Fampyra, Aid for Walking, Favored for Inclusion in NHS Scotland

After being rejected twice in the last four years, Fampyra (fampridine; marketed as Ampyra in the U.S.) is now being recommended by the Scottish Medicines Consortium (SMC) for use in the country’s National Health System (NHS) to treat walking disabilities in adults with multiple sclerosis (MS).

Scotland will become the second nation in the United Kingdom to offer the oral treatment; it was favored for use in Wales in December.

The SMC advises NHS Scotland on the clinical and cost effectiveness of all new medicines; once brought into the NHS, they are available to patients at low or no cost.

Fampyra, marketed by Biogen in Europe, will be available to MS patients who have a score of 4.0 to 7.0 on the Expanded Disability Status Scale (EDSS), meaning significant disability (the higher the EDSS score, the greater is a patient’s disability). It is available as a 10 mg tablet, taken without food twice a day, at morning and at night.

Fampyra was initially rejected in 2016, and at the time Biogen requested a re-evaluation after submitting additional data from clinical trials and real-world studies. Two years later, the SMC again issued a negative opinion, citing the medicine’s poor cost-effectiveness.

The new and favorable opinion “takes into account a confidential discount offered by the pharmaceutical company that improves the cost-effectiveness of fampridine,” the SMC states on its website.

Fampyra (prolonged-release tablets of fampridine) is the first approved treatment to aid walking in adults with MS. It is approved in the United States under the brand name Ampyra, marketed by Acorda Therapeutics.

In MS, the immune system attacks myelin (the protective coating of nerve fibers), disrupting electric signals traveling along nerve fibers from the brain to the body and back. This causes symptoms that can include difficulties with walking.

Fampyra is a potassium channel blocker that helps signals that come from the brain to travel along nerve fibers, restoring neuronal conduction. It improves the quality of nerve impulses conducted by nerve fibers, which can help to mitigate gait difficulties.

Compared with those given a placebo, about one-third of MS patients in clinical trials had a 25% improvement on average in walking speed after treatment with Fampyra.

“It’s fantastic that fampridine (Fampyra) has been approved for use on the NHS in Scotland,” Morna Simpkins, director of MS Society Scotland, said in a press release.

“This treatment could be life-changing for many people living with the symptoms of MS, making an important difference to walking and energy levels. We are delighted to hear that SMC has accepted the drug but it’s up to our health boards to make sure people who could benefit can get it,” Simpkins added.

She hopes the therapy soon becomes available to MS patients in other parts of the U.K.

One patient, Nina — no last name is given — is a former occupational therapist who lives in the Scotland’s largest county, Inverness-shire. She has had MS for more than 25 years, and gives Fampyra a positive review.

“When I was first told I’d progressed from relapsing-remitting to secondary progressive MS, my consultant at the time simply said, ‘There’s nothing to do, just look after yourself,’” Nina said. “But when I moved further north I had a new consultant who suggested I try Fampyra, and it’s been brilliant.”

Nina, who has a “shortening of my right Achilles tendon,” reported that after starting treatment with Fampyra, she’s been able to move fairly frequently the toes of her right foot, something she “hadn’t been able to do for years,” and has more energy. Disease progression has also slowed.

“One of the most fantastic things was on my daughter’s wedding day,” Nina said. “I didn’t have to use my wheelchair at all, which I had fully expected to, and Fampyra definitely played a role in that. Even when the dancing started I was still standing.”

She added, “a treatment like this is invaluable. It’s fantastic news that Fampyra will now be available for people with MS on NHS Scotland. I’ve seen first-hand the positive impact it can have so to know that it should now be an option for more people across the country is really welcome.”