First oral MS drug, Gilenya, rejected by NICE

[MSUK]

Campaigners have expressed disappointment after the National Institute for Health and Clinical Excellence (Nice) rejected the first pill to treat multiple sclerosis.

The MS Society urged the medicines watchdog and drug firm Novartis to work together so that Gilenya – also called fingolimod – can be reappraised.

In draft guidance which is subject to consultation, Nice rejected the drug due to "uncertainties" over its effectiveness, a lack of appropriate data and concerns over cost-effectiveness.

It said it was unclear how much the drug would help the specific group of people for whom it was licensed – adults with relapsing-remitting multiple sclerosis (RRMS) who experienced at least one relapse a year despite being treated with beta interferon drugs. Another group of patients suitable for the drug were those with rapidly evolving severe RRMS, who experience two or more disabling relapses regardless of their treatment.

Nice said Novartis had submitted data mainly looking at a subgroup of patients with the former type of MS. The firm also only submitted data comparing Gilenya with a placebo and a type of beta interferon not believed to be widely prescribed on the NHS, according to Nice.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309

[bil]

Professor Carole Longson, director of the health technology evaluation centre at Nice, said: "While it's important that people with multiple sclerosis have treatment options, Nice has to ensure that the NHS provides treatments that bring benefits that are value for money.

"Unfortunately, our independent committee wasn't given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used.

"Based on the available clinical evidence and economic analysis, our independent committee concluded that fingolimod would not be effective good use of NHS resources."

This is disingenuous at best and outright lies at worst. From the studies done so far Fingolimod is quite clearly a lot lot better than interferon or copaxone. In fact so much better that there's not even any point in doing a comparative study, no interferon or copaxone study against placebo has come anywhere close to the results that Fingolimod has achieved.

[NHE]

Here are numbers quoted for Gilenya's efficacy. The first number is for reduction in relapse rate while the second is for reduction in disability progression.

1. BG12 53% 38%
2. Cladribine 58% 33%
3. Fingolimod 54% 30%
4. Laquinimod 23% 36%
5. Teriflunomide 32% 30%

What is interesting is that Biogen reported that Avonex had a 37% reduction in disability progression from their phase III trials.

Relative % reduction = (34.9-21.9)/34.9*100




I'm not trying to be controversial, just trying to give the conversation some perspective. For $48,000/year, it doesn't seem like much of an improvement.

NHE

[mrbarlow]

Professor Carole Longson, director of the health technology evaluation centre at Nice, said: "While it's important that people with multiple sclerosis have treatment options, Nice has to ensure that the NHS provides treatments that bring benefits that are value for money.

"Unfortunately, our independent committee wasn't given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used.

"Based on the available clinical evidence and economic analysis, our independent committee concluded that fingolimod would not be effective good use of NHS resources."

This is disingenuous at best and outright lies at worst. From the studies done so far Fingolimod is quite clearly a lot lot better than interferon or copaxone. In fact so much better that there's not even any point in doing a comparative study, no interferon or copaxone study against placebo has come anywhere close to the results that Fingolimod has achieved.

Pretty much the norm from the No Hope Service that us Brits have come to love

I wonder how much of the NHS resources will be spent on Breast Augmentations (not reconstruction), tatoo removal, hymen reconstruction for Muslim brides......