The latest consultation from the UK’s National Institute for Health and Care Excellence (NICE) has got off to a bad start today with charities warning the proposals represent a step back for cancer patients. The NHS rationing body has outlined new criteria for deciding which new medicines & medical devices are cost effective and can therefore be routinely used.
Andrew Wilson, the Rarer Cancers Foundation’s Chief Executive said: « Plans to abolish special rules for drugs used near the end of a patient’s life have been slipped out in the small print of this consultation. They amount to a stealth cut for cancer and could have a devastating impact on access to life-extending drugs, with no guarantee that other changes to the rationing formula will compensate.” At Beating Bowel Cancer, Chief Executive Mark Flannagan added; “Any system which doesn’t lead to patients accessing latest cancer medicines is fundamentally flawed.”
At issue is NICE’s intention to take the concept of “burden of illness” into account more “explicitly and systematically” as part of a move towards the concept of “value based assessment” (VBA), formerly referred to as “value based pricing”, which was included in the Government’s Coalition Agreement to ensure “all patients can access the drugs and treatments their doctors think they need.” VBA is a policy idea still in development, with the current intention to incorporate ideas around measuring “wider societal benefit”, including controversial elements such as evaluating the potential of a medicine to restore the ability of an individual to contribute to society.
NICE outlines the technical aspects of calculating the total amount of future health lost for people with a condition, measured in quality adjusted life years (QALYs). Whilst this may sound academic and esoteric, working out QALYs raises fundamental question about how the value of life is weighed, and is why the charities were so quick to raise understandable concerns. As well as the end of life concerns, other fears are that the assessment process may be discriminatory, on the basis of age (older people have less life left to contribute to society), and gender (women tend to work less and hence “contribute” less in an economic sense). Due to the sensitivities around discrimination, NICE has had to explicitly say it will not use age as the basis for deciding whether or not the NHS should offer new treatments. Other tricky ethical issues arise such as if medicines keep a person in residential care alive longer, they may then be placing additional costs on social care budgets, and in an age of austerity, such things matter a great deal.
Also up for discussion is the “maximum” value a QALY can be before NICE says “no” to the medicine (or device) being approved for routine NHS use. NICE proposes a maximum QALY limit of £50,000, with the QALY generally being set at £20,000. This is of critical importance for industry decisions about UK investment into researching and developing new medicines and devices, as if companies cannot obtain a “fair” reimbursement price, then that is a strong disincentive to invest in the first place.
Representing an industry frustrated that several of its innovative cancer medicines have been turned down by NICE, the Association of the British Pharmaceutical Industry (ABPI) said; “The ultimate aim [of VBA] should be to increase overall access to innovative, effective medicines for conditions that impose a substantial burden on patients and society… [However], we need to ensure that [VBA] does not lead to fewer medicines for patients at the end of their life being approved.” Taking a stronger industry line, the Daily Mail reports Pfizer’s Head of Oncology, Ben Osborn, as saying; “We fear these proposals could be yet another sticking plaster solution that won’t solve the problem. Government must [set] a new mandate that frees NICE to champion innovation for the benefit of patients. Failing to act will create a two-tier health system, where patients in England are denied treatments available elsewhere in the UK.”
The consultation runs to June 20th. Expect to see a lot of debate between now and the expected introduction of the changes in the autumn. It’ll be a brave pharmaceutical company to be the first to have its latest innovative medicine assessed under the new regime. There are a lot of brave cancer patients waiting for them to do so, and for the Government’s Coalition commitment to finally be fulfilled.