Pharmacogenomics and Health Policy

Transcription

1 Pharmacogenomics and Health Policy Amalia M. Issa, PhD, MPH Founding Director, Program in Personalized Medicine & Targeted Therapeutics Professor and Chair Department of Health Policy and Public Health University of the Sciences Philadelphia, PA

2 Disclosures I didn t do it. Nobody saw me do it. You can t prove anything.! None related to this presentation.! No Commercially Relevant Financial Relationships

3 What this talk is about What could we learn now that would help establish the potential utility of pharmacogenomic products? Provide an update on policy-relevant questions in pharmacogenomics Discuss some methods to investigate policyrelevant questions in pharmacogenomics

4 Successes of Genome Wide Association Studies (GWAS) Celiac disease Atrial fibrillation Colorectal cancer Breast cancer Prostate cancer Diabetes Gallstones Asthma Multiple sclerosis Rheumatoid arthritis Crohn disease Age-related macular degeneration Manolio TA. N Engl J Med 2010;363:

5 How is Pharmacogenomics being used? Drug development Drug product labels Large-scale global studies Utilization by pharmacy benefit managers Improvements in technology

6 Clinical Applications of Pharmacogenomics

7 Drug Labels and Pharmacogenomics Drug Safety " HLA-B*5701 for abacavir " CYP2D6 in nursing mothers taking codeine Drug Efficacy " CYP2C9 and VKORC1 for warfarin " CYP2C19 for clopidogrel " CYP2D6 and tamoxifen

8 Some Current Pharmacogenomic Based Drugs Available Today

9 Coming to a clinic near you "

10 What Do We Do With Genes When We Find Them? Key Stakeholders in PGx

11 Factors Driving Personalized Medicine Forward # State of the science and information systems now evolved to enable personalized medicine # Regulatory agencies have taken steps to integrate biomarkers into drug development # Payer struggles to balance quality and costs # Limit access to responders/subpopulations effectiveness & safety # wastage and unnecessary costs # Manage increasingly expensive drug categories (e.g., oncology) # Aggregate affordability of health services is a significant concern in many nations # Manufacturers recognize challenging reimbursement landscape and emphasis on PM is one tool to support market access

12 The Goal of Health Policy Research in Pharmacogenomics: Bridging the Research Application Gap Goal: To develop an evidence-base to maximize Impact, Adoption, Reach Science Documenting, improving & communicating discovery and knowledge Delivery Capacity Building the capacity of relevant systems to apply the knowledge Market pull and demand

13 Policy A set of principles guiding decisionmaking Public Policy: policy of governments Health Policy: health promotion, health protection, health services (plus ) Clinical Policy: policy related to the functioning of clinical environments

14 Why Conduct Policy-Relevant Research? To provide rigorous evidence to appropriate stakeholders (clinicians, patients, government regulatory agencies, payers, etc.) To impact decision making

15 Policy-Relevant Research Questions in Pharmacogenomics

16 Policy-Relevant Concerns about Pharmacogenomics: Stakeholder Perspectives

17 Policy Analysis Process Evaluation Policy Issue Implementation Issue Adoption Issue Identification

18 Research Tool Box Surveillance Quantitative Risk Assessment Economic Evaluation Expert Panels Systematic Reviews Meta-Analysis & Evidence Synthesis New Methods

19 Relationship between Clinical Epidemiology and Policy Basic (Bench) Research - Uncovers Promising Intervention Epidemiology Assesses Efficacy and Effectiveness Economic Evaluation Assesses Efficiency Health Policy Assesses Implementation Clinical Policy Consensus Statements; Formulary Decisions; CPGs Health Policy Evaluation of the use of research findings & determinants of that use

20 Example of Research to Inform Policy

21 Markov decision analytic modeling

22 Oncotype DX is dominated Why this study is interesting:

23 What does this mean for pharmacoepidemiologists? Opportunities to get involved in pharmacogenomic and drug safety studies Opportunities for development of methods to ensure analytical and clinical validity of genotype-phenotype associations Opportunities to help manage the data deluge (databases) Health policy has to be informed by evidence and good data!