Treatment to improve walking in MS under review for the PBS
26th September, 2012
Walking impairment is a common symptom of MS, which greatly affects independence and quality of life. Around half of all people with MS will require some form of walking assistance within 15 years of disease onset. A study published last week showed that 43% of people with MS considered walking impairment to be their most bothersome symptom. People who had more difficulty walking also required greater support from carers and the health system, and walking impairment had an impact on work productivity.
Fampridine (Fampyra) has been available in Australia by private prescription since its approval by the Therapeutic Goods Administration (TGA) in May 2011 for the treatment of walking impairment in MS. It is now under review with the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS) in Australia.
The PBAC is an independent body that includes health professionals and a consumer representative. The Committee recommends whether treatments should be subsidised by the government as part of the Pharmaceutical Benefits Scheme. The panel looks at clinical effectiveness, safety and the value for money of new treatments in comparison to other available therapies. As part of the review, the PBAC considers comments from the public, patients, carers, health professionals or consumer interest groups. Comments on fampridine can be made through this website and will be accepted from today, September 26th until October 10th 2012. As part of the form you will need to include the name of the medication under review (fampridine/fampyra) and the date of meeting submission (November 2012).
Fampridine acts by blocking potassium channels that are exposed by the loss of myelin in MS. This blocking leads to better signalling along the nerve fibres which have been damaged by the disease. In a Phase III clinical trial that included 301 people with MS, fampridine was shown to improve the walking speed in 35% of the treatment group. Walking speed was measured by the recognised standard ‘timed 25-foot walk’ test where individuals are asked to walk 25 feet as quickly but safely as possible. In those who responded to the treatment, walking speed improved by around 25% and individuals reported improvement on questionnaires.
In a follow-up Phase III clinical trial similar results were reported for walking speed and leg strength also improved. Improvements in walking speed were seen across all forms of MS and were independent of other disease modifying treatments. Side effects of fampridine include headaches, insomnia and dizziness. Seizures have been reported in a very small number of cases.
MSRA welcomes new treatments that have undergone rigorous clinical testing as a way of giving people living with MS more options in reducing the impact of the disease on their lives.