UK pharma industry regulation undermines NICE drugs appraisal work

Government policies that support UK pharmaceutical science and enhance export income are costing the country’s National Health Service (NHS) millions and undermine the National Institute for Health and Care Excellence.

In an essay published today by the Journal of the Royal Society of Medicine, health economists Professors Alan Maynard and Karen Bloor describe an inflationary regulatory system that lacks accountability, is not evidence-based and subverts the efficiency of the technology appraisal work carried out by the NICE, a target of pharmaceutical industry hostility since it was established in 1999.

Profs Maynard and Bloor, of the Department of Health Sciences at the University of York, point to the evaluation of end-of-life products such as cancer drugs. In 2009, the NICE was instructed to increase the threshold of the cost-QALY ratio (where a QALY is one year of good quality life) for these drugs from £30,000 ($45,510). Provided firms do not exceed regulated rates of return on historical capital set out in the Pharmaceutical Price Regulation Scheme agreements, they are free to set their own prices. Prof Maynard said: “This has added billions to NHS costs, partly because the cost-per-QALY threshold is relatively high, contentious and is not evidence-based.”

Cancer Drugs Fund also criticized