1. Roles of NICE (UK)
United Kingdom (UK) is well known as a country that actively utilizes result of cost-effectiveness analysis to the healthcare policy. In the UK, there is a famous organization that was founded in 1999, called NICE (The National Institute for Health and Care Excellence).
UK has a tax-based healthcare system, namely, the “NHS (National Health Service).” NICE evaluates the cost effectiveness of medicines, medical devices, etc. If NICE judges that a product is not cost-effective, use of that product under the NHS is not recommended.
Even in such cases, use of the product is not prohibited. But a product not recommended by NICE is difficult to use, because of limited healthcare budget. Furthermore, even after a product is judged to be not cost-effective at its original price, the product may be acceptable if manufacturer agrees on supply to the NHS at a discounted price. This is called patient access scheme (PAS) as one type of risk-sharing scheme.
2. Cost per QALY threshold at NICE
For cost-effectiveness analysis at NICE, the threshold is GBP 20 000 to 30 000 (JPY JPY 3 million to 4.5 million; GBP 1 = JPY 150) per QALY. In the case of anticancer drugs, GBP 50 000 (JPY 7.5 million) is referred to. If the ICER is higher than this level, the medicine or medical device is often judged to be not cost-effective.
However, ICER over the threshold does not necessarily make it impossible to use the medicine or medical device. A recommendation is generally decided in a comprehensive manner, taking into account various factors, such as severity of the illness, benefit other than health and reliability of the analysis, in addition to cost-effectiveness.
3. Views of NICE
If a medicine or medical device cannot be used in public healthcare because of poor cost-effectiveness, some patients may feel unsatisfied by the decision. In practice, there are disputes via mass media over the NICE decision of not recommending products, protests by patients and lawsuits brought about by manufacturer over such a decision.
Of course, NICE is aware of the existence of patients who strongly desiring to receive “a new treatment”, if it is not cost-effective. NICE certainly shares the same goal of making healthcare better. At the same time, however, NICE seems to have the following view.
There is a powerful human impulse, known as the ‘rule of rescue’, to attempt
to help an identifiable person whose life is in danger, no matter how much it
costs. When there are limited resources for healthcare, applying the ‘rule of
rescue’ may mean that other people will not be able to have the care or
treatment they need.
NICE recognises that when it is making its decisions it should consider the
needs of present and future patients of the NHS who are anonymous and who
do not necessarily have people to argue their case on their behalf.
NICE. Social value judgments: Principles for the development of NICE guidance (2nd edition).