Fast-Track Appraisal and HST Evaluation: Overview from NICE 2017

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With contributions from Caroline Ling and Jessica Costello

Several members of the RTI-HS team, including Caroline Ling and Jessica Costello, recently attended the National Institute for Health and Care Excellence (NICE) 2017 conference in Liverpool, UK. This is a valuable way for our team to stay abreast of updates at NICE, and ensure we have the appropriate understanding to guide our clients through the ever-evolving UK HTA landscape.

A key area of focus was the Accelerated Access Review and the resulting changes to the appraisal pathways for assessing and funding technologies; NICE’s Technology Appraisal programmes (TA) and their Highly Specialised Technologies (HST) programmes. The following developments were discussed:

Fast-Track Appraisal
The fast-track appraisal (FTA) process was approved by NICE in March 2017 as a pathway to get treatments to patients more quickly. It provides funding for the most promising new technologies which fall below an incremental cost-effectiveness ratio of £10,000 per QALY (quality adjusted life year). The process is completed within 30 days, rather than the 90 days for the standard single technology (STA) process. Topics are not appraised through the FTA process if NICE considers the uncertainty too large for an appropriate recommendation to be made. The FTA process is being introduced for products with a first evidence submission post-March 2017.

HST Evaluation Process
This process was established in 2013 for evaluating HST drugs and considers a greater range of criteria addressing the benefits and costs of these drugs than is the case with appraisals of mainstream treatments. Companies must be invited by NICE to apply through this process, and NICE aims to evaluate three products a year.

In 2016, automatic funding from routine commissioning budgets was made available for products up to £100k per QALY (either immediately if there are no budget impact concerns or phased in over time if the budget impact threshold of £20 million is triggered). Products above £100,000 per QALY have an opportunity to be considered for funding through NHS England’s Clinical Priorities Advisory Group (CPAG) relative prioritisation process.

In 2017, NICE also proposed to introduce “a QALY modifier,” which could raise the threshold to £300,000 for some HSTs. This modifier involves weighting lifetime QALY gains by size of gain. However, considerable opposition exists from companies and patient/carer organisations around these updates.

Budget Impact Test

Since 1 April 2017, NICE has been operating under a ‘budget impact threshold’ set by NHS England. This threshold of £20 million per year (in any of the first 3 years) is intended to prompt early dialogue with companies to better manage the introduction of new technologies recommended by NICE. This applies to a small number of technologies that would have a significant impact on the NHS budget, even though they are determined to be cost-effective. The timescale for the funding requirement may be varied when the budget impact threshold is reached or exceeded, and therefore provides a compelling case that the introduction of the new technology would risk disruption to the funding of other services. This will usually be for no more than three years. A new budget impact submission template was also introduced in June 2017.


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