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

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.

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

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)

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.

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?

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

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

Keeping an eye on decisions

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: