Calls for National Institute for Health and Clinical Excellence (NICE) appraisals to take account of the “social benefits” provided by drugs and other treatments have been rejected by Professor Sir Ian Kennedy.

Such benefits, which include easing the burden on carers and allowing patients to work, should not find their way into NICE’s system of appraisal because they would represent “a hard-to-justify bias in favour of those capable of working and being productive, as against children and the elderly,” says Sir Ian, presenting his report yesterday into how NICE establishes the value of innovation and other benefits. Moreover, he warns against the “privileging of those who are heard as against those who are not – NICE exists to weigh the interests of all patients, hot merely those who make their cause known.”

Nevertheless, he acknowledges the arguments for accommodating at least some social values in NICE appraisals and calls for further research to determine whether this could be done and, if so, how.

Many submissions for NICE appraisal have claimed that they do not, and should, take account of a range of benefits. One group of these relates to how patients value their own health, a second covers how the health of different groups is valued by society, including patients at the end of life. The severity of the condition belongs in both groups.

The presence of such benefits should not result in an increase in the threshold (ie price) used by NICE, says Sir Ian, nor should they create a second stage of formal analysis in the ICER/QALY (incremental cost-effectiveness ratio/quality-adjusted life year) approach to appraisal used by NICE. ICER/QALY is “quite simply the best tool available to do the job” and “both right and essential,” says Sir Ian.

Nevertheless, among his report’s 25 recommendations is that NICE should consult all relevant parties and draw up a list - reviewed regularly - of health-related benefits to be taken into account in its appraisals. It should also sponsor or participate in research to determine whether the instruments used to calculate QALYs and capture health benefits are “entirely appropriate” to its needs, and whether they are applied properly and consistently.

Sir Ian is also highly critical of the recent changes to NICE’s changes in the case of “end of life” treatments, warning that these could represent a “Trojan Horse” which will make it increasingly difficult for it to withhold approval. Nor should the Innovation Pass fast-track to allow certain products to become available on the NHS without having gone through NICE appraisal for a certain period of time, as proposed in the Office of Life Sciences Blueprint earlier this month, be used as a “back door to approval,” he adds.

NICE needs to formulate a definition of “innovation” which, he suggests, could include criteria such as: - the product significantly improves the way that a current need is met, and this need has been identified by the NHS as important; and - research has identified the populations in which the product is effective, eg, benefiting 70% of the intended target group.

And, in order for a product to be judged as meeting the NHS’ needs, the Health Secretary should, from time to time, “make explicit the priorities of the NHS regarding intervention and treatment,” he adds.

Speaking to journalists yesterday, Sir Ian said his report aims to bring some form of détente between NICE and the pharmaceutical industry, where at present, he writes: “the impression is one of undeclared hostilities, if not war. Pharma sees NICE as a barrier to its ambitions to bring products to patients. NICE sees itself as the guardian of the public purse and of all patients.”

NICE is highly respected across the world, but is not well-known beyond those inside the loop of health policy, and this is “unfortunate,” he says. The Institute rarely appears to be on the front foot in terms of setting and discussing the agenda of resource allocation, it can appear complacent and its decisions are not always as transparent as it would claim and others might expect.

Pharma, on the other hand, appears to be unprepared to accept the notion of a fix sum of money available to the NHS which it is for NICE to allocate in a fair manner. “For reasons which are understandable from a commercial perspective, but make for what looks like a permanent state of guerrilla warfare, Pharma regularly adopts an approach based on the supremacy of the consumer/patient,” he says.

Among his recommendations are for manufacturers to be routinely invited to attend NICE Appraisal Committee meetings, and he calls on NICE to work much more closely with Pharma in a wide range of areas.

Commenting on Sir Ian’s report yesterday, NICE chairman Professor Sir Michael Rawlins said it raises a number of issues that need considering but also welcomed “the broad confidence he has expressed in NICE and its methods.”

“NICE’s Board will set out a formal response at its next public Board meeting in September, which will then be the subject of a three-month consultation,” added Sir Michael.

A spokesman for the Association of the British Pharmaceutical Industry (ABPI) said that, in his report, Sir Ian “has recognized the need for NICE to change - for it to be more transparent, to foster innovation and to take greater account of wider health benefits. Patients will only benefit if the recommendations he sets out are implemented, and the sooner they are implemented, the sooner patients in the UK will start to enjoy the access to the modern treatments currently being enjoyed by their counterparts in other European countries."