Meeting minutes - Technical Working Group November 28, 2018
12:00 p.m. to 2:00 p.m. EDT
Participants: Dr Doug Coyle (University of Ottawa), Marie-Claude Aubin (INESSS), Don Husereau (Institute of Health Economics), Dr Frédérick Lavoie (Pfizer Canada), Dr Karen Lee (University of Ottawa and CADTH), Dr Christopher McCabe (University of Alberta and Institute of Health Economics), Geoff Sprang (Amgen), Dr Tania Stafinski (University of Alberta)
Observers: Edward Burrows (Innovation, Science and Economic Development), Nelson Millar (Health Canada)
PMPRB: Mitch Levine, Tanya Potashnik, Matthew Kellison, Isabel Jaen Raasch, Guillaume Couillard, Theresa Morrison, Barbara Jazewski
The Working Group to Inform the Patented Medicine Prices Review Board (PMPRB) Steering Committee on Modernization of Price Review Process Guidelines (WG) met via teleconference on November 28, 2018.
Following the WG meeting of September 25, 2018, the deadline to prepare the final draft WG report was extended to early 2019. As a result, members designated more time to discuss the usefulness of developing case studies, the possibility of applying equity weights and the application of a market size adjustment. Summaries of these discussions are below.
In general, members remained unclear on what the goals of case studies would be and what specifically would be required to carry out case studies, but agreed that real world case studies for a variety of types of medicines would be useful to provide a tangible sense of the impact of the proposed framework. Members expressed interest in cases that highlight 3 key areas: how uncertainty could be addressed, the impact to commercial viability of medicines, and potential operational challenges.
Members discussed several approaches to developing case studies and the challenges of each method. Some members felt pharmacoeconomic models were necessary to adequately evaluate the questions laid out in the WG Terms of Reference, whereas others felt published research (i.e. academic publications, CDR reports) would be sufficient. As pharmacoeconomic models provided by manufacturers to CADTH are confidential, they cannot be relied on to develop case studies.
The PMPRB is developing high-level case studies for the Steering Committee. It was agreed these case studies could be circulated amongst the WG members when they are shared with the Steering Committee. After reviewing these case studies, WG members will collectively determine if additional technical information or examples are required.
Members discussed whether adequate empirical evidence exists to support the use of “equity weights” in setting the ceiling price for certain types of Category 1 medicines. Dr Tania Stafinski summarized work that has been done to date and indicated that there remains many gaps in knowledge. In her opinion, current research in this area is not sufficiently advanced to support the use of equity weights. Members discussed that unless societal preferences are well-defined, they cannot decide to which medicines these types of weights should be applied. The distinction between society’s view of a disease as opposed to a specific patient with that disease was used as an example. It was generally agreed that there is not enough information to make any recommendations on equity weights and that the PMPRB should consider supporting future research in this area.
Market Size Adjustment
Members were asked to provide feedback on approaches to derive an appropriate adjustment, up or down, to a medicine’s ceiling price based on an application of the market size factor. Medicines with a small market size may have a higher cost per patient, and an upward adjustment could help these products be viable at the expense of consumer surplus. It was agreed that there is currently not enough information to determine what the supply curve looks like for new drugs. Some members felt that more empirical work is needed to determine when and how a ceiling price should be adjusted based on market size.
Next Steps for the Working Group
The next meeting will be scheduled in January, 2019.