NICE, or not so NICE?

*NICE has rejected Novartis’ application to use fingolimod for MS’ers on the NHS. NICE has again stated that the cost-effectiveness of fingolimod does not hold up as a treatment for highly active relapsing remitting multiple sclerosis (RRMS). This is despite a proposed patient access scheme from Novartis that would see the drug offered at a discount price to the NHS.

Sir Andrew Dillon, CEO of NICE, said: “While Novartis submitted evidence that shows fingolimod can reduce relapses, our independent committee has not been convinced that it is a cost effective treatment option for the NHS, even with the proposed patient access scheme.”

Dr Jayne Spink, director of policy and research at UK charity the MS Society, said: “This is incredibly disheartening news for people with MS and it will leave some people with no effective treatment option. We would like to see fingolimod freely available to all those that could benefit and remain hopeful that this will happen.”

Fingolimod has an annual cost of treatment is £19,196 per patient, when prescribed at the recommended dosage of 0.5mg once a day, but NICE said it did not provide enough clinical benefits when compared to treatments such as natalizumab, which costs £14,730 per patient per year.

Details of the patient access scheme remain confidential, but Novartis said the most plausible incremental cost effectiveness ratio was £40,000 per quality of life year (QALY) gain. NICE generally considers a treatment cost-effective if this figure is below £30,000. Novartis disputed the decision, claiming the cost per QALY was pushed above the threshold due to NICE’s recommendation for use of best supportive care in combination with the treatment. When supportive care is removed from the care model, the cost per QALY for fingolimod comes under £30,000, the company said.

NICE will consult on its draft guidance until January 5, with final guidance expected in April 2012.

“This is very disappointing news. NICE have simply got it wrong! It is not a choice between no treatment or fingolimod. According to its license fingolimod will be offered alongside natalizumab; MS’ers should be able to choose which drug they want. If you are currently on natalizumab you should be able to switch to fingolimod, which has a different risk profile.”

“It seems as if the MS’er has been forgotten in this decision. What do you think?”

CoI: multiple

5 thoughts on “NICE, or not so NICE?”

  1. Re: "Does this apply if the PPMS trial shows benefit?" No! NICE will have to look at it separately for PPMS. That is if fingolimod is shown to be effective in PPMS and gets a license for this indication in Europe.

  2. I think NICE are not being very nice.What sucks for us MS’ers is the lack of range with in terms of treatments. What’s more, those poor souls with highly active MS are the very people needing potent medicines like Fingolimod, not those whom are coping with relative ease with their MS.I sense you are as equally unhappy with this decision Prof G. I cannot understand why such decision making doesn’t involve people like you. Is it because you don’t think about fiscal concerns when prescribing medicines?Is there any chance this decision can be reversed? Will the drug company be less willing to carry on in terms of pushing for a license in PPMS patients?

  3. Re "If you are currently on natalizumab you should be able to switch to fingolimod"What makes you certain that a switch between the two drugs is safe? Is there a research to confirm it?Re "MS'ers should be able to choose which drug they want.""Choice" is only a marketing trick to create the illusion of taking steps in the right direction. "Choices" are all about having more mouths fed by MS.You have it all upside down. Instead of "lobbying" Novartis to make generous discount, you blame NICE for refusing to pay the ransom of the glorious ORAL drug. What makes fingolimod unique is only this, its oral form of administration. The necessary hype has been carefully building up for years. Before asking all that money, Novartis should wait a few years in order to provide proof that a wide and long term use of its drug is safe and effective. The rest is extortion.

  4. See the rates of pml on tysabri posted a few days ago and it is clear why alternatives are needed. They are no cases….yet of fingolimod pml.The only way to see if a drug is safe is to give people access to it and do phase iv monitoring.This was the mistake made with oral cladribine.Ps. I still think even more now that safety studies withiv cladribine need to be done to gives a cheaper option. We know it works but is it safe? This would be cost effective. Ok i have said my piece on this for the last time.

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