Despite recent studies showing that treatment with Ampyra (Fampyra in Europe; fampridine) improves both walking speed and ability, and offers psychological benefits to patients with multiple sclerosis (MS), the Scottish Medicines Consortium (SMC) recently decided to not recommend the drug for use on the National Health Service (NHS) in Scotland.
The SMC’s reason was that there was not a sufficiently robust economic analysis to recommend the drug’s use.
“We are disappointed that Fampyra has not been recommended by the SMC and we are concerned about the number of people who could have benefited from this treatment who will now potentially miss out,” Morna Simpkins, director for MS Society Scotland, said in a news release.
“We will continue to campaign for all licensed medicines, including Fampyra, to be made available on the NHS so that people with MS have access to the right treatments and the right time, regardless of where they live or their financial situation.”
The SMC advises NHS Scotland on the value of every newly licensed therapies for patients. When they issue a “not recommended” notice for a given drug, health boards do not make the treatment routinely available. However, patients can ask for access to Ampyra/Fampyra if their doctor agrees on the potential benefits that the treatment may bring. This is done through an Individual Patient Treatment Request (IPTR) process.
The decision of the SMC applies only to Scotland.
Oral Ampyra/Fampyra is currently the only drug approved in the U.S. to specifically treat walking impairments in MS, a common disability in these patients, after two Phase 3 clinical trials showed that the treatment resulted in consistent increases in walking speed.
Recent studies have shown that this drug also improved MS scales evaluating psychological parameters in patients. Studies with larger groups to confirm the positive effects of Ampyra/Fampyra are currently ongoing in the U.S.
Ampyra/Fampyra acts by blocking potassium channels in neurons, reducing the leakage of current from these cells, and thereby restoring conduction and communication in neurons whose myelin sheath (a coating that protects neurons) has been damaged by MS.
Oral Ampyra/Fampyra is usually administered twice daily in a dose of 10 mg. An increase in dosage should always be approved by a specialist, as high amounts of this drug can induce seizures. The most common side effects of this treatment include allergic reactions, insomnia, dizziness, urinary tract infections, throat pain, constipation, headache, and nausea.