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NICE will consult on its draft guidance until January 5, with final guidance expected in April 2012.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

Source: PMLive press release

CoI: multiple