Fampridine shown to be clinically effective when compared to best supportive care, with patients reporting significant improvement in walking ability and quality of life1
Maidenhead, UK. – Wednesday 18th December 2019 – Biogen Inc. (Nasdaq: BIIB) today announced that Fampyra® (fampridine) has been recommended for funding by the All Wales Medicines Strategy Group (AWMSG). The recommendation released by the AWMSG states that ‘Fampridine (Fampyra®) is recommended as an option for use within NHS Wales for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale [EDSS] 4 to 7). This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price.’1
Fampridine is recommended for use in all subtypes of MS, including relapsing remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS), and progressive relapsing MS (PRMS) that have either very limited or no treatment options, depending on disease severity.2 Wales is the first country in the UK to recommend fampridine receives funding, the Scottish Medicines Consortia are due to review their funding decision in March 2020.
“Although disease-modifying therapies have been shown to be effective in reducing relapse rates and disease progression in people with relapsing remitting MS, they do not specifically target the symptoms of MS, like problems with walking and general mobility, which can have a significant impact on quality of life,” said Dr. Simon Beck, Medical Director, Biogen UK & Ireland. “Two out of every three patients with MS will develop a degree of disability and walking impairment2, for which fampridine is licensed, making the AWMSG’s recommendation an important step forward for people in Wales who have, until now, been self-funding their own treatment.”
Fampridine’s approval came as a result of an extensive clinical trial programme; a phase II study (MOBILE) and three phase III studies (MS-F203, MS-F204 and the ENHANCE clinical trial). All studies have shown that a higher proportion of patients treated with fampridine met the response criteria (using 25-foot walking test and/or MSWS-12 end-points) compared to those treated with best supportive care.3, 4, 5 Patients responding to fampridine noted substantial improvements in routine day-to-day functional activities including, for example, the ability to walk independently without the use of sticks or any other aid for a sufficiently long enough time to manage daily tasks, with further real-world data confirming the importance of such benefits.2, 3, 4, 5 Fampridine is also a cost-effective medicine.
Ireland granted reimbursement of fampridine in September 2015 along with 12 other countries in Europe.
1 All Wales Medicines Strategy Group Final Appraisal Recommendation – 1919: Fampridine (Fampyra®) 10 mg prolonged-release December 2019
2 Executive summary of fampridine reimbursement submission
3Prolonged-release fampridine and walking and balance in MS: randomized controlled MOBILE trial. Hupperts R et al. 2015.
4 Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials. Goodman A et el. 2015.
5Assessment of Clinically Meaningful Improvements in Self‑Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double‑Blind, Phase III ENHANCE Trial of Prolonged‑Release Fampridine. Hobart J et al. 2018.