Comparative Effectiveness: Implications for the Pharmaceutical Sector Health Policy Audioconference February 23, 2009

Transcription

1 Comparative Effectiveness: Implications for the Pharmaceutical Sector Health Policy Audioconference February 23, 2009 Dr Marc Berger Vice-President, Global Health Outcomes Eli Lilly and Company

2 It Comes Down to Basics Payers want value for money Pharmaceutical sector wants money for value! Comparative effectiveness research is necessary but not sufficient to promote these objectives. 2

3 The Pharmaceutical Sector can respond by linking Health Outcomes to Product Development Strategies Develop drugs that deliver better patient outcomes that are valued b payers and providers Better patient outcomes means embracing Comparative Effectiveness. New treatments will need to be superior to currently available therapy in some dimension of value important to payers, providers, and patients. Valued by payers and providers means that better outcomes must translate into obtaining good pricing, reimbursement, and access; and more rapid uptake but are the goalposts continuing to move? Delivery: The pharmaceutical sector will need to choose either to provid the opportunities for improvements in patient outcomes or to share / tak on responsibility for realizing patient outcomes

4 Delivering Outcomes Adoption + Use Outcomes Adoption Evidence of relative value over Standards of Care EBM / HTA Analyses Guidelines / Recommendations Patient Access Reimbursement and Formulary Design Physician Rx Writing Use Patient Compliance & Adherence Increase in # of Adopters Early Adopters Clinical Trial Process Outcomes Consensus Guideline Performance Measure Reimbursement & Coverage Clinical Trial Endpoint Outcomes Quality Improvement L Ado Tim

5 How are the goalposts set for assessing value? Studies Economic Information Evidence Review and Synthesis (Formulary Committee Staff, EPCs, DERP, Academic Analysts) Framing Key Questions Rigor Required 1 2 Evidence Review +/- HECON Models Evidence-Based Decision Making (Formulary Committee of PBM, Private Payer, States, NICE, etc.) 3 Budge Constra Equ Prece Accepta Values & Preference eutsch S, Berger M, Evidence Synthesis and Evidenceased Decision Making: Related But Distinct Processes. edical Decision Making Sep-Oct 2005, pp Decisions

6 ISSUE: What constitutes adequate evidence? Harbour, R. et al. BMJ 2001;323:

7 ISSUE: Evidence Evaluation is an evolving discipline Country Who Evaluates Stakeholder Input Transparency Timeline Flexible Appeals Scope Study Australia - PBAC Pharma + Acad Low but increasing Moderate <120 days Rx $/QALY Canada - CDR Low Moderate <180 days No $/QALY Germany - IQWiG Low Moderate Post Launch Efficiency Frontier Scotland - SMC <120 days CEA Sweden Adequate <180 days $/QALY OB UK - NICE Acad + Pharma Post Launch Med/ Rx $/QALY OB US - AHRQ EPCs Moderate NA No Med/Rx Comp Eff Syste Rev *Processes in Australia and Germany have undergone recent reforms that are not yet well tested (Austra implemented (Germany). Australia has instituted an independent review option rather than an appeals p None of these agencies meet the full criteria of Accountability for Reasonableness.

8 Issue: Medicine is evolving toward Tailored Therapeutics Therapeutic Area Effectiveness Rate (%) On colo g y Alzhe ime r's 25% 30% Inco ntin en ce He p atitis C viru s Oste op o ro sis Rh eu mato id arthritis M ig ran e 40% 47% 48% 50% 51% + Benefit - Risk Card iac Arryth mias Asth ma 60% 60% Spear et al. TRENDS in Molecular Medicine Vol. 7 No. 5 May 2001

9 ISSUE: Data Quality and Quantity Who is responsible for generating the evidence? Who is responsible for synthesizing the evidence? IOM EBM Roundtable Pharma Sector Statement: Shared public-private responsibility Requires collaboration of all stakeholders Requires establishment of methodological and evidence standards What types of studies are necessary/sufficient for different decisions? What are good research practices for observational studies? Requires the development of standards/best practices for communicating ev to consumers and patients

10 Comparative Effectiveness Legislation The mission of any entity conducting CE research should focus on improv the science and practice of medicine in a way that does not impede acces care and diminish patient outcomes for the sake of cost. The scope of CE research should be broad including evaluations of benef design. The scope of CE research must extend beyond analyses compar pharmaceutical treatments. To enhance its credibility, CER requires an environment and processes that are transparent and inclusive of all stakeholders. Conducting CER in multiple settings will promote new, valid reliable methodologies and a broad body of research. Studies limited to comparing drug therapies cannot be expected to solve a health care cost and quality issues in the U.S. health care system. Becau drugs comprise approximately 11% of overall health care spending, the potential payoff for health care reform is greater by also studying other are health care, including health delivery systems, benefit designs, and proce