Biosimilars Market Update Panel: Matthew Brougham Consultant Economist, Brougham Consulting Inc Mark Jackson Consultant Pharmacist, TELUS Health Dr. Ed Keystone Professor of Medicine, University of Toronto Moderator: Suzanne Lepage Suzanne Lepage Consulting, Inc. March 23, 2016
Agenda 1 2 3 4 5 Why are we discussing biosimilars? Biosimilars overview What is happening in the rest of the world with biosimilars? Payer Considerations Biosimilars In Private Drug Plans Biosimilars Market Update 2
Panel Panelist Perspective Matthew Brougham Consultant Economist, Brougham Consulting Inc. Public Policy Mark Jackson Pharmacist, TELUS Health Private Drug Plan Manager Dr. Ed Keystone Rheumatologist, Professor of Medicine, University of Toronto Prescriber Biosimilars Market Update 3
1 Why are we discussing Biosimilars?
Why are we discussing Biosimilars? Biosimilars may offer potential cost relief from the brand name biologic medications and result in drug plan savings Biosimilars present unique regulatory and reimbursement challenges In 2015 TELUS Health adjudicated $703.2 million for biologic drugs 19% of the total eligible drug costs 2.6% of total claims Biosimilars Market Update 5
2 Biosimilars overview
What s in a name? Region Term Substitution? Canada: Subsequent Entry Biologic (SEB) No US: Biosimilar Standards Not Developed Europe: Follow on Biologic No Australia: Biosimilar Yes, In Some Cases Biosimilars Market Update 7
What s in a name? Term What? Who? Interchange or Generic Substitution Replace brand product with interchangeable generic Pharmacist Switching or Therapeutic substitution Replace a product with a different one Prescriber Biosimilars Market Update 8
What Health Canada Says Health Canada definition: An SEB is a biologic drug that enters the market subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug. 1 Biosimilars are similar......but not identical to the original medicine 1 Health Canada Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), 2010/03/05 Biosimilars Market Update 9
Size & Complexity Small Molecule Drugs & Proteins Small Molecule Drug Large Molecule Drug Large Biologic Aspirin 21 atoms hgh ~ 3000 atoms lgg Antibody ~ 25,000 atoms Size Bike ~ 20 lbs Car ~ 3000 lbs Business Jet ~ 30,000 lbs (without fuel) Complexity Biosimilars Market Update 10
Chemical Drug Laboratory Biologic Drug Laboratory Biosimilars Market Update 11
Chemical Drugs Biologics Generic Drug Biosimilar Submission Abbreviated new drug submission New drug submission requires clinical trials. Bioequivalence Pharmacist Substitution Physician authorize Biosimilars Market Update 12
Biosimilars Approved in Canada Brand Reference Biosimilar Biosimilar Approval Date Discount Genotropin Omnitrope 4/20/2009 25.54% Remicade Inflectra 1/15/2014 46.84% Lantus Basaglar 9/1/2015 15.00% Neupogen Grastofil 12/7/2015 16.67% Biosimilars Market Update 13
Indication Extrapolation Biosimilar is approved for each of the same indications as a branded originator Regardless of whether clinical testing has been carried out for each indication *First Canadian SEB Approved under new guidance January 15, 2014 Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis Crohn s Disease (Adult) Crohn s Disease (Pediatric) Ulcerative Colitis (Adult) Ulcerative Colitis (Pediatric) REMICADE INFLECTRA (extrapolated) (extrapolated) March 11, 2016 - CADTH request for input from for Inflectra (infliximab) for Crohn s disease and Ulcerative Colitis (by May 2, 2016). Submission date April 8, 2016 (Tentative) https://www.cadth.ca/infliximab-19 Biosimilars Market Update 14
Brand Name Earliest Patent Expiry Date Biosimilar Pipeline Last Patent Expiry Date Potential Biosimilar Approval Enbrel February 2023 Summer 2016 Humira Feb 2017 April 2025 February 2017 Neulasta July 2024 2017 Eprex May 2015 2017 or later Lucentis March 2016 April 2018 April 2018 Erbitux March 2016 2017 Herceptin August 2017 May 2021 August 2017 or later Avastin April 2018 April 2018 April 2018 Rituxan June 2018 August 2020 June 2018 Biosimilars Market Update 15
Brand Name Earliest Patent Expiry Date Biosimilar Pipeline Last Patent Expiry Date Potential Biosimilar Approval Enbrel February 2023 Summer 2016 March 9, 2016 CADTH Call for Patient Input: SEB for Etanercept (Enbrel) CADTH has received the following drug submission(s) and/or notice(s) of pending submission(s). https://www.cadth.ca/news/call-for-patient-inputetanercept Humira Feb 2017 April 2025 February 2017 Neulasta July 2024 2017 Eprex May 2015 2017 or later Lucentis March 2016 April 2018 April 2018 Erbitux March 2016 2017 Herceptin August 2017 May 2021 August 2017 or later Avastin April 2018 April 2018 April 2018 Rituxan June 2018 August 2020 June 2018 Biosimilars Market Update 16
Prescriber Perspective
3 What is happening in the rest of the world with biosimilars?
United States Biosimilar product : approved based on showing it is highly similar to an FDA-approved biological product Interchangeable biological product Biosimilar to an FDA-approved reference product Meets additional standards for interchangeability (in development) First biosimilar approved (March 6 2015) Zarxio (filgrastim-sndz) biosimilar to Amgen Inc. s Neupogen (filgrastim) Approved as biosimilar - not as an interchangeable product. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm Biosimilars Market Update 19
Indication Extrapolation (United States) FDA advisory committee recommended approval of Celltrion s infliximab biosimilar, CT-P13, for the same indications as its reference product, Remicade (February 9, 2016) *First Canadian SEB Approved under new guidance January 15, 2014 Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis Crohn s Disease (Adult) Crohn s Disease (Pediatric) Ulcerative Colitis (Adult) Ulcerative Colitis (Pediatric) REMICADE INFLECTRA (extrapolated) (extrapolated) Biosimilars Market Update 20
Australia Brands that can be substituted by the pharmacist when dispensed are indicated in the Schedule of Pharmaceutical Benefits by an a-flag Biosimilar for listing on the PBS will consider whether the biosimilar and reference medicine should be substitutable will only recommend that substitution be allowed where the clinical evidence supports this Brand Biosimilar a-flag Remicade (infliximab) Inflectra (infliximab) Approved Neupogen (filgastrim) Nivestim (filgastrim) Rejected Lantus (insulin glargine) Basaglar (insulin blargine) Under consideration http://www.pbs.gov.au/info/publication/factsheets/biosimilars/biosimilar-medicines-factsheet-for-healthcare-professional Biosimilars Market Update 21
United Kingdom Introducing biosimilar versions of infliximab: Inflectra and Remsima Summary of issues considered of significance to the NHS, but not NICE guidance Not presented as best practice but as real-life examples of how NHS sites have planned and managed the introduction of biosimilars. 1. University Hospital Southampton NHS Foundation Trust - Inflammatory Bowel Disease (IBD) Safe switch program started in April 2015 2. University College London Hospitals NHS Foundation Trust - Agreement reached for patients starting a new course of infliximab in the IBD service to be prescribed a biosimilar http://publications.nice.org.uk/introducing-biosimilar-versions-of-infliximab-inflectra-and-remsima-htta329/introduction Biosimilars Market Update 22
Norway The NOR-SWITCH Study The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis. Estimated Study Completion Date: January 2017 https://clinicaltrials.gov/ct2/show/nct02148640 Biosimilars Market Update 23
Canadian Impact
4 Payer Considerations
Public Payer Reviews of Biosimilars Reviewer Date Recommendations CADTH/CDR December 23, 2014 Inflectra listed in accordance with Health Canada approved indications List in a manner similar to Remicade Quebec February 1, 2015 British Columbia February 19, 2016 Ontario February 25, 2016 Lowest price method (LPM) Reimbursement of Remicade allowed for patients who received before April 24, 2015 NEW patients covered for Inflectra only Patients who previously received Special Authority coverage for Remicade will continue to receive coverage Inflectra added as Limited Use (LU) for new and existing patients No new requests for Remicade Patients who have an existing EAP approval for Remicade can continue coverage Biosimilars Market Update 26
Pharmacy regulatory authorities (switching) Provinces regulate when pharmacists can switch drugs without consulting the prescribing physician Health Canada recommended against the automatic substitution of an originator with a biosimilar. Only AB has made a statement about biosimilars subsequent entry biologics are not eligible for review as interchangeable products https://www.ab.bluecross.ca/dbl/pdfs/dbl_full_list.pdf https://www.ab.bluecross.ca/dbl/pdfs/ahwdbl_sec1_critint.pdf Biosimilars Market Update 27
5 Potential Impact on Private Drug Plans
What policies will encourage use of biosimilars in private drug plans? Biosimilars are different than traditional generic drugs Traditional drug plans will NOT generate savings from biosimilars Pharmacist can t automatically switch to biosimilar What strategies should plan sponsors consider to encourage biosimilar use? Biosimilars Market Update 29