This document summarizes the results of a survey of 588 patients on their knowledge and perceptions of biosimilars. The majority of patients felt not well-informed about biosimilars and had concerns that biosimilars may differ in effectiveness or safety compared to original biologics. Most patients would not want to switch from an original biologic and had little trust in automatic substitution of a biosimilar. The document recommends engaging patients through trusted sources to provide balanced biosimilar information and involving patients in decisions through informed consent without mandatory switching. Real-world monitoring of outcomes for specific biologics was also recommended.

1. Patient-Centred Access to
Innovator and Similar
Biologics
Durhane Wong-Rieger, PhD
Consumer Advocare Network

2. Why Patient-Centred Access to Biologics
Patients responsible for safe and (cost) effective use of biologic
– Patients actively monitor for desired benefits and potential
harms
– Patients adhere to (rigorous) treatment schedules plus lifestyle
management, a.k.a, diet, alcohol, smoking, exercise, and stress
management
Patients often experience challenges adapting to biologic
– Patients learn what to expect and how to manage risks;
reluctant to change medications
– Patients must be confident that medicine is best for them
personally
– Patients need to whether changes in symptoms are due to their
condition or due to medication

3. Budgetary Options for Managing Access
• Price caps (individual products or total budgets)
• Open competition based on price and other
benefits
• Balanced basket with quotas for minimum
number
• Bundling options (products, indications,
services)s

4. Access Scenarios to Biologics Combining
Patient Choice & Budget
Principles for Patient-Centred Access to Biologics
– Provide Individual informed choice
– Honor Patient preferences
– Avoid non-clinical switching
– Monitor desired and adverse effects (registry)
Alternative scenarios based on choice and price facors
1. Monopoly: Single innovator or similar biologic (based on
negotiated $ and other services)
2. Open Formulary: Access to innovator or similar biologic not
restricted by “price”; physician or patient choice
3. Mandatory Switch: Required switch based on (lowest) $ with
potential repeated switching
4. Open Market: Innovator and similar biologics equally available
if similar $ and other services

5. Access Scenarios for Innovator and Similar
Biologics
NEAR MONOPOLY
(Current and New Innovators OR
Biosimilar Only with Gainshare)
Little Choice
Moderate to High Budget
OPEN FORMULARY
(No prescriber or patient penalties or
incentivized switch)
Much Choice
Moderate to High Budget
INCENTIVIZED SWITCH
(Forced Biosimilar Switch with Price
Competition or Tender)
Little Choice + Biosimilar Switching
Low Budget (if No Rebate to User)
OPEN MARKET
(Innovator and Similar Biologics
Competitvely Priced and Supported)
Much Choice
Moderate to Low Budget
Patient and
Budget Impact
Patient Choice
B
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6. Patient Survey: Innovator and Similar Biologics
6
• 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 the understanding of
biosimilars
• HOW will learning from the survey be used to engage
patients?
– develop up-to-date information accessible by patients and the public
– assure a balanced approach to promote informed decision-making

7. How was Survey Implemented
7
• 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 2017)
– Respondents = 588
– Conditions = inflammatory, blood, immune-related, diabetes, cancers, multi-
systemic, lysosomal storage, heart, pulmonary, rare disorders
– Use biologics: 37% current/past; 12% future; 35% not likely, 16% not aware
– Informed about biosimilars: 49% mostly/not at all; 24% somewhat; 27%
very/well
– Sources for information on biosimilars: 62% Web, 38% forum; 32% media; 25%
clinician (note: respondents could pick more than one)

8. Patients’ Use of Biologics - 2017
8
Preliminary results web-based survey (May – June 2017) n = 588

9. Informed About Biosimilars - 2017
9
Not at all
34%
Mostly not
15%
Somewhat
24%
Well
13%
Very well
14%
Prior to receiving this survey, how well informed do you feel
you were you with biosimilars?
Preliminary results Web-based survey (May - June 2017) n = 588

10. Trust in Source of Biosimilar Info
10
Who do you trust for accurate, balanced information on biosimilars?
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Govt, academic Patient group Health provider Pharma website Public media Social media
Yes Not Sure No

11. Patient Perceptions of Biosimilars 2017
11
To what degree do you agree a biosimilar as compared to original…?
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
OK switch biologic & biosimilar
Expect no differences switching
Biosimilars similar to each other
Biosimilar is generic copy
New patients may start biosimilar
Cause different adverse effects
Differ in effectiveness
Choose original even costlier
Agree Neither Disagree

12. Patient Initial Perceptions - Summary
• Patient initial perceptions of biosimilars
• 90+% Patient has right to choose original biologic even if
costlier
• 80% believe biosimilars differ in effectiveness and safety
(adverse effects)
• Switching is not desirable; 60% believe it will lead to
different outcomes, that switching back and forth is not
acceptable; 2 biosimilars to same original are not similar to
each other

13. Patient Agreement to Biosimilars Use (1)
13
Would you agree to us… if biosimilars as compared to original biologics …
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Differ from biologic incease over time
Monitoring required; lack enforcement
Made by band & new manufacturers
Safely used in Europe w/few SAEs
Biosimilar cost 30% to 70% less
Head-to head clinical trials
Strongly agree Somewhat agree Neither Somewhat disagree Strongly disagree

14. Switch or No Switch…How to Decide?
14
Which circumstance is it okay to receive biosimilar instead of original?
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Receive support at different clinic
"Automatic" substitution of biosimilar
Only tested in similar indications
Biosimilar is cheaper
Pay difference in price for original
Physician discusses switching
No previous biologic use
Unique names to trace safety
Monitoring for each biosimilar
Monitoring to track outcomes & safety
Support biosimilar use Neither Not support biosimilar

15. Patient Views: “Forced” Switching
15
Should government regulator, drug plan, HTA, or payer do following?
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Physician required to switch
Switch if biosimilar cheaper
Naïve patient start on biosimilar.
Patients right to informed choice
Assure no substitute or switch
Agree Neither Disagree

16. Patient Willingness to Switch
16
1. Monitoring in real-world use is a key requirement
– If can track for effectiveness and adverse events (50% agree)
– If can monitor each biosimilar separately (50% agree)
– If each biosimilar has unique name (50% agree)
2. Patient should be engaged in informed decision
– If physician discusses biosimilar use (30% agree; 65% disagree)
– IAutomatic substitution biosimilar for prescribed original (20%
agree; 70% disagree)
3. Cost differential has some impact
– If biosimilar cheaper (<30% agree; 55% disagree)
– If personal pay difference (30% agree; 40% disagree)

17. Additional Observations
17
• Patients are hesitant to accept biosimilars and especially to switch from an original.
• Patients with inflammatory, autoimmune or GI conditions tended to be better informed;
those with metabolic (diabetes) and cancer less well informed
• Patients with rheumatoid arthritis were more likely to accept biosimilars for “new starts”
but still NOT switching for themselves
• Patients with RA were most concerned about the possible introduction of multiple
biosimilars that could be used interchangeably
• Patient with diabetes and GI conditions were more likely to resist any disturbance to a
medication on which they were stabilized, citing previous challenges in adapting and
monitoring their responses
• Patients with cancer were most concerned about approval based on extrapolation and
fear of not accessing “improved” formulation of the original if they had been switched to a
biosimilar
• Patients who used a biologic on a short-term basis were least concerned about starting on
a biosimilar versus the original biologic but also preferred NOT to switch

18. Recommendations
18
• Work through trusted information sources
(government, patient organizations, and physicians) to develop
and distribute accurate, balanced and evidence-based
information about biosimilars
• Engage with patients in informed decision-making. To promote
acceptance, do not impost mandatory switching or substitution
for nonclinical (financial) reasons.
• Provide tools to monitor patient use of biologics that can track
outcomes to specific biologic
• Develop and implement platforms to collect and analyze real-
world evidence to support and update appropriate use
guidelines
• Engage patients as partners in every step of the process,
especially patient organizations

19. Contact
Durhane Wong-Rieger
Consumer Advocare Network
www.consumeradvocare.org
416-969-7435
durhane@sympatico.ca