Refusing to play NICEly

The U.K.'sNational Institute for Health and Clinical Excellence recently terminated four technology appraisals because manufacturers failed to submit evidence the agency needed to issue a positive or negative recommendation. Given the growing influence of NICE's decisions on the uptake of technologies both in the U.K. and other countries, avoiding a negative recommendation conceivably could be considered a viable regulatory strategy by some companies. But not everyone agrees.

NICE influences whether drugs will be available to NHS patients in England and Wales but does not have the authority to compel companies to submit evidence necessary for an appraisal. The agency can appraise a technology without a manufacturer's submission if it is able to obtain the data it wants from publicly available information. But the data are not always available for newer technologies, according to Pippa Anderson, a senior principal in the Pricing and Market Access practice at healthcare consultancy IMS Health...