Is it possible to get Rituximab for ME on the NHS?

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CharlotteV
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by CharlotteV on Wed Aug 14, 2013 8:59 am

Is it possible to get Rituximab for ME on the NHS?

Hi Dr Shepherd – as you know, a trial of the immune drug Rituximab was found to show major to moderate improvement in 67% of patients with ME vs 15% of controls in a placebo-controlled, randomised trial conducted in Norway and published in 2011. According to a Norwegian TV news report, the same team have just bettered those results in a follow-up study using an improved dosing schedule (detailed results are embargoed pending publication). Money is being raised for confirmation trials in the US and Germany and now in the UK (by Invest in ME and the ME Association so far and I strongly suggest that people reading this donate and spread the word about the trial).

Rituximab is already used for rheumatoid arthritis and other autoimmune diseases in the UK but isn’t licensed for ME. Is it possible for patients to get it off-license, and if so, how?

Many of us have been sick and untreated for decades. I’ve been mostly bedbound for nearly 30 years. In a few years, I’ll be entering my old age and I’d like the choice of taking an informed risk while there’s still some chance for me of having an adult life of some quality. What freedom do our GPs and consultants have to treat people with ME like me – or those desperately ill patients such as those who are tube-fed, in constant pain, with very little quality of life – off-license or on compassionate grounds? Do we have any chance, now, of being prescribed Rituximab?

Here’s a link to an article about the UK Rituximab trial, which includes donation links – hope it’s OK for me to give it here:

http://phoenixrising.me/archives/18320

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Dr Charles Shepherd
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by Dr Charles Shepherd on Wed Aug 14, 2013 12:01 pm

Re: Is it possible to get Rituximab for ME on the NHS?

Charlotte

There are several discussions taking place about Rituximab on the MEA Facebook page:

https://www.facebook.com/pages/ME-Assoc ... 1469583186

where I have been answering lots of questions over the past week or so.

The MEA Ramsay Research Fund has set aside almost £60,000 in research funding for a Rituximab trial and we are very happy for this money to be used for a trial at UCL once a protocol has been prepared, costings are known and the trial has been approved by the Clinical Trials Unit at UCL. So provided the proposal is acceptable to the MEA, and our peer review is satisfactory, there is a considerable amount of funding available from this charity. Additional funding may also be available from a collaborative charity approach that is now being discussed.

Regarding availability of Rituximab on the NHS. This is a very expensive drug that can cause very serious side-effects - so it is not going to be made available on the NHS until a number of high quality clinical trials have shown that it is a safe and effective form of treatment for at least a sub-group of people with ME/CFS.

Even if all goes to plan with a small UK trial, the whole process of drug evaluation, licensing and approval from NICE (who will want to look at cost effectiveness) for a treatment such as this is going to take several years. So we have to be realistic: Rituximab is not going to be available on the NHS for ME/CFS outside a clinical trial until we have a lot more information on benefits and safety.
Dr Charles Shepherd
MB BS, Honorary Medical Adviser, ME Association

Bluebottle
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by Bluebottle on Wed Aug 14, 2013 4:24 pm

Re: Is it possible to get Rituximab for ME on the NHS?

The charity Invest in ME already have such a study set up apart from raising all the funding


http://www.ukrituximabtrial.org/IIMEUKRT%20Summary.htm
Quick Overview of the Trial


Invest in ME have initiated a UK rituximab Trial




Our advisor Professor Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College London (UCL)


• The clinical trial would be performed at University College London




The UCL service set up when we started treating rheumatoid arthritis, lupus and a range of other conditions has the most extensive experience.




There is laboratory expertise in B cell immunology under Dr Jo Cambridge.




UCL also has a new Clinical Trials Research Facility with staff appointed to manage trials of this sort.




The trial is being set up in collaboration with clinicians with expertise in ME from around London, and in particular Dr Amolak Bansal.




The UCL proposal will be rigorously evaluated by UCL in their customary comprehensive and very professional manner.




External peer reviewing will be arranged by UCL and the charity.




Invest in ME have arranged for Professor Edwards to visit Dr Fluge and Professor Mella in Bergen, Norway to discuss this - enhancing cooperation and research.

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Dr Charles Shepherd
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by Dr Charles Shepherd on Wed Aug 14, 2013 4:34 pm

Re: Is it possible to get Rituximab for ME on the NHS?

I am obviously following all these developments and am in contact with Professor Edwards at UCL

Professor Edwards is currently looking at the feasibility of a clinical trial taking place at UCL

He is (very wisely) collecting information from a wide variety of sources and going to Norway next month to talk to the Norwegian doctors

A trial protocol (= patient election, dose of drug, length of treatment etc) then has to be agreed, costed and approved by an ethical committee at UCL

The trial protocol also has to be approved by the UCL Clinical Trials Unit

Like everyone else I hope this trial will proceed without delay and without problem (it is not an easy thing to do) but we are not yet in a position where the trial has been 'set up' and approved as 'ready to start' at UCL
Dr Charles Shepherd
MB BS, Honorary Medical Adviser, ME Association

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