Regulatory and Reimbursement Harmonization Brent Fraser VP, Pharmaceutical Reviews April 11, 2016

Current State Regulatory HTA Payer Flexible licensing pathways Adaptive licensing Funding recommendations to public drug plans based on clinical and cost effectiveness and patient input. Pre-NOC submissions Funding agreements - Finance models - Managed entry agreements - Coverage w/ evidence development

Why Change? Access: Therapeutic need Managing expectations post market approval Increasing certainty: Time to decision Health Canada approval Funding decision Partially addressed through regulatory and HTA processes

What’s Missing Regulatory HTA Payer Managing issues along the continuum to drug access Many voices including the payer, patients and clinicians

Opportunities Innovative approaches arising from collaborative work in Europe and the US Medicines Adaptive Pathways to Patients (MAPPs) ADAPTSMART Public / Private partnerships Huge opportunity for lessons learned

Are “we” Stalled? Is the “trust” strong enough to have these conversations in a safe environment in order to find solutions? We need to ensure some of level of transparency within this work. Are we willing to accept real world effectiveness data in decision making? Who collects the data? Who funds the collection? When do we collect the data and what do we do with it once we get it? Does Canada have the infrastructure to support this work? How do we get started? How do we ensure all voices are heard? How do we include other pan-Canadian entities as appropriate? Is this for all drugs or some drugs?

Things We’re Doing Now Identifying opportunities for joint discussions. Identifying issues earlier in the review process. Earlier engagement with manufacturers. pCODR clinician engagement.