This was not funded in 2014/15 partly on the basis of considered lack of need and the cost of the trial: Though £32,000,000 would have been saved for the NHS by doing the study our request was £2,000,000 above the ring-fenced budget that British Science (NIHR) would fund.
Since that time, with the failure of the repurposing bill, UK Government ministers have asserted that generic Cladribine can be prescribed off-label.
It is just as safe (or safer) than current highly effective agents and not known for the development of PML or autoimmunities characteristic of other MS drugs.
It is as convenient (or more convenient) than any agent, requiring only a few cycles of administration a year, and after just over one year you monitor and wait & see whether you remain NEDA or re-dose, compared to monthly monitoring for drugs such as teriflunomide or alemtuzumab.
Cladribine is the only MS DMT that is CNS penetrant and has a mechanism of action that can work inside the CNS. It targets dividing (like beta interferon, teriflunomide, DMF) and non-dividing lymphocytes and may kill plasma cells (antibody producing cells). We know that targeting lymphocytes is beneficial in MS, because HSCT can be very effective.
This sounds like good news for Merck (Serono no more), who claim they are going back to the regulators to get their oral version licensed for relapsing MS, yet we have heard that for about 18 months now with submission still being “imminent”, confirmed as recently as yesterday…
I am also told Merck might try hard to keep the price at a reasonable level
should a license come their way, but is this likely I wonder? More likely this will be priced in the region of current MS DMT, i.e. 20-30 times the cost of generic subcutaneous Cladribine, of which all gets into the body (100% bioavailability) compared to only 42% of what is ingested with the Cladribine pro-drug pill, which is converted to Cladribine after digestion.
Cladribine could be a cost effective alternative for resource strapped healthcare settings, such as the UK. Current MS drugs cost about $50,000, multiplied by 5 years thats $250,000 for most MS drugs, for some it is more. If you are NEDA after only 1 course of Cladribine that could be $350 – $1000 depending on the source. In the UK one course costs about £1600.
How about creating access to an effective DMT for the 300,000 or so pwMS on the planet whose annual income is lower
than the annual cost for a DMT (and that is for the least efficacious
brands)? ECTRIMS, ACTRIMS, PACTRIMS, MSIF, MS Societies of the World – anybody interested?
That aside, Cladribine may still be a useful approach for people with progressive MS, who have slipped through the current DMT net, and this is where we can focus our energy in the UK to give people with nothing an alternative to nothing.
Please tweet the Video: https://youtu.be/Yk7_JpK33i4
I’ve tweeted the link earlier today, so you could just retweet that if you prefer (https://twitter.com/KlausSchmierer).
+++ Latest Brexit News +++ Withdrawal of video considered as according to LEAVE campaign leaders now £350 Million/week extra for NHS available +++ Apparently, The Palace considers overuling referendum due to concerns over new Scottish exit vote +++ As a result video remains available on Youtube until further notice +++