In October 2016 NICE (National Institute for Health and Care Excellence) and NHS England issued a public consultation relating to proposals for changes to the arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s technology appraisal and highly specialised technologies (HST) programmes.
The proposals which were subject to the consultation were as follows:
- Introduction of a ‘fast track’ technology appraisal process for the most promising new technologies which fall below an incremental cost-effectiveness ratio of £10,000 per QALY (quality adjusted life year).
- Operation of a ‘budget impact threshold’ of £20 million, set by NHS England, to signal the need for a dialogue with companies to agree special arrangements to better manage the introduction of new technologies recommended by NICE.
- Variation of the timescale for the funding requirement when the budget impact threshold is reached or exceeded, and there is therefore a compelling case that the introduction of the new technology would risk disruption to the funding of other services.
- Automatically fund, from routine commissioning budgets, treatments for HSTs up to £100,000 per QALY, and provide the opportunity for treatments above this range to be considered through NHS England’s process for prioritising other HSTs.
The proposals, as drafted, stand to have a significant impact on access to the market and during the consultation NICE and NHS England held a number of webinars and face-to-face consultation events to discuss the proposals in more detail and answer questions about them. In particular, there are considered to be flaws in applying the QALY methodology to HSTs, which are currently assessed on the basis of the nature of the condition and the cost, benefit and impact of the treatment. Technologies above the £100,000 per QALY threshold would have to go through NHS England’s specialised commissioning prioritisation process, not of itself straightforward given the relative prioritisation methodology used and some lack of transparency. In addition, if a product is below the QALY threshold but above the NHS England budget threshold, which is proposed to be set at £20 million per annum, then a way to manage the budget impact will be required through a commercial agreement with NHS England (for example a patient access scheme).
The consultation closed on 13 January 2017, and it is proposed that the new arrangements will apply to topics that have their first committee meeting after 1 April 2017. NICE’s website currently states that “we will be reviewing your comments and working on amendments to the proposed changes”. Although it is as yet unclear to what extent the proposals will change, NICE’s willingness to consider changes may be linked to the government’s desire for the UK to remain an attractive place for business in light of Brexit.
The consultation web page and document can be found here.