From 1 March 2000 to 31 December 2017, NICE (National Institute for Health and Care Excellence) published over 800 healthcare technology recommendations. In total, 81% of those decisions were recommended, optimized or recommended for use in the Cancer Drugs Fund (CDF). Why then is NICE considered such a tough cookie when it comes to HTA (health technology assessment) appraisals?
The fact that 81% of all decisions are recommended in some form by NICE is a great soundbite, but does it provide the full picture? As stated in the report published by NICE, the 81% figure breaks down into the three types of recommendation: 57% recommended, 23% recommended after optimization and 1% recommended to the CDF. This means that in reality, just over half of decisions were genuine recommendations. Optimized recommendations can range from close to a full recommendation to an extremely restrictive one, reducing the target patient group down to a very small sub-population. Without comparing individual decisions with those in similar countries, like Germany and France, there is no way of truly telling whether this is too high or too low.
The QALY (Quality Adjusted Life Years) system used by NICE is often said to be outdated and limiting. The standard threshold of £30,000 per QALY that NICE uses to determine whether a drug is cost-effective has some drawbacks that need to be addressed. The QALY threshold has not increased at all since its inception, whilst the U.K. has undergone sustained period of inflation. This has led to a real-terms reduction in spending on new medicines. Another problem with the NICE system is the need for manufacturers to conduct trials comparing their drug to the standard of care in the U.K. Whilst this sounds all well and good, the standard of care in the U.K. lags behind the international standard in some disease areas. NICE must take its share of the blame for this as it has historically rejected the most expensive drugs that have been approved in other countries that have become the standard. According to Jennifer Lee, Janssen’s U.K. pricing chief, “the standard of care [in the NHS] is so far behind the rest of the world, there is no data. It is a mixed bag of drugs”, as reported in Pharmaphorum.
One area where NICE has a particularly poor reputation is in the evaluation of cancer drugs, especially end-of-life treatments. These treatments typically do not fare as well as others in the cost-effectiveness analysis. The lower percentage of recommendations in cancer drugs as compared to standard drugs in the report is evidence of this.
In recent years, NICE has tried to address some of the fundamental issues that have earned it this reputation. An ‘End-of-Life’ threshold cost per QALY was introduced 2009, with a particular focus being able to pay for cancer drugs that provide a seemingly small effect on life expectancy. In 2017, NICE introduced a higher £100,000 per QALY limit for highly specialised technologies that treat very rare conditions, first used in the appraisal of GSK’s Strimvelis, which is a very high value treatment.
NICE is attempting to distance itself from its reputation through these measures, but there is still some way to go. Moving forward, there is a growing appetite for international HTA cooperation that could see NICE align more with international counterparts. More work is needed to provide a measure of quality of life which is an improved version of the QALY that covers both individual patient health and broader social impact.
Author: Maximus Rex, Analyst.
Email Max at [email protected]