This document summarizes the results of a survey conducted by ACE (Arthritis Consumer Experts) on patient perspectives regarding the regulation of subsequent entry biologics (SEBs). The key findings were that patient safety was the top priority for regulation of SEBs. Patients also wanted SEBs to undergo the same rigorous review processes as originator biologics and wanted to discuss treatment options with their physician. The document then discusses evidence on the benefits of originator biologic therapies in controlling rheumatoid arthritis and reducing healthcare costs. It notes patients still have unanswered questions about SEBs and discusses ambiguity around Quebec's listing of an SEB together with its originator biologic. In conclusion, the document states patients need timely access to

1. SEBs:
“What do patients say?
Presented by Cheryl L. Koehn
2015 CADTH Symposium
Saskatoon, Saskatchewan
April 14, 2015

3. Acknowledgements
Over the past 12 months, ACE received unrestricted grants-in-aid from:
AbbVie Corporation, Amgen Canada, Arthritis Research Canada,
BIOTECanada, Bristol-Myers Squibb Canada, Canadian Institutes of Health
Research, Celgene, Hoffman-La Roche Canada Ltd., Janssen Inc., Pfizer
Canada, Sanofi Canada, St. Paul’s Hospital (Vancouver), the University of
British Columbia.
ACE also receives unsolicited donations from its community members
(people with arthritis) across Canada.
ACE thanks these private and public organizations and individuals for their
unrestricted support.

4. Agenda
• What arthritis patients said about SEBs policy
development
• Impact of originator biologic therapy
• Patients’ questions remain unanswered
• The Quebec decision

5. ACE Consumer/Patient Survey Results
on Policy Making Priorities
Input from real people living
with real diseases
Health Safety - Patients’ overriding concern for SEB regulation is safety, safety,
safety (85% of respondents)
HC and HTA Review Rigour - Patients wanted SEBs to undergo the same rigorous review
processes as their originator biologic
(48% of respondents)
Prescribing - Patients want to discuss and decide what meds to take in consultation
with their physician
(48% of respondents)
Choosing a SEB - Patients want to know how well the SEB will work compared to its
originator and how at risk they will be of having an adverse immune reaction
(49% and 30% of respondents)

6. Impact of originator biologic therapy –
Canadian evidence
• Alberta Rheumatoid Arthritis Biologics Pharmacosurveillance
Program (ABioPharm) data published 2014
• What the evidence says:
– 60% of total costs for RA patients not related to disease
– Key cost drivers are hospitalization, physician visits, emergency room
visits – NOT MEDS
• Disease control is the “silver bullet” in managing RA
• Optimally managed RA means people living with it maintain
physical function and health care system costs go down
significantly
*Ohinmaa, A, Maksymowych, W et al. Canadian estimates of health care utilization costs for
rheumatoid arthritis patients with and without therapy with biologic agents. Arthritis Care &
Research Sept 2014.

7. Patients’ question remain unanswered
• What’s happening with the naming issue?
• Will the rates of infusion and/or injection site
reactions be similar?
• What about the rates and types of serious infections?
• If a SEB is substituted for the prescribed drug, will
this have any adverse impact?
• Will the pricing of SEB products affect the overall
price of the originator biologic class?
• Will there be a national, systematic approach to post-
marketing surveillance?
• How frequently, how and where will these date, if
collected, be disseminated?

8. The Quebec Decision – A story of ambiguity
• Infliximab-Inflectra listed together in same category with
Infliximab-Remicade for 4 indications (RA, PsA, AS, PS)
• “Lowest price alternative” (or PPB) applied to category –
patients have to pay the difference between the two
medications if they wish to continue on infliximab-Remicade
• Policy suggests they are interchangeable; Health Canada
states they are not
• Rheum/derm can stipulate “do not substitute” with one of
several allowable exceptions for generics, this alone
suggests they are interchangeable or that Inflectra is a
generic form of Remicade
• Unless there is a shortage, Quebec pharmacy cannot
switch a brand medication for another; Inflectra is a brand
in its own right, not a generic

9. At the end of the day…..
What patients need are….
• Timely access to evidence-based (safe and effective)
medicines
• Timely and fair reimbursement access on public and
private drug formularies – SEBs are still not affordable
for patients if they have to pay from their own pocket
• The right to choose with their health care team the
therapy best suited to their unique health needs, beliefs,
preferred route of administration, and have that choice
respected by patient-centred policy
• Rigorously collected real world evidence to best decide
to put something in their body, or not

10. Keeping an eye on decisions

11. At the end of the day…..
Thank you for listening to what arthritis
patients are saying about SEBs.
Feel free to contact ACE with
comments or questions:
feedback@jointhealth.org
koehn@jointhealth.org