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

2. 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

3. 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

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

5. 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

6. 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?

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