GVS assessment of fampridine (Fampyra®) for use in a subgroup of MS patients

Previous assessments

A negative reimbursement advice was given for fampridine (Fampyra®) in 2012 and 2018, due to insufficient evidence of the effectiveness of fampridine on improving walking in adult patients with MS with an EDSS score of 4-7.

Registered indication

The current reimbursement request is for a subgroup of the above-mentioned MS patients, for whom fampridine may be effective. The subgroup includes adult MS patients with EDSS 4-7 and severely impaired walking ability, defined as a walking speed of 6 seconds or longer on the Timed 25 Foot Walk test (T25FWT ≥ 6 seconds).

Assessment of interchangeability

No product is included in the Medicine Reimbursement System (GVS) with which fampridine (Fampyra®) is interchangeable. Based on this, fampridine (Fampyra®) cannot be placed on List 1A. The National Health Care Institute has assessed whether fampridine (Fampyra®) is eligible for inclusion on List 1B.

Therapeutic value

Fampridine (Fampyra®) has a therapeutic added value for the improvement of walking in adult MS patients with an EDSS-score of 4-7 and severely impaired walking ability (T25FWT ≥6 seconds) in comparison with placebo, both added to best supportive care, taking into account the trial treatment strategy as recommended by the specialists (MS working group of the NVN). Fampridine thus complies with established medical science and medical practice for this subgroup of MS patients. The National Health Care Institute was advised by the Scientific Advisory Committee (WAR).

Trial treatment strategy

The MS working group of the NVN recommended a trial treatment strategy for subgroup of MS patients. Only patients who demonstrate at least a 20% improvement on the T25FWT after two weeks of the trial treatment are allowed to continue the treatment with reimbursement via the standard health care package.

Moreover, re-assessment will take place annually. During re-assessment, the treatment with fampridine will be terminated for at least 48 hours, after which the T25FWT will be
carried out. Only patients who achieve at least 6 seconds on the T25FWT will receive a 2-week trial treatment, after which the T25FWT will be repeated. Patients must demonstrate at least a 20% improvement in this T25FWT (in comparison with the first T25FWT) to be able to continue treatment with fampridine with reimbursement from the standard health care package.

The National Health Care Institute's advice

The National Health Care Institute advises that fampridine (Fampyra®) for improving the walking ability of adult MS patients with EDSS 4-7 and severely impaired walking ability (T25FWT ≥6 seconds) should be included on List 1B and List 2 of the Health Insurance Decree and to attach the following conditions.

Conditions for fampridine (Fampyra®)

Only for an insured person aged 18 years or older with multiple sclerosis, with Expanded Disability Status Scale of 4 to 7 (EDSS 4-7) and a severely impaired walking ability based on a Timed 25 Foot Walk Test Score of at least 6 seconds (T25FWT ≥6 seconds), who fulfils the conditions of the trial treatment strategy:

1. At the start, a two-week trial treatment with this product. 
2. After an initial trial treatment, an improvement of at least 20% is achieved in the T25FWT. 
3. If treatment is continued, the trial treatment is repeated at least once a year, whereby treatment with this product is terminated for at least 48 hours, after which the first T25FWT is carried out, and after a renewed two-week trial treatment, an improvement of at least 20% is achieved in this T25FWT (in comparison with the first T25FWT).​​​​​​

After 2 years, together with the parties, the National Health Care Institute will re-assess these List 2 conditions on the third point, to determine whether this condition is still necessary within the framework of appropriate use.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.