Biogen to reapply for HSE funding for multiple sclerosis drug

The makers of a drug that helps people with multiple sclerosis to walk are to make a fresh application to have it covered by the Health Service Executive-funded drug schemes. People with MS, who say Fampridine (known commercially as Fampyra) has greatly increased their mobility, have criticised the HSE for not reimbursing the cost of the drug on the long-term illness scheme.

In 2012, regulatory authorities concluded that Fampyra was not demonstrably cost-effective for the treatment of MS. The HSE said the manufacturers, Biogen Idec, had failed to demonstrate or provide any formal justification of the prices proposed, but did not rule out a revised application.

The National Centre for Pharmaco-economics (NCPE), which rules on the cost-effectiveness of new drugs, said Fampyra would cost nearly €7,000 a patient each year. It said the €20 million annual cost to the State over five years would take money from other areas. Biogen later made the drug available free of charge to some patients as part of a late-stage clinical trial.

Since Fampyra was licensed for sale and became commercially available here this year, Biogen started charging for the product, leaving patients facing a €500 monthly bill to continue treatment.

One of these is Rosaleen Rafter, from Ballina, Co Mayo, whose daughter Caitríona Redmond says it will be impossible for her mother to afford the drug on her pension. Ms Redmond has been running a campaign through Facebook to highlight her mother's battle to continue getting "the only treatment that has improved and stabilised her symptoms of MS".

“My mum retired early because of the illness and her loss of mobility and loss of power in her arms and hands. She uses a rollator to walk and has a hand-controlled adapted car as her legs have severely reduced power. She has foot drop and has had two falls, one of which took me and my brother ages to get her off the ground and resulted in a fractured shoulder.

“Watching the effects that her condition has on her has been awful and, without her medication, things will progress sooner.”

Last week, Minister of State for Primary Care Alex White told the Dáil he understood Biogen had told the HSE it intended to submit a revised application to the NCPE. The HSE would then reconsider the application "in line with the agreed procedures and timescales for the assessment of new medicines".

Mr White said he was aware that studies were ongoing to assess the wider impact of the drug on both walking and quality of life for people with MS.

Their results would contribute to the evidence base demonstrating the clinical effectiveness of the product, which could be used to support future applications for inclusion on HSE drugs schemes.

Biogen said it was working with the authorities to make Fampyra available to all patients. It said it provided the drug free for 2½ years to qualifying patients and continued to provide the first four weeks of treatment free, so that patients who responded to it could be identified.