Consultation looking at the way NICE evaluates medicines

The National Institute of Health and Social Care Excellence (NICE) and NHS England have been consulting on proposed changes to the way NICE evaluates medicines through their Technology Appraisals (TA) and Highly Specialised Technologies (HST) programmes.

The HST programme is the approach that NICE has been using since May 2013 to determine whether very rare disease treatments should be recommended for NHS-wide commissioning in England.

The HST programme has, in the past, taken into account some of the particular challenges of developing, trialling and approving the nationwide commissioning of treatments for rare diseases.

The proposals being considered present a serious change in the way that rare disease treatments would be commissioned. We have particular concerns about:

• The HST programme will begin using Quality Adjusted Life Years (QALYs) to determine the value of medicines – something specifically avoided in the way the programme has evaluated medicines previously. Treatments for the size of population served by the programme are not compatible with calculations involving QALYs.
• The policy proposes setting a threshold that technologies would have to fall below to receive funding. The decisions from the HST programme would no longer be mandatory when it is considered higher than the threshold. Under the current arrangements the funding requirement is an important consequence of gaining a positive recommendation from NICE that guarantees commissioning. This in particular is concerning as the HST programme has never evaluated a topic with an estimated cost per QALY that would fall below the proposed threshold.