The forgotten many: not any more

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Most of you will have heard by now that NICE has green-lighted siponimod for the treatment of active secondary progressive multiple sclerosis on the NHS. As the UK member of the EXPAND trial steering committee, Novartis who market the drug asked me for a quote, which sums up my opinion about the news.

“The NICE approval of siponimod to treat secondary progressive multiple sclerosis with active disease is a landmark that promises to transform the way we view and manage MS. At last, we have a treatment that can modify the progressive pathology that underpins secondary progressive MS with active disease. The ‘Forgotten Many’ is how people with secondary progressive multiple sclerosis have described themselves; but not anymore. Our challenge is to configure our NHS services to treat patients with secondary progressive MS and to manage expectations, as not all people with secondary progressive multiple sclerosis will be eligible for siponimod. However, this is the beginning of a new era in the management of MS and should be celebrated for that.”

CoI: multiple

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

9 comments

  • “Active secondary progression , that is relapses or imaging features of active disease”

    As you stated, MS is one disease. How does this distinction of active secondary progressive MS as opposed to non active MS with underlying smouldering disease fit with your thesis? By making active secondary progression a separate type of MS this seems to refute the idea of MS is one disease. Or do you mean that there are different mechanisms for progression in MS pathology e.g. lymphocyte inflammation, microglial activation etc.?

    • This classification system was created by Fred Lublin and colleagues and is not consistent with my thinking. But for NHS patients we have to play along. If you want to hear about what I think about this please watch the following YouTube video: https://youtu.be/PN_CiZcZp9Y

  • Now comes the big question: How does Siponimod fit in the treatment decision algo for an RRMS nearing the end of his “RRMS cycle”?

    Are we ready to address this approach of treat early in the seconday progressive context?

  • If one becomes SPMS, then has relapse and therefore becomes active SPMS, then gets treated and gets no relapses thanks to drug activity so the treatment is stopped, then after some time he relapses again going on with this loop. This way of treatment will make the patient accumulate damage by both progression and relapses. Under this light doesn’t make sense to just treat patient even if they are SPMS independently on activity? I have heard that many people actually relapse in SPMS phase. Having relapses in that phase is adding unnecessary damage in my opinion… it seems not so ethical

    • My thoughts exactly… all good points and funnily enough the question of ethics and morality comes into play as well…guess what we ain’t stupid

      Yes, this is the sister of vastly unpopular and expensive FINGOLIMOD

      With all the same issues…..

      (Mayzent may increase the risk of infections, so patients should have a complete blood count taken before treatment is initiated.

      The drug may cause macular edema, so patients should contact their physician if they experience a change in vision.

      Mayzent may cause transient decreases in heart rate and may cause a decline in lung function.

      Liver enzymes should be checked before initiation of the drug and health care professionals should closely monitor patients with severe liver impairment.

      Health care professionals should monitor the patient’s blood pressure during treatment.

      Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug due to the potential risk of fetal harm.

      Health care professionals should monitor patients for posterior reversible encephalopathy syndrome and monitor patients that had treatment with immunosuppressive/immune-modulating therapies because there may be unintended additive immunosuppression with Mayzent. )

      (So good luck with that, on our stretched NHS in the middle of a pandemic)

      … and with the less well understood ramifications (well they can’t be …or more would have been done to date for us pp and spMs folks ) of the disease turning secondary progressive- (the RR stage Is a breeze in comparison…)

      And vastly more expensive (than say Sativex c 400) I think it 1600 a month at least in England – part of the reason NICE didn’t want to approve it …their stance also being:

      “NICE says that due to the limited clinical evidence, the cost-effectiveness estimates are uncertain, and none of the analyses reflect the committee’s preferred assumption that it cannot be recommended.

      The committee has requested further analyses to be included in the company’s economic model. These include comparing siponimod with best supportive care and assuming that there is a reduction in its treatment effect over time’.

      Well I’m glad they got their favourable deal; but I don’t think many SPs will take this one up

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