Monday, 1 September 2014

ClinicSpeak: Are you confused about DMTs prescribing for CIS?

Who is responsible for keeping UK neurologists up-to-date about prescribing policy? #ClinicSpeak #MSBlog #MSResearch

"Unfortunately, this post is for UK, and possibly English and Welsh,  MSers only. The MSer who contacted me last week about her frustrations about getting onto a DMT for CIS has forwarded me her email correspondence she has had with her MS team and the Commissioners who pay for the drug. It is clear that nobody really understands what policy they should apply when prescribing DMTs for CIS and other forms of MS. It looks as if some of the neurologists are still prescribing interferon-beta and glatiramer acetate according to the Department of Health's Risk Sharing Scheme (RSS) for Disease Modifying Therapies in MS (2002). The RSS scheme uses the Association of British Neurologists (ABN), Guidelines for the use of Beta Interferons and Glatiramer Acetate in Multiple Sclerosis (January 2001). The following is the paragraph from these guidelines that refers to CIS."

B.1.2 Clinically isolated syndromes

Because: (i) the treatment effect on relapse rate appears similar but not superior to that seen in established relapsing remitting MS, and (ii) many patients will not have new relapses in the early years (e.g. 50% of placebo patients in the CHAMPS trial did not have further relapses during the 3 years of follow up), treatment is not currently recommended at presentation with a clinically isolated syndrome. Should a relapse occur during the first two years of follow up, the patient then has relapsing remitting MS and the treatment criteria in B.1.1. should be used. Current efforts are being made to develop MRI criteria which enable an earlier diagnosis of MS at or near presentation with a clinically isolated syndrome and to identify those who have a high probability of early clinical relapses; such criteria may lead in future to guidelines for earlier treatment after the first clinical event.

"What this patients MS Team and Commissioner's don't appreciate is that since April 2013 the RSS guidance has been superseded by NHS England's policy; 'Clinical Commissioning Policy: Disease Modifying Therapies for Patients with Multiple Sclerosis (MS) (First published: April 2013, revised May 2014)'. The policy document states that Neurologists may, in certain other circumstances where the evidence for efficacy is less secure, also consider advising treatment after discussion with the patient  concerning the risks and benefits. For (i) patients within 12 months of a clinically significant clinically isolated syndrome when MRI evidence predicts a high likelihood of recurrent episodes (i.e. development of MS); (ii) patients with only a single major relapse in the preceding two years, but combined with MRI evidence of continuing disease activity (i.e. meet the revised McDonald criteria for MS); and (iii) individuals aged less than 18. These guidelines are based on the 'ABN Revised Guidelines for Prescribing in Multiple Sclerosis (2009)."

"The NHS guidelines are clear to me; neurologists in England and Wales can prescribe interferon-beta, but not glatiramer acetate, for patients with CIS provided they have (1) an abnormal MRI that predicts a high likelihood of recurrent episodes, (2) had a discussion with the patient about the benefits and risks of treatment and (3) start the interferon within 12 months of the clinical attack. The guidelines are not too prescriptive and allow the neurologist to make his/her call on what constitutes an abnormal MRI that predicts a high likelihood of recurrent episodes."


"The question we should be asking is whose responsibility is it to make sure MSologists are aware of the change in prescribing policy? Surely as in this case it should not be the responsibility of the patient themselves?"

CoI: multiple

11 comments:

  1. Prof G, how do I access the ABN guidelines so that I can quote them to my neurologist?

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  2. http://www.england.nhs.uk/wp-content/uploads/2013/10/d04-p-b.pdf

    This is what you need. I suggest you print it off and take it with you. Verbally quoting may it not be sufficient.

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  3. Thank you so much for this. I feel like I've been pushing a boulder up a mountain forever to get this across and finally someone hears me.

    I hope other CIS patients are reading this. DMT's may not be the right choice for everyone but everyone should have access to the right information.

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  4. Just got this off the MS Decisions website. Not sure how up to date it is.

    http://www.msdecisions.org.uk/

    Clinically Isolated Syndrome (CIS)

    Clinically Isolated Syndrome (CIS) is the first episode of MS symptoms lasting at least 24 hours, but before a formal diagnosis of MS has been made. People with CIS who show abnormalities on MRI scans within one year may receive treatment with interferon beta or glatiramer acetate provided local health service commissioners agree. Four of the five self-administered drugs are licensed for CIS. These are: interferon beta 1a (Avonex®), interferon beta 1b (Betaferon® and Extavia®), and glatiramer acetate (Copaxone®).

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    Replies
    1. Re: "http://www.msdecisions.org.uk/"

      It is out of date and is currently being updated by the MS Trust. I have had to resign from the steering committee due to other commitments. The MS Trust provide the best evidence-based guidelines, so I am sure the new site when it goes live will be helpful and up-to-date.

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    2. I hope so as its so difficult trying to make sense of all the information across different sites and organisations. Having one site which clearly sets out the guidelines will help a lot of people.

      I have found the MS Trust the most helpful charity in providing information and in their understanding of current policy.

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  5. This debate just highlights how poor the entire diagnostic process for MS is. A disease that attacks the most critical of systems in the body relying on outmoded forms of diagnosis, with a seeming emphasis on keeping people off treatment for as long as possible.

    It's a shame that no biomarker and no reasonable measurement of CNS inflammation can be found to in some way guide treatment.

    For those with rheumatoid if they have multiple inflamed joints and a corresponding high ESR it seems relatively straightforward to know when people need treatment. In MS a lot of the early damage seems hidden, yet it is occurring to one of the most important systems in the body. The means of diagnosis then the seeming reluctance to treat is deeply frustrating. The rationale of "if there are already signs of a fair amount of damage on MR, then consider treatment", seems similar to the requirement for disabling relapses before Tysabri will be paid for. People shouldn't have to show signs of damage or disability before treatment is considered. Either those paying for the drugs think they work or don't.... if it is still thought that they only reduce relapses then it could be suggested that MSers are simply being palliated though the relapsing phase with no hope for decreased/delayed progression and a discussion needs to occur if this is worth it. If, however (as I suspect) it is thought that the progressive phase can be delayed or stopped then why mess around in the early phases of the disease?

    This is the CNS - any damage is too much. I'm not religious, and it's the only place I can see the 'soul' being.

    We seem to have come some way in treatment, diagnosis needs to improve considerably.

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  6. Prof G why don't you produce your own decision aid that we can use based on your posts on this blog? I for one would find it very helpful. I is difficult remembering everything that you have said in the past, collecting it all into one resource would make a big difference to me and I assume newly diagnosed MSers coming to this blog for the first time.

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  7. Yes, and so are the neuros.

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    Replies
    1. I don't think Prof. G is confused. His posts on this issue seem pretty clear to me.

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