Tuesday, 11 July 2017

#NeuroSpeak & #ClinicSpeak: NHS England has yet to greenlight a 3rd course of alemtuzumab

Help! What do we do if a 3rd course of alemtuzumab is needed? #NeuroSpeak #ClinicSpeak 

This is a post for MSologists working in England. Yesterday I received confirmation from NHS England that they have not yet green-lighted a third course of alemtuzumab. In addition, I was told not to bypass the current NICE guidance by simply opening up another entry for a specific patient on Blueteq (Blueteq is the online system the NHS uses for high-cost drug vetting and accountability). I am aware that some of my colleagues have been doing this. 

Not being able to offer a 3rd course is a problem in that an IFR (individual funding request) will not be processed as there will be more than 20 patients in England eligible for a third course. This situation has also put me in an awkward position as I have counselled most of my patients that about 40-50% of them will need a 3rd course. 


I already have two patients who have broken through after the second course and we have to treat them with alternative DMTs. The latter is not a satisfactory solution to the problem. I sincerely hope Genzyme is getting the EMA label changed, on which the NICE guidance is based, to allow subsequent courses of treatment. 


CoI: multiple

7 comments:

  1. What about if you received infusions as part of a study? My infusions were 13 years ago and 12 years ago. I have been relapse free and stable. If I'd been on an injectible for the last 13 years it would have cost the NHS c.£130,000. I'd be annoyed if I couldn't get a third course if I needed it.

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  2. "Re. about 40-50% of them will need a 3rd course. "

    That's quite a high proportion and much more than I was expecting.

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    1. People in the MS-CARE trials have received multiple infusions and you are very good example of why this treatment should be an available option.

      P.S. Whilst changing the EMA licence remember to remove comments that alemtuzumab increase memory T and B cells and Tregs

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  3. Two questions. Firstly if after 2 infusions some function has worsened eg hand function which dmts have you been prescribing? Secondly if nice did approve a third treatment would the blueteq form need to be submitted if you had already had two infusions?

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  4. The data seems very clear, people with breakthrough disease benefit from more infusions, not having it available its very cruel to the patient who is losing brain.

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  5. It is a worry, particularly given the risks associated with the drug. As someone who has had both rounds I would hope to be given a 3rd round if needed. If two rounds are the limit the risk v benefit ratio of lemtrada tips the wrong way imo.

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