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How patient groups can have more say in the drug approval process


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In this presentation, Bill Dempster and Johanne Chambers of 3Sixty Public Affairs walk through the different steps in bringing a new medicine through the regulatory review process, health technology assessment and funding, highlighting where patients can make a difference, and how their role is rapidly expanding.

Published in: Health & Medicine
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How patient groups can have more say in the drug approval process

  1. 1. How patient groups can have more say in the drug approval process Today’s webinar will begin with a sound check and introduction at 12:55 p.m. EST. 1
  2. 2. Patient Involvement in the Lifecycle of a Medicine February 2015
  3. 3. What today is about • UNDERSTAND the lifecycle of a medicine • HOW are patients currently involved in the various steps of this lifecycle? • WHAT are the upcoming opportunities for patients to help shape how drugs are approved and reimbursed? • HOW can the various review processes evolve to better meet patients’ needs? 3
  4. 4. 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 4
  5. 5. Research and Development • Participating in clinical trials • Public registries: and • Getting involved in research • CIHR’s Strategy for Patient-Oriented Research (SPOR): • patients provide input on identifying health research priorities and participate in the design and undertaking of research projects • Patient and Community Engagement Research (PACER) program: • joint initiative between Alberta Health Services (AHS) and the Institute for Public Health at the University of Calgary • trains patients in research methods so that they can become patient- engagement researchers and join AHS’ Strategic Clinical Networks in order to determine how the health system can deliver high-quality, patient-centred care 5
  6. 6. Health Canada Pilot Project • Announced by Minister Ambrose in August 2014 • Targets patient input for approval of orphan drugs • simulate how input from patients will be gathered and incorporated into the drug review process once the Orphan Drug Framework is in effect • 2 drugs: Hoffmann-La Roche’s drug Gazyva for Chronic Lymphocytic Leukemia and Hyperion Therapeutics’ drug Ravicti for Urea Cycle Disorders (UCDs) • Questions posed to patients: • how the rare disease affects their ability to manage their day-to-day lives • what treatments are currently available • what therapeutic benefits are most important to them • their risk tolerance for any new treatments 6
  7. 7. 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 and ODPRN’s drug class reviews • Quebec: l’INESSS 30 day feedback • Hospitals and Private Payers: • Limited opportunities for patient input 7
  8. 8. National HTA processes • All provinces participate in CDR and pCODR, except Quebec 8 • Federal drug plans also participate in CDR (not pCDOR) CDR’s expert committee (CDEC) makes one of four recommendations: pCODR’s expert committee (pERC) makes one of three recommendations: i. List ii. List with clinical criteria and/or requirements iii. Do not list at the submitted price iv. Do not list i. Recommend ii. Consider with conditions iii. Do not recommend
  9. 9. 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 9
  10. 10. Provincial Reviews 10 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, priorities and budgets Negotiations on price/criteria of drugs often take place: • joint negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA), which includes all provinces except QC - QC recently announced its intention to join but legislative changes are required first • 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)
  11. 11. CDR Patient Input Process (2010) • Part of the CDR process and fits into review timeframes • Seeks input via Canadian patient groups • Guide, you tube videos, on-line submissions • Template for most medications and template for subsequent subsequent entry biologics (SEBs) • 35 days deadline for input and CADTH advises that focus should be on “expectations for the new drug and reporting any patient experiences with the drug in review” • Letters of appreciation with feedback on the submission are sent • Patient input summaries are included in clinical review reports posted online and patient groups can comment on the summaries before they are finalized • Entire patient submissions are shared with the expert committee, participating plans and posted online • Creation of CADTH Patient Community Liaison Forum • Patient involvement in Scientific Advice Program • Pilot project underway to obtain input from individual patients and caregivers in cases where there is no patient group (until Aug. 3, 2015) • CADTH is piloting patient input in therapeutic reviews (until Nov. 30, 2015) 11
  12. 12. 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 12
  13. 13. 13 CADTH 2014
  14. 14. Patient Group Participation at CDR 14 CADTH 2013
  15. 15. pCODR Patient Input Process • Canadian patient groups are invited to provide input: • Must be registered • Mandate must pre-date decision to register • Only one submission per registered group is permitted • 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 (deadline: 10 business days) • after an initial recommendation is published (deadline: 10 business days) • 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 • pCODR is working with Canadian Cancer Action Network on a Patient HTA Navigator pilot project • navigator provides support to patient groups to optimize patient submissions
  16. 16. Patient Group Participation at pCODR
  17. 17. pCODR Merger with CADTH • pCODR transferred to CADTH in April 2014 • Steering committee has been established with representation from drug plans and cancer agencies • pCODR and CDR to remain independent programs • CADTH now focusing on aligning both processes: • adopting one set of common guiding principles for both processes • aligning CDR and pCODR evaluation criteria • standardizing the recommendation options • building on efficiencies and best practices from both programs • CADTH plans to consult stakeholders on these initiatives in coming months 17 pCODR CADTH
  18. 18. Engagement Opportunities • pCODR transfer to CADTH: • Opportunity in coming months for stakeholders to provide input on common guiding principle, evaluation criteria and recommendation options to be established for both processes • Opportunity to also highlight any best practices that should be incorporated or improvements that should be in both processes • CADTH’s evaluation of medical devices: • Plans to refine its approach to health technology assessment of medical devices throughout the product life cycle • Potential opportunity to help shape patient involvement process in this context • pCPA • New pCPA office expected to be established in Spring 2015 • Roundtables to engage stakeholders about this new coordinating organization suppose to be held early 2015 – no details on this has yet been released • CADTH Symposium • CADTH has started to offer financial support for patient groups wanting to attend the annual CADTH symposiums 18
  19. 19. How to Increase Patient Voice in the Lifecycle of Medicines • How and at what stage should patients be involved? • What are the criteria for successful involvement of patients in regulatory, HTA and reimbursement processes? • What is the current impact of patient input to HTA and funding decisions? 19 • 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?
  20. 20. 20 DISCUSSION
  21. 21. 21 ANNEXES
  22. 22. CDR – How Patient Input is Used 22 CADTH 2014
  23. 23. 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
  24. 24. Canadian Cancer Survivor Network Contact Info Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail or Web site Blog: Twitter: @survivornetca Facebook: Pinterest: