The New NICE Guidelines for Management of Breast Cancer—A Personal Commentary

And now, the NICE face

So, given our general approval, as a profession, for rationing in the 1940s, why do we—and our patients—fail to sense any warm glow of righteous positivity in the aura of healthcare rationing imposed by NICE in 2009?

Well, as oncologists, the only war we’re involved in is the battle against cancer, and what we have sensed over the past few years is, on the one hand, a frustrating series of delays and restrictions in the supply of magic bullets, and on the other, some very strict rules of engagement, masquerading as ‘guidelines’. The latter term is particularly misleading; put simply, clinical activity outside of the so-called guidelines will not be commissioned and, since no organisation with an obligation to balance its books can brook unfunded activity, it will not be permitted. Forget clinical freedom; what with clinical governance, audit, job plan review and appraisal processes in place, and part of our contracts, a subaltern in Helmand probably has greater scope for using his initiative and discretion than a Consultant Medical Oncologist.

Furthermore, unlike rationing in the 1940s, there is no sense of fairness, and absolutely no sense of our all being in it together. Indeed, possession of private medical insurance effectively provides access to a legal ‘black market’ for a section of the population. Thus, many oncologists now practise two standards of medicine—one Neulasta^® injection for the rich, and 10 days of granulocyte colony stimulating factor (G-CSF) injections for the poor, or maybe no prophylactic G-CSF at all, depending on network policy. Lastly, there’s no sense of improved health as an unplanned by-product, instead unwelcome frustration and suffering inherent in disease progression.

The much-trumpeted uniformity of care across the NHS remains a myth. The major impact of NICE on clinical activity has been to delay the introduction of new drugs into the NHS. And, until very recently, the prospect of a patient’s treatment being funded as a special case outside of NICE guidelines depended more on the imagination and literary skills of the consultant than on clinical reality.

Another source of unease for many oncologists is the lack of transparency as to the nature of the criteria on which so many NICE technology assessments are based, in particular, the play of health economic data around the phase III clinical trial endpoints of disease progression, relapse-free survival and overall survival.

There are two particularly widely held concerns. The first centres on the impact of trial crossover on the natural history of malignant disease. For a chronic disease like metastatic breast cancer, progression-free survival provides the cleanest data cut, and many an ethically minded data and safety monitoring committee has authorised the subsequent use of the research intervention in the control arm, thus blurring the evidence for any impact on survival.

The second concern relates to the methodology used to assay the additional costs of a new drug used in combination, and the inevitable failure of any intervention so structured to meet NICE’s criteria on cost per quality adjusted life year (QALY). Both elements of the combination are costed together in the denominator, but only the incremental QALY gain is used in the numerator, making such combinations appear expensive for the benefits gained.

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