A new report has highlighted how the National Institute for Health and Clinical Excellence (NICE) – the regulatory body charged with assessing new drugs destined for the NHS – could be giving approval to too many new products. The report, which was prepared by the King’s Fund and City University, and published in the current edition of the British Medical Journal, added that NICE’s judgment of what constitutes “value for money” far exceeds the budgetary limits of the NHS. A further fear described in the report was that potentially life-changing and pivotal drugs could be denied market availability – their place taken by inferior products.
When calculating a drug’s suitability for investment by the NHS, NICE employs a complex string of equations. The drug’s performance and side effects are assessed against its cost, in order to generate a workable price per additional year of good health – known as a ‘Quality Adjusted Life Year’. Roughly speaking, when a new product demonstrates that it can provide a QALY, and the price is below £20,000, NICE will theoretically deem it as providing value for money and recommend NHS adoption. This can still be the case even when the drug’s QALY cost is as much as £30,000.
According to the King’s Fund and City University, £30,000 is much too great a figure, when placed alongside the financial calculations used in other areas of the NHS. This is illustrated when it comes to issues including circulatory disease – QALYs for which cannot exceed £12,000.
If the NICE’s £30,000 threshold was sliced to £12,000, the effect could be that far fewer drugs make it through to the NHS.
In the eyes of City University’s Nancy Devlin, NICE lowering its financial limit would be a favourable outcome. "It's all about value for money”, she said, adding: “There is no such thing as the correct threshold throughout time.”
She continued: "Even if £20,000 to £30,000 was the right threshold when NICE was set up, in the current NHS, where there is far less money to spend, it doesn't appear to be now."
Ms Devlin further commented on the possibility of treatments, declared acceptable for the NHS under NICE’s £30,000 regulation, being inferior to ones that, with better performance, are sacrificed in the process. It is understood that NICE is currently assessing the levels under scrutiny, however, in line with intimations from Sir Michael Rawlins (the Chairman of NICE), this could actually result in an increase.
Source – Pharmaceutical International’s Sub Editor
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