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Ampyra (Fampyra)


Irish HSE to reconsider funding of MS drug Fampyra(19/11/14)

The Irish Health Service Executive has said its drugs committee will meet to reconsider a decision not to fund a life-changing drug for multiple sclerosis patients.

Fampyra, or Fampridine, which is made by Biogen Idec, costs between €220 and €500 for a monthly dose.

Patients were receiving the drug for free until July of this year, but since then they have had to start paying for it themselves.

The drug helps MS patients to walk and walk faster.

It does not work for everyone, but some of the thousand or so patients taking the drug have claimed it has meant the difference between whether they could leave their homes unaided or not.

In May 2013, the HSE decided not to approve the reimbursement of the drug under any of its free schemes as the manufacturer had failed to formally justify the high price it was charging.

Earlier this year, patients stopped getting the drug for free and now have to pay up to €500 for a monthly dose.

The HSE has since had further contact with the makers of the drug.

It has said its drugs committee will reconsider the outcome of its commercial discussions with the manufacturer before the end of next month.

Independent TD Denis Naughten, who raised the plight of MS patients on a number of occasions in the Dáil, has called on the HSE to ensure that the drug is provided under one of its free schemes.

Source: RTÉ News © RTÉ 2014-RTÉ Commercial Enterprises Ltd (19/11/14)

Irish health service executive rejects MS drug Fampridine again(30/10/14)

Decision comes as a blow to patients who are paying up to €500 a month for Fampridine.

The Health Service Executive has rejected a second application from the makers of a drug that helps people with multiple sclerosis to walk to have it covered by State-funded drug schemes.

The decision will come as a blow to MS patients who are paying up to €500 a month for Fampridine (known commercially as Fampyra), which greatly increases mobility among some of those with the condition.

The HSE first rejected the reimbursement of the drug in May 2013, saying the manufacturer, Biogen Idec, had failed to demonstrate or provide any formal justification for the prices it proposed.

Its drugs committee recommended further discussions take place with neurologists about new drugs that are emerging to treat MS, before Fampridine was reconsidered. Discussions with Biogen Idec started again in July and the company said it offered “additional and significant reductions” in price.

However, yesterday the HSE told Independent TD Denis Naughten “the manufacturer has been unable to demonstrate the cost-effectiveness of Fampridine in the Irish healthcare setting”.

“The HSE decision on Fampridine is in line with many other European countries which have also, to date, not provided the drug under their public health systems.”

Mr Naughten said: “Rather than both sides continuing to horse trade on this life-altering drug, I’m proposing that the HSE and the company sit down and let Ireland become a specific pilot to design a roll-out scheme and pricing structure for Fampyra.”

Outlining his proposal Mr Naughten said: “With 8,000 people with MS in Ireland, which is a relatively small cohort, and in light of the fact that the northwest of Ireland has one of the highest incidence of multiple sclerosis in the world, we are in an ideal situation to evaluate which patients can benefit from this drug.

Mr Naughten called on the HSE and the Government to enter direct talks with the manufacturer with the aim of making Ireland a pilot country for rolling out the drug.

The National Centre for Pharmacoeconomics, which rules on the cost-effectiveness of new drugs, found 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.

Source: The Irish Times © 2014 The Irish Times (30/10/04)

MS Cannabis drug ‘too costly’ for England but not Wales(08/10/14)

A drug derived from cannabis, which many people with multiple sclerosis say helps ease their symptoms, has been ruled too expensive to be used by the NHS in England even though it is approved for Wales.

In new guidelines for the diagnosis and treatment of people with the disabling disease, the National Institute for Health and Care Excellence (Nice) says the price set by the manufacturer of Sativex (nabiximols) is too high for the benefit it gives patients. But the decision opens up the sort of “postcode lottery” that Nice was set up to end, with MS patients in Wales able to use the drug on the NHS while those in England either have to buy it themselves or go without. Some will use the illegal drug instead.

A second drug, Fampyra (fampridine), designed to improve people’s ability to walk, has been rejected by both England and Wales. Neither drug is routinely available in Scotland.

“The substantial cost of Sativex and fampridine compared to the modest benefit does not justify their use; there are better ways to improve care for people with MS,” said Dr Paul Cooper, a consultant neurologist who chaired the guideline development group.

In a Guardian podcast, he suggested Wales had been “a little naive” in their assessment of Sativex: “They have taken information from the drug company at face value without seeing the original data and they’ve used dosages and potential benefits that we would not agree with.”

But the MS Society’s chief executive, Michelle Mitchell, said the rejection of the two drugs by Nice was disappointing. “Surely we should be striving for the most innovative treatment and care to be made available to people with MS, not limiting options even further,” she said.

The charity published a survey of nearly 4,000 people with MS that found 82% of those taking Sativex considered it essential or a high priority. The main reasons people gave for not taking Sativex were that it was not available where they lived – prior to Nice’s decisions, the NHS makes local decisions about funding the drug – or that they would have to pay privately.

“I experience very painful spasms around my ribs, the MS hug, and tightness in my arms and legs. I’ve been told that Sativex could give me some relief but it seems so out of reach,” said Shona Garrett, 38, from Lowestoft, who was diagnosed two years ago and is on a waiting list for the drug in her area. “I also experience nerve pain like constant pins and needles in my feet, and I’ve heard Sativex could help with this too. No one has offered me any other options.”

She and her husband had discussed paying for the drug privately, but they had been told it would cost £500 a month, which is more than they can afford.

About 100,000 people in the UK have MS. It tends to hit younger people and can lead to serious long-term disability.

The guideline says people with suspected disease should be referred promptly to a consultant neurologist for diagnosis. Among other recommendations are that they should have a single expert to speak to about their care, concerns and treatment options so they are not shuttled about between different doctors and nurses. They should also be encouraged and helped to exercise.

The MS Trust said although it welcomed its publication, “regrettably, we believe that the guideline falls short. Though it contains a number of welcome recommendations, it also contains some significant gaps and omissions. Overall we believe it demonstrates a lack of ambition to provide what people with MS need, that is, a genuinely comprehensive description of best practice in MS care.”

Source: The Guardian © 2014 Guardian News and Media Limited (08/10/14)