Meeting minutes - Technical Working Group August 24, 2018
2:00 p.m. to 4:00 p.m. EDT
Participants: Marie-Claude Aubin (INESSS), Don Husereau (University of Ottawa), Dr Frédérick Lavoie (Pfizer Canada), Dr Christopher McCabe (University of Alberta and Institute of Health Economics), Maureen Smith (Patient), Geoff Sprang (Amgen), Dr Tania Stafinski (University of Alberta)
Observers: Edward Burrows (Innovation, Science and Economic Development), Nelson Millar (Health Canada)
PMPRB: Tanya Potashnik, Isabel Jaen Raasch, Guillaume Couillard, Matthew Kellison, Richard Lemay, Theresa Morrison
The PMPRB 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 August 24, 2018. The draft minutes from the July 26, 2018 meeting and written comments from members were discussed.
The Chairperson, Dr. Mike Paulden, summarised the policy background and scope of the WG’s remit. Members then discussed six topics designed to elicit specific feedback on areas of focus. Each of these topics was the subject of an hour long teleconference previous to this meeting.
Topic 1: Options for determining which medicines fall into ‘Category 1’
Four criteria for classifying a medicine as “Category 1” (i.e., “high priority”) were presented:
- The medicine is first in class or a substantial improvement over existing medicines
- The medicine’s opportunity cost exceeds its expected health gain
- The medicine is expected to have a high market impact
- The medicine has a high average annual treatment cost
Members were asked the following questions:
- Should other criteria be considered?
- What are the relevant metrics for selecting medicines that meet the identified criteria and what options exist for using these metrics?
The Chairperson summarised the August 22, 2018 teleconference. Members discussed whether the opportunity cost of a medicine, criteria ‘B’, is potentially an inappropriate tool for screening purposes and should be removed as a classification criterion. As part of this discussion, members were unable to identify examples where the other three criteria would not be sufficient in capturing high priority medicines. Members discussed whether criteria “C” and “D” should be incremental in theory. The need to have clear, uncomplicated, “bright line” classification criteria to mitigate uncertainty was reiterated. Some members indicated that “real life” examples of medicines that would trigger each classification criteria would be useful to inform the discussion. The PMPRB is developing case studies to share with the Steering Committee in October and will share with the WG when they are available.
The PMRPB agreed to provide WG members with analysis on retrospective data that determines the number of medicines screened into Category 1 when using each of the four classification criteria at various thresholds.
Topic 2: Application of supply-side cost effectiveness thresholds in setting ceiling prices for Category 1 medicines
Feedback was sought on two main issues: potential approaches for implementing a price ceiling based on a medicine’s opportunity cost, and potential approaches for allowing price ceilings above opportunity cost based for certain types of medicines (e.g., pediatric, rare, oncology, etc.). Members were asked the following questions:
- What are the potential approaches for considering a medicine’s opportunity cost and implementing a price ceiling?
- Should higher price ceiling(s) be adopted for certain types of medicines? If so, which medicines? How should the higher price ceiling(s) be determined?
The Chairperson summarised the August 22, 2018 teleconference. Group members generally agreed that the $30,000/QALY opportunity cost threshold lacked face validity and that more research may be needed to definitively determine a supply side estimate. Members discussed possible interim solutions, with some expressing the view that time must be taken to create an appropriate Canadian model based on sound research without increasing uncertainty for patentees in the interim.
Topic 3: Medicines with Multiple Indications
Feedback was sought on options for addressing medicines with multiple indications (e.g., multiple price ceilings or a single ceiling reflecting one particular indication).The following questions were posed to the members:
- What are the available options regarding pricing for multiple indications?
- Which option should be recommended, and why?
The Chairperson summarised the August 22, 2018 teleconference. Some group members expressed that, in principal, the price of a medicine should reflect its value and different indications with different values would have different ceiling prices. Members discussed the challenges with collecting utilisation information by indication and the implementation of indication based price ceilings. Members representing the pharmaceutical industry expressed concern that the first approved indication would set the price of a medicine and that it is an unrealistic expectation that the price could increase with subsequent indications.
Topic 4: Accounting for Uncertainty
Members were asked to provide feedback on options for using the CADTH and/or INESSS reference cases to set a ceiling price, as well as options for accounting for and/or addressing uncertainty in point estimates. The following questions were posed to the members:
- Do existing ‘reference case’ analyses provide the most appropriate estimates from which to derive a ceiling price?
- If not, what modifications from the ‘reference case’ assumptions are desirable?
- How should uncertainty be accounted for, or addressed, when setting price ceilings?
The Chairperson summarised the August 24, 2018 teleconference. Additionally, one member described the various causes of uncertainty and highlighted the question of how to address the use of surrogates in clinical trials.
Topic 5: Perspectives
Members were asked to provide options to account for the consideration of a public health care system vs societal perspective, including the option of applying a higher value-based price ceiling in cases where there is a ‘significant’ difference between price ceilings under each perspective. Feedback was also sought on how to define a ‘significant’ difference in price ceilings between each perspective. The following three questions were posed to members:
- What are the key differences between a public health care system vs societal perspective?
- What are the options to account for these differences?
- How should a ‘significant’ difference be defined?
The Chairperson summarised the August 24, 2018 teleconference. Members confirmed with Board Staff that the policy intent, as communicated in the Regulatory Impact Analysis Statement and the WG Terms of Reference, is to adopt the healthcare system perspective. One member suggested the possibility of a health economic committee that would make recommendations regarding how societal perspective could be taken into consideration.
Topic 6: Market Size
Members were asked to provide feedback on approaches to derive an appropriate affordability adjustment to a medicine’s ceiling price based on an application of the market size and GDP factors (e.g. based on the US ‘ICER’ approach). The specific questions posed were:
- What approaches are available to consider an ‘affordability adjustment’ to a medicine’s ceiling price?
- Should other factors be considered (in addition to market size and GDP)?
- How should each of these factors be considered?
The Chairperson summarised the August 22, 2018 teleconference. Members discussed whether medicines with a high market impact should have a lower cost effectiveness threshold. One member noted that more research from a Canadian perspective is needed to inform the debate as there are not many robust studies evaluating demand size, supply size thresholds and willingness to pay and those that exist don’t show a willingness to pay above $150K/QALY. Members further discussed the possibility and feasibility of considering budget impact only for a subset of medicines. The members representing the pharmaceutical industry expressed concern regarding the operational challenges of implementing this factor.
The next WG meeting will take place at the end of September during which preliminary and potential recommendations of the WG will be discussed. A draft of these recommendations will be circulated a week before the meeting. A vote with respect to these recommendations will occur following the meeting before the draft final report is written.
Members may share additional information or suggestions with the Chair via email. If members wish these emails to be “on the record”, the email, including the member’s name, will be added to the final WG report as an Appendix. The content of all other emails will be anonymously shared with the WG unless the originator wishes the information to remain in confidence. The member representing patient groups confirmed that there will be future opportunities to comment “on the record” following the September meeting.
Meeting summaries will be shared with members via Briteshare.