PMPRB Steering Committee on Modernization of Price Review Process Guidelines - Final Report

July 2, 2019

Table of Contents

• 1. Purpose
• 2. Introduction
  • 2.1. Membership
  • 2.2. Governance
  • 2.3. Procedure and Process
• 3. PMPRB Framework Modernization
  • 3.1. Part 1: MLP based on MIPC
  • 3.2. Part II: Categorization
  • 3.3. Part III: Category 1: MRP
  • 3.4. Part IV: Category 2: MLP
  • 3.5. Part V: Re-benching
  • 3.6. Price review by class of customer
  • 3.7. Application of new Guidelines to existing medicines
• 4. Topics for Discussion
  • 4.1. Use of External Price Referencing (EPR) in Part 1: Median International Price Test (MIPC)
  • 4.2. Use of List Price and Net Price Ceilings (MLP, MRP)
  • 4.3. Risk Assessment and Prioritization Criteria for Category 1 and 2 Medicines
  • 4.4. Re-benching Criteria
  • 4.5. Tests for Category 1 Medicines
  • 4.6. Tests for Category 2 Medicines
  • 4.7. Use of Confidential Pricing Information
  • 4.8. Application of New Regime to Existing Medicines
  • 4.9. Additional Questions for Consideration
• 5. Feedback
• 6. Summary of Working Group Recommendations
• 7. Final Report and Next Steps
• 8. Written submissions
• 9. Appendix

1. Purpose

The purpose of this report is to summarize the deliberations of the PMPRB’s Steering Committee on Modernization of Price Review Process Guidelines (the “Steering Committee”) in providing stakeholder feedback on the Patented Medicine Prices Review Board’s (“PMPRB”) proposed new framework for regulating the prices of patented medicines. The report has been prepared by PMPRB staff and will be shared with the Board for its consideration prior to the publication of new draft guidelines for public consultation later this year.

2. Introduction

The PMPRB is consulting with its stakeholders on changes to its non-binding guidelines (the “Guidelines”), as contemplated by subsection 96(4) of the Patent Act. The purpose of these changes is to modernize the PMPRB’s approach to carrying out its mandate to protect Canadian consumers from excessive patented medicine prices. Two main types of changes are contemplated. The first type would operationalize Health Canada’s proposed amendments to the Patented Medicines Regulations in order to make patented medicines more affordable for Canadians. The second would enable the PMPRB to make more efficient use of its resources by adopting a risk-based approach to how it regulates.

The mandate of the Steering Committee is to assist the PMPRB in synthesizing stakeholder views on key technical and operational modalities of new draft Guidelines that would give effect to these changes. This work was based in part on the analysis and recommendations of a technical Working Group (the “Working Group”) with expertise in health technology assessment and other economic and scientific matters.

Any analysis or recommendations resulting from the Working Group’s review or from the Steering Committee’s deliberations will be carefully considered by the Board prior to the release of new draft Guidelines but are not binding on the Board or PMPRB staff.

2.1. Membership

The Steering Committee was jointly chaired by Tanya Potashnik, the PMPRB’s Director of Policy and Economic Analysis and Matthew Kellison, the PMPRB’s Director of Regulatory Affairs and Outreach. The Steering Committee consisted of 15 members from the stakeholder community and included observers from Health Canada and Innovation, Science and Economic Development (ISED). PMPRB officials attended meetings to provide administrative and other support, as required. Members and observers are identified below.

2.2. Governance

Steering Committee members represent organizations with competing points of view on the policy rationale for the proposed amendments to the Patented Medicines Regulations upon which the proposed framework changes are partly based. This was expressly acknowledged in the Steering Committee’s Terms of Reference. As the regulator responsible for giving effect to these amendments, the PMPRB’s role is to conceive a Guidelines framework that is fair, functionally sound and rationally connected to the nature and scope of Health Canada’s proposed policy. Members were encouraged to work constructively with the Steering Committee to help the PMPRB fulfill its responsibilities in this regard, irrespective of their views on the underlying policy.

During the Steering Committee’s tenure, the proposed amendments to the Patented Medicines Regulations had not been approved for final publication in Part II of the Canada Gazette. As a result, some members expressed the view that any discussion about the operationalization of the amendments was premature and that, in positing passage of the amendments in their currently proposed form, the proposed Guidelines framework was too narrow. PMPRB officials reiterated that comments or concerns about the proposed amendments were outside the scope of the Steering Committee’s mandate but would be included in the appendices to this report.

2.3. Procedure and Process

The Steering Committee held three face-to-face meetings in Ottawa on June 25, 2018, December 13, 2018, and May 13, 2019, as well as four teleconferences on July 24, 2018, August 15, 2018, September 12, 2018 and March 15, 2019. Meeting presentations and summaries prepared by Board Staff are included in the Appendix to this report.

At the first meeting, the co-chairs presented an outline of a new proposed five-part Guidelines framework to members. Subsequent meetings were spent discussing each of these parts in greater detail, with members exchanging ideas and seeking clarifications from Board officials. In general, members representing patient groups were concerned about the potential impact of the changes on continued access to medicines, clinical trials and patient support programs. Members representing the pharmaceutical industry generally expressed concerns that the proposed framework could introduce uncertainty with respect to the price of a medicine in Canada and thereby impact the decision of whether to bring it to market. Conversely, members representing payers generally expressed the view that the proposed changes would provide much needed collaborative federal support to manage the challenges posed by high drug prices.

Members were asked to provide written feedback on specific questions relating to each part of the proposed framework by April 8, 2019. All written feedback is included in Section 8 of this report, including feedback that is outside the scope of the Terms of Reference.

Steering Committee members representing BIOTECanada requested that specialized groups be struck to examine certain operational matters not before the Technical Working Group. However, it was the view of the co-chairs that the matters identified were not sufficiently high level to warrant elucidation at this stage in the consultative process.

Throughout the Steering Committee’s deliberations, PMPRB officials provided regular updates on the parallel progress of the Working Group. On March 15, 2019, the Chair of the Working Group summarized its findings to the Steering Committee by webcast. The Chair also attended the final Steering Committee meeting on May 13, 2019, to present the report in greater detail and answer technical questions from the Steering Committee on its content.

PMPRB officials presented case studies to the Steering Committee at the December 13, 2018 meeting to illustrate how the PMPRB’s current approach to regulating prices would change under the proposed framework.

On March 20, 2019, a questionnaire soliciting final written feedback was sent to the Steering Committee members. At that time members were also asked to identify any additional questions they had regarding the final report of the Working Group.

The draft Steering Committee report was sent to members on May 7, 2019 and discussed at its meeting on May 13, 2019. Steering Committee members were given the opportunity to review the draft and provide feedback prior to the publication of the final report.

3. PMPRB Framework Modernization

The co-chairs presented an outline of the proposed five-part Guidelines framework to the Steering Committee on June 25, 2018 (See Appendix 9.2), which is summarized below.

3.1. Part 1: MLP based on MIPC

Part 1 envisions a ‘Maximum List Price’ (MLP) for all new medicines at introduction. The MLP would be a transparent ceiling price based on public list prices net of any rebates. The initial MLP would be based on the median international prices of the PMPRB12 (MIPC). The MLP would be interim until the medicine is sold in seven countries or has been sold in Canada for three years, whichever comes first. Following this it would be fixed and the prices of the medicine could vary freely below this level in subsequent reporting periods.

3.2. Part II: Categorization

Medicines would be screened as either high priority (Category 1) or low priority (Category 2) based on the anticipated impact on Canadian consumers, including individual patients and institutional payers. Four screening criteria were proposed:

1. The medicine is first in class or a substantial improvement over existing therapy^{Footnote 1};
2. Expected sales exceed the affordability threshold of $20 million annually^{Footnote 2};
3. The opportunity cost of any clinically significant indication of the medicine is greater than $30,000/quality-adjusted life year (QALY);^{Footnote 3} and/or
4. The average annual treatment^{Footnote 4} cost is above per capita GDP.

3.3. Part III: Category 1: MRP

Category 1 medicines would have both a MLP, which would be public, and a ‘Maximum Rebated Price’ (MRP), which would be known only to the patentee. The MRP would be assessed against net (after rebate) prices and determined in a two-step process for Category 1 medicines based on pharmacoeconomic, market size and GDP factors.

In the first step, the cost-effectiveness of Category 1 medicines would be considered by applying a pharmacoeconomic factor. Patentees would be required to provide the PMPRB with all published cost-utility analyses that express value in terms of the cost per QALY. All Category 1 medicines would be subject to a maximum cost effectiveness threshold of $60,000/QALY, although certain clinical characteristics (e.g., a high burden or disease or significant absolute gain in QALY) could warrant a higher absolute ceiling price.

The MRP could be further adjusted following the application of the pharmacoeconomic factor if there were affordability concerns based on the prevalence of the indication the medicine is expected to treat. In the second step, the MRP of Category 1 medicines that have a market size exceeding $20M^{Footnote 5} per year would be subject to a percentage reduction that increases with expected market size. An initial market size threshold of $20M per new medicine is proposed based on the contribution of new medicines to GDP and GDP growth from 2012 to 2017.^{Footnote 6} This threshold would change annually depending on GDP growth.

The MRP would be fixed at introduction and the price of the medicine could vary freely below this level in subsequent years without triggering further review (except in the case of re-benching discussed below).

3.4. Part IV: Category 2: MLP

The final MLP for Category 2 medicines would be set the lower of the MIPC and the average of the domestic therapeutic class (TCC).^{Footnote 7} Category 2 medicines will only have an MLP and no Category 2 medicine will have an MLP that is lower than the lowest price in the PMPRB12 (LIPC).

3.5. Part V: Re-benching

The framework contemplates possible adjustments to the MLP and MRP after introduction (i.e., “re-benching) in response to specific changes in market conditions such as:

1. Approval of a new indication;
2. Actual revenues that diverge significantly from those forecasted at introduction;
3. New evidence on cost-effectiveness (e.g., a CADTH/INESSS therapeutic class review or the lifting of Health Canada conditions for a Notice of Compliance); and/or
4. Significant changes in prices in the PMPRB12 comparator countries (e.g., the MIPC exceeds the MIPC at introduction by more than 25%).

Patentees could also seek to have their medicines re-benched if there is evidence of improved cost-effectiveness, smaller than expected market size, or a significant increase in CPI.

3.6. Price review by class of customer

Price reviews would be conducted for three customer classes based on patentee filings. All medicines would have be assessed against the MLP, with assessment against an MRP reserved for Category 1 medicines only:

1. National Retail: The list prices of all medicines would be reported and assessed against the MLP.
2. National Private Payer: Sales to private payers will be reported at the national level. The national average transaction price (ATP) of all sales reported to private payers will be assessed against the MRP. The ATPs are calculated net of all direct and indirect benefits and discounts.^{Footnote 8}
3. Provincial Public Payer: Sales to public payers will be reported at the provincial/territorial level. The ATP in each province/territory, net of all discounts, will be assessed against the MRP.

Complaints would trigger an investigation into whether the price of medicine is consistent with the Guidelines and whether market conditions have changed following the original assessment such that a re-benching and/or re-classification is warranted.

3.7. Application of new Guidelines to existing medicines

Medicines being sold in Canada prior to the implementation of the new framework (“existing medicines”) would be given an interim price ceiling based on the MIPC of the PMPRB12^{Footnote 9}. If the cost of any indication exceeds $100,000/QALY, the medicine would be classified as Category 1 and prioritized for re-benching. All other existing medicines would be considered Category 2 and re-benched at a later date, with all medicines within a therapeutic class being re-benched at the same time. Re-benching of Category 2 medicines could be prioritized if a complaint is received.

Patentees whose medicines are slated for re-benching would be advised in advance and, if a price reduction is warranted, given two reporting periods to respond accordingly.

4. Topics for Discussion

Over the course of their deliberations, Steering Committee members discussed several topics, as summarized below.

4.1. Use of External Price Referencing (EPR) in Part 1: Median International Price Test (MIPC)

PMPRB officials presented the proposed use of EPR:

• All new medicines would be assigned a Maximum List Price (MLP) based on the median of the PMPRB12 (MIPC).
• This MIPC would be interim until the medicine is sold in seven countries or three years post first date of sale.
• The MLP could be re-benched over time.

Members were asked the following questions:

1. Is an MLP based on the median of PMPRB12 (MIPC) for all medicines reasonable?
2. Should exceptions be made to the MLP-MIPC test and, if so, when and why?
3. Should there be a price floor for Category 2 medicines based on Lowest International Price (LIPC)?
4. Does the 7 countries or 3 years approach provide the right balance of reflecting international prices and providing stakeholders with reasonable predictability?
5. Should an increasing gap between the MIPC and the MLP trigger a re-bench?
6. Should EPR differ depending on the category or vintage of the patented medicine?

4.2. Use of List Price and Net Price Ceilings (MLP, MRP)

PMPRB officials reviewed the proposed framework previously presented to the Steering Committee.

• Category 1 medicines would have two ceilings: one based on list price (MLP) and one based on net (rebated) price (MRP).
• Category 2 medicines would have one ceiling price (MLP) based on the lower of the average domestic Therapeutic Class Comparison test and the MIPC test. No Category 2 medicine would have an MLP that is lower than the lowest country in the PMPRB12.

Members were asked the following questions:

1. Should a Category 1 medicine ever have more than one MRP?
2. Are there economic considerations that would support a higher MRP for some Category 1 medicines that would result from the proposed application of the new factors?
3. Should confidential third party pricing information only be used for compliance purposes?

4.3. Risk Assessment and Prioritization Criteria for Category 1 and 2 Medicines

PMPRB officials reviewed the proposed classification criteria previously presented to the Steering Committee.

• New medicines would be categorised as Category 1 or 2 based on their anticipated impact to Canadian consumers.
• Categorization criteria would take into consideration:
  • Therapeutic alternatives
  • Market size
  • Opportunity cost
  • Annual/treatment cost
• Category 1 medicines would be subject to a comprehensive review to determine if the price is excessive.

The PMPRB shared analysis that models the impact of using different threshold parameters for each of the categorisation criteria.

Members were asked the following questions:

1. Is the proposed division and treatment of Category 1 and Category 2 medicines a reasonable risk-based regulatory approach?
2. Should further categories exist with differential treatment modalities?
3. Should more or less criteria be considered in screening a medicine as higher risk and where should the line be drawn with respect to the criteria?
4. Should the pharmacoeconomic, market size and GDP factors apply as both screens and thresholds?
5. Should Category 2 medicines be scrutinized more or less than proposed?

4.4. Re-benching Criteria

PMPRB officials reviewed the proposed re-benching criteria previously presented to the Steering Committee.

• Approval of a new indication
• Sales in excess of expected market size
• New evidence of cost effectiveness
• Significant changes to international prices
• Application by the patentee for a re-bench with evidence of increased cost effectiveness, smaller market, or a significant increase in CPI

Members were asked the following questions:

1. How often and in what circumstances should a medicine be re-benched?

4.5. Tests for Category 1 Medicines

PMPRB officials presented the following tests for Category 1 medicines:

• Category 1 medicines would be assigned a Maximum List Price (MLP) based on the median of the PMPRB12 basket (MIPC).
• Category 1 medicines would subsequently be given a Maximum Rebated Price (MRP).
• The MRP would be based on application of the pharmacoeconomic, market size, and GDP factors.

Members were asked the following questions:

1. Is an MLP based on the median of the PMPRB12 (MIPC) for all medicines reasonable?
2. Should exceptions be made to the MIPC test and, if so, when and why?
3. Should the cost effectiveness threshold for Category 1 medicines vary?
4. Should a Category 1 medicine ever have more than one MRP?
5. Are there economic considerations that would support a higher MRP for some Category 1 medicines than would result from the proposed application of the new factors?

4.6. Tests for Category 2 Medicines

PMPRB officials reviewed the proposed tests for Category 2 medicines.

• Category 2 medicines would have an MLP based on the lower of the MIPC and the average of the domestic therapeutic class.
• However, no Category 2 medicines would be given an MLP that is lower than the lowest price country in the PMPRB12 (LIPC floor).
• An MRP would not be established for Category 2 medicines.
• The MLP would be established based on publicly available list (ex-factory) prices, domestically and internationally.

Members were asked the following questions:

1. Is an MLP based on the median of the PMPRB12 (MIPC) for all medicines reasonable?
2. Should exceptions be made to the MIPC test and, if so, when and why?
3. Should there be a price floor for Category 2 medicines and, if so, should it be based on LIPC?
4. Should Category 2 medicines be scrutinized more or less than proposed?

4.7. Use of Confidential Pricing Information

PMPRB officials reviewed the proposed ways in which confidential pricing information may be considered.

• Price reviews would be conducted for the following customer classes:
  1. National/Provincial Retail – list price assessed against MLP
  2. National Private Payer – ATP assessed against MRP
  3. Provincial Public Payer – ATP assessed against MRP in each market
• ATPs would be calculated net of all direct and indirect discounts and benefits.
• Category 2 medicines would be assessed against MLP only.

Members were asked the following questions:

1. Are the proposed definitions of markets and customer classes reasonable?
2. Is the proposal to use third-party pricing information for compliance with the MRP reasonable?
3. Other questions proposed by Steering Committee members?

4.8. Application of New Regime to Existing Medicines

PMPRB officials reviewed the proposed method of applying new Guidelines to existing medicines.

• Existing medicines would be given an interim price ceiling based on the lower of their current ceiling and the MIPC of the PMPRB12.
• Existing medicines would only be classified as Category 1 if they do not meet a $100K/QALY screen for any indication. These would be prioritized for re-benching and subject to the same methodology proposed for new Category 1 medicines.
• Category 2 medicines would be re-benched later unless a complaint is received.
• All medicines within a therapeutic class would be assessed at the same time for the purposes of the ATCC test.
• Patentees would be advised in advance of re-benching and given two reporting periods to address the issue.

Members were asked the following questions:

1. Is the use of MIPC as an interim ceiling reasonable?
2. Should existing medicines be subject to a Category 1 or 2 classification and re-benched on this basis?
3. Are there reasonable alternative approaches to bringing existing medicines under the new framework?
4. Other questions proposed by Steering Committee members?

4.9. Additional Questions for Consideration

The following additional questions were put to Steering Committee members for their consideration:

1. Are there opportunities to further reduce regulatory burden while still operationalizing the new factors?
2. Are there other questions proposed by Steering Committee members?

5. Feedback

All the written feedback received during this process was shared with all Steering Committee members and is included in section 8 of this report. Given that not all Steering Committee members responded to the questions posed on the proposed framework, it was not possible to identify common points of agreement. Some members indicated they did not feel informed enough to meaningfully respond in writing, given the technical nature of some of the topics posed to the Steering Committee.

Steering Committee deliberations were summarized by PMPRB officials and circulated to Steering Committee members for review and comment subsequent to each meeting. These summaries are in section 9.3 of the Appendix to this report.

Steering Committee members agreed that PMPRB officials would summarize any questions that arose over the course of each meeting and provide members with an opportunity to provide relevant written feedback afterward. The deadline to provide that feedback was three working days before the next such meeting so that officials would have sufficient time to prepare a response if warranted.

As their deliberations unfolded, some members expressed concern, both verbally and in writing, that the framework presented to them by PMPRB officials was in such an advanced state of design that it left little room for a discussion of possible alternative approaches. PMPRB officials sought to assure the Steering Committee that alternative approaches to operationalizing the proposed regulatory amendments were welcome, but that the framework reflected the agency’s best efforts to provide stakeholders with the level of detail necessary to understand the full import of the policy behind the amendments. At the Steering Committee’s meeting of December 13, 2018, the PMPRB’s Chairperson further observed that it would not have been fair or realistic to put the onus of conceiving the framework from a more embryonic state on stakeholders given their competing views on the merits of the underlying policy.

Steering Committee members were asked to provide final written feedback to the questions identified by the PMPRB over the course of deliberations by April 8, 2019.

Written responses to these questions and earlier requests for feedback were received from CORD and Myeloma Canada, the CMA, the BC Ministry of Health, BMC, BIOTECanada, IMC and CHLIA.

Discussion and feedback from the Steering Committee also resulted in changes to the proposed framework over the course of the Steering Committee’s work. For example, the proposed screening criteria and thresholds used to classify a medicine as Category 1 or Category 2 have evolved, as noted in Section 3 of this report. Additionally, technical issues that warrant subsequent working groups, such as tracing ex-factory sales to the end user in order to provide the PMPRB with a medicine-level breakdown of specific benefits given to public or private payers, were identified for subsequent consultations.

6. Summary of Working Group Recommendations

In July 2018, the Technical Working Group was established to provide expert insight and advice to the Steering Committee on certain economic and scientific matters relating to the new framework.

The Working Group’s Terms of Reference directed it to examine and make recommendations with respect to specific considerations and questions within the following six ‘areas of focus’:

1. Criteria for classifying medicines as ‘Category 1’
2. Supply-side cost effectiveness thresholds
3. Multiple indications
4. Accounting for uncertainty
5. Perspective
6. Market size factor

The Working Group’s final report was provided to the Steering Committee on March 15, 2019 and the Chair of the Working Group briefed the members on the report personally at their final meeting on May 13, 2019. A presentation summarizing the Working Group’s report is included in the Appendix to this report. More information on the Working Group’s activities, including its membership, process and procedure, a summary of deliberations, and ‘on the record’ comments from members, can be found in its final report, included in the Appendix of this report.

7. Final Report and Next Steps

PMPRB officials presented a draft of this report to the Steering Committee on May 13, 2019. In addition to discussing the draft and reiterating their feedback, members discussed the importance of developing a flexible system that is adaptable to future challenges in an environment where medicines are increasingly individualized. Further, members recommended the need to implement a change management plan to evaluate the success of the new regulatory framework going forward and to adjust the framework based on real world evidence. PMPRB officials agreed that a transparent evaluation plan should be put in place and reported on annually.

The final report was published on July 5, 2019.

The PMPRB will publish draft Guidelines for public consultation once the Board has had an opportunity to review the Steering Committee’s report and following final publication of the amended Patented Medicines Regulations in Part II of the Canada Gazette. Details on the nature and scope of the public consultation will be made available at that time.

The PMPRB would like to thank members of the Steering Committee for their participation in this phase of the consultative process and looks forward to an open and constructive consultation process on its new Guidelines in the coming months.

8. Written submissions

• 8.1. July 13, 2018 IMC questions to PMPRB re Working Group
• 8.2. July 15, 2018 letter from CORD to PMPRB
• 8.3. July 19, 2018 letter from PMPRB to CORD
• 8.4. September 6, 2018 CORD Feedback to August 15, 2018 meeting
• 8.5. September 6, 2018, MOHLTC Feedback to August 15, 2018 meeting
• 8.6. September 7, 2018 Myeloma Canada Feedback to August 15, 2018 meeting
• 8.7. September 7, 2018, BIOTECanada Feedback to August 15, 2018 meeting. Resent in response to Steering Committee Questionnaire, April 8, 2019
• 8.8. December 13, 2018, BIOTECanada Case Studies
• 8.9. March 29, 2019, BIOTECanada and IMC Questions and Comments to Steering Committee Regarding the Technical Working Group Report.
• 8.10. April 5, 2019, Gastrointestinal Society/Best Medicines Coalition response to Steering Committee Questionnaire
• 8.11. April 7, 2019, Owen Adams response to Steering Committee Questionnaire
• 8.12. April 8, 2019, IMC response to Steering Committee Questionnaire
• 8.13. April 8, 2019, CORD and Myeloma Canada Open Letter to the Prime Minister in response to Steering Committee Questionnaire
• 8.14. May 22, 2019, Dr. Paulden letter to Prime Minister - Clarifications of the Mandate and Recommendations of the PMPRB ‘Working Group’
• 8.15. April 16, 2019, Canadian Life and Health Insurance Association response to Steering Committee Questionnaire
• 8.16. May 3, 2019 Mitch Moneo response to Steering Committee Questionnaire
• 8.17. May 13, 2019, BIOTECanada email and final case studies
• 8.18. May 17, 2019, IMC email to Steering Committee
• 8.19. May 27, 2019, BIOTECanada letter to Dr. Levine, PMPRB modernization initiative’s Steering Committee process
• 8.20. May 27, 2019, IMC Correspondence to Dr. Mitchell Levine
• 8.21. June 27, 2019, Dr. Levine Correspondence to IMC

9. Appendix

• 9.1. Terms of Reference
  • 9.1.1. Patented Medicine Prices Review Board (PMPRB) Terms of Reference for Steering Committee on Modernization of Price Review Process Guidelines
  • 9.1.2. Working Group to Inform the Patented Medicine Prices Review Board (PMPRB) Steering Committee on Modernization of Price Review Process Guidelines Terms of Reference
• 9.2. Materials Presented at Meetings and Background
  • 9.2.1. PMPRB Framework Modernization: Presentation to Steering Committee June 25, 2018
  • 9.2.2. Assessing health opportunity costs for the Canadian health care systems. Ochalek J., Lomas J. and Claxton K. University of York. March 12, 2018
  • 9.2.3. Canada Gazette – Regulations Amending the Patented Medicines Regulations, Regulatory Impact Analysis Statement, December 2, 2017
  • 9.2.4. IHE White paper: Theoretical models of the cost-effectiveness threshold, value assessment, and health care system sustainability. March 2018.
  • 9.2.5. PMPRB Guidelines Scoping Paper: High Level Overview of Potential New Framework, December 2017
  • 9.2.6. Guiding document for the second meeting of the Steering Committee on Modernization of Price Review Process Guidelines, August 15, 2018
  • 9.2.7. Data Analysis to Inform Guidelines Modernization SC and TWG, August 27, 2018
  • 9.2.8. Guiding document for the third meeting of the Steering Committee on Modernization of Price Review Process Guidelines, September 12, 2018
  • 9.2.9. Guideline Modernization: Case Studies, December 13, 2018
  • 9.2.10. Proposed Application of PE and Market Size Factors to Category 1 Drugs, December 13, 2018
  • 9.2.11. Steering Committee Consultation Roadmap - Update, December 13, 2018
  • 9.2.12. Final Report of the Working Group to Inform the PMPRB Steering Committee on Modernization of Price Review Process Guidelines, March 2019
  • 9.2.13. Recommendations of the Technical Working Group, PowerPoint presentation, March 15, 2019
  • 9.2.14. Steering Committee Questionnaire- March 20, 2019
  • 9.2.15. PMPRB Steering Committee on Modernization of Price Review Process Guidelines PowerPoint presentation May 13, 2019
• 9.3. Steering Committee Meeting Minutes
  • 9.3.1. Steering Committee Meeting June 25, 2018
  • 9.3.2. Steering Committee Meeting July 24, 2018
  • 9.3.3. Steering Committee Meeting August 15, 2018
  • 9.3.4. Steering Committee Meeting September 12, 2018
  • 9.3.5. Steering Committee Meeting December 13, 2018
  • 9.3.6. Steering Committee Meeting May 13, 2019
• 9.4. IMC Disclaimer