The most high-profile part of NICE’s work is in deciding whether new health technologies are sufficiently good value for money to be provided on the NHS. The unit of measurement? The dreaded QALY, or “quality-adjusted life year.” Sure enough, the QALY is a creation of economists, in which a year of life is discounted based on the state of a patient’s health. A year spent in impaired health—no matter what the disease or cause of illness—counts for less; the more severe the impairment, the more the life year is discounted.

 

There is no explicit upper limit above which NICE regards the cost of a QALY as too high, in part because if there were one, it would, some fear, become regarded as a price target by pharmaceutical companies. Even so, seasoned observers say that the organization works to an implicit maximum of £30,000 (about $59,000) per QALY.

 

To date it has carried out more than 100 “technology assessments,” and another 50 are under way. Some compare a number of different treatments for the same disease and rule on which are better value for the money; some consider one treatment alone. The subjects can be suggested by anyone: members of the public, doctors, government ministers. It is, however, the Department of Health’s decision which ones are carried out.

 

The economic analyses use data provided by licence holders and manufacturers, usually under contract by health-economics groups in university departments. Once they are completed, a panel of experts meets to agree on guidance. If it can’t agree, drug companies and patient groups can make presentations. “Awful,” is how one observer describes these meetings. “They’re so confrontational. You get distraught patients standing up and shouting: ‘You’re condemning me to death.’”

 

Many NICE rulings are extremely controversial and have highlighted the inherent difficulty of its Solomonic brief. In 2005 there was an outcry when the agency ruled that none of four drugs licensed for the treatment of Alzheimer’s disease (donepezil, rivastigmine, galantamine, and memantine) offered sufficient benefit to be funded by the NHS. In 2006, after being provided with further trial data by the license holders, it relaxed this ruling and said three of them could be used—but only once the disease had progressed to “moderate” or “severe” levels. The fourth, memantine, was still regarded as not worth using for anyone.

 

Eisai, the Japanese pharmaceutical company which holds the license for donepezil (Aricept), promptly took NICE to court with the support of Pfizer, which markets the drug, and the Alzheimer’s Society registered as an interested party in the suit. It was an attempt to broaden the criteria for covering a drug so as to include patients in the earliest stages of dementia. But only one of the six points in Eisai’s suit was upheld, and that a minor, procedural one. The guidance still stands, and early-stage Alzheimer’s patients are not granted these drugs by the NHS.