NICE chief: Approval changes 'won't increase NHS drugs bill'

NICE chief executive Sir Andrew Dillon told HSJ he did not think its plans, details of which were published today for consultation, would make a “substantial difference” to the total bill for branded drugs.

NICE currently generally considers a drug to be a good use of resources if it costs between £20,000 and £30,000 per quality adjusted life year of benefit which it gives, an internationally recognised way of measuring the value of interventions.

It today set out plans for a new upper limit of £50,000 per QALY. While the body has in some cases approved drugs up to £50,000 per QALY in the past, these measures would formalise this threshold.

Sir Andrew said: “There may well be drugs that we’ll look at in the future that under the current arrangements may be at risk of not receiving a positive recommendation. [However,] we may find that risk [of high cost per QALY drugs being approved is] reduced with the application of these new arrangements.”  

The consultation paper also says the body would take a different approach to considering the value of drugs. It will consider the “burden of illness” - the impact in QALYs on an individual’s life compared to that of someone without the condition – and “wider societal impact” of illness, or the disease’s impact on QALYs based on a wider social group.

The document published today, called the Methods Guide, suggests the wider societal impact of a disease is measured by the shortfall in a person’s capacity to engage in society compared with the same capacity if that person did not have the condition.

The proposals also include incorporating NICE’s currently separate criteria for considering end of life drugs into its normal approval process.

The Association of the British Pharmaceutical Industry expressed concern this move could lead to fewer medicines being approved.

The association’s director of value and access Paul Catchpole said: “We have a particular concern about the potential impact of incorporating NICE’s existing ‘end of life criteria’ into the new system. We need to ensure that this does not lead to fewer medicines for patients at the end of their life, being approved.  There is currently an issue with NICE approving too few new cancer medicines, which the new agreement must address.

“The vital role of patients should not be overlooked by NICE when assessing medicines and we hope the opportunity will also be taken to allow greater contributions from patients and clinicians in the appraisal decision making process.”