biosimilars pfizer symposium - derick mitchell - nov 12th 2016
TRANSCRIPT
Biosimilars: What do patients need to consider?
PATIENTS – SCIENCE – INDUSTRY
Biosimilars Symposium: Nov 12th, 2016
Overview
• IPPOSI – the patient-led perspective
• Biosimilars – what are Irish patients asking?
• How can we assist patients in their understanding and assessment of biosimilars?
IPPOSI Members (examples)
100+ Patient Organisations
100+ Scientific/Regulatory/Agencies
(200+ individuals)
16 Industry members
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
Public-Private Partnership
• Grant from Department of Health (via Health Research Board)
• Industry membership fee
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
European Patients Academy on Therapeutic Innovation (EUPATI)
www.eupati.eu
What questions are Irish patients asking?
• https://vimeo.com/161616248
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
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
Do you know the difference between a biologic and a biosimilar?
Yes8%
No92%
Yes43%
No57%
Irish Patient Organisations Irish Arthritis Patients
Do you know the difference between a biosimilar and a generic medicine?
Yes19%
No81%
IRISH PATIENT ORGANISATIONS
Yes8%
No92%
IRISH ARTHRITIS PATIENTSIrish Patient Organisations Irish Arthritis Patients
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
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
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..”
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 importantNot at all important
IRISH PATIENT ORGANISATIONS
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
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?
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
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
