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.
Labels: CRAB, high-cost drugs, NHS, NICE, QALY