A presentation about biosimilars delivered from a patient perspective

1. Biosimilars:
What
do
patients
need
to
consider?
PATIENTS – SCIENCE – INDUSTRY
Biosimilars Symposium: Nov 12th, 2016

2. Overview
• IPPOSI – the patient-led perspective
• Biosimilars – what are Irish patients asking?
• How can we assist patients in their understanding
and assessment of biosimilars?

4. IPPOSI Members (examples)
100+ Patient Organisations
100+ Scientific/Regulatory/Agencies
(200+ individuals)
16 Industry members

5. Partnership Approach
Other Stakeholders
Patient
Experts
• Encourage open, constructive
dialogue and interaction
• Highlight value that patients can bring
• Develop new opportunities for patients
to influence decision-making

6. Public-Private Partnership
• Grant from Department of Health
(via Health Research Board)
• Industry membership fee

7. Patient-led activities
Health Hacks
Workshops
Conferences
Consultations
Round-Tables
Working Groups
Training Days
Twitter Chats
Webinars
eHealth
Clinical Research
Health Information
Health Economics
Patient Registries
Rare Diseases
Biobanking
Patient Data

8. European Patients Academy on
Therapeutic Innovation (EUPATI)
www.eupati.eu

9. What questions are Irish patients asking?
• https://vimeo.com/161616248

10. Irish patients’ understanding of biosimilars
Patient
Organisations
• Not
restricted
to
inflammatory
conditions
• Introduction
may
facilitate
greater
access
due
to
the
savings
that
potentially
could
be
made… not
currently
convinced!
• Regulatory
guidelines
very
important
for
guidance
on
safety
and
efficacy
Patients,
Families
(via
Arthritis
Ireland)
• Low
levels
of
awareness
&
little
understanding
• Patients
prioritise safety
over
effectiveness
• Importance
of
patient
involvement
in
decision-­‐making
re:
switching
• Clear
need
for
understandable,
patient-­‐
focused
information

11. Please indicate if you are familiar with these terms*:
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
Biologics Biosimilars Neither
0%
20%
40%
60%
80%
100%
Biologics Biosimilars Neither
Irish
Patient
Organisations Irish
Arthritis
Patients
*Multiple
answers
possible

12. Do you know the difference between a biologic and
a biosimilar?
Yes
8%
No
92%
Yes
43%
No
57%
Irish
Patient
Organisations Irish
Arthritis
Patients

13. Do you know the difference between a biosimilar and
a generic medicine?
Yes
19%
No
81%
IRISH
PATIENT
ORGANISATIONS
Yes
8%
No
92%
IRISH
ARTHRITIS
PATIENTSIrish
Patient
Organisations Irish
Arthritis
Patients

14. When a doctor is prescribing a biologic or biosimilar,
what question do you think patients would ASK FIRST?
Is
it
safe
/
what
are
the
side
effects?
63%
Is
it
effective?
37%
IRISH
ARTHRITIS
PATIENTS
Is
it
safe
/
what
are
the
side
effects?
57%
Is
it
effective?
43%
IRISH
PATIENT
ORGANISATIONSIrish
Patient
Organisations Irish
Arthritis
Patients

15. Do you have access to patient-friendly, easily
understandable information about biosimilars?
No
Yes,
the
information
is
present
-­‐ but
it
is
of
poor
quality
Yes,
but
only
some
patients
are
aware
of
it
I
don't
know
Yes
IRISH
ARTHRITIS
PATIENTS
No
Yes,
the
information
is
present
-­‐
but
it
is
of
poor
quality
Yes,
but
only
some
patients
are
aware
of
it
I
don't
know
Yes
IRISH
PATIENT
ORGANISATIONSIrish
Patient
Organisations Irish
Arthritis
Patients

16. What information would you like to receive on biosimilars?
“Everything I should know..”
“I will now Google Biosimilars as never heard of them”
“Safety and side effects..”
“The key differences between
them and biologics…”
“Effectiveness in comparison to Biologics…”
“Long term effects..”

17. How important is patient involvement and consent in
any decision by the prescriber to change from a current
treatment to an alternative treatment?
Very
important
Quite
important
IRISH
ARTHRITIS
PATIENTS
Very
important
Quite
important
Not
at
all
important
IRISH
PATIENT
ORGANISATIONS

18. Patients are discerning and have concerns
Patient advocacy groups are broadly
neutral or positive regarding biosimilars but
have concerns regarding extrapolation
A comprehensive discussion should take
place between the prescriber and the
patient
“My experience with my patients is that they
have been more sceptical than my
colleagues, about starting, but especially
about extrapolation and switching from a
stable treatment.”
Prof. Bjorn Moum, Oslo Hospital

19. Assisting patients in their understanding and
assessment of biosimilars
• Managing the perception of biosimilars
• Create understanding between generics, biologics, biosimilars and switching
• Difference between an original medicine and a biosimilar?
• Are biosimilars as safe as the original medicine?
• Are biosimilars as effective as the original medicine?
• Approval process?
• I am changing from an original to a biosimilar - what does this mean for me?

21. Biosimilars are here to stay
• So far biosimilars appear safe and can save great
resources but the future is complex
• Personalized/Precision Medicines
• More biologics being prescribed
• More biosimilars expected
• Biogenerics, Biobetters, Biosuperiors
• Second generation biologics

22. Conclusions
• Awareness and understanding of biosimilars is low among Irish patients
• Patients have limited access to appropriate information on these
treatments
• Patient concerns remain about switching and interchangeability
• Close follow-up is required if a patient is prescribed a biosimilar
• Patient experience must inform value assessments

23. Thank you!
@IPPOSI www.ipposi.ie
@DerickOMisteal dmitchell@ipposi.ie