TOOLS YOU CAN USE April 8, 2014

Transcription

1 TOOLS YOU CAN USE April 8, 2014 Academy of Managed Care Pharmacy International Society for Pharmacoeconomics and Outcomes Research National Pharmaceutical Council

2 Speakers Brian Sweet, MBA Executive Director, U.S. Payer & Real World Evidence, AstraZeneca (Moderator) Marc Berger, MD Vice President, Real World Data and Analytics, Pfizer Bernadette Eichelberger, PharmD Director, Pharmacy Affairs, AMCP Jennifer Graff, PharmD Director, Comparative Effectiveness Research, NPC Dan Allen, PharmD Clinical Pharmacist Consultant, OmedaRx

3 How to Ask a Question To Submit Questions Submit questions and comments via the Questions section in the Control Panel

4 How to Ask a Question Twitter using #npcwebinar We also encourage you to tweet during the webinar using #npcwebinar 4

5 Marc Berger, MD Vice President, Real World Data and Analytics, Pfizer

6 AMCP/ISPOR/NPC CER Collaborative Part 1: Evaluate Quality of Individual Studies Prospective Retrospective Modeling Indirect Methods Part 2: Synthesizing the Evidence Across Multiple Study Types RCT, Observational studies Part 3: Assessing the Evidence by Decision Makers: A Toolkit Tools Educational Materials and Training 6

7 The Issues Pharmacy decision-makers ( users ) are uncertain to interpret CER evidence not derived from RCTs Inherent Causal Inference Challenge Due to Observational Nature Less Rigorous Regulatory Oversight Complex Statistical Modeling Heterogeneous Perspectives and Training The issues are growing more challenging More studies and more complex analytic approaches

8 Appraisal tools: Design Objectives Easy, fast, accurate, minimal skill required Help end users assess the quality, credibility, and relevance of studies Promote the use of non-rct evidence in decision making Educational tools Prospective and Retrospective Obs. Studies Indirect Treatment Comparison Studies Modeling Studies

9 Evolution of the Tools Agreement on 2 main Categories Relevance (Are the results applicable?) Generalizability/PICO Credibility (Can I trust the results?) Validity Agreement on not to formally provide a score Concerns regarding false precision Concerns regarding fatal flaws Decision to ask rater to provide global assessment of each domain as either sufficient or insufficient Formal scoring would undermine the educational value of the tools

10 Examples of Questions Retrospective/ Prospective Modeling Indirect Treatment Comparisons Design Data Analysis Reporting Interpretation Conflicts of Interest 33 items Validation External Verification Face Design Data Analysis Reporting Interpretation Conflicts of Interest Evidence Base Analysis Reporting Interpretation Conflict of Interest 15 items 26 items

11 Source: Value in Health 2014; 17: (DOI: /j.jval ) Fig. 1

12 Evaluation History Step by Step Instructions 12

13 Explanation/ Definitions 13

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15 More Information Check Out the March 2014 Value in Health Editorial: Tools for Health Care Decision Making: Observational Studies, Modeling Studies, and Network Meta-Analyses A Questionnaire to Assess the Relevance and Credibility of Observational Studies to Inform Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report Indirect Treatment Comparison/Network Meta-Analysis Study Questionnaire to Assess Relevance and Credibility to Inform Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report Questionnaire to Assess Relevance and Credibility of Modeling Studies for Informing Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report

16 Dan Allen, PharmD Clinical Pharmacist Consultant, OmedaRx

17 Who is OmedaRx? Stand-alone PBM wholly owned by Cambia Health Solutions Formerly RegenceRx Cambia Health Solutions BlueCross/Blue Shield franchise in Oregon, Washington, Idaho, Utah Full PBM services to the Regence family of health plans Provide formulary guidance and utilization management strategies to Blues and non-blues plans nationwide Medication Reviews Medication Policies P&T Support

18 Why Implement ICER? Challenge: How do you systematically summarize separate clinical trials and available safety information? Institute for Clinical and Economic Review (ICER) Rating system evolved from earlier AHIP workgroup guided by insurers to meet needs for coverage decision-making Freely available, nationally vetted, meshes with current evaluation methods

19 Extensive staff training Implementation In-service to clients P&T committees over multiple meetings Ongoing training Continuous quality improvement Decision tracking Developing custom formulary frameworks for each clients

20 The ICER Rating Matrix High Certainty D (Inferior) C (Comparable) B (Small/Modest Benefit) A (Moderate/ Large Benefit) Moderate Certainty I (Insufficient to determine) P/I (Promising but Inconclusive) Low Certainty I (Insufficient to determine) Negative Health Benefit Comparable Health Benefit Incremental Health Benefit Substantial Health Benefit

21 The ICER Rating Matrix Effect of Certainty High Certainty D (Inferior) C (Comparable) B (Small/Modest Benefit) TE A (Moderate/ Large Benefit) Moderate Certainty I (Insufficient to determine) P/I Treatment Effect (Promising but Inconclusive) Low Certainty I (Insufficient to determine) Treatment Effect Negative Health Benefit Comparable Health Benefit Incremental Health Benefit Substantial Health Benefit

22 OmedaRx ICER Process Estimate certainty in the overall clinical data Estimate the magnitude of net-health benefit Identity point estimate on the ICER matrix Make safety modification to point estimate

23 Consideration for Using the ICER Matrix Most reviews involve two comparisons against placebo and against existing therapies New therapies often lack direct comparative trials Compare the evidence synthesis of placebo-controlled data This process is always subject to peer review We challenge each other on our assessment of the evidence, our assessment of the standard of care, and our assessment of the safety profile

24 Certainty of Benefit High Certainty Moderate Certainty Low Certainty Finding Certainty of Benefit Definitions of Evidence (ICER) Allows estimation for the relative potential chances / magnitude of net health benefit Difficult to estimate the net health benefit with precision Insufficient to allow assessment of the net health benefit Quantification of Studies (OmedaRx) 1 high confidence study; consistent results OR 2 fair confidence studies with: Consistent results Possibly clinically meaningful endpoint 1 high confidence study; consistent results OR 1 fair confidence study with: Consistent results Possibly clinically meaningful endpoint OR 2 low confidence studies with: Consistent results Possibly clinically meaningful endpoint low confidence studies not meeting threshold for moderate certainty (defined above) OR 2 fair confidence studies with inconsistency in the results

25 Determining Magnitude of Health Benefit High Certainty D (Inferior) C (Comparable) B (Small/Modest Benefit) A (Moderate/ Large Benefit) Moderate Certainty I (Insufficient to determine) P/I (Promising but Inconclusive) Low Certainty I (Insufficient to determine) Negative Health Benefit Comparable Health Benefit Incremental Health Benefit Substantial Health Benefit

26 Make Safety Modification to Point Safety Conclusion Example Track record with proven advantages (over active comparator) Estimate Estimate of Certainty Estimate of Benefit Track record with no new safety concerns Insufficient track record

27 2013 New Medications: Overall Evidence High confidence (1) 1% and Clinical Trials Quality High certainty (1) 2% Fair confidence (11) 13% Review in progress (8) 18% Low confidence (76) 86% Low certainty (17) 40% Moderate certainty (17) 40% Individual Clinical Trials Medications ICER Evidence Synthesis

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29 Lessons Learned Successful clinical evidence synthesis is dependent on rigorous clinical evidence evaluation Agreed upon, uniform grading and synthesis guidelines important for maintaining quality across multiple reviewers Never allow the quantification guidelines to override professional judgement

30 Bernadette Eichelberger, PharmD Director, Pharmacy Affairs, AMCP

31 AMCP/ISPOR/NPC CER Collaborative Part 1: Evaluate Quality of Individual Studies Prospective Retrospective Modeling Indirect Methods Part 2: Synthesizing the Evidence Across Multiple Study Types RCT, Observational studies Part 3: Assessing the Evidence by Decision Makers: A Toolkit Tools Educational Materials and Training 31

32 Additional Tools and Resources at

33 Summary Reports Can Be Downloaded in Word or Excel

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35 Register Today for the CER Certificate Program

36 CER Certificate Program Demo and Modules Available Today

37 Jennifer Graff, PharmD Director, Comparative Effectiveness Research, NPC

38 CER Collaborative Tool Improves the Evidence Assessment Dialogue Clarity Agreed upon elements of good practice for conducting studies When evidence is considered = ROI for investing in further research Consistency Evaluation of evidence in a similar fashion at different times or different individuals or organizations Transparency Need for evidence is considered for those generating and using evidence 38

39 CER Collaborative Improves Evidence Generation Certainty Began with good practices for research; goal is to ensure there is consistency in evidence evaluation Tools can be incorporated in study design, management, conduct and reporting processes Starting point for dialogue Feasibility of inclusion in a journal vs. on-line appendix vs. study report

40 CER Collaborative Continues the Dialogue to Improve Evidence Communication Framework for dialogue with managed market accounts and field based research groups Increase decision-maker awareness of all types of evidence May provide additional support for determining competent and reliable scientific evidence

41 Resources You Can Use Protocol and Publication Questionnaires NPC Champion Slides

42 Implications for Industry Use familiar language of the decision-maker Ensure research meets good practice principles through eyes of reviewers Consider when designing research Review when finalizing publications Consider when communicating evidence to decisionmakers Training Dialogue, dialogue, dialogue

43 Special Thanks to Work Groups Members Prospective Retrospective Indirect Treatment Comparisons Dan Allen RegenceRx Karen Worley Humana Scott Devine Merck John Graham Bristol- Myers Squibb Don Husereau U. Ottawa Dan Mullins U. Of Maryland Marc Berger (Chair) Pfizer Winnie Yang Blue Shield of California Eric Cannon SelectHealth Kristijan Kahler Novartis Nicole C. Quon Optimer William Crown Optuminsight Life Sciences Michael Johnson U. of Houston Bradley Martin (Chair) U. of Arkansas Sherry Andes Catamaran Jessica Daw UPMC Health Plan Joseph C. Cappelleri Pfizer Vijay Joish Bayer Thomas Trikalinos Tufts Medical Center Georgia Salanti U. of Ioannina Jeroen Jansen (Chair) Redwood Consulting Modeling Cheryl Kaltz U. of Michigan Bimal Patel MedImpact John Penrod Bristol-Myers Squibb Hong Kan GlaxoSmithKline David Eddy Archimedes Inc. Andy Briggs U. of Glasgow J. Jaime Caro (Chair) United BioSource Corp. Synthesizing a Body of Evidence Lisa Cashman MedImpact Jon Clouse OptumInsight Jeff White WellPoint NextRX Rahul Ganguly GlaxoSmithKline Bryan Luce PCORI Richard Willke Pfizer Brian Sweet (Chair) AstraZeneca Helen Sherman (Chair) Select Benefit Guidance

44 Questions? 44

45 Q&A Panel Brian Sweet, MBA Executive Director, U.S. Payer & Real World Evidence, AstraZeneca (Moderator) Marc Berger, MD Vice President, Real World Data and Analytics, Pfizer Bernadette Eichelberger, PharmD Director, Pharmacy Affairs, AMCP Jennifer Graff, PharmD Director, Comparative Effectiveness Research, NPC Dan Allen, PharmD Clinical Pharmacist Consultant, OmedaRx

46 Thank You The webinar will be archived and posted on NPC s website in coming days. For further information, contact: Brian Sweet brian.sweet@astrazeneca.com Marc Berger marc.berger@pfizer.com Dan Allen dan.allen@omedarx.com Bernadette Eichelberger beichelberger@amcp.org Jennifer Graff jgraff@npcnow.org cercollaborative.org 46