Evaluation and reassessment of further conditions for fampridine (Fampyra®)

2019 advice on fampridine

Since 1 September 2019, fampridine (Fampyra®) has been included in the medicine reimbursement system (GVS) on List 1B, subject to further reimbursement conditions.

The further condition for fampridine is:

Only for an insured person 18 years or older with multiple sclerosis with an Expanded Disability Status Scale rating from 4 to 7 (EDSS 4 to 7) and a severely limited walking capacity with a Timed 25 Foot Walk Test score of at least 6 seconds (T25FWT ≥ 6 seconds) meeting the requirements of the trial treatment strategy:

1. at the start a 2-week trial treatment with this medicinal product;
2. after an initial trial treatment, an improvement of at least 20 percent on the T25FWT is achieved;
3. if the treatment is continued, the trial treatment shall be repeated at least once a year, with the treatment being discontinued for a minimum of 48 hours, after which the first T25FWT is carried out and after the 2-week renewed trial treatment an improvement of at least 20 percent on the latest T25FWT (compared to the first T25FWT) is achieved.

Evaluation annual trial treatment

The National Health Care Institute established in the GVS assessment of fampridine (Fampyra®) for use in a subgroup of MS patients that the third List 2 condition would be evaluated together with the stakeholders, in the context of appropriateness. It concerns the annual repetition of the trial treatment and walk test. The evaluation should determine whether this medicinal product is sufficiently effective.

National Health Care Insitute's conclusion and new advice

The National Health Care Institute concludes that an annual repetition of the walk test by MS patients who use fampridine has disadvantages: it is perceived as not useful and stressful (temporary worsening of symptoms) by both neurologists and patients and it imposes a burden on the healthcare capacity. The advantages are not clear either.

The COVID-19 pandemic has reduced the number of walk tests that could be expected in a regular situation, but there is no evidence that the medicinal product is not being used appropriately. The National Health Care Institute therefore advises the Minister to revise the List 2 conditions for reimbursement.

The National Health Care Institute advises to cancel the third List 2 condition:

• if the treatment is continued, the trial treatment shall be repeated at least once a year, with the treatment being discontinued for a minimum of 48 hours, after which the first T25FWT is carried out and after the 2-week renewed trial treatment an improvement of at least 20 percent on the latest T25FWT (compared to the first T25FWT) is achieved.

If the Minister accepts the National Health Care Insitute's advice, the new conditions for fampridine reimbursement are as follows:

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