Patient’s and Consultant’s Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Overview
2.2. Relationship with Participants and Patient Recruitment
- immune medicated inflammatory diseases (IMIDs) such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)
- conditions affecting the skin, e.g., psoriasis (PS)
- inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC) >18 years of age
2.3. Consultant Recruitment
2.4. The Focus Groups and Consultant Interviews
2.5. Data Collection
2.6. Data Analysis
2.7. Governance
3. Results
- (1)
- Benefit to the NHS
‘cost, to my mind, actually also directly translates into access to the drug, you know, if we can, if the cost of these drugs come down sufficiently, the reality is that a higher fraction of our patients will be able to access those drugs and or…if you like a lowered bar for the indication’Consultant 4
- (2)
- Evidence for efficacy and safety
‘as long as the other data in terms of efficacy and safety is there, which with biosimilar I believe is there and they have been approved by the FDA (Food and Drug Agency) and the EMA (European Medicines Agency) so they have been regulatory body approved’Consultant 2
“we have not as at least as I am aware and again I have not studied the data in detail but I am not aware that we have had anything that is outside the sort of normal envelope of expected side effects”Consultant 4
‘Quality assurance over time will actually be a bigger challenge with vendors that we are not aware of’Consultant 5
‘so we have now made patients aware that we are using a what do you call it a ‘cheaper compound’ and, and, and so I would expect that we would have a slightly higher likelihood of reporting adverse outcomes, so essentially judging them properly would be a challenge for us’Consultant 5
‘Exactly the same way that we measure normally as well, and we are actually quite generous in the way that we monitor our patients’Consultant 5
- (3)
- Team roles
“well I think you have to be I think a lot of the patients would be wary without you know if they just met say someone they had not met before who said I am going to change you, do not worry your consultant is fine with this I think they’d probably want to hear the consultant say this is the right thing to do as far as I am concerned but in terms of them having cos doctors I do not tend to have a lot of time to and probably are not so good at just having lengthy sort of reassuring discussions so that is something that might be better done by nurses I think”Consultant 3
- (4)
- Effective communication of information during switching
- (a)
- Subtheme was ‘What patients want to know’
“theoretically then, you could send a letter out in three months’ time we are thinking of doing this if there’s any issue can we perhaps talk with you face to face”Etanercept originator FG Pt 6
“if it becomes clear that there is a very obvious change in efficacy of the treatment, are patients able to go back to the original version. If, if that is true, then I think you say to people, look its identical, its fine, we are so confident that it will be identical, if necessary we can take you back to the other treatment if you need to.”Infliximab originator FG Pt 1
- (b)
- Subtheme was ‘How it should be communicated’
“Yeah, this would be better if you had a simple sheet, because I often actually do not bother with reading up, it would be nice to have a choice, while producing a large amount of literature can be very expensive, if you do a simple link to a website, could actually keep a reference when you need to”Infliximab originator FG Pt 1
“I mean I guess it would be helpful to you know, I mean patients need to understand the savings and perhaps give them some examples of what you could do with that if you if this works for you this releases it is a bit like that television programme you know this is 20 hip replacements a year”Consultant 3
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A. Topic Guides/Questions for Patient Focus Groups
A presentation explaining the difference between biologic medicines and biosimilar medicines was delivered prior to asking questions. | |
Questions | Prompts |
What are your initial thoughts on the content of the presentation? | Concerns? Safety? Cost? Treatment for other patients? |
Will switching to a biosimilar affect anything about how you take your medication in any way? | Frequency? Attendance at appointments? |
If we change your medication to a biosimilar product, how should we introduce the switch? | Via letter, face-to-face consultation? Who should switch your medication? Doctor, Nurse, Pharmacist? What should your medication be switched? |
If we change to the biosimilar, what information should be given to patients? | Who do you see is the correct person or method of receiving this information? Patient information leaflets? Letter in the post? Social media, i.e., Apps (applications)? What information can we provide to encourage patients to adopt the change? |
Is it necessary to be monitored if prescribed a biosimilar, and if so, how should this be done? | How should this be done? Via telephone, face to face? How often? How soon after the first dose? Who should monitor you? What should be monitored? Drug levels, disease activity? |
Thank you for your input and time. Is there any advice you could give us? |
Appendix B. Topic Guides/Questions for Consultant Interviews
Questions | Prompts |
---|---|
What are your views about switching patients from one biosimilar to another biosimilar? | Cost? Experience? Patient registers? |
What are the important drivers for switching? | |
What are the roles of the different members of the team? | Doctor, specialist nurse, pharmacist |
What should be monitored once the patient has been switched to a biosimilar? | What should be monitored? Drug levels, disease activity? |
What information do you think the patient should be given? | In what form? i.e., patient information leaflets? |
How should the information be delivered to the patient? | Content? Letter in the post? Social Media, i.e., applications? Presentations? |
How do you see the future of biosimilars? | Pathways? Cost changes every year? |
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Infliximab Originator Focus Group | Etanercept Originator Focus Group | |
---|---|---|
Number of patients | 2 | 7 |
Females | 1 | 5 |
Age | 34–55 | 28–79 |
Diagnosis | ||
Spondyloarthritis | 2 | |
Rheumatoid arthritis and psoriasis | 1 | |
Rheumatoid arthritis | 1 | 4 |
Crohn’s disease | 1 |
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Rosembert, D.C.; Twigg, M.J.; Wright, D.J. Patient’s and Consultant’s Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study. Pharmacy 2024, 12, 65. https://doi.org/10.3390/pharmacy12020065
Rosembert DC, Twigg MJ, Wright DJ. Patient’s and Consultant’s Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study. Pharmacy. 2024; 12(2):65. https://doi.org/10.3390/pharmacy12020065
Chicago/Turabian StyleRosembert, D. C., M. J. Twigg, and D. J. Wright. 2024. "Patient’s and Consultant’s Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study" Pharmacy 12, no. 2: 65. https://doi.org/10.3390/pharmacy12020065