Asking to change the rules for cladribine? It’s already happened !

A

Fair enough, there has been a build up to this. After all, a couple of days ago MD ProfB explained – again – that whilst both cladribine and alemtuzumab are immune reconstitution treatments (IRTs) with significant long term effects on B cell subsets, particularly the memory B cell pool, this is where their similarity largely ends.

Next came ProfG detailing 17 attributes of cladribine that should make it eligible for as a first line treatment. By now we know this would need to be submitted to NHS England via their clinical policy portal, I guess this is somewhere here. I’d be surprised if this were a swift, straightforward process, but we’ll look into it, of course.

However, looking at lower hanging fruit, some UK neurologists steamed ahead and recently facilitated a change in prescription guidelines. This was driven by the significantly reduced capacity of many Trusts across England & Wales to undertake MRI. Here’s our letter:

NHS England agreed that, during the pandemic, cladribine can now be started – as a first line DMT – in people with two significant relapses over the past 12 months (“rapidly evolving severe MS”) even if supporting MRI evidence is not available because patients were either (i) shielding or (ii) unable to be scanned due to capacity issues. The same rules apply to pwMS switching from a first-line DMT to cladribine due to a relapse – no supportive MRI evidence is currently required for this switch. Here is the new Blueteq form:

Cladribine-for-MS-Initial-COVID

These changes are consistent with the revised guidance for natalizumab during the early stages of the pandemic, and provide welcome extra flexibility in the choice of DMT for pwMS.

CoI: Multiple, including my role as Chief Investigator of ChariotMS, which is supported by Merck, over and above the NIHR/MRC, MS Society of Great Britain & Northern Ireland, National MS Society (US), and Barts Charity.

@KlausSchmierer

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2 comments

  • Well done ProfK, Bob and Nikos

    18. Normalizing brain volume loss when used early.
    Start 9 years after dianosis CLARITY = ~0.5-0.6
    Start at onset ORACLE Supplementary data Table 1. Do what other modern studies have learn to done and rebaseline.

    Take week 96 from week 48 and you have annualised brain volume loss 5.25mg = 0.1 and 3.25 = 0.2mg what is the brain volume loss of alemtuzumab year 1-2 it is about 0.2 (CARE-MS) what is the volume loss in healthy humans = 0.2. They are no different in their efficacy. The cladribine safety data is much better!

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