Biosimilars Market Update - Home - TELUS Health · Biosimilars Market Update 5 Why are we...
Transcript of Biosimilars Market Update - Home - TELUS Health · Biosimilars Market Update 5 Why are we...
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
Biosimilars Market Update 2
Agenda
Why are we discussing biosimilars? 1
Biosimilars overview 2
What is happening in the rest of the world with biosimilars? 3
Payer Considerations 4
Biosimilars In Private Drug Plans 5
Biosimilars Market Update 3
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
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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
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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
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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
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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
1 Health Canada Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), 2010/03/05
....but not identical to the original medicine Biosimilars are similar...
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Size & Complexity – Small Molecule Drugs & Proteins
Small Molecule Drug Large Molecule Drug Large Biologic
Size
Aspirin 21 atoms
hGH ~ 3000 atoms
lgG Antibody ~ 25,000 atoms
Complexity
Bike ~ 20 lbs
Car ~ 3000 lbs
Business Jet ~ 30,000 lbs (without fuel)
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Chemical Drugs Biologics
Generic Drug Biosimilar
Submission Abbreviated new drug submission
New drug submission requires clinical trials.
Bioequivalence Pharmacist Substitution
Physician authorize
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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%
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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
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
*First Canadian SEB Approved under new guidance January 15, 2014
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Biosimilar Pipeline
Brand Name Earliest Patent Expiry Date
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
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Biosimilar Pipeline
Brand Name Earliest Patent Expiry Date
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
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-input-
etanercept
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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
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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)
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)
*First Canadian SEB Approved under new guidance January 15, 2014
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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
http://www.pbs.gov.au/info/publication/factsheets/biosimilars/biosimilar-medicines-factsheet-for-healthcare-professional
Brand Biosimilar “a-flag”
Remicade (infliximab) Inflectra (infliximab) Approved
Neupogen (filgastrim) Nivestim (filgastrim) Rejected
Lantus (insulin glargine) Basaglar (insulin blargine) Under consideration
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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
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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
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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 • Lowest price method (LPM) • Reimbursement of Remicade™ allowed for patients
who received before April 24, 2015
British Columbia February 19, 2016
• NEW patients covered for Inflectra™ only • Patients who previously received Special Authority
coverage for Remicade™ will continue to receive coverage
Ontario February 25, 2016
• 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
Public Payer Reviews of Biosimilars
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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
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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?