Amidst the recent fallout from the publication of NICE’s Appraisal Consultation Document on the four drugs for metastatic/advanced renal cell cancer, and sundry other collateral episodes of “NICE-bashing”, it would have been easy to overlook the appearance of the second edition of Social Value Judgements – Principles for the development of NICE guidance (SVJ) which crept quietly onto the NICE website, without fanfare, last month. SVJ describes its remit as being “mainly about the judgements that NICE and its advisory bodies should apply when making decisions about the effectiveness and cost effectiveness of interventions, especially where such decisions affect the allocation of NHS resources”.
The second edition takes account of the growing prominence of so-called orphan and ultraorphan drugs, for the treatment of rare and very rare conditions respectively. NICE is quite clear that it will evaluate drugs to treat rare conditions in precisely the same way as it evaluates other drugs. By contrast, however, “NICE does not expect to receive referrals from the Secretary of State for Health to evaluate ultra-orphan drugs”; these will be channelled through the department’s “other mechanisms” (which are unspecified).
Most interesting of all, however, is the explicit statement in this edition that NICE has elected not to adopt the “rule of rescue” – the idea that you help an identifiable person in peril, whatever the cost. Only a small minority of NICE’s Citizens Council (an advisory body with a 30-strong lay membership) had recommended rejecting the rule, on the principle that the NHS had no duty to save life “at any cost” but had to try to achieve the greatest good for the greatest number. In affirming the conclusion of the minority, NICE has confirmed the advice we have given our PCT clients to date in respect of their commissioning responsibilities. Whilst it is, some would say, human instinct to wish to apply the rule, it is important for PCT panels to stand firm, in order not to prejudice the other, as yet unidentified, patients in their populations, on whom a “rescue” funding decision, in terms of its effect on resources, could ultimately impact.