We welcome the acknowledgement that the overlap of NICE activities with other bodies, such as parallel cost effectiveness evaluations with NHS England, undermines NICE’s role and leads to increased cost, delays and inconsistencies. We look forward to further discussion of rationalisation of this area of NICE’s work in the wider context of all relevant bodies working in this arena in England.
In a context where resources are scarce and where there are insufficient resources to appraise all medicines that might require a cost effectiveness assessment, it is paramount that unnecessary system overlaps be eliminated and for the system to be rationalised. Improved communication between NICE and NHS England is necessary so that the most appropriate access route is selected, and so that there is no duplication in future. This is an integral point, affecting patients, which the DH has not fully addressed in its response to the review. NHS England recently appraised two treatments in parallel with NICE, terminating the process with a decision to await NICE’s decision. This whole process caused a great deal of anguish and misplaced expectation within the patient community.
Whilst the issue of system overlap was addressed to some extent, other issues have not been addressed. For example, in our submission to the DH for this review we outline issues around the Pharmaceutical Price Regulation Scheme (PPRS) and Value Based Assessment (VBA). There is no clear message regarding whether PPRS should be taken into account as part of cost-effectiveness calculations. VBA represents a missed opportunity for NICE to consider new ways of assessing ‘value’. Neither of these issues were addressed in the triennial review.
Issues around the Highly Specialised Technologies (HST) programme are also not addressed within the document. NICE committed to evaluate its HST process in 2014, yet there has been no progress made with this, and it appears that we will not see any for some time. Whilst NICE drags its heels over this, the capacity and eligibility criteria need updating. There needs to be flexibility between HST, Single Technology Appraisals (STAs) and Multiple Technology Appraisals (MTAs) to ensure that all drugs are appraised using the most appropriate methodology. The criteria “clinically distinct” also needs updating to reflect current thinking in this area. The criteria rule out stratified medicines designed to treat patients with rare but molecularly defined forms of common conditions. The criteria need to recognise patient subgroups defined by symptoms, genetics or biomarkers.
NICE only look at three medicines every year under the HST programme and there appears to be little coordination between NICE and NHS England in determining which three medicines should be selected for a NICE appraisal and how those not selected will be prioritised for evaluation by NHS England. There needs to be transparency in this topic selection process, and there needs to be a coordinated approach so that treatments do not fall through the cracks, leaving the Independent Funding Request (IFR) route and the Clinically Critically Urgent route as patients’ only options.
Patient and public involvement, an area discussed within the review, has been addressed inadequately. While the review acknowledges some of the bad feedback that NICE has received, the recommendations do not reflect this to an appropriate degree, instead suggesting that NICE should “continue to work with patient groups” in the same way that they have been doing up to this point.
Looking forward, the Accelerated Access Review should take up some of the key issues raised by the triennial review. But there needs to be a more detailed approach to the next steps for NICE, with more specificity about the issues raised. Our response to the Accelerated Access Review will raise the points discussed here.