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U.K. Drug Watchdog To Lose Industry Power

Government to Strip NICE of Ability to Reject Medecines; Agency, Pharmaceutical Industry Clashed Over Costs

By JEANNE WHALEN

A U.K. agency that has clashed with the drug industry through its attempts to control health-care costs appears set to lose some power under the country's new coalition government.

The National Institute for Health and Clinical Excellence, or NICE, scrutinizes the cost and clinical benefits of new drugs to determine whether the state health-care system should pay for them. If NICE decides that a drug isn't worth its price tag, the agency advises doctors not to prescribe it, which effectively results in a ban.

But Britain's new coalition government, led by the Conservative Party, is planning to strip NICE of the ability to reject drugs, the Department of Health said in a written response to questions Monday. Conservative Party leaders are both trying to limit the size and reach of government and put power in the hands of doctors, rather than administrators, when it comes to treatment decisions.

In the future, NICE will advise doctors on the best approaches to treating various diseases. Decisions on how much the health-care system will pay for new treatments will be made through "a new system of value-based pricing," the statement said.

Under the new system, the "price of a drug will be determined by its assessed value," Health Secretary Andrew Lansley said in the statement, suggesting that the government will review clinical trials and other data on a drug's effectiveness before negotiating a price with drug companies. That's different from the current system, in which the company sets its own price and leaves NICE to decide whether the U.K. will pay for it.

NICE's decisions have at times drawn criticism from drug companies and some patient-support groups who say the agency has deprived patients of drugs that might help them. NICE has been particularly tough on expensive cancer medicines, rejecting those that it deems to be of limited benefit. The agency has rejected several drugs made by U.K. pharmaceutical giant GlaxoSmithKline PLC in recent months, including Arzerra for leukemia, Revolade for a rare blood condition and Tyverb for breast cancer. Last month, the Association of the British Pharmaceutical Industry called for NICE's role to be reformed, saying that "many medicines that improve clinical practice and patient outcomes have struggled to enter" the U.K.'s health-care system because NICE has rejected them.

In an emailed statement, NICE said the changes would happen in 2014. Until then, a current agreement between the state health-care system and drug companies will remain in force. The agreement limits the amount of profit companies can earn on sales to the state, but allows firms to set their own prices.