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Similar a Update on Cancer Meds Review and Approval 23Mar2023.pptx(20)


Update on Cancer Meds Review and Approval 23Mar2023.pptx

  2. What we will discuss… 1. Overview of the Canadian Medication Approval Process 2. Opportunities and Issues 3. Discussion and Q & A 2
  3. 1. Overview of the Canadian Medication Approval Process 3
  4. Sequential process leads to long reimbursement timelines 4 Provincial listing (variable) pCPA negotiation process (Avg 8 months) Possibility of parallel reviews Average time it takes to complete pCPA negotiation process Average time Health Canada takes to review a medicine Average time CADTH review process takes for cancer medicines following Health Canada’s approval CADTH review process (Avg 7 months) CADTH source: IQVIA, Provincial Reimbursement Advisor, Vol. 24, Issue 3 (August 2021), p. 60; pCPA wait time source: CADTH review reports: and pCPA brand name drugs negotiations status: Health Canada review (6-12 months) Average time it takes for provinces to add product to their formularies following pCPA deal
  5. Reimbursement review timeframes - oncology 5 Source: Innovative Medicines Canada, Canadian public insurance plans and delays in patient access to innovative medicines, Dec. 2021:
  6. The reimbursement journey for new cancer therapies in Canada • Several steps to manage after Health Canada approval – mostly conducted sequentially • Private plans are generally faster and more generous with reimbursement than public plans (but that is converging) 6 © 2023 3SIXTY PUBLIC AFFAIRS INC. ALL RIGHTS RESERVED.
  7. Health Canada review 7 Ad hoc input when requested by Health Canada • Health Canada responsible for protecting Canadians’ health and well-being • Regulatory reviews ensure medicines are safe, effective and of high quality; cost / price not considered • Success comes in the form of a Notice of Compliance (NoC) / Notice of Compliance with conditions (NoC/c): • For products that are not yet approved, Health Canada administers the Special Access Programme • Post-marketing surveillance is also a key role for Health Canada
  8. Patented Medicine Prices Review Board • Federal regulatory agency • PMPRB’s mandate is to ensures that prices for patented medicines sold in Canada are not “excessive” • Determines the maximum (factory-gate) prices that can be charged in Canada for patented medications • Also regulates the level of price increase manufacturers may take on an annual basis • Currently undergoing significant change / reforms 8 No formal input – although can engage on policy / guidelines
  9. Health Technology Assessment 9 • Canada’s health technology assessment agency • Reimbursement reviews offer public payers non-binding, scientifically-based, expert recommendations addressing whether a medication should be publicly reimbursed and under what circumstances • Reviews typically prompted by manufacturer submissions, but opportunity exists for clinician or public payer-driven submissions • Formal, multi-step review process examining clinical and economic data leads to recommendations • Recommendations developed for oncology- specific expert review committee which follows a deliberative review framework • Recommendations forwarded to participating public drug plans and cancer agencies for listing decisions Formal patient and clinician input opportunities! • Plays the same role in Quebec that CADTH provides to the rest of the country • Review processes are similar, but not identical
  10. Reimbursement review process 10 Overview of CADTH’s Reimbursement Review Processes
  11. pan-Canadian Pharmaceutical Alliance 11 • National, multi-jurisdictional negotiations (all provinces, territories and the federal government) • One jurisdiction negotiates on behalf of all – or the office of the pCPA can lead negotiations • If negotiations are successful, separate agreements are completed with each interested jurisdiction No formal opportunity for stakeholder input
  12. Public formularies and hospitals 12 Public Formularies • Secure confidential agreements between innovative manufacturers and public drug benefit programs to facilitate improved access (rebates or other criteria) • They vary significantly in terms of structure with the common factor being the pCPA to inform which products are reimbursed by the plan on a formulary • Some conduct additional HTA reviews • All maintain special / exceptional access programs to consider case-by-case coverage for prescribed meds not listed, but needed for a specific patient • All offer catastrophic prescription coverage (e.g., Trillium) or universal income-adjusted plans (BC) Hospitals • Medications administered in Canadian hospitals to eligible residents are fully funded by the public health care system (medicare) • Reimbursement decision are typically made at the regional local level Various opportunities for stakeholder input
  13. Private payers 13 • Plans offered by employers, associations and other groups, but provided by health benefit providers such as SunLife, Blue Cross or Canada Life • Coverage offered is often based on standardized plan templates, but customization is common • Typically provide much faster access to a broader range of medicines than public plans • Increasingly plans are adopting plan design tools to manage those costs relying on annual and lifetime caps, managed formularies, prior authorization schemes and HTA reviews before listing Patient access programs and Access Navigators!
  14. 14 2. Opportunities and Issues
  15. Other access pathways 15 • Specialized provincial funding programs • Hospital foundation funding • Patient enrollment in clinical trials • Health Canada’s Special Access Programme • Manufacturer-funded compassionate access programs and patient support programs
  16. CADTH recommended price reductions for oncology medicines, 2020 16 Source: Macdonald-Laurier Institute’s More than a dose of collaboration (Jun. 2021) 78% of oncology medicines required 50% to 100% price reduction based on CADTH reviews
  17. Number of Health Canada and HTA submissions lower and more delayed than in the United States 17 “The reason for discordance between [US accelerated approval] and [Health Canada and HTA] submission is multifactorial and may include the uncertainty around comparative clinical benefits.” Source: Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program • Since August 2019, of 31 medicines that have been approved for cancer-related indications by FDA, 13 have not been submitted to Health Canada Source: new-therapeutic-biological-products/novel-drug-approvals-2021 approval/submissions-under-review.html pharmaceuticals-in-canada-the-united-states-and-the-european-union
  18. Other issues related to the HTA processes and pCPA 18 • Alignment of CADTH’s oncology and non-oncology process • New organization structure (EVP) • Collaboration between CADTH & INESSS • Real World Evidence • Funding algorithms, diagnostics, etc. • pCPA/PMPRB at global tables on negotiations • pCPA incorporated as its own separate not-for-profit corporation
  19. Discussion and Q&A 19
  20. 20
  21. Canadian Cancer Survivor Network Contact Information Website: Twitter: @survivornetca Facebook: Pinterest: 21 Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 613 898-1871

Notas del editor

  1. Clinicians Clinician involvement in all phases of a CADTH review Call for input issued before a submission is received Clinician groups have 35 days to provide input after submission is initiated Must be provided by a registered clinician group and submitted in the template provided, which is summarized for reviewers and posted publicly Selected clinicians, including at least one specialist with relevant expertise, also involved in clinical reviews The more complex the file, the more clinical experts are involved Interested clinicians can respond to CADTH calls for clinical experts INESSS opportunity is similar
  2. All consider: Budgetary capacity Plan characteristics Determination of clinical criteria (if any) Price and utilization negotiations