Meeting minutes - Technical Working Group July 26, 2018

09:00 a.m. to 4:00 p.m. EDT

Participants: Dr Chris Cameron (Dalhousie University and Cornerstone Research Group), Dr Tammy Clifford (University of Ottawa and CADTH) (on the phone), Dr Doug Coyle (University of Ottawa), Patrick Duford (INESSS), Don Husereau (University of Ottawa), Dr Peter Jamieson (University of Calgary), Dr Frédérick Lavoie (Pfizer Canada), Dr Karen Lee (University of Ottawa and CADTH), Dr Christopher McCabe (University of Alberta and Institute of Health Economics), Dr Stuart Peacock (Simon Fraser University and BC Cancer Agency), 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: Dr. Mitch Levine, Doug Clark, Tanya Potashnik, Isabel Jaen Raasch, Guillaume Couillard, Theresa Morrison

The first meeting of the Working Group to inform the PMPRB Steering Committee on Modernization of Price Review Process Guidelines was held July 26, 2018 in Ottawa.

Discussion was led by the Chair. The Terms of Reference were agreed upon by all members present. IMC noted for the record that, although it will attempt to participate constructively in the process, it is opposed to many of the proposed regulatory changes to the Patented Medicines Regulations and that its participation in the Working Group did not imply support for the aforementioned proposed changes.

Board Staff presented the proposed PMPRB framework modernization structure to the members for informational purposes. Members then discussed six topics designed to elicit specific economic feedback to inform the Steering Committee. Each member had the opportunity to provide input for each topic.

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:

  1. The medicine is first in class or a substantial improvement over existing medicines
  2. The medicine’s opportunity cost exceeds its expected health gain
  3. The medicine is expected to have a high market impact
  4. The medicine has a high average annual treatment cost

Members were asked the following questions:

  1. Should other criteria should be considered?
  2. What are the relevant metrics for selecting medicines that meet the identified criteria and what options exist for using these metrics?

Some members expressed the view that the opportunity cost of a medicine, criteria ‘b’, may be too difficult to implement for screening purposes and should be removed as a Category 1 classification criterion. Members engaged in some discussion as to whether drugs that have extremely high opportunity cost should result in a Category 1 classification.The need to clearly define ‘substantial’ improvement was also identified.

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.

  1. What are the potential approaches for considering a medicine’s opportunity cost and implementing a price ceiling?
  2. 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?

Members had a lengthy discussion on these issues following which it was agreed that subsequent discussion was needed in order to reach a consensus.

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:

  1. What are the available options regarding pricing for multiple indications?
  2. Which option should be recommended, and why?

Some members were of the view that the highest-priced cost-effective indication would be the appropriate basis for review. The possibility of reviewing each new indication to determine if a full re-review would be needed was also considered. Some members expressed concern that re-benching the ceiling price following the introduction of each new indication would increase uncertainty.

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:

  1. Do existing ‘reference case’ analyses provide the most appropriate estimates from which to derive a ceiling price?
  2. If not, what modifications from the ‘reference case’ assumptions are desirable?
  3. How should uncertainty be accounted for, or addressed, when setting price ceilings?

Members discussed potential approaches to take in situations where the existing reference case was not relevant or where the CADTH and INESSS reference cases differ. It was suggested that the PMPRB create a committee of health economists to review the HTA assessment to determine if submitted reference cases are appropriate for PMPRB use in determining price ceilings.

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:

  1. What are the key differences between a public health care system vs societal perspective?
  2. What are the options to account for these differences?
  3. How should a ‘significant’ difference be defined?

Some members expressed concern with applying a public payer perspective health technology analysis to ceilings that would also apply for private payers. In general, members expressed the importance of considering private, public payer and societal perspectives; however, there was concern regarding need and feasibility of considering all possible perspectives at the guidelines level..

Topic 6: Market Size

Finally, 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:

  1. What approaches are available to consider an ‘affordability adjustment’ to a medicine’s ceiling price?
  2. Should other factors be considered (in addition to market size and GDP)?
  3. How should each of these factors be considered?

Members had a lengthy discussion on these issues following which it was agreed that subsequent discussion was needed.

Given the need for further detailed discussion of each topic, all members agreed that subsequent meetings will be scheduled to discuss each topic in further detail. Members will be surveyed for availability in advance of selecting dates for the next meeting.

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