Meeting minutes - Technical Working Group August 22-24, 2018

The Technical Working Group to inform the PMPRB Steering Committee on Modernization of Price Review Process Guidelines agreed during its meeting on July 26, 2018 that detailed discussions of each topic identified in the terms of reference were needed to collect input from Working Group members. As a result six one-hour teleconferences took place between August 22 and August 24, 2018.

Discussions were led by the Chair and attended by Working Group members who were interested and available. During each session the Chair summarised previous discussions on the area of focus and each participant had the opportunity to provide input. Summaries of these discussions are found below.

Teleconference Topic 1: Options for determining which medicines fall into ‘Category 1’

August 22, 2018
11:00 a.m. to 12:00 p.m. EDT

Participants: Dr Chris Cameron (Dalhousie University and Cornerstone Research Group), Dr Frédérick Lavoie (Pfizer Canada), 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

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

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 definitions of “high market impact and “high average annual treatment cost” was identified, as well as what would be the relative comparators for criterion “A”. Members representing the pharmaceutical industry expressed concern that it was difficult to provide meaningful feedback on the criteria for classifying a medicine as “Category 1” without knowing what the downstream effects of each Category were. 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 PMRPB agreed to provide Working Group 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

August 22, 2018
12:00 p.m. to 1:00 p.m. EDT

Participants: Dr Chris Cameron (Dalhousie University and Cornerstone Research Group), Dr Frédérick Lavoie (Pfizer Canada), Maureen Smith (Patient), Geoff Sprang (Amgen), Dr Tania Stafinski (University of Alberta), Dr Stuart Peacock (Simon Fraser University and BC Cancer Agency)

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

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?

Group members agreed that the $30,000/QALY opportunity cost threshold lacked face validity and that more research was needed to definitively determine a supply side estimate. Members discussed the potential of using a $100,000/QALY threshold until this research is completed. Members discussed the possibility of using surveys that reflect the diversity of Canadians, to determine medicines that should have higher cost effectiveness threshold. Members representing the pharmaceutical industry were concerned with the uncertainty surrounding the lack of clarity regarding point estimates and thresholds and the operationalisation of this factor.

Topic 3: Medicines with Multiple Indications

August 22, 2018
4:00 p.m. to 5:00 p.m. EDT

Participants: Don Husereau (University of Ottawa), Dr Frédérick Lavoie (Pfizer Canada), Maureen Smith (Patient), Geoff Sprang (Amgen), Dr Tania Stafinski (University of Alberta), Dr Peter Jamieson (University of Calgary)

Observers: Edward Burrows (Innovation, Science and Economic Development), Miguel Pommainville-Cleroux (Health Canada)

PMPRB: Tanya Potashnik, Isabel Jaen Raasch, Matthew Kellison, Richard Lemay

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?

Group members discussed the potential advantages and disadvantages of setting one ceiling or multiple ceilings for medicines with more than one indication. Some members expressed the view that price ceilings should be fixed based on a single indication (e.g., the least cost-effective) rather than set ceilings by indication, which could be complex or impractical to manage. Members also discussed the possible for gaming by introducing drugs by indication strategically based on which is the most cost-effective. There was discussion as to whether this would be a practical concern, such as in oncology where drugs are typically introduced as less-effective second and third-line treatments. Industry representatives expressed the view that rebenching in response to new indications would create uncertainty and that currently, 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.

Members came to the general consensus that using one price ceiling for medicines with multiple indications is the most reasonable approach, but that additional discussion would be required to establish which indication is appropriate.

Topic 4: Accounting for Uncertainty

August 24, 2018
12:00 p.m. to 1:00 p.m. EDT

Participants: Dr Tania Stafinski (University of Alberta), Marie-Claude Aubin (replacement for Patrick Duford) (INESSS), Dr Frédérick Lavoie (Pfizer Canada), Maureen Smith (Patient), Geoff Sprang (Amgen), Dr Christopher McCabe (University of Alberta and Institute of Health Economics), Dr Chris Cameron (Dalhousie University and Cornerstone Research Group)

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

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 the existing reference case models; how uncertainty is addressed, quantified, incorporated and expressed to decision makers. Some members voiced concern that the price reduction tables in the reference cases are not peer reviewed.

Members discussed the necessity of having a point estimate instead of a range in the ICER, and where in the range the point estimate should fall. Members representing the pharmaceutical industry voiced concern that a range of possible reference cases introduces uncertainty. Additionally, who should bear the burden of uncertainty (i.e. payer or manufacturer) was discussed.

One member expressed that the principle methods for characterising uncertainty are well described in the CADTH reference case and there is not a strong reason to move away from it. However, what to extract for PMPRB’s purposes might be different than current outputs.

Some members indicated that “real life” examples would be useful to inform the discussion.

Topic 5: Perspectives

August 24, 2018
11:00 a.m. to 12:00 p.m. EDT

Participants: Marie-Claude Aubin (replacement for Patrick Duford) (INESSS), Dr Frédérick Lavoie (Pfizer Canada), Maureen Smith (Patient), Geoff Sprang (Amgen), Dr Christopher McCabe (University of Alberta and Institute of Health Economics)

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

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 that it would be appropriate to include societal perspective in setting the ceiling price for some medicines when relevant. Members discussed the challenges surrounding sources of information and the difficulty in quantifying issues such as productivity loss, spill over effect and care of burden. It was suggested that without the appropriate tools to capture societal perspective inputs, the perspective should be the government payer perspective. Members discussed the concern of discrimination regarding differing productivity costs for different people. One member expressed that if spill over was incorporated this would address potential for discrimination from not including productivity costs.

Some members felt that excluding productivity analysis from the societal perspective would exclude the perspective of private payers. Members representing the pharmaceutical industry expressed concern over the uncertainty due to the lack of bright lines and the increased risk of delayed innovation and potential delayed entrance of new medicines to Canada.

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.

Topic 6: Application of the Market Size Factor in setting Ceiling Prices

August 22, 2018
2:00 p.m. to 3:00 p.m. EDT

Participants: Dr Chris Cameron (Dalhousie University and Cornerstone Research Group), Dr Frédérick Lavoie (Pfizer Canada), Maureen Smith (Patient), Geoff Sprang (Amgen), Don Husereau (University of Ottawa), 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

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 discussed the current US ICER approach and what a Canadian solution might resemble. It was noted that different provinces and payers will have different tolerances for expenditure growth based on their individual circumstances which would result in a range of tolerances. Additionally, the market size that will displace a technology in one province is different from what it would displace in another province.

The need to have a clear “line” at a medicine’s launch was identified, one high enough to catch extreme cases yet not so low that payers would be concerned. One member was concerned at the difference between looking at market size versus incremental budget impact.

There was concern that access to medicines for rare diseases could be negatively impacted by using market size to determine a medicine’s ceiling price. The group explained how consideration of market size would benefit medicines with small market sizes, such as medicines for rare disease. Some members expressed the need for examples to inform the discussion. Members representing the pharmaceutical industry voiced concern that the anticipated market size is not always defined at a medicine’s introduction to the Canadian market and this increases uncertainty for patentees.

PMPRB shared preliminary results of analysis regarding the use of $20M or $40M Category 1 screening factor. This data will subsequently be shared with Working Group members.

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