Summary of PMPRB Webinar on Meds Entry Watch, 2017

MORSE Consulting has prepared a summary of the key highlights from the Patented Medicines Prices Review Board’s (PMPRB) recent webinar on the release of their Meds Entry Watch 2017 report (third edition).

Date: February 20th 2019

Time: 1pm-2pm

Presented by: Elena Lungu (Manager NPDUIS, PMPRB), Jared Berger (Policy Analyst, Policy and Economic Analysis Branch, PMPRB)

Objective: To present the Meds Entry Watch, 2017 report to interested stakeholders and allow an opportunity for questions.

Webinar Agenda:

1. Background and Objectives
2. Method & Limitations
3. Key Findings
4. Next Steps
5. Questions

Meds Entry Watch: the 3rd edition examines the market entry dynamics of new medicines within a Canadian and international context.

• Explores the dynamics of new medicines entering Canadian and international markets, providing information on their availability, launch timing, market penetration, sales, and prices.
• This issue features new information highlighting (1) the emerging market for biosimilars; (2) CADTH recommendations; and (3) pipeline indications in pre-registration or Phase III clinical trials.
• Prepared by the PMPRB as part of the National Prescription Drug Utilization Information System (NPDUIS) initiative.

Key Findings

1. Considering Canada and the PMPRB7, new medicines launched account for a sizable share of the market.
   • New medicines accounted for 30% of brand name pharmaceutical sales by 2017Q4.
   • 2014 launches, mainly direct-acting antivirals (DAA) treatments, have continued to impact sales greatly.

2. The number of new medicines launched in Canada is in line with the OECD median, but behind the PMPRB7 countries, many of which have lower average patented medicine prices.
   • Canada is ranked 13th in the OECD for the number of new medicine launches (48%) with available sales by 2017Q4.

3. Compared to an average of 35 in previous years, fewer new medicines were launched through the FDA, EMA, and/or Health Canada in 2016 (31) and a higher number was launched in 2017 (51).
   • Of the 51 new medicines launched in 2017:
     • 23 received an orphan designation from the FDA and/or the EMA.
     • 18 were classified as biologics.
     • 17 were oncology products.

4. In Canada, many new medicines had high treatment costs, with limited therapeutic improvement, and received listing recommendations conditional on prices being reduced.
   • Of the 15 new medicines approved by Health Canada in 2016:
     • 8 were assessed by the PMPRB. All but one of those assessed showed only “slight or no therapeutic improvement. ”
     • All new medicines reviewed by CDR/pCODR received conditional reimbursement recommendations (12).
       • Majority of assessments explicitly mention price reduction as a condition of reimbursement.
     • Of those with CDR/pCODR recommendations, 7 have completed pCPA negotiations, and 5 remain in active negotiations.
     • 8 received reimbursement from at least one private plan.

5. Canada lags behind Europe in terms of biosimilar availability and uptake.
   • Health Canada approved less than half (6) of the 14 biosimilar medicines available in international markets, lagging behind the EMA (13).
   • While there have been great successes in the European market in terms of the uptake and pricing of these medicines, biosimilars are often priced higher in Canada, and their uptake is relatively modest.

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  IISSN 2560-6204
  Catalogue number: H79-12E-PDF
  February 2019
  PDF – 3.35 MB