NICE, drugmakers reject analysis that price watchdog is too generous

Drugmakers are often at odds with the National Institute for Health and Care Excellence (NICE) in England, saying it is stingy in what it will approve as payments for their best new treatments. But the industry and the gatekeeper have pulled together in defending against a study that says NICE is paying drugmakers too much for their best new treatments.

The study from the University of York says the measure NICE uses of paying £20,000 to £30,000 for quality-adjusted life years (QALY)--which weighs price against how much a life can be extended by a drug--should be capped at around £13,000, the BBC reports. "The increasing pressure to approve new drugs more quickly at prices that are too high will only increase the harm done to NHS patients overall," claims co-author Karl Claxton. The study was particularly critical of the Cancer Drugs Fund, which allows even higher payments in some cases.

NICE chief Sir Andrew Dillon

But Sir Andrew Dillon, chief executive of NICE, says researchers are fooling themselves if they think drugmakers would provide their drugs in the England at that rate. He told the BBC that "using a threshold of £13,000 per QALY would mean the NHS closing the door on most new treatments."

A £13,000 threshold would not affect the availability of new drugs but treatments as routine as "palliative care for dying patients and maternity services," said Paul Catchpole of the Association of the British Pharmaceutical Industry. He said the study may be of academic interest but isn't something that policy should be molded on.

Still, the study is likely to add to the global debate that has been building over the high, and escalating prices, of many new drugs. In the U.S., and in Europe, much of that debate last year was centered on the hepatitis C cures from Gilead Sciences' ($GILD), Sovaldi and Harvoni, which racked up combined global sales of about $13 billion in their first year on the market. They are priced at about $85,000 and $94,500 for a 12-week treatment, although the resistance put up by payers has led to a pricing war in the U.S. that led Gilead to offer average discounts of 22% last year. It has said that will rise to 46% this year.

The same kind of cost concerns are driving India to take an aggressive stance on patents of many drugs it considers lifesaving, but which are priced beyond the reach of most patients there. Authorities last month invalidated a patent for Sovaldi, and have taken actions against Bayer's Nexavar and Novartis' ($NVS) blood-cancer treatment Glivec.

Drugmakers have often criticized NICE for being unreasonable it its demands for discounts, while patient groups have lambasted it for not approving some new and promising treatments. NICE's Dillon said drug companies need a "critical eye," to understand that they can't charge just whatever they might want.

The country "can't just say yes to anything and everything. "We don't have enough money--and anyway, not everything is worth having," Dillon said. But he insists that in the 16 years that NICE has been serving its role, that it has struck a balance between the extremes, "that reflects what we believe the public expects the NHS to do."

- here's the BBC story
- more from PharmaTimes

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