Friday, 30 September 2016

ClinicSpeak: not so NICE - alemtuzumab vs. cladribine

NICE is not so NICE; alemtuzumab is too expensive to use properly. #ClinicSpeak #MSBlog #MSResearch

Could oral cladribine steal alemtuzumab's thunder? #ClinicSpeak #MSBlog #MSResearch

I naively discovered yesterday that NHS England will only be allowing us to use two courses of alemtuzumb in our patients with active relapsing MS. If these patients breakthrough and need a third, fourth or additional course of alemtuzumab we will have to apply for additional funding via an IFR (individual funding request). The problem with the latter is that as soon as there are more than 5 patients in England requiring an IFR for the same indication this triggers the requirement for a business case. Making a business case stack-up for additional courses of alemtuzumab, when it costs so much, will be difficult outside of formal NICE guidance. At present ~40-50% of patients treated with alemtuzumab will require additional courses. Based on my previous experience with NHS England, and their dire financial predicament, I suspect getting a green-light for additional courses of alemtuzumab is going to be an uphill battle. In short we have been truly NICED. The question is whether or not Genzyme-Sanofi will come to the table with additional courses at a lowered price? If not we are going to need a plan B. What DMT will we use in patients who breakthrough post-alemtuzumab?"


I am now going to have to take this information into account when counselling patients. I suspect that this may turn many patients off alemtuzumab as a treatment option. Does this also mean we should be routinely be offering our patients, who want an induction therapy, off-label cladribine or in those with highly-active disease HSCT? This new information also means that if oral cladribine gets a license it is going to disrupt alemtuzumab's market. The following is my ECTRIMS poster showing you the effect of oral cladribine. The difference with oral cladribine is that we have access to the much cheaper generic oncology version that could be used for subsequent courses if NICE, and NHS England, say no to additional courses of cladribine. Unfortunately, at present we don't have this option with alemtuzumab.


CoI: multiple

29 comments:

  1. Is profG becoming a white knight:-)

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    1. I thought he was a black swan ;-)

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    2. Neither! Just trying to work-out the best way to implement an induction therapy protocol for pwMS being treated under the NHS in England. Only being able to use two courses of alemtuzumab, or oral cladribine for that matter, is like having one arm tied behind your back. I hope you realise the gravity of the situation; this is going to cause a lot of anxiety amongst many of our patients.

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  2. It is a worry. I've had both courses. If I get breakthrough disease where to I go next?
    Feeling out of options so soon after diagnosis is not a great feeling.

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    1. If the MS breakthrough disease is not severe then what about Tecfidera? Unless this has already been used and failed.

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  3. Prof G,

    Imagine I am a new patient - recently diagnosed with quite severe RRMS. We discuss options and I decide lemtrada is the best option for me. I have 5 days of infusions and a year later have the second round (3 days of infusions). I am NEDA for 3 years and then it becomes active again. I come back and see you and ask for another round of Lemtrada. Are you saying would say no to this request? I assume there is a cupboard of lemtrada vials in Barts. Why not get some out and give me the third round of infusions? I can't see how NICE can monitor this? It should be your professional judgment. Would such a case go to trial / a tribunal "I accuse you Prof G of giving a third round of infusions to a patient whose disease had reactivated"! Will these rules apply to other patients - you can only be treated for 2 broken limbs in a lifetime, a third case of melanoma will not be treated. Bonkers situation.

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    1. I wish we did but we don't have spare vials of Lemtrada lying around. Each vial costs £7,045, which equates to £21,135 for 3 vials for the 3rd and subsequent courses. Then there are the infusion and monitoring costs that go with this. Each time you have a repeat course the clock for monthly monitoring gets reset to zero, i.e. you need 48 months of monthly monitoring after the last course.

      Unfortunately, our Trust doesn't have this money, which is why we have to get NHS England to fund the drug.

      Believe me when I say that I only found out yesterday that at present NHS England are only prepared to pay for the initial 2 courses of alemtuzumab. This not so subtle point of the guidance passed me by.

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    2. Prof G, level with us: Where is the NHS going? What will become of it? Can it be saved?

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    3. Re: "Where is the NHS going?"

      I think we all know where it is going. The political parties have all agreed that the current funding model is unsustainable and the current government are pushing it to the limit with efficiency gains, etc. I suspect they will want MSers to self-fund similar to what is happening in the oncology space. This is why I am so against private prescribing in the NHS.

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  4. Prof G this is very bad news. I know two people who have had 3 treatments of alemtuzumab and they are both now looking good. In both cases the third round was this year after a serious relapse, obviosly they were they lucky that the relapse happened a few months ago not that any relapse is good news.

    They originally had alemtuzumab because their first relapses of MS were serious and the outlook was not good. What will happen with them if they have further relapses which is more than likely.

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    1. Yes, I agree. The majority of pwMS who need a third course do very well and don't need a fourth course. If we switch MSers who fail after two courses to another licensed maintenance DMT it will cost more than the third course within 2 years. I have little doubt that the third course will be cost effective when you compare it to other treatments.

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  5. As a patient starting with first course of alemtuzumab very soon, this is very worrying. I am concerned as to whether this remains the right decision. If a third course is indicated, what would be the other option, switching to a less effective dmt? Is there benefit to starting on an alternative treatment which could be continued.

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  6. In November, it will be 10 years since my first round of infusions (I had my second round of infusions a year later). I've had no treatment since the second round of infusions. I have been NEDA since the first set of infusions (diagnosed with aggressive MS). I work full time and must have paid c. £300k of taxes since my first round of infusions (without the treatment I would have been heading for unemployment). I have one visit to the neuro each year for a check-up. How short-sighted can the NHS be?

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  7. I read the document but I can't find the section where they specifically say no funding for treatment after 2 courses? Would this mean that HSCT would then be recommended as the next step by the NHS seeing as the NHS ask RRMS patients to have failed tysabri and/or Lemtrada before moving on to HSCT? Perhaps that will be more available now as it does save money

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    1. I get the feeling HSCT would only be considered if the MS is very aggressive/severe.
      Lemtrada being a first line DMT for active MS. Some MSers have Lemtrada for mild but active MS.

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  8. The Cladribine would be the quickest way out, but there are "hidden forces" waging its release ...

    The same chaos in Brazil is going on, the Brazilian NHS even remove the free supply of Fingolimod who has MS...

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  9. Will this also be the case for NHS Wales?

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  10. It is as if the committee members have no clue of MS and they care only about saving costs and nothing more. How can their decision be justified? How can they argue about that against an MS patient/family member/MSologist?

    The last page has a paragraph named "Responsibilities". My understanding of that is that healthcare professionals should follow the guidance, but they should also act responsibly and take into account individual circumstances. What does it mean? Can a neuro say that a 3rd course is needed because of the individual circumstances of their patient?

    Is there any way the MS community could protest and appeal against this decision?

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  11. This is nuts, NHS England must have read the information that about half of people need a third treatment.

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  12. This is nuts, NHS England must have read the information that about half of people need a third treatment.

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  13. Dear Prof,

    Thankyou for everything that you have been doing for MS. You've really given the MS community a voice. I've had RRMS for a year and had 6 relapses so very active disease. Being JC positive, we decided it was best to start alemtuzumab. It's really upsetting to hear that they will no longer fund a 3rd dose of alemtuzumab when approx 50% people need it. Is there anything the MS community can do to appeal this decision?

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  14. Wow, having had two rounds, i'm now praying that i won't be in that 50% that need more. It is crazy that many of us spent many fretful weeks weighing up the risks of this DMD against it's potential efficiency...now we've taken on those potential risks for life, the drug will be withdrawn after the minimum dosing, whether it's successful or not! This is not what i would have based my risk assessment on! Very very worried

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  15. Is this an existing regulation, or is it about to come into place? I had my second course 9 months ago and wondering if I can fit in a third course before the rules are tightened up??

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    1. What is the current criteria needed for the 3rd dose of Lemtrada? New lesions on MRI and one relapse?

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  16. I have had a lot of email correspondence on this issue over the weekend and some people think that NHS England signed-up to more than 2 courses. However, I had an email exchange with them on Thursday to the contrary. I will go back to them for definitive clarification. Unfortunately, the neuroscience lead is off until the 10th October.

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  17. Please update the blog once you know more. Thank you.

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  18. Thank you for looking into this for us. This is extremely worrying news for MSers. When we started on this drug, we balanced all the risks against the efficacy. If 3rd round is taken away, then all of us have taken the same high risk but for lower efficacy than we were given to expect. And so has the NHS.

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