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Allan F. Miranda Ph.D. MBA Reimbursement Lead Immunology and Primary Care Government Affairs and Market Access
November 8th, 2016
Appropriate Use of SEBs– What’s Next?
Jennifer Jacobs, Stowaway Jennifer is a New York based artist
living with Type 1 diabetes.
Objectives
§ Key SEB policy issues § Impact on patient and physician choice § Future Look
2
J&J’s Position on SEBs
§ Johnson & Johnson fully supports a regulatory framework for the approval of SEBs
§ Standards and policies must be based on an understanding of the complexities of biologics
§ Patient safety is the key issue § SEBs are not generics § New policies designed for SEBs must maintain an
environment that encourages innovation § Our aim is education
Health Canada Position
§ SEBs are not “generic” biologics § SEB authorization is not a declaration of pharmaceutical or
therapeutic equivalence § Health Canada does not support interchangeability / automatic
substitution for SEBs Health Products and Food Branch, Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php
§ The relevance of specialized clinical studies that can be used to support therapeutic interchangeability (which are not usually done) will diminish over time as SEB and reference biologic drug manufacturers make their own independent manufacturing changes, differences could be introduced that affect drug products Biologics and Genetic Therapies Directorate: Letter to Provincial/Territorial Drug Plan Directors. Re: Interchangeability/Substitutability of SEBs July 29, 2010 10-116885-569
SEB Substitution – International Summary Country Effec-ve Date
(if law enacted) New vs Exis-ng Pa-ents
Can Physician Prevent
Subs-tu-on? (Y/N)
Pa-ent Consent Required (Y/N)
France1 Dec 2013 New Y N
Finland2 Recommenda2on only (May 22, 2015)
New and exis2ng
Y N
Netherlands3 Recommenda2on only (April 27, 2015)
New Y N
United Kingdom4
Individual hospital/trusts implemen2ng switching
protocols
New and exis2ng
NA Y
Australia5,6 June 23, 2015 New and exis2ng
Y Y
USA*7 Varies by State (following FDA designa2on)
New and exis2ng
Y Y/N†
Note: countries included above are those for which detailed SEB subs2tu2on informa2on is available * Legisla2on enacted on individual State basis † The following states require pa2ent consent for biosimilar subs2tu2on to occur: GA, ND, UT, VA, WA
Remaining on Stable Therapy: Patient Quotes
6
“Achieving remission/stability through medica2on provides me with confidence. The idea of having to switch medica-ons for non-‐medical reasons makes me quite nervous and could seriously compromise that confidence that has taken so long to achieve!”
C.H. (Canadian IBD pa-ent)
“I have had an 18 year history to finding treatment stability. I have
tried countless topicals, orals, lights, tars, diets and "cures" combined with nine clinical trials, four of
which were biologics of which three failed and only the last one truly stable and effec-ve. Having to switch would put me back into misery, pain and
hopelessness.” A.G. (Canadian psoriasis pa-ent)
"It seemed like forever trying to find the treatment that would gain control of the beast that was ravaging my son. Aaer two months of Remicade treatment, the glimmer of the boy we once knew slowly came back to us. Stabilizing my son’s Crohn’s meant more than controlling inflamma2on, it gave him his life back and restored the family life we desperately missed. The thought of my son having to switch from a treatment he has thrived on for almost 3/4 of his life, is unfathomable to me. I believe the impact switching would have on my son could be detrimental, and forcing him to switch would be robbing him of his right to have a healthy and happy life, a life he deserves.”
K.L. (parent, Canadian CD pa-ent)
What’s Next: SEBs in the Future
7
1. SEB in IBD…oncology
2. Mul2ple SEBs for each innovator
3.Unprecedented policy change
4. Impact to industry
5. Erosion of physician &
pa2ent choice
6. Erosion of value of
innova2on
7. Impact on pa2ent
experience
8. Addi2onal data or more
ques2ons?
9. Language causing more confusion?
Final Thoughts…
§ SEB products should increase patient and physician choice not restrict or remove choice
§ Patients doing well on any treatment shouldn’t be forced to switch
§ Value framework that appropriately balances supporting clinical data, cost, innovation and patient-based factors
Biosimilars: Appropriate Place in Therapy
Canadian Experts in Health Technology Conference November 7-8, 2016
John Snowden
Director, Biosimilars, Amgen Canada Inc.
© 2016 Amgen Inc. All rights reserved.
Biosimilars
Amgen’s Position on Biosimilars
• Amgen believes that biosimilars have a role to play in the health care system
• Biosimilars -- unlike generic drugs -- are not identical to the originator products they attempt to copy
• Amgen’s guiding principles:
Ensuring quality manufacturing
Ensuring patient safety
Following sound science
© 2016 Amgen Inc. All rights reserved.
• Amgen believes in an open and competitive market that includes both the biosimilars and innovators, and supports physician and patient choice
Source: Letter to Provincial and Territory Drug Plan Directors from Director General BGTD Dr. Elwyn Griffiths Regarding Interchangeability/ Substitutability of SEBs dated 29 July 2010
Health Canada Does Not Support Automatic Substitution
© 2016 Amgen Inc. All rights reserved.
Opportunity to Educate Stakeholders on Biosimilars
Source. The Arthritis Society SEB Survey, November 2015
TAS Survey of >650 Individuals Touched by Arthritis
SERMO Survey of 1,201 physicians knowledge about Biosimilars
The survey showed 5 major gaps in the knowledge of many physicians: 1. Defining biologics, biosimilars
and biosimilarity 2. Regulatory approval process 3. Safety profile requirements 4. Determining extrapola-on 5. Defining interchangeability
© 2016 Amgen Inc. All rights reserved.
Source. Biosimilars Forum (US), October 2016
Biosimilars: Appropriate Place in Therapy
November 2016
Dawn Richards, PhD
Vice President, Canadian Arthri2s Pa2ent Alliance
What is CAPA?
• Virtual, pa2ent-‐driven, na2onal arthri2s advocacy organiza2on • About: educa2on, awareness, collabora2on & advocacy • Find us at:
www.arthri2spa2ent.ca www.facebook.com/CAPA.Aca
@CAPA_Arthri2s
CAPA Believes
• The first expert in arthri2s is the person living with arthri2s. • People with arthri2s have the right and responsibility to be included in the
policy, health care and research decisions related to their health and quality of life.
“Those affected by the decision must be involved
in making the decision”
Our Posi-on on Biosimilars
Health Canada states: ‘Subsequent Entry Biologics are not “generic” biologics. Authoriza2on of an SEB is not a declara2on of pharmaceu2cal or therapeu2c equivalence to the reference biologic drug.’ www.hc-‐sc.gc.ca/dhp-‐mps/brgtherap/applic-‐demande/guides/seb-‐pbu/seb-‐pbu_2010-‐eng.php#int
Ourposition: 1
Biosimilars have a role to play in providing addiDonal treatment opDons for paDents and potenDal cost savings to drug reimbursement programs only if prescribed appropriately following clinically-‐approved guidelines.
Ourposition: 2
Biosimilars must not be considered for automaDc subsDtuDon or interchangeable with the reference biologic PaDents should not be forced to switch from one therapy to another when they are well managed on their current medicaDon. Treatment decisions need to be discussed and agreed upon between the physician and paDent based on the best available evidence with the best health outcome for paDents as the primary goal.
Ourposition: 3
Biosimilars should have unique and disDnct names to ensure no accidental subsDtuDon by the pharmacy. This will ensure conDnued post-‐market surveillance of adverse drug reacDons for the correct drug.
Ourposition: 4
Biosimilars should be subject to rigorous Health Technology Assessment and to post-‐approval safety and efficacy monitoring.
Ourposition: 5
Biosimilars should not be fast-‐tracked through the drug review process, that is, being reviewed before other, possibly more criDcal drugs that have been placed in a queue simply due to economic reasons.
Ourposition: 6
Biosimilar manufacturers should be encouraged to put in place paDent support programs similar to those that exist for reference biologic medicaDons. These programs employ trained professionals to answer any quesDons paDents may have about these complex drugs. This type of support is criDcal for paDents to feel comfortable about and confident in taking their medicaDon.
Pa-ents’ Knowledge and Beliefs about
Biosimilars
Durhane Wong-‐Rieger, PhD Consumer Advocare Network
Patient Survey on Biosimilars
§ WHAT is current status of biosimilars? – Increasing number of biosimilars approved and available for
use – Increasing evidence about safety, effectiveness, and quality – Uncertainty about long-term outcomes and interchangeability
§ WHY were patients surveyed about biosimilars? – Learn patient knowledge, beliefs, and opinions about
biosimilars – Identify sources of patient and public information – Engage patients to contribute to evolving understanding of
biosimilars § HOW will learning from survey be used to engage patients?
– Develop up-to-date information accessible by patients and public
– Assure balanced approach to promote informed decision making
26
How was Survey Implemented § Canada-wide Web-based survey
– Conducted by Advocare and Canadian Organization for Rare Disorders – Directed to existing patient cohort of 2,000+ – Secondary distribution to patient organizations and umbrella associations – Promoted through Facebook and Twitter
§ Patient characteristics (Preliminary May-June 2016) – Respondents = 320; Complete survey = 200 – Conditions = inflammatory, blood, immune-related, diabetes, cancers,
multi-systemic, lysosomal storage, heart, pulmonary – Use biologics: 54% current, past or future; 24% not likely, 22% not aware – Familiar with definition: 44% unfamiliar; 36% somewhat; 20% very – Sources for information on biosimilars: 62% Web, 38% forum; 32% media;
25% clinician (note: respondents could pick more than one)
27
Patient Perceptions of Biosimilars
16%
24%
40%
8%
16%
27%
19%
18%
8%
16%
57%
57%
42%
84%
68%
0% 20% 40% 60% 80% 100% 120%
OK to use if NOT on original
Be unwilling to switch
Should accept if "much cheaper"
Could have other adverse effects
Could expect different response
Disagree Neither Agree
28
To what degree do you agree a biosimilar as compared to the original …?
Patient Perceptions of Biosimilars
48%
78%
50%
6%
18%
24%
4%
8%
22%
6%
24%
28%
96%
14%
28%
88%
58%
0% 20% 40% 60% 80% 100%
Encourage switching if cheaper
Patient right to informed choice
Recommend patient be switched
Approve biosimilar if originator NOT approved
Assure NO interchangeability
Approve more biosimilars
Disagree Neither Agree
29
Should government regulator, drug plan, HTA, or payer do following?
Summary Patient Attitudes re: biosimilars
30
40% believe may subs2tute a biosimilar for the
originator 40% believe should NOT
subs2tute
40% believe pa2ents should accept a biosimilar if much
cheaper 40% believe price should
NOT be a factor
About 60% would be UNWILLING to switch from the originator to a biosimilar 60% say okay to prescribe a biosimilar to NEW pa2ents
About 60% would be UNWILLING to switch from the originator to a biosimilar 60% say okay to prescribe a biosimilar to NEW pa2ents
About 90% say drug plans should assure NO interchangeability
Almost 80% say governments should NOT recommend switching from the originator to a biosimilar
Almost 100% say pa2ents have the right to informed
consent
Almost half say governments should NOT encourage switching on the basis of “cheaper” cost; about a quarter agree should encourage switching based on
cost
Contact:
Durhane Wong-Rieger Consumer Advocare Network www.consumeradvocare.org
416-969-7435 [email protected]
