Professor Alan Maynard OBE warns that although emotionally appealing, moves towards higher cost-per-QALY thresholds for spending on end-of-life and rarer conditions are inequitable and inefficient

Governments believe that they may lose votes (and know that they will get hammered by the Daily Mail) if they deny we all have a terminal sexually-transmitted disease called life, whose certain clinical outcome is that one day we will surely die. Nowhere is this clearer than when dealing with end-of-life treatments for cancer and other patients.

The debate over top-ups has led to the National Institute of Health and Clinical Excellence (NICE) being pressured by Whitehall to treat ‘rarer diseases’ and ‘end-of-life’ care differently from other interventions. This is inherently inequitable and inefficient, but it would get the politicians off the dreaded Daily Mail radar.

30 : 70?
When NICE’s new policies for end- of-life and rarer diseases was announced in January this year, there were reports that the NICE cut-off could be raised from £30000 per QALY to £70,000 per QALY. Michael Rawlins, newly re-appointed as Chair of NICE thanks to a special rule-bending dispensation, has subsequently denied this figure.

This leaves uncertainty. This should be resolved by careful consideration of reducing the £30,000 per QALY cut-off to levels exhibited by research of PCT rationing decisions - to £20,000 per QALY as a maximum. This is needed both to cut out marginally cost-effective drugs and to help the NHS ride out the fiscal storms created by the recession.

The pharma industry, and its powerful client ‘patient’ lobbies, will fuel the media to oppose this.

"The NHS should not use a higher and more generous cut-off"

The NHS should not use a higher and more generous cut-off. To do so would be to treat end-of-life and rarer condition patients more favourably than the rest of the population. This inequity would be compounded by inefficiency - using scarce NHS resources on drugs whose clinical and cost-effectiveness is slight.

Not rushing to share risk
The Government also should not rush into risk-sharing schemes. The contract for the use of beta interferon for MS is of unknown cost-effectiveness. Industry promised to pay back the taxpayers the high price they received if the drug was not cost-effective, as NICE considered it to be when they evaluated it. No results have yet been published from this industry-government sponsored trial, and rumours abound about why this is so.

This works better with a back-load

” If government is to enter into risk-sharing schemes with industry they should be back-loaded: companies should get low prices if the product is not well proven, and be given higher rewards if subsequent trials show the drug to have an improving performance when in use.”

If government is to enter into risk-sharing schemes with industry they should be back-loaded: companies should get low prices if the product is not well proven, and be given higher rewards if subsequent trials show the drug to have an improving performance when in use.

Front-loaded trials, like that for beta interfero,n give all too little protection to patients and taxpayers and loads of lucre to industry

Value-based pricing is a policy advocated by the Office of Fair Trading in 2007, and to which the Department of Health is responding - very slowly. One problem with this policy is that the Department funds the NHS - but is also the sponsor of the pharmaceutical industry. This, when combined with an impending election that must be held by June 2010, makes politicians loath to disturb those whose lobby activities can mobilise much adverse publicity!

In conclusion NICE should not wobble but adhere to £30,000 per QALY at worst and perhaps be even more restrictive given economic circumstances and the low cost-effectiveness of some of the products it appraises. It should also be much more aggressive in telling industry to go back and do more research, rather than ‘blowing’ favourably on their embers of evidence and giving them access to NHS funding!

Rawlins still denies that NICE is there to ration access to care for NHS patients. This is nonsense and should be ignored. As the rationing body, NICE should be obliged to complement the reform of the NHS, rather than undermine it with crazily generous cut-offs for drugs which work poorly and are excessively priced.