A wnaiff Ysgrifennydd y Cabinet ddatganiad am argaeledd Orkambi i drin dioddefwyr ffibrosis systig yng Nghymru?
My previous answers to Welsh Assembly Questions 73727 and 73835 on 4 July explain the position fully regarding the routine availability of lumacaftor/ivacaftor (Orkambi®).
NICE issued final guidance in July and did not recommend lumacaftor/ivacaftor (Orkambi®) for routine use in the NHS in Wales or England. In December last year, NICE re-issued its Technology Appraisal guidance under its “Do Not Do” guidance, emphasising this treatment should not be made routinely available. The NICE independent appraisal committee found that when compared to the current standard of care, the clinical benefit offered was modest and comes at a considerable cost. The Scottish Medicines Consortium has also turned down this medicine for the same reason.
Should the manufacturer wish to reconsider their pricing they may do so and consider submitting for re-appraisal. However this will remain subject to assessment against the overall benefits.