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Biosimilars Presentation - CADTH

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Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #2 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.

Published in: Health & Medicine
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Biosimilars Presentation - CADTH

  1. 1. About Biosimilars: What we know and what we want to know SAVE YOUR SKIN FOUNDATION WEBINAR JANUARY 19, 2018 HELEN MAI, LL.B POLICY AND STRATEGY ADVISOR, CADTH
  2. 2. Outline 1. Public Reimbursement Pathway for Biosimilars 2. Top of Mind Questions about Biosimilars a) What is switching? b) How are studies selected for a particular condition? c) What are patients saying? d) Are biosimilars all about cost savings? e) Is Canada unique? 3. Potential Biosimilars for Cancer Indications 1
  3. 3. Public Reimbursement Pathway for Biosimilars: Where does CADTH fit in? Health Canada Regulator (Efficacy & safety) Pan Canadian Pharmaceutical Alliance (pCPA) Value negotiator F/P/T Ministries of Health and Cancer Agencies Decision maker/ funder CDR (CADTH) pCODR (CADTH) Quebec (INESSS) HTA (Assess value) 2
  4. 4. Public Reimbursement Pathway for Biosimilars: Review Processes 3 Assessment: Quality, safety, and efficacy Output: Issuance of NOC / NOC(c) Assessment: Clinical effectiveness, cost effectiveness, patient input, clinician input, jurisdictional input (pCODR) Output: Biosimilar Summary Dossier Assessment: value negotiation (through the pCPA office), implementation considerations, budget impact analysis, may review products individually Output: Final funding decision CADTHHealth Canada Public Payers
  5. 5. Streamlining CADTH’s Biosimilars Process Objective • To reduce duplication of work, optimize resources, and ensure that all participating jurisdictions benefit from a single approach to evidence review, which in turn would facilitate decision-making for biosimilars Purpose • A streamlined approach for biosimilar reviews would support improved access for patients 4
  6. 6. Revisions to CADTH’s Biosimilar Process Key Process Highlights: • Reduce timelines • Opportunity for stakeholder input • Patient Groups • Registered Clinicians • Public Drug Programs and Cancer Agencies • Transparency – information will be made publicly available 5
  7. 7. CADTH CDR Biosimilar Review Experience Inflectra Grastofil Basaglar Erelzi Brenzys Inflectra2 July 2017 October 2016 October 2016 April 2016 March 2016 December 2014 Notes: 1. Predated current CADTH review process for biosimilars 2. Submitted for IBD indications 3. Brand Name To Be Confirmed Omnitrope1 2009 Infliximab Biosimilar3 Under Review
  8. 8. Top of Mind Questions about Biosimilars 7 a) What is switching? b) How are studies selected for a particular condition? e) Is Canada unique? c) What are patients saying? d) Are biosimilars all about cost savings?
  9. 9. a) What is switching? 8 Term Interchangeability Drug plan decision (automatic substitution) Substitution Dispensing (automatic vs therapeutic) Switching Patient and provider decision
  10. 10. b) How are studies selected for a particular condition? 9 Authorization of Indications • Health Canada’s guidance:  “Where similarity has been established, indications may be granted even if clinical studies are not conducted in each indication. A detailed rationale that scientifically justifies authorization of the biosimilar in each indication should be provided taking into consideration mechanism(s) of action, pathophysiological mechanism(s) of the disease(s) or conditions involved, safety profile, dosage regimen, clinical experience with the reference biologic drug, and any case-by-case considerations. Certain situations may warrant additional clinical data for a particular indication.” • Comparative clinical safety and efficacy trial is to be completed in the most sensitive population
  11. 11. b) How are studies selected for a particular condition? 10 - Example: Remicade and Inflectra - Reference product: Remicade - Indications: ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn disease, fistulizing Crohn disease, and ulcerative colitis - Biosimilar: Inflectra - Indications (NOC January 2014): ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis - Indications (NOC June 2016): Crohn disease, fistulizing Crohn disease, and ulcerative colitis Note: EMA approved Inflectra for all indications, including IBD via extrapolation in 2013 / FDA approved Inflectra for all indications, including IBD via extrapolation in April 2016.
  12. 12. c) What are patients saying? 11 • CDR Submissions (Grastofil, Inflectra, Basaglar, Inflectra IBD, Brenzys, Erelzi) • Access and cost • Safe and efficacious / Regulation / Surveillance • Switching / Substitution • Patient Support Programs
  13. 13. d) Are biosimilars all about cost savings? 12 • Health Canada – does not assess cost and affordability • CADTH – drug cost comparison to reference product • CDR reviews (based on Ontario’s transparent price) • Grastofil: 25% less than Neupogen (filgrastim) • Inflectra: 34% less than Remicade (infliximab) • Basaglar: 15% less than Lantus (insulin glargine) • Inflectra IBD: 47% less than Remicade (infliximab) • Brenzys: 25% less than Enbrel (etanercept) • Drug formularies – limited budgets • Patients – greater access and affordability • Providers – stewards of the healthcare system
  14. 14. e) Is Canada unique? 13
  15. 15. Potential Biosimilars for Cancer Indications • Bevacizumab (metastatic colorectal cancer)  Patent Expiry Date: 2018-04-03 • Panitumumab (metastatic colorectal cancer)  Patent Expiry Date: 2018-05-05 • Trastuzumab (breast cancer, gastric cancer)  Patent Expiry Date: 2018-12-10 • Rituximab (Non-Hodgkin lymphoma, chronic lymphocytic leukemia)  Patent Expiry Date: 2019-08-11 *Source: Health Canada’s Patent Register 1 4
  16. 16. Thank You 15
  17. 17. 16 @CADTH_ACMTS linkedin.com/company/cadth slideshare.net/CADTH-ACMTS youtube.com/CADTHACMTS cadth.ca/photoblog requests@cadth.ca Connect With Us

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