How Canada's health technology assessment system can change to better meet patients' need
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How Canada's health technology assessment system can change to better meet patients' need

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Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs. ...

Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs.

The presentation covers the following topics:

- An overview of Canada’s health technology assessment (HTA) system, including the national and provincial processes, which evaluate individual medications or therapeutic classes to inform funding decisions by governments and private payers

- How these systems have evolved to date to include patients’ experiences

- Attendees will also explore, together, how the HTA system could be improved to become more patient-centered in order to better meet the needs, expectations and values of patients, looking at a number of key questions, including:

- How and at what stage should patients be involved in HTA processes?

- What are the criteria for successful involvement of patients in HTA processes?

- How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?

- What are some of the current obstacles/barriers for successful patient involvement and what are the strategies/approaches to address them?

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How Canada's health technology assessment system can change to better meet patients' need Presentation Transcript

  • 1. HOW CAN CANADA’S HEALTH TECHNOLOGYASSESSMENT (HTA) SYSTEM EVOLVE TO MEET PATIENTS’NEEDS May 2014
  • 2. What today is about • UNDERSTAND Canada’s HTA system • HOW are patients involved in the HTA system? • WHAT are the upcoming opportunities for patients to provide their perspectives on the HTA system? • HOW can the HTA system evolve to better meet patients’ needs? 2
  • 3. Drug Development Health Canada Review Patented Medicines Prices Review Board Health Technology Assessment Hospitals Patient Access Private Drug Plans Provincial Drug Plans First – an overview of the Canadian drug review process Manufacturer clinical trials: quality, safety and efficacy Regulatory review: quality, safety and efficacy “Pricing” review: maximum “non-excessive” price Funding recommendations: Comparative safety, efficacy and cost effectiveness FUNDING DECISIONS Patient criteria /appropriate use 3 Our discussion will focus on this stage
  • 4. Various HTA Processes • National processes: • For MOST meds: Canadian Agency for Drugs and Technologies in Health’s (CADTH’s) Common Drug Review (CDR) • For cancer meds: Pan-Canadian Oncology Drug Review (pCODR) – now transferred to CADTH as of April 2014 • Provincial processes: • British Columbia: “Your Voice” program • Ontario: Ontario Public Drug Programs • Quebec: l’INESSS 30 day feedback • Hospitals and Private Payers: • Limited opportunities for patient input 4
  • 5. National HTA processes • All provinces participate in CDR and pCODR, except Quebec • Federal drug plans also participate in CDR (not pCDOR) 5 CDR’s expert committee (CDEC) makes one of four recommendations: • List • List with clinical criteria and/or requirements • Do not list at the submitted price • Do not list pCODR’s expert committee (pERC) makes one of three recommendations: • Recommend • Consider with conditions • Do not recommend
  • 6. HTA Expert Committees • Appointed experts who review the clinical and economic evidence and patient input • They are responsible for developing funding recommendations which are passed on to participating plans • A typical expert committee is comprised of… • Pharmacologists / Pharmaco-epidemiologists • Physicians • Pharmacists • Health economists • Sometimes public/lay voice or patients 6
  • 7. Provincial Reviews • Jurisdictions have their own expert review committees • some consider the national review again and make a further recommendation to province • Provinces consider CDR/pCODR recommendation and account for local circumstances, practices, priorities and budgets • Negotiations on price/criteria of drugs often take place: • joint negotiations through the pan-Canadian Pricing Alliance (PCPA) – this initiative includes all provinces except QC • individual provincial negotiations • In most cases, the minister of health is the final decision- maker, but the real decision is delegated to relevant government officials (such as Ontario’s Executive Director of the Ontario Public Drug Programs) 7
  • 8. HOW ARE PATIENTS CURRENTLY INVOLVED IN HTA SYSTEM 8
  • 9. CDR Patient Input Process (2010) • Part of the CDR process and fits into review timeframes • Seeks input via Canadian patient groups • Guide, template, online submission • Templates for subsequent entry biologics (SEBs) and drugs for rare diseases under development • Invitation for patient input for CDR submissions now delayed because of CDR queue – no indication of when and how the queue will be eliminated • Letters of appreciation with feedback on the submission are sent • Patient submissions are shared with participating plans and posted online • Patient input summaries are included in clinical review reports posted online and patient groups can comment on the summaries before they are finalized • Creation of CADTH Patient Community Liaison Forum • Pilot project underway (until August 2014) to obtain input from individual patients and caregivers in cases where there is no patient group input • CADTH is piloting patient input in therapeutic reviews (until July 2014) 9
  • 10. Expert Committee Deliberation Steps 1. One public member presents summary of patient group input - stated values and preferences and issues of patients and/or their caregivers related to the condition for which the medication is indicated and its treatment 2. Two discussants present their overviews of the clinical and economic evidence 3. Members provide input; and CDR staff, including clinical and economic reviewers, and invited experts provide input as required 4. Deliberation on patient group input, clinical and economic evidence, and formulate a recommendation and provide reasons for it. 5. Members choose one of four recommendation options 6. Secret ballot voting on the recommendation option and the reasons for the recommendation; decided by majority of votes 10
  • 11. Patient Group Participation at CDR 11 CADTH 2013
  • 12. CDR – How Patient Input is Used 12 CADTH 2014
  • 13. pCODR Patient Input Process • Canadian patient groups are invited to provide input: • Must be registered • Only one submission per registered group is permitted • Mandate must pre-date the pCODR review • Must be funded by more than one funder and no funder may provide more than 50% of the group’s funding • No individual patient submissions are permitted • Patient groups have two opportunities to provide input: • at time of review initiation • after an initial recommendation is published • Patients are members of the expert committee – they will summarize and present the patient input • this input is one of four considerations within pCODR’s deliberative framework
  • 14. pCODR Patient Input Process 5. Summarize & Review with pERC 3.2 Collect Patient Advocacy Group Input 7.3 Get Feedback from Patient Advocacy Group 8. Summarize & Review with pERC 6. Prepare & Publicly Post Initial Recomm, Post Reviews 4.2. Conduct Economic Review 4.1. Conduct Clinical Review 9. Prepare & Publicly Post Final Recomm & Post Input Direct impact of patient perspective Indirect impact of patient perspective pCODR 2013
  • 15. pCODR Merger with CADTH • pCODR transferred to CADTH in April 2014 to: • consolidate policy direction across different drug programs • improve the pCODR governance structure to ensure its long-term viability and sustainability • Two-phase transfer: • Phase 1 (effective April 1, 2014): staff, processes, funding, and expertise remain intact as a program, and still based in Toronto but now under the governance of CADTH • Phase 2 (to commence April 2015): exploration of better alignment of pCODR and CDR evaluation criteria, while taking advantage of best practices of both processes • CADTH plans to consult stakeholders at different steps of transition 15
  • 16. British Columbia – Your Voice program 16 Ontario – Patient Evidence Submission Quebec – INESSS
  • 17. Some are going beyond the basics… • Press release and public posting / memo to patient members to inform them of the opportunity • Collection and compilation of data and submission • Press release and posting of input and expectations • Continued communication with members and public when recommendation becomes public 17
  • 18. Engagement Opportunities • pCODR transfer to CADTH: • Information session for patient groups on June 9, 2014 to to discuss the progress to date and next steps • Survey sent by CADTH to stakeholders to be completed by May 21, 2014 • Opportunity for patients to provide input on the transfer, including best practices from pCODR and CDR that should be retained and any other improvements that should be made to the process • CDR Patient Input Templates and Guide • template for SEBs and drugs for rare diseases under development (CADTH plans to consult on the SEB template in May 2014) • CADTH plans to write a new guide for patient input • PCPA • IBM consulted stakeholders in fall 2013 on a formal PCPA process and governance structure • First draft of IBM report tabled - provinces still waiting to receive final version • Patient groups may want to provide ongoing feedback to provinces and territories to ensure the provinces have sufficient input to inform policy 18
  • 19. Ideas on Improving the HTA System? • How and at what stage should patients be involved in HTA processes? • What are the criteria for successful involvement of patients in HTA processes? • How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions? • What are some of the current obstacles/barriers for successful patient involvement? • What are strategies/approaches to address them? 19
  • 20. 20 DISCUSSION
  • 21. APPENDIXA – LIST OF ACRONYMS Acronym Definition CADTH Canadian Agency for Drugs and Technologies in Health CDR Common Drug Review CED Committee to Evaluate Drugs HTA Health Technology Assessment INESSS Institut National d’Excellence en Santé et en Services Sociaux OPDP Ontario Public Drug Programs pCODR Pan-Canadian Oncology Drug Review RAMQ Régie de l’Assurance Maladie du Québec PCPA Pan-Canadian Pricing Alliance 21
  • 22. How input is referenced 22
  • 23. How input is referenced 23
  • 24. pCODR - How Patient Input is Used pCODR 2013