Saturday, 31 May 2014

Alemtuzumab approved in the UK...Let the European Experiment begin

A news report has been issued the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending that Lemtrada should be reimbursed on the NHS, as an option for treating adults with active RRMS, within its marketing authorisation.

So the "game" changes as more choice arises and a new first line appears.

The FDA has expressed concerns about Alemtuzumab, but will re assess the licencing package.

Perhaps they are waiting to see what happens with the European Guinea Pigs. They will look to see how safety issues play out as the drug is used post-licencing. Look at Tysabri the plug was pulled pretty soon, once the risk of PML appeared.

Already we know of some risks from Alemtuzumab, what new ones will appear?

At least people are being monitored monthly for 4 years after their last dose, so hopefully things will be picked-up and any problems will be treatable.

Whilst this regular follow-up may be a reminder that you have/had? MS, to some it will be re-assuring and means that you will get better care, with a regular check up rather than seeing someone once a decade.


The trial data suggested 20% autoimmunities but the long-term follow up was closer to 50%. This all adds to the cost to the NHS and all cost of monitoring and dealing with these autoimmunities will add at least an extra third as much as the drug costs. So when the anti-CD20's (that is if they use it as an induction therapy...which I doubt although the data probably supports this belief) come to try knock anti-CD52 off its perch. Will they add an extra 30% to the cost?

9 comments:

  1. Wonder why they did not try to use anti-cd20's atop of alem to get rid of autoimmunities as they believe it's all about B-cells?

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    1. May be a good thing to try but anti CD20,s are Roche GSK and not genzymeSanofi can they gettheir hands on one.

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    2. Sometimes I'm so happy to live in russia.All sorts of things are available hare as long as you got cash. And they don't bother themselves with any evidence

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    3. Oh Vasy that gave me a laugh.

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  2. Let's not forget about the FDA HSCT phase 3 trial in Chicago.

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  3. Are their two phase III othervwise pharma will say quite rightly double standards. Can it be worldwide?
    Do they have £30,000 to talk to the EMA or do they not care about MSers outside USA.

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    1. Yes, precisely this is not a pharmaceutical approach so I don't see why they would have the same standards. As for other countries, I guess their health systems have other priorities.

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    2. This an interesting question if there is a double standard, then pharma are wasting millions and maybe they have recourse against the FDA for putting them through the hoops. Maybe you are right or maybe academics need to wake up and smell the roses.

      So. if I have a drug and can develop i,t but can' t afford to get it available in the US then this alright I guess..

      Interesting dilema

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