Changes to the NICE process

NICE is well regarded globally as a leader in the field of health technology assessment. NICE’s methodology has developed over its lifetime to be responsive to the needs of society. However, we believe that cancer still challenges this methodology and that a more flexible approach needs to be developed to ensure that we continue to support innovation and give patients in the UK access to those drugs which we are already benefiting patients in other countries.

Does one size fit all?

NICE works to a very specific process of appraisal which has a firm basis in clinical evidence. But while this approach is appropriate for conditions and treatments for which good clinical evidence is available, there are some conditions for which evidence is limited, such as those affecting a small number of people or where there are no or few other treatments.

We believe NICE needs flexibility within its system to deal with these special cases.

‘Willingness to pay’ thresholds.

We also think that NICE and the Government need to re-examine whether the threshold they are using to decide whether a drug constitutes value for money for the NHS is appropriate. We know that NICE use a rough figure of £30,000 per quality adjusted life year (QALY) gained.

NICE say they take a flexible approach to the use of this threshold. However, there is still some confusion about how NICE decided on this figure, and whether it is the right figure to use for all conditions and all types of drugs. NICE has recently funded a study to look at whether this threshold is appropriate. We want the Government to take a lead on working with NICE to evaluate how this threshold is being used and how it might better serve cancer patients.

Defining quality of life

There are also some concerns about some of the measures used to reach this ‘QALY’ figure. A measure known as EQ-5D is used to define this ‘quality’ of life for all treatments for all conditions under scrutiny by NICE. However, we are concerned that this measure isn’t sensitive enough to capture all those things that are especially important to cancer patients, such as fatigue. We would like NICE to reassess this measure and whether it needs to be adjusted.

Greater expert involvement

We would also like to see greater involvement by specialist cancer doctors in the decision making when NICE make recomendations. We are concerned that NICE is making decisions at odds with clinical opinion. By including experts earlier in the appraisal process, NICE might well come out with more appropriate decisions, at an earlier stage, thus speeding up access for patients to these new drugs.