Tuesday, 26 December 2017

NICE and not so nice

Bah, humbug! 

The cynic in me would say would say that NICE (The National Institute for Health Care & Excellence) timed the release of this consultation document in the UK exactly right. Dare I say, an overused political strategy this year has been to shoe it under the door before anyone is the wiser (I won't mention any specifics). And again they will be correct in assuming that over the yuletide, key opinion leaders in MS would either be inebriated, or staving off the first signs of a diabetic coma to take much notice. I don't mind people exercising a bit of stealth when it is required. However, it is the calculated nature by which the process is undertaken that I take umbrage to. It would be a mistake to assume, just simply because their is acquiescence, their is also acceptance.

On the 20th December 2017, NICE published an appraisal document on the use 1st line DMTs (disease-modifying treatments), specifically the interferon's and glatiramer acetate (see below for the full report).

The summary points are:
  • Extavia (IFNB 1b) is recommended as a treatment for people with relapsing remitting MS or secondary progressive MS with continued relapses.
  • Copaxone, Avonex (IFNB 1a), Betaferon (IFNB 1b), Plegridy (pegylated IFNB 1b) and Rebif (IFNB 1a) are not recommended.
  • Anyone already taking one of these drugs will not be affected by this guidance and can continue without change until they and their neurologist consider it appropriate to stop.
This consultation only applies to those resident in the UK (excluding Scotland).

Historically, NICE performed an assessment of all 1st line DMTs and in accordance with the submitted evidence concluded that they were more clinically effective than best supportive care, but not cost effective for the NHS (National Health Service). In response, the Department of Health (DoH) and various stakeholders got together and established the Risk Sharing Scheme (RSS). RSS allowed clinicians to prescribe 1st line DMTs in the NHS at a deduct price, and as part of the agreement, data on efficacy was also collected. This ran for 10 years and has now come to an end; which is the reason for the reappraisal.

It's been a tough year! Make no mistake, this consultation is all about money. NHS has limited resources and increasingly finds its funding squeezed on all fronts. High-cost drugs, firstly in cancer, then Rheumatology & Respiratory, and now MS are under heavy scrutiny. 

The incremental cost-effectiveness ratio (ICER) for Extavia is less than £30,000 per QALY (quality adjusted life year) gained. For the others (glatiramer acetate, Avonex, Betaferon, Plegridy and Rebif) who also boast similar clinical effectiveness (~30% annualized relapse rate reduction) the calculations exceed that of £30,000. The DoH and Novartis (proprietor of Extavia) have agreed that Extavia will be made available to the NHS through a patient access scheme for an unknown amount.

As we're living in a democratic society, the closing date for comments on this consultation is the 24th January 2018 (tighter than some of my grant deadlines!). The MS Trust is compiling view points in a survey, so please take a moment to complete: www.surveymonkey.co.uk/r/MTApwMS.


  1. I imagine that reaction will be greatest over Copaxone, as many MSers (I was one) chose it for its low side effects profile. Also, for those so scared of injections, Avonex was popular. Excuse my ignorance - I'd never heard of Extavia. Will the decision encourage conservative neuros to prescribe second-line drugs post an MS diagnosis? If so, could this be seen as a good move?

    1. Extavia is the the same as betaferon but is the generic

  2. Pharma needs a good lesson on their pricing policies but this is definitely not the way to do it.
    Sweden showed a way to do it. They invested public money on a trial on Rituxan that would bring them huge relief on medical costs long term and of course on the benefit of their patients -and without excluding them from any other choice of drug.
    It is horrible that UK is one of the wealthiest countries of the world with a health care system that reminds the ones of much poorer countries (because politics).

  3. But are these drugs really cost effective? They provide only modest efficacy. Also only work in 50% of people. Why use them when you have caldribine, a much more effective drug? And a induction therapy. I think it's time to clear the cupboard. Make room for more effective therapies on the horizon. Such as Ocrelizumab, Spinimod, Ozanimond, Posin8mod, Ofatumumab, etc.

    1. The CRAB drugs were never considered cost effective, that's where the risk sharing scheme came in.

      Surely it time to re-evaluate what is is first, second and third line treatment as the current system is not based on logic, price, safety or efficacy

  4. Although people on these drugs might feel worried it’s great that NICE are stopping neurologists who are behind the times from damaging their patients any further. Until I got armed with information from this blog I was with a slowly slowly let’s see if this doesn’t work and meanwhile your brain is frying type of neuro. Why are the MS charities opposing? They are supposed to lobby for the best for MSers.

    1. I agree.

      This decision is not likely to change our practice much.

      Now it is time for me to review the use of copaxone in animals

  5. What is the qaly for dmf and Teri?
    Will cpx generic be available in the uk soon?
    Do you think Biogen etc will re-evaluate the price of plegridy etc to meet the price of the qaly?

  6. It is about bloody time that the CRAB drugs were removed from the market. Please show me one solid RCT study that shows they stop progression of MS over placebo.

    Hopefully, with this acknowledgment by NICE that CRABs are both a medical and economic disaster, pharma will now step up and advance the treatment of MS by comparing any new DMD to current highly efficacious DMDs and not low lying fruit (ie. CRAB drugs).

  7. From the ~30 patients/year that NICE "loses" from HSCT abroad, could save enough money to offer Copaxone to the rest patients :P


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