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In
the news ...
Pharmaceutical
industry regulation undermines drugs appraisal work
Government
policies that support UK pharmaceutical science and
enhance export income are costing the NHS millions and
undermine the National Institute for Health and Care
Excellence. In an essay, health economists Professor Alan
Maynard and Professor 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 NICE, a target of
pharmaceutical industry hostility since it was established
in 1999.
Professors 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 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. 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.
Professor 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."
Also singled out for criticism is the Cancer Drugs Fund,
which allocates £280 million per year to non-NICE approved
cancer drugs on a case-by-case basis. Professor Maynard
said: "The Coalition government renewed and increased the
Cancer Drugs Fund to serve two political goals: the
garnering of votes from public interest groups and the
subsidisation of the pharmaceutical industry. This is an
inefficient and inequitable scheme, not least because it
discriminates against other diseases which may be equally
in need of additional funding."
To illustrate how policy may support the pharmaceutical
industry at the expense of the NHS, the authors give an
example of how switching patients with age-related macular
degeneration from one drug to another very similar drug
that is licensed for the treatment of colorectal cancer
could save the NHS in England £100 million each year.
However, licensing issues and the threat of legal
challenges from the pharmaceutical industry is thwarting
NHS commissioners seeking greater efficiency in the use of
their constrained budgets.
Professor Maynard concludes: "Government continues to
subvert the efficiency of technology appraisal work
carried out by NICE in order to subsidise industry. Does
this benefit the UK taxpayer and NHS patients? Or does
government tacitly wish to tax the NHS with high
pharmaceutical prices of sometimes inefficient drugs and,
in so doing, increase the wealth of industry?"
Journal of the Royal
Society of Medicine
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