Common Ground: Exploring Opportunities to Enhance the Drug Review Process in Canada

Transcription

1 Common Ground: Exploring Opportunities to Enhance the Drug Review Process in Canada Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review November 2012

2 Table of Contents 1.0 Executive Summary Glossary of Terms Acknowledgements Introduction Project Goal and Objectives of the National Summit The Common Drug Review and Why it is Important to Canadians Exploring Key Thematic Areas and Ways Forward Next Steps List of Appendices Appendix A: Summit Participants Appendix B: Recommendations from In The Balance: A Renewed Vision for The Common Drug Review Appendix C: Revised Recommendations from Carousel Discussions Appendix D: Notes Concerning Key Thematic Areas And Ways Forward Appendix E: Summit Agenda Appendix F: An Overview of How The Common Drug Review Process Currently Works.22 Appendix G: Summary of Panel Session Summary Appendix H: Highlights of Keynote Address by André Picard Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 2

3 1.0 Executive Summary Access to needed medications is critical for people with chronic diseases to optimally manage their condition and live healthy lives. However, Canadians without publicly funded coverage or private insurance can have outof-pocket costs that can be a barrier to accessing these drugs. In order for Canadians to have appropriate access to medications that can improve their lives, the drug review process must ensure an appropriate balance of costeffectiveness, clinical efficacy and patient experience. To ensure this balance is achieved, the Canadian Diabetes Association engaged key stakeholders through a Summit on a Renewed Vision for the Common Drug Review (Ottawa, June 2012). The Common Drug Review (CDR) was established in 2003 to consolidate separate drug review processes at the federal, provincial and territorial level into a pan-canadian process. It is an important component of the drug review continuum, following Health Canada s review for safety and efficacy and preceding participating drug plan formulary decisions. Participants explored recommendations within the Association s report In the Balance: A Renewed Vision for the Common Drug Review (2012). The following themes emerged during discussion: 1) Ensure clarity regarding all aspects of the drug review process. While the CDR is the focus of In the Balance, to address challenges concerning drug approvals, the entire drug review process must be examined. There is no common understanding or clarity of the review process or key concepts held by stakeholders. All stakeholders must have a shared understanding of the process, including the roles and responsibilities of all participants, as well as review criteria and their application. 2) Improve how patient experience and societal costs and benefits are included in the assessment of cost-effectiveness. An enhanced understanding is needed of the criteria applied to assess cost effectiveness. Clarification of the criteria used to evaluate cost effectiveness and how factors are weighted in the final assessment is required. Optimizing modelling to enhance what is meant by patient experience would assist reviewers to determine cost-effectiveness and whether or not to list a drug. 3) Strengthen transparency, accountability and public disclosure. Governments, the CDR, and manufacturers must be held accountable to disclose assessment criteria, evidence, and rationale for decisions, with sufficient detail to allow stakeholders to understand inputs that lead to final drug funding decisions. This will allow public discussion on what is the optimal weighting of criteria. Ultimately, equity and access concern where people live as well as their ability to afford medications and requires an examination of the entire drug review process. Access is not consistent across jurisdictions, and approaches such as a national program for essential drugs and a common formulary are important advocacy directions to achieve pan-canadian solutions to continuing challenges in accessing needed medications by all Canadians. Moving forward, the Association will continue to engage all key stakeholders to consider best practices in drug approvals to achieve an optimal drug approval process that meets the needs of Canadians. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 3

4 2.0 Glossary of Terms CADTH: Canadian Agency for Drugs and Technologies in Health CDEC: Canadian Drug Expert Committee CDR: Common Drug Review CEDAC: Canadian Expert Drug Advisory Committee CIHI: Canadian Institute for Health Information F/P/T: Federal/Provincial/Territorial HC: Health Canada HESA: House of Commons Standing Committee on Health HTA: Health Technology Assessment INESS : Institut national d excellence en services en santé et en services sociaux NICE: National Institute for Clinical Excellence (United Kingdom) OECD: Organisation for Economic Co-operation and Development PMPRB: Patented Medicines Pricing Review Board pcodr: pan-canadian Oncology Drug Review P/T: Provincial/Territorial QALY: Quality-Adjusted Life Year Rx&D: Canada s Research-Based Pharmaceutical Companies The Association: Canadian Diabetes Association Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 4

5 3.0 Acknowledgements We gratefully acknowledge the important contributions of the following individuals to the Canadian Diabetes Association Summit on the Future of the Common Drug Review: All participants who attended and contributed to the dialogue; Dr. Jan Hux, Chief Scientific Advisor (the Association) for welcoming participants; Panelists Kathy Kovacs Burns (moderator, University of Alberta), Linda Wilhelm (Best Medicine Coalition), Mark Ferdinand (Rx&D), and David Bougher (consultant; former member, F/P/T Pharmaceutical Issues Committee); Dr. Chander Sehgal, Director, CDR, CADTH, for providing an overview of the process; André Picard of the Globe and Mail, for his insightful keynote speech; All members of the project advisory committee, in particular, Kathy Kovacs Burns, Aileen Knip (Diabetes Educator Section, the Association), and Colin Mallet (National Advocacy Council, the Association) who participated as facilitators for the Carousel discussion; One World Inc. for their design and facilitation of the summit dialogue process; and Julia Atkin from Intergage Consulting for note-taking support. Finally, we thank you for taking the time to read this report, and we welcome your feedback at Note: The participant dialogue expressed within this report s appendices reflects the presentations to and exchange between those who attended the summit. The advocacy directions drawn from this dialogue in section 5 are the interpretation of the Association and may not necessarily reflect those of the Project Advisory Committee, or consultants for the report, or all conference participants. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 5

6 4.0 Introduction 4.1 Project Goal and Objectives of the National Summit The Canadian Diabetes Association has taken a longstanding leadership role in calling for a new vision for the CDR in Canada so that access to needed medications is assured for Canadians to manage their health. Toward this end, In the Balance: A Renewed Vision for the Common Drug Review 1, a 2012 Association report, brings together the results of a literature review, a review of 10 international jurisdictions with centralized drug review processes in place, and a survey of key stakeholders. To move this new vision forward to action and change, the Association engaged key stakeholders through a Summit on a Renewed Vision for the Common Drug Review. Approximately 50 participants attended the event on June 6 and 7, 2012 in Ottawa, including representatives of patient groups, health charities and providers, researchers, government and industry (see Appendix A). Summit participants met to: 1) Exchange perspectives on inherent strengths and challenges in the CDR; 2) Arrive at common ground on recommendations for enhancing the CDR; and 3) Identify some important considerations in moving such recommendations forward to positive change outcomes. Dr. Jan Hux, Chief Scientific Advisor for the Canadian Diabetes Association, welcomes Summit delegates Participants focused on an interactive dialogue exploring the five key recommendations from In the Balance (Appendix B), possibilities for modifying them (Appendix C) and strengthening the CDR process (Appendix D). The full agenda is included in Appendix E. This report summarizes the shared themes and common ground for moving forward explored by participants. Detailed notes concerning inputs into this discussion are also available, including how the CDR process works, by Dr. Chander Seghal (Appendix F), a summary of the panel session discussion by key stakeholders (Appendix G), and highlights of keynote address by André Picard of The Globe and Mail (Appendix H). 4.2 The Common Drug Review and Why it is Important to Canadians The CDR was established in 2003 in an attempt to consolidate nearly 18 drug review processes into a collaborative pan-canadian federal/provincial/territorial (F/P/T) process (with the exception of Quebec). It is an important component of the drug review process in Canada, following Health Canada s (HC) review for safety and efficacy and preceding final decisions by participating drug plan concerning formulary listings. Unlike hospitals and physician services, public coverage for drugs is not guaranteed in Canada. While some provinces have enhanced coverage for those on low incomes or with high drug costs, a national plan remains stalled and access to medications depends not necessarily on need but instead on where Canadians live, work, and their income. A CDR review considers how a drug compares with alternatives, which patients it will benefit, and whether it delivers value for money. While the CDR is an advisory body and its recommendations to participating drug plans are not binding, these plans will only consider listing drugs that have been reviewed by the CDR. Millions of Canadians are affected by CDR recommendations. 1 Report available at: Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 6

7 The CDR has enhanced the drug review process in Canada through: Improving the transparency of the drug review process; Decreasing the median time-to-listing for all drugs (i.e. the time between submission to CDR, final recommendation and when the drug is listed by public drug plans; 2,3 and) Strengthening public engagement and involvement. Equal and timely access to needed medications is important for people with chronic diseases to optimally self-manage their condition. However, since the Canada Health Act does not cover drugs outside of those administered in hospitals 4, Canadians with chronic disease who do not have public coverage (e.g. social assistance, benefits to seniors, etc.) or private insurance through employers or other sources can have excessive out-of-pocket costs Dr. Chander Sehgal, CDR, provides delegates that prevent access to prescribed drug therapy. For example, while about with an overview of the CDR process 10% of Canadians overall skip medications due to cost, this rises to almost one-quarter for those with chronic disease. 5 While one in 10 has difficulty paying for medications even if they have insurance, this rises to one in four for those without coverage. 6 Those with the most difficulty have chronic conditions with recurring drug costs. While equitable access to drugs is important, the drug review process must include cost-effectiveness to ensure that limited public dollars are spent wisely. But there must be an appropriate balance of cost-effectiveness, clinical efficacy and patient experience so that Canadians are not denied access to medications that can improve their lives. A 2007 review of the CDR by the House of Commons Standing Committee on Health (HESA) concluded that while the CDR was a good start, further improvements are necessary for the drug review process. In this spirit, the Association produced In the Balance to launch a dialogue to build on the CDR s strengths while addressing remaining challenges, including: Continued duplication in the review process; Differences in length of time to reach decisions; Lack of agreement between CDR recommendations and drug plan decisions; Unequal access across participating drug plans to some drugs; Concerns over the appeals process; and Achieving the appropriate balance of efficacy, cost effectiveness and patient experience. 2 Gamble, J. M., Weir, D. L., Johnson, J. A. Analysis of Drug Coverage Before and After the Implementation of Canada s Common Drug Review, Canadian Medical Association Journal, 183(2011): p. E While the CDR appears to have streamlined the drug review process for some jurisdictions, significant variations in the length of time exist for drug funding decisions across participating drug plans. For provinces west of Quebec, the median average review time has increased, while for those east of Quebec it has decreased. (Ibid) It should be noted that CDR has no control over the ultimate timing of listing decisions by participating drug plans. 4 Despite the Canada Health Act, some drugs administered within hospitals and healthcare settings are not covered; see: A. Attaran. Take Your Medicine?: The Risk of Patient-led Litigation in Canada s Medicine Access System. McGill Journal of Law and Health, 3, Health Council of Canada, How Do Sicker Canadians with Chronic Disease Rate the Healthcare System? (Toronto: HCC, 2011). 6 Law, M. R., Cheng, L., Dhalla, I. A., Heard, D., Morgan, S. G. The Effect of Cost on Adherence to Prescription Medications in Canada, Canadian Medical Association Journal, (184) 3, 2012, pp Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 7

8 5.0 Exploring Key Thematic Areas and Ways Forward Using a rotational carousel discussion format, participants worked in small groups to discuss the recommendations. With each round, the groups focussed on one specific recommendation, reviewing and building on the discussion points of the previous group. The following questions guided each carousel round: 1) Do you generally agree with the recommendation? What elements do you particularly like about it? 2) Are there any elements of the recommendations that you don t agree with? 3) How would you improve the recommendation? 4) If this recommendation was to be moved forward what would be a priority next step action that should be taken? Shared overarching themes and suggested actions emerging from discussion are presented below as potential guidance for the Association and stakeholders in moving forward. 7 A record of discussions concerning each recommendation is available in Appendices C and D. 1) Ensure clarity regarding all stages of the drug approval process. While the CDR is the focus of In the Balance, participants felt strongly that to address timelines, transparency, balance in application of review criteria, the use of patient input, and issues of equity, the entire continuum of the drug approval process needs to be examined, Kathy Kovacs-Burns, Chair of the Summit Panel, engages delegates in the Panel s observations. including the manufacturer submission, HC s Proof of Concept review, CDR and P/T reviews, and post-market surveillance. Participants noted the need for a shared understanding by all stakeholders of the review process, including review criteria and their application, noting that not all stakeholders have a common understanding or clarity of the review process or some key concepts. They identified areas where additional information is needed to fully develop informed approaches to strengthening this process. Specific suggestions included: Identify areas of duplication in the various stages of review, especially the CDR and P/T review processes; Clarify current drug review criteria used by HC, CDR and P/Ts, and any weighting of these criteria in their application; Define cost-effectiveness and the inputs/measures used to assess cost-effectiveness in the drug review process; Clarify how patient experience is currently measured and applied in the drug review process, both quantitatively through Quality Adjusted Life Years (QALYs) and qualitatively through patient submissions and other mechanisms; and Clarify how criteria and recommendations take into consideration evidence-based Clinical Practice Guidelines. 7 It is important to note that these themes were developed based on detailed notes taken during each carousel discussion and developed by the Association after the summit to encapsulate the most evident areas of general agreement. As such, there was no opportunity to have them validated by summit participants. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 8

9 Panelists Linda Wilhelm, Mark Ferdinand, and David Bougher listen to delegates questions 2) Improve how patient experience and societal costs and benefits are included in the assessment of costeffectiveness. A better understanding is needed of the criteria currently being applied by CDR and P/Ts in assessing cost effectiveness. It is unclear what specific criteria are used for evaluating cost effectiveness or how factors are weighted in the final assessment, e.g., cost vs. patient experience or healthcare system costs vs. broader societal costs such as workplace productivity. Optimizing modelling to enhance what is meant by patient experience would also assist reviewers in their determinations concerning cost-effectiveness and whether or not to list a drug. Specific suggestions included: Clarify current factors used in assessing cost effectiveness and their application, both in terms of the measures and the processes used in decision-making; Strengthen measures to assess proof of value, not simply proof of cost, including both quantitative and qualitative factors; Apply varied methods of assessment that consider the impact of context on drug approval decisions, such as provincial factors (e.g., prevalence of chronic conditions, budget constraints), culture, nature of the drug or disease, e.g., a different method or weighting might be necessary to assess a new, novel drug that greatly improves quality of life; Include patient experience and key patient outcomes as elements of cost effectiveness earlier in the assessment process, e.g., in the manufacturer submission to the CDR; and Include post-market surveillance as a criterion for conditional listing of drugs, e.g., incorporate a one-year post-market assessment into the drug review process to test the assessment criteria/balance based on real world patient experience. 3) Strengthen transparency, accountability and public disclosure. Participants felt strongly that HC, CDR, P/Ts and manufacturers should be held accountable to disclose assessment criteria, evidence, and rationale for decisions, with sufficient detail to allow stakeholders to understand the various inputs that led to final drug funding decisions. Once this information is disclosed and understood, it will allow stakeholder and public discussion on what is the optimal weighting of criteria. Specific suggestions included: Make the CDR rationale for decision more explicit, expanding on a simple yes/no (e.g., no, but at a different price point the decision would be different) so that when manufacturers appeal a decision, they might be able to offer different conditions; Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 9

10 Provide formal CDR feedback on patient group submissions and disclose how the submissions are included in the review process to help them improve the relevancy of their submission documents; Disclose information about the involvement of subject matter experts in the review process (e.g., who is involved, how they are involved) and develop strategies to allow more expert participation, e.g., give consideration to conflict of interest guidelines that might allow for participation with disclosure of potential conflicts; and Address pricing variability across jurisdictions resulting from bilateral negotiations between manufacturers and P/Ts that impacts consistent adoption of CDR recommendations across the country. The CDR assessment should include the real cost of the drug as opposed to a CDR assessment cost to save funds by eliminating unnecessary duplication along the F/P/T drug review continuum that occurs as part of the budget impact assessment by participating drug plans. Options for discontinuing drug manufacturer submission of different prices to the Patented Medicines Pricing Review Board (PMPRB), CDR and P/Ts should be explored. The Globe and Mail s Andre Picard delivers his keynote address At the final round of the carousel group discussion, participants reviewed and discussed the common ground that had emerged from the preceding rounds of discussion and began to refine the five recommendations. Participants presented these refined recommendations in plenary as works-in-progress, along with a synthesis of high level points emerging from the carousel discussion. Participants discussed apparent areas of common ground and ways forward, identifying some potential changes to the recommendations (Appendix D). 6.0 Next Steps Fundamentally, equity and access concern where people live as well as their ability to afford medications, and require an examination of the entire drug review process across jurisdictions within Canada. Pan-Canadian solutions are required to assure access to prescribed medications by all Canadians. Participants saw moving toward a national program for essential drugs and a common formulary as important advocacy directions within the recommendations. They advocated that the Association continue to engage all key stakeholders to consider Canadian and international best practices in drug approvals to optimize the drug review process to meet the needs of all Canadians. A review of best practices could capture valuable lessons concerning streamlined, timely and consistent review processes, patient input, appeal mechanisms, and structural and funding mechanisms for a national drug program and common formulary. Governments, arm s length agencies, industry and patient groups must work together to assure access to needed medications. Going forward, in collaboration with key stakeholders, the Association will work to advocate a pan-canadian approach grounded in evidence-based best practices to: Clarify all aspects of the drug review process, including the roles and responsibilities of the CDR and participating drug plans to ensure optimal effectiveness and efficacy by: Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 10

11 clarifying current drug review criteria used by governments (HC, CDR and participating drug plan) by requesting applicable information from each party; and bringing together drug review experts (drug plan managers, chairs of expert committees) to consider ways to minimize duplication within the review process. Meaningfully capture patient and societal values to ensure that the patient experience is optimally represented within determinations concerning cost-effectiveness by clarifying: what is meant by patient experience in terms of clinical information, impact on health system utilization, and quality of life; and how patient experience is measured and considered in the drug review both through QALY and also through patient submissions by requesting formal feedback from CDR and participating drug plans on patient submissions. Strengthen transparency to ensure that governments, the CDR, and manufacturers are held accountable to disclose assessment criteria, evidence, and rationale for decisions. Require sufficient detail to allow stakeholders to understand inputs that lead to final drug funding decisions; and Coordinate negotiations concerning pricing across drug review processes to ensure consistency. Working together to ensure access to needed medications Clarify all aspects of the drug review process Capture patient and societal values Governments Arm s-length agencies Governments Arm s-length agencies Patient groups Manufacturers Strengthen transparency to ensure that governments, the CDR, and manufacturers are held accountable Governments Manufacturers Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 11

12 Appendix A: Summit Participants ALBEE, Christine Director, Government Relations and Advocacy, Atlantic, Canadian Diabetes Association ANIS, Aslam Professor, University of British Columbia ATKIN, Julia Senior Consultant/Researcher, Intergage ATTARAN, Amir Professor, Faculty of Law, University of Ottawa BABIAK, Lesia Executive Director, Government Affairs, Lifescan BARBER, Kristen Manager, Public Policy, Canadian Diabetes Association BAYNE, Patricia Senior Manager, Policy and Government Affairs, Eli Lily BERG, Angelique VP of Community Development, Canadian Diabetes Association BINGHAM, Tara Federal Government Affairs, AstraZeneca Canada Inc. BORGES, Pamela Associate Director, Market Access, Novo Nordisk BOUDREAU, Michelle Executive Director, Patented Medicine Prices Review Board BOUGHER, David President, D Bougher Consulting Former Member, Federal, Provincial and Territorial Pharmaceutical Issues Committee BRACE, Jeremy Senior Manager Public Affairs, Novo Nordisk BROUGHAM, Matthew Vice-President, Products and Services, CADTH CLOUTIER, Michael President and CEO, Canadian Diabetes Association CRITCHLEY, Wayne Senior Associate, Global Public Affairs DE FRANCO, Emanuela Advocacy & Alliance Development Manager, GlaxoSmithKline DOBSON-HUGHES, Lauren Senior Analyst Public Issues, Canadian Cancer Society DOUCET, Glen Vice President, Government Relations and Public Affairs, Canadian Diabetes Association DZIARMAGA, Alison Senior Manager, Reimbursement & Health Economics, AstraZeneca Canada Inc. FALK, Nadine National Director, Programs and Public Policy, Kidney Foundation of Canada FERDINAND, Mark Vice President of Policy Research & Analysis, Rx&D FERNANDES, Aida Chief Science & Education Officer, Crohn s and Colitis Foundation of Canada FRASER, Brent Director, Drug Program Services, Ontario Ministry of Health and Long-term Care GROETZINGER, Deanna Vice-President, Government Policy Relations, Multiple Sclerosis Society of Canada HUX, Jan Chief Scientific Advisor, Canadian Diabetes Association JIWA, Famida President & CEO, Osteoporosis Canada Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 12

13 KEARNS, Melanie Vice President, Marketing & communications, Canadian Liver Foundation KNIP, Aileen Chair, Diabetes Educator Section, Canadian Diabetes Association KOVACS BURNS, Kathy Associate Director, Health Sciences Council, University of Alberta LAMOUREUX, Eric Director, Public Affairs, Alzheimer s Society of Ottawa & Renfrew County LEO, Aileen Director, Public Policy, Canadian Diabetes Association MALLET, Colin Member, National Advocacy Council, Canadian Diabetes Association SEHGAL, Chander Director, CDR, CADTH SMITH, Jennifer President, Intergage SNELGROVE, Barbara National Director, Education and Services, Parkinson Society of Canada THOMAS, Kim Director of Programs, Canadian AIDS Society TOOMBS, Millicent Senior Policy Analyst, Health Policy and Research, Canadian Medical Association TREMBLAY, Sabrina Senior Manager Public Affairs, Bristol-Myers Squibb WILHELM, Linda Advocate, Best Medicines Coalition MCELROY, Carrie Manager, Stakeholder Relations Ontario, Sanofi-Aventis MCKINNEY, Shelley Institute for Safe Medication Practices MORTELL, Lisa Member, Best Medicines Coalition PICARD, André The Globe and Mail REID, Jake Director, Government Relations and Advocacy, Atlantic, Canadian Diabetes Association SAIDLA, Karl Health Policy and Information Analyst Heart and Stroke Foundation of Canada SARYEDDINE, Tina Assistant VP, Research & Analysis (Ottawa), Canadian Academic Healthcare Organization Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 13

14 Appendix B: Recommendations from In The Balance: A Renewed Vision for The Common Drug Review Recommendation 1: Recommendation 2: Recommendation 3: Recommendation 4: Recommendation 5 The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Eliminate duplication in the drug review process. Work with participating drug plans to minimize duplication of effort and differences in coverage decisions by establishing: set review criteria; and a drug review and regulatory process that leads to conclusions respected by each participating drug plan. The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Introduce greater transparency in the public engagement and review process. Implement practices to standardize and ensure quality in the review process by: Ensuring an appropriate proportion of subject-matter experts for each medication under review; and Improving the appeals process by establishing: A formal appeal process for patients and patient groups; and An independent appeals review body The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Reduce the timelines of the drug review process. Implement mechanisms to reduce the length of time for making decisions across jurisdictions and disparities in access, including implementation time frames. The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Improve the balance of the criteria used to make drug funding decisions. Ensure the appropriate balance between cost-effectiveness, clinical effectiveness and patient experience through enhanced public engagement mechanisms. Federal, provincial and territorial governments collaborate to enhance pharmacare coverage in Canada, as committed to under previous F/P/T health accords. Improvements such as catastrophic drug coverage and a common formulary can reduce disparities and improve access across jurisdictions, and there is evidence that such measures can also ultimately contain costs. In particular, such efforts will require strong federal leadership with appropriate incentives for provinces and territories. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 14

15 Appendix C: Revised Recommendations from Carousel Discussions Suggested changes are shown in italics. Recommendation 1: Recommendation 2: Recommendation 3: Recommendation 4: Recommendation 5 Suggested changes: Change Eliminate to Minimize duplication in the drug review process. Work with participating drug plans to minimize duplication of effort and differences in coverage decisions by establishing: Set review criteria; and Change to A drug review and regulatory process that leads to more congruency with CDR decisions. Additional Comments: Split eliminate duplication from leads to decisions that are respected move to recommendation #5; greater transparency would assist re: who has the power to make decisions; Emphasize importance of increasing transparency throughout the entire drug review process - more information should be available/shared. Suggested changes: Introduce greater transparency in the public engagement, review criteria, and decision making process and final decisions (including HC, CDR and provinces.) Implement practices to standardize and ensure quality and accountability in the review process by: Ensuring an appropriate proportion of subject-matter experts for each medication under review, by allowing more experts to present with an understanding of a declaration of conflict of interest; Ensuring patient values and perspectives are integrated more explicitly in the process; Improving the appeals process by establishing: a formal appeal process for patients and patient groups; and an independent appeals review body; Disclosing the review criteria and rationale for decision in order to validate outcomes. Suggested changes: Implement mechanisms to both: Reduce the length of time to final provincial availability of drugs (HC/CDR/Provincial Review); Reduce disparities in timeliness to access. Recommendation 6 A new recommendation should be drafted that integrates points regarding disparities in access. These points are, in essence, reflected through other recommendations concerning enhancing coverage and reducing disparities. Suggested changes: Improve the balance of the criteria used to make drug funding decisions. Ensure that the drug review and listing criteria used reflect the societal values (e.g. Patient quality of life considerations; cost-effectiveness; sustainability of the system) Suggested changes: No changes made to the recommendation. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 15

16 Appendix D: Notes Concerning Key Thematic Areas and Ways Forward Recommendation 1: The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Eliminate duplication in the drug review process. Work with participating drug plans to minimize duplication of effort and differences in coverage decisions by establishing: set review criteria; and a drug review and regulatory process that leads to conclusions respected by each participating drug plan. Areas of agreement and disagreement Suggested improvements Next step priority actions There was agreement in principle for this recommendation. There was no strong disagreement, but participants identified some areas where either clarification or further refinement is needed: Rather than a focus on CDR, there is a need to look at the entire review process (HC, CDR, P/T, post-market surveillance); Clarification is required on what is meant by set criteria does this imply one set of criteria used by both CDR and P/Ts or is it more about P/Ts having greater transparency (Ontario is the only province that currently shares criteria)?; How much are differences in P/T formulary listings based on pricing issues? Consideration could be given for both private and public drug plans. In terms of wording: Split eliminate duplication from leads to decisions that are respected move to recommendation #5; greater transparency would assist re: who has the power to make decisions; Emphasize importance of increasing transparency throughout the entire drug review process - more information should be available/shared. CDR could explore why P/Ts conduct their own drug reviews (is it just about budget impact, or are there other factors?); Rather than eliminate duplication, the recommendation could be to identify, stream-line, or minimize duplication the aim should be to complement national criteria, not duplicate elements of the CDR review process; Rather than leads to conclusions respected by each participating drug plan, the emphasis could be on leading to informed/better decisions for their populations; The current system could be altered to prevent drug manufacturers from submitting different prices to the Patented Medicines Pricing Review Board (PMPRB), CDR and P/Ts to avoid re-negotiated prices at the P/T level; Stream-line to prevent patient groups from having to re-submit for multiple reviews. Bring the recommendation forward to the appropriate authorities; Establish an inventory of central drug review processes such as pcodr, INESS, CDR (scan for duplication, assess if duplication is required/valuable, seek multiple perspectives on the inventory, capture learnings, e.g., from pcodr, Quebec); The Association could bring drug review expert panels together to consider inventory findings as well as issues concerning duplication, possibly bringing together expert committee (drug plan managers, chairs of these committees); Consider having members of each review committee sit on the CDEC. Eliminate duplication where it is the cause of differences in coverage or where it is causing too much cost to the system. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 16

17 Recommendation 2: The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Introduce greater transparency in the public engagement and review process. Implement practices to standardize and ensure quality in the review process by: Ensuring an appropriate proportion of subject-matter experts for each medication under review; and Improving the appeals process by establishing: A formal appeal process for patients and patient groups; and An independent appeals review body Areas of agreement and disagreement Suggested improvements Next step priority actions There was agreement that transparency is needed. There was no strong disagreement, but participants had some differences of opinion with respect to emphasis and identified some areas where either clarification or further refinement is needed: Clarity is needed about where in the process more openness or clear information is required, especially in the appeals process; There were differences of opinion about whether or not a formal appeal process and independent appeals review body are needed; some participants felt these measures were important; others felt the focus should be on greater transparency, reducing the need for appeal; Guidelines/criteria are needed as to what might be grounds for an appeal; more information is needed about effectiveness of appeals processes in other jurisdictions; Clarity is needed about what constitutes an appropriate proportion of subjectmatter experts. The recommendation could be expanded to address transparency across the whole system, not just a focus on CADTH (drug submission, HC, CDR, P/T, post-market); A qualifier could be added specifying that improvements to transparency or public engagement should not be made at the cost of lengthening the process; More transparency is needed in the weighting of review criteria; weighting should take into consideration proof of value, not just proof of cost; Recommendations made by CDR back to the manufacturer should be more explicit re: rational for decision, expanding on yes/no recommendations (e.g., no, but at a different price point the decision would be different); Clearer accountability could be introduced into the review process, overall and for the response time from date of submission; this best practice is followed in Quebec; Transparency with respect to subject matter experts could be improved by releasing information about who is involved in the review process and introducing conflict of interest guidelines that allow for participation with disclosure of potential conflicts. There was insufficient time to arrive at common ground actions. However, the following suggestions were offered: Review and potentially adopt existing practices from other jurisdictions that have transparent processes in place and effective avenues for including patient values/perspectives (e.g., could look to pcodr, INESS, international comparators); Consider mechanisms that could improve processes for patient input, such as: a patient advisory body; rotating public members on CDEC (experienced with the chronic condition/drug under review); public hearings where individual patients could provide input; 9 9 Ask for formal feedback on manufacturer and patient submissions, outlining review criteria followed and rationale for decision. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 17

18 Recommendation 3: The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Reduce the timelines of the drug review process. Implement mechanisms to reduce the length of time for making decisions across jurisdictions and disparities in access, including implementation time frame. Areas of agreement and disagreement Suggested improvements Next step priority actions There was general agreement in principle for this recommendation, with people wanting to see quicker and improved access; it was seen as a motherhood statement. There was no strong disagreement, but participants identified some areas where either clarification or further refinement is needed: There is a trade-off between time-lines and quality; it is important to clarify what we are trying to achieve (e.g., healthy, productive Canadians, prevention of premature death) and to design processes accordingly; With respect to time-line, the central issue is not CDR itself, which has clear time-lines posted on its website, it is the sequential time-line across the whole review process; When the review process moves to the P/T level, clear time-lines are not available ( it is a black hole ); there may also be elements that could be improved in the manufacturer/ industry time-line; Time-lines may be impacted by the public appeal process and processes that strengthen transparency; this recommendation cannot be considered in isolation from other recommendations. Ensure the recommendation differentiates between CDR time-lines and the total picture; Consider what is an acceptable range for improvement in time-lines: Specify what time-lines should be along the full continuum of the drug review process; Take into account whether the drug is a first drug in a new drug group vs. a subsequent version of an existing drug group; Regularly publish differences between CDR recommendations vs. P/T listings, taking into account special access programs; Consider a parallel drug review process with HC and P/Ts; are there certain circumstances where the HC results are good enough for early uptake; Define equity of access to drugs (e.g., across disease groups) vs. inequity across the provinces for the same drugs; Introduce a common formulary to improve equity of access, as outlined in the portability principle of the Canada Health Act. There was general agreement on the following action items: Introduce public reporting of time-lines (responsible: CADTH or CIHI); Expand the use of parallel review (HC/ CDR/Provincial); Enhance the prioritization/ fast-track process, i.e., expand the criteria; extend the process to P/Ts, consider including patient and quality of life perspectives (HC/CADTH/Provinces); Expand conditional listings (coverage for evidence development in provinces) and identify criteria (HC/Provinces). The following other actions items were discussed, but there was not general agreement: Introduce a pan-canadian review of catastrophic drug expenditures /drug prices through CDR (to include a sample of one or two drugs); Review best practices (international) and conduct a benchmarking exercise to determine time-lines for review (HC, CDR, P/Ts, manufacturer), with the inclusion of patient group perspectives in assessment of performance targets; Integrate/regulate private and public coverage to address inequities; Conduct a definitive comparative analysis of approval differences: Once established, study to determine the why of those differences; 9 9 Consider including this as part of a regular evaluation (e.g. 5 year). Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 18

19 Recommendation 4: The CDR, in collaboration with participating drug plans, examine national and international best practices to address challenges in the drug review process to: Improve the balance of the criteria used to make drug funding decisions. Ensure the appropriate balance between cost-effectiveness, clinical effectiveness and patient experience through enhanced public engagement mechanisms. Areas of agreement and disagreement Suggested improvements Next step priority actions There was agreement in principle for this recommendation. There was no strong disagreement, but participants identified some areas where either clarification or further refinement is needed: Clarity is needed about what is meant by appropriate balance; what criteria are currently used by CDR and P/Ts and how are they weighted to arrive at recommendations and final funding decisions? The assumption is that criteria are out of balance, but what supports this? It will be necessary to unpack what is meant by cost-effectiveness, i.e., what does the term mean, what are the criteria, how are the inputs measured; The recommendation does not take into account the big picture with respect to cost-effectiveness; impact on societal costs outside of the drug/healthcare budget should be included to accurately reflect costs (e.g., productivity); Patient experience can make an important contribution to assessment of cost-effectiveness (e.g., patient convenience that improves compliance); It is currently presented separately from costeffectiveness, but should be embedded within it; It is unclear how patient input is currently brought into the review process; How can qualitative measures such as patient experience be brought into the assessment? Caution is needed in developing a one-size fits all weighting system; a different weighting might be needed to assess a new, novel drug that greatly improves quality of life, but that may be costly when first on the market; using a standard assessment and weighting of criteria, the new drug might not be recommended; context is important, including province, culture, drug or disease; The recommendation does not take into account that critical information feeding into the assessment can change, e.g, pricing of drugs can and does change after CDR decisions through bilateral negotiations with P/Ts. Define key terms in the recommendation such as costeffectiveness and appropriate balance ; Be more directive and clear in the recommendation that it is about incorporating patient input and how this input is used in the assessment process; Recommend that conditional listing be introduced that incorporates a one-year post-market assessment into the drug review process to test the assessment criteria/ balance based on real world patient experience (e.g., safety, compliance); The CDR assessment should include the real cost of the drug as opposed to a CDR assessment cost that is different from the cost negotiated province by province by the manufacturer; Include societal costs with impact broader than the healthcare budget in assessment of cost-effectiveness, e.g., a measure of productivity which is tracked through clinical trials. Develop a process where a negotiated price is set for a drug across the country (for a set period of time); this would mean that an assessment of costeffectiveness is based on the same price; CDR and P/T criteria for assessment/ weighting should be transparent and made available to the public to open up discussion about what balance is important; Include societal costs with impact broader than the healthcare budget in assessment of cost-effectiveness, e.g, a measure of productivity which is tracked through clinical trials; Include patient experience in assessment of cost-effectiveness and key patient outcomes as part of the manufacturer s submission earlier in the process; Develop a better understanding of the Quality Adjusted Life Year (QALY) measures with respect to patient experience and patient outcomes, including quantitative vs. qualitative measures; Request that CDR and P/Ts provide feedback on how patient input is used; Work towards harmonizing recommendations from Clinical Practice Guidelines with those from CDR/P/Ts. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 19

20 Recommendation 5: Federal, provincial and territorial governments collaborate to enhance pharmacare coverage in Canada, as committed to under previous F/P/T health accords. Improvements such as catastrophic drug coverage and a common formulary can reduce disparities and improve access across jurisdictions, and there is evidence that such measures can also ultimately contain costs. In particular, such efforts will require strong federal leadership with appropriate incentives for provinces and territories. Areas of agreement and disagreement Suggested improvements Next step priority actions There was agreement in principle for this recommendation, but participants felt it could be stronger and more clear in calling for a national program for essential drugs and/or catastrophic drug coverage. Areas of Disagreement There was no strong disagreement, but participants identified some areas where either clarification or further refinement is needed: This recommendation to enhance pharmacare requires strong federal leadership which is currently not there, so may not be immediately practical to move forward; the upcoming renewal of the health accords may provide a window of opportunity for this discussion; Clarify the terms catastrophic and common, and consider replacing catastrophic with essential drugs and emphasize the concepts of universal access and addressing equity issues. Strengthen the language in the recommendation; rather than enhance pharmacare or universal, it could recommend that a national pharmacare program be established for essential drugs, to include a common formulary; Add eligibility criteria (e.g., income, age); Provide information about trade-offs that may be introduced with the introduction of a common formulary (e.g., restrictions on the number of drugs covered) however, there is no evidence that quality of care and patient outcomes have suffered in jurisdictions that use a common formulary; Be clear on who pays; funding must accompany any recommendations for a national program or common formulary or P/Ts, particularly those with less resources, will not join; mechanisms could include a Memorandum of Understanding or new legislation. Clarify financing and coverage levels, taking into account public and private payers; Bring provinces together with the federal government; this requires identifying funds; Consider other incentives, such as an annual report card ranking (Grades A to F) of CDR and P/T performance to be issued by a coalition of health charities; Develop a burning platform to provide a common voice for health charities; consider a Pick a Disease pilot program; Introduce this recommendation as a health accord topic; focusing on increments of risk-pooling by drug plans, working with risk-sharing cost ( a middle ground risk-pooling in advance of Pharmacare ); Conduct additional cost-effectiveness studies that demonstrate the benefits of keeping people well through access to essential drugs; Provide concrete examples of how much it will cost, and the cost savings expected, from introducing a national program for essential drugs/common formulary. Report of the Canadian Diabetes Association Summit on a Renewed Vision for the Common Drug Review 20