PHARMCOGENETIC TESTING AND EVIDENCE-BASED DECISION-MAKING IN ONTARIO: THE APPLICATION OF ONTARIO'S DECISION DETERMINANTS FRAMEWORK TO THE EVALUATION OF PHARMACOGENETIC TESTS

Background: The Ministry of Health and Long Term Care (MOHLTC) has a well-established decision-making framework to help stakeholders including government make policy and funding decisions about health technologies in Ontario. The Decision Determinants Framework guides the Ontario Health Technology Advisory Committee (OHTAC) in making decisions and recommendations on evidence-based analyses conducted by the Medical Advisory Secretariat (MAS).  To date, this framework has not been applied to pharmacogenetic tests.  MAS in collaboration with the Toronto Health Economics and Technology Assessment Collaborative (THETA), has developed a process to evaluate these tests within the existing Decision Determinants Framework addressing the unique aspects of pharmacogenetics.  It was hypothesized that these methods would help establish a platform to guide future evaluations of pharmacogenetic tests in Ontario.

Purpose: To apply the Decision Determinants Framework to the evaluation of three oncology-related pharmacogenetic tests and develop a process to address the unique aspects of these tests. 

Method: The existing framework was applied for the evaluation of these tests.  Additional developments included a) identification of an analytical evidentiary framework specific to the evaluation of the clinical and cost-effectiveness of pharmacogenetic tests b) creation of a Provincial Expert Panel on Pharmacogenetics (PEPP), and c) utilization of an existing Citizens’ Reference Panel on Health Technologies to contextualize patient-centric issues.  The PEPP was involved in guiding research questions, contextualizing evidence and liaising with key stakeholders.  Subcommittees were developed for each test. Findings from the evaluations were taken through the OHTAC.    

Result: The ACCE methodology was used to evaluate the analytical and clinical validity and clinical utility of these tests.  Economic models were developed to assess their cost-effectiveness.  Through the engagement of key internal and external stakeholders, the evidence was contextualized for the Ontario setting.  The results of the evaluations, to be presented, have led to evidence-based recommendations for policy decision making surrounding the reimbursement of these tests.

Conclusion: The existing Decision Determinants Framework along with a process developed to address the unique aspects of pharmacogenetic testing has been successful in the evaluation of three oncology-related pharmacogenetic tests in Ontario. This has led to recommendations aimed to support evidence-based decision making surrounding their reimbursement. Lessons learned and requirements for future evaluations of pharmacogenetic tests, including non-oncology related tests, have been established through this process.