Evaluating Impact and Cost-Effectiveness of Fampridine in MS
Research type
Research Study
Full title
Changing the Game: Evaluating the Real World Impact and Cost-Effectiveness of Fampridine in Multiple Sclerosis.
IRAS ID
291618
Contact name
Jeremy Hobart
Contact email
Sponsor organisation
University of Plymouth
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Research Summary:
This study explores the beneficial effects of fampridine as a symptomatic treatment in people with Multiple sclerosis (MS). It is an observational, non-interventional study gathering qualitative data from questionnaires, interviews and focus groups from people with MS who are eligible to take fampridine.
There are two parallel strands run concurrently at two MS centres (Plymouth and Swansea). Strand 1 is a retrospective evaluation of people with MS already taking fampridine aiming to gather information identifying longer term impacts of taking the medication, such as any change in frequency of accessing other services. Stand 2 is a prospective evaluation of people with MS who are fampridine-naïve and are due to start treatment. The aim of strand 2 is to gain real-time information about fampridine’s benefits in people as they initiate treatment.
Consenting participants in both strands of the study will complete a range of questionnaires (symptom questionnaire, domain specific questionnaires and quality of life questionnaires), participate in 'in-depth' interviews (face to face or virtual) and will have the opportunity to take part in a focus group.
The research study sets out to determine the real world benefits of fampridine on people’s symptoms of multiple sclerosis, explore suitability of two quality of life questionnaire frequently used in judging cost effectiveness and identify whether patient response to fampridine is person specific or MS symptom specific.Lay summary of study results:
Changing the Game: Evaluating the Real-World Impact and Cost-Effectiveness of Fampridine in Multiple Sclerosis (MS)Fampridine use in MS (Introduction and aim) Fampridine is a medication that can help relieve the symptoms of MS in some people. It is not a disease modifying therapy. It works by enabling nerve signals to pass down the nerves more normally. Approximately 50% of people with MS respond to fampridine and this response is noticeable within 2-4 weeks. Fampridine has been shown to improve walking speed for some adults with MS and is approved for use by NHS Wales and NHS Scotland in adults with MS. It hasn’t been approved by NHS England. Plymouth’s MS service recommends people consider the fampridine free 1-month trial if they can afford the costs of private prescriptions in the longer term. This cost is approximately £2,500 per year.
Plymouth collaborated with an MS centre in Wales (Swansea Bay University Health Board) to explore the benefits of fampridine for people about to commence fampridine and for people already taking fampridine.
The aim of the study was to explore the personal impact on people with MS who start or who are already taking fampridine and to assess the suitability of measures presently used when evaluating its’ value for money.
How we explored the impact of fampridine (Method) Forty five people with MS participated who were already taking fampridine. They completed questionnaires and were interviewed.
Fifty four people with MS who hadn’t yet commenced fampridine participated. They all completed questionnaires before they started and after their trial of fampridine. Some participants were interviewed before they started and all who responded to fampridine were interviewed after their trial of fampridine.
What we found (Results)
We found that people with MS who responded to fampridine (PwMS responders) gained widespread benefit in their MS symptoms beyond walking. When we looked at 18 common MS symptoms, three quarters of PwMS responders benefited in 5 symptom areas, nearly two thirds benefited in 6 symptom areas and a third benefited in 10 symptom areas.
We also showed that the cost effectiveness questionnaires used in early fampridine research studies may have underestimated the cost effectiveness of fampridine.
What next (Discussion)
Information gathered here will help inform future studies that evaluate medication like fampridine.
This study supports the wider benefits of fampridine in MS beyond walking, supporting that NHS England should follow Wales and Scotland’s decision to approve fampridine use for MS in England.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0108
Date of REC Opinion
15 Jun 2021
REC opinion
Further Information Favourable Opinion