Friday, 16 March 2012

NICE: fingolimod gets the thumbs up in the UK

In its final draft guidance, out today (16 March), NICE, has recommended fingolimod, to help reduce the number of relapses for some MS'ers with highly-active MS. This positive recommendation is a change from NICE's previous draft guidance from December and follows a public consultation during which the manufacturer (Novartis) and clinicians provided additional information and analyses.
" This is very good news and a big relief for all of us who work in the MS field in the UK. If fingolimod was turned down by NICE the implications for other drugs coming through the pipeline, in the future, would have been very dire. At last we now have something to offer MS'ers with highly-active MS in parallel with Natalizumab. In addition, we can now offer MS'ers on natalizumab at high risk of PML the option of switching. MS'ers must be aware that fingolimod comes with its own list of issues; no decision is going to be simple and straightforward."

CoI: multiple, I coordinated a UK MSology lobby to get NICE to reverse their decision

10 comments:

  1. That's great- now those MSer's with highly active disease have a choice. What's happened to alemtuzumab though? I thought it had got through it's phase 3 trials, and as it is already a licensed drug why can't neurologists prescribe it?

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  2. But isn't fingolimod killing people?

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  3. Re: "What's happened to alemtuzumab though?"

    Although the phase 3 trials are completed it has yet to get a license for MS. PCT or commissioners are reluctant to agree to pay for the use of a drug off-license when there are licensed therapies available. We simply have to wait for its approval, which should happen in the next few 12 to 18 months.

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  4. Re: "But isn't fingolimod killing people?"

    There have been 11 unexplained deaths on Fingolimod. The EMA and FDA are reviewing the safety of the drug. The deaths, may or may not be related to fingolimod. I suspect some will and other won't. You also have to remember that there are over 30,000 MS'ers on the drug. So for some MS'ers the risks may be worth taking.

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  5. This is very news. I can see that over the next 18 months we may well see a number of new treatments being approved e.g. Alemtuzumab and BG12.

    It will be interesting to see how this all plays out i.e. which treatments gain the most market share. I'll be glad to see the back of the first line treatments with their 30% efficacy (reduction in relapses). Fingolimod offers c.50% efficacy, Tysabri (c.65-70%) and Alemtuzumab (?90%). It should also make the neuros job more interesting / satisfying.

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  6. Oh, some more gret news for those with RRMS.

    Glad they've got options.

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  7. Is the macular issue reversable if the drug is stopped or does it cause permanent damage?

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  8. Re: "Alemtuzumab (?90%)"

    Over-hyped by Cambridge. The phase 3 results are much more modest than this.

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  9. The phase 3 results were more modest, but they were comparing the use of rebif v. alemtuzumab in early stage disease. It would be interesting to do a further comparison between these groups after 5 or 10 years.

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  10. "follows a public consultation during which the manufacturer (Novartis) and clinicians provided additional information and analyses".

    Yeh right what happened was they dropped the price it was going to cost the NHS thus paving the way for more sales.

    11 dead says enough for me.
    Thanks but no thanks

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