findings on the Prescribing and Use of Proton Pump Inhibitors has been posted on the COMPUS website for stakeholder feedback

24 Next Steps Stakeholder consultation Multidisciplinary Review Panel: - gastroenterology - internal medicine - family practice - clinical pharmacy - geriatrics - health economics - methodology Panel will determine Best Practices, using - PPI interim report information - evidence update - stakeholder feedback

25 Questions?

Summary of Findings on the Prescribing and Use of Proton Pump Inhibitors. COMPUS Interim Report CCOHTA. March 6, 2006

Summary of Findings on the Prescribing and Use of Proton Pump Inhibitors COMPUS Interim Report CCOHTA March 6, 2006 Note that the information presented in this document does not constitute recommendations