Slide Presentation - University of Ottawa

Slide Presentation - University of Ottawa

pCPA Overview 1 Drug Approval & Reimbursement Landscape 2 Background The pCPA was introduced to address issues faced by the jurisdictions stemming from old policies of each jurisdiction making individual decisions. This often resulted in different drug coverage across the country. Jurisdictions struggled with increasing budget costs and dealt with this in different ways through policy, formulary restrictions, product listing agreements (PLAs), etc. Jurisdictions were at different points in terms of negotiating and implementing PLAs leading to inconsistencies in access and pricing across the country.

Jurisdictions realized that working collaboratively on drug funding could help improve the balance of access and pricing across the country. This would also help the smaller jurisdictions which were at a distinct disadvantage to negotiate pricing given their population size. *adapted from IBMs Pan Canadian Drug Negotiations Report 2 pCPA Milestones Sep 2014: Agreement to establish pCPA Office Aug 2010: Premiers (CoF) announce pan-Canadian Pricing Alliance May 2016: pCPA MoU finalized & 100 LOIs Completed July 2017: 150 LOIs Completed

Mar 2014: IBM Report Sep 2015: pCPA Office launched Jan 2010 2010 2011 2012 pCPA Savings Estimate pCPA efforts on brand and generic initiatives up until March 31, 2017 have resulted in estimated $1.28 B in combined savings annually. Brand: $925 M 2013 2014 2015 Jan 2015:

50 LOIs Completed May 2014: Generic Framework reached with CGPA 2016 Jan 2016: Federal Drug Plans join pCPA 2017 Apr 2017: Generic Bridging Agreement Oct 2015: Qubec joins pCPA Generic: $355 M 3 pCPA Objectives Increase access to clinically-effective and cost effective drug

treatment options Achieve consistent and lower drug costs for Participating Jurisdictions Reduce duplication of effort and improve use of resources Improve consistency of decisions among Participating Jurisdictions 5 pCPA Scope of Activity 6 Governance Evolution The success of the pCPA and the expansion of this initiative has resulted in a desire to implement of a more formal governance structure to enhance the effectiveness and efficiency of the initiative going forward December 2016: pCPA engaged in the Institute of Governance (IOG) to assist members in articulating a governance model that builds on current success, clearly articulates roles and responsibilities, and provides for clarity, consistency and accountability in decision-making IOGs based its final recommendation on a review of the pCPA, member interviews, several facilitated discussions and the Institutes experience in developing

appropriate governance structures and processes May 2017: Official approval for implementation in the Fall for IOGs recommended governance model. Governing Council: o o o Membership: ADMs or equivalent from all jurisdictions Chair: Ontario Vice Chair: British Columbia 7 Generic Products Timeline ~$355M Total Annual Savings FY 13/14 FY 13/14 6 Drugs at Drugs at 18%6of Brand 18% of Brand FY 14/15

FY 14/15 10 Drugs at 18%10ofDrugs Brandat 18% of Brand FY 15/16 FY 15/16 14 Drugs at 18%14ofDrugs Brandat 18% of Brand FY 16/17 FY 16/17 18 Drugs at 18%18ofDrugs Brandat 18% of Brand FY 17/18 FY 17/18 6/18 Drugs 6/18toDrugs dropped 15% dropped of Brandto 15% of&Brand Additional&value

Additional discussionvalue discussion underway underway Generic Products Timeline cont. Generic 2.0 Agreement Reached FY 18/19 $385M First year FY 19/20 FY 20/21 Up to $3B over 5 years FY 21/22 FY 22/23 Nearly 70 selected generic drugs (molecules) will be priced below

20% of the branded drug, - ranging from ~10% to ~18% Overview Completed Brand Files Since May 2015, all completed negotiations have gone through the pCPA collective 13 Not Pursued 55 246 Total Files Completed No Agreement 18 Not Pursued 5 Agreement 160 No Agreement 7 39

Completed in FY 17/18 Agreement 27 10 Summary of files entering pCPA Process vs. Activity # of Files 140 120 86% in Activity in 2 Years 100 80 128 60 102 40 20 0 69 72

82 51 Pipeline Entry 2014/15 pCPA Process Entries - HTA - Other Sources 1 pCPA Activity - In Consideration/Active - Closed 2015/16 2014/2015 51 47 4 69 29 40 pCPA Activity 2016/17 2015/2016 72 67 5 102

50 52 2016/2017 82 63 19 128 61 67 Analysis Note(s): 1. These include unsolicited proposals, pCPA initiated negotiations/renegotiations, line extensions, etc. 11 Priorities 2018 Transparency How do we work? Measurement How well do we work? Sorting How can we work differently? Engagement How can we work with you?

Capacity How can our workflow evolve? 12 Regulatory Environment Regulatory Evolution E.g. Generic Bioequivalence 20 years ago - Federal government, Ontario Today Federal government, Ontario Last 3 years further regulatory amendments to align Regulatory Regimes E.g. Generics Initiative Pan-Canadian agreement jurisdictional implementation (ON, AB) Regulatory Reforms E.g. PMPRB Policy guidance document consultations Need for associated regulatory modernization identified Federal government proactive/thoughtful engagement with jurisdictions Allows for jurisdictional support on thorny issues (industry perspective)

15 Access, Affordability, Appropriateness Access aligned regulatory and reimbursement systems System collaboration parallel/overlapping processes (not sequential) HC, CADTH/INESSS, PMRPB, CAPCA etc.) Real World Evidence Affordability lower prices PMPRB modernization pCPA Capacity negotiations, policy, strategic Appropriateness post-market regulatory decisions Lifecycle approach Clinician engagement 16

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