Plenty of drugmakers have grumbled about the U.K.'s cost-effectiveness gatekeepers. The National Institute for Health and Care Excellence does routinely reject new drugs, particularly unless--and until--their makers offer price breaks. But until now, no major drugmaker has threatened to stop investing in Britain unless NICE changes its game.
Eisai, the Japanese drugmaker, is now on record saying NICE's criteria for approving drugs are too limited, Pharmafile reports. The company is spending £100 million ($161.5 million) on a new European headquarters and factory in the U.K., and now Deputy President Yutaka Tsuchiya says NICE is a stumbling block for new drug launches.
Tsuchiya recently met with Health Secretary Jeremy Hunt and told him just that. "We tell him that unless you improve this, we will withdraw our investment in the U.K.," Tsuchiya told Pharmafile. Hunt was "very open" to his comments, Tsuchiya said.
Tsuchiya suggests that NICE consider new quality-of-life measurements, plus weigh a new product's value to society, its economic benefit, and the innovation required to develop it. He also noted that doing business in the U.K. is expensive--about four times the cost of setting up new operations in India, he said.
NICE's appraisal criteria have come under fire before. In fact, the British government had considered sidelining the agency, turning it into an advisory body with no actual gate-keeping powers. But that idea fell by the wayside. Last year, NICE agreed to revamp its appeals approach, putting outsiders in charge of appeals panels.
In the meantime, with cancer drugs hit particularly hard by NICE assessments, the U.K. set up a special fund to pay for treatments NICE wouldn't sanction. And as more cancer drugs target patients with specific gene mutations, drugmakers have called on the agency to weigh those products differently. Meanwhile, British officials continue to work on a new value-based pricing scheme that would change NICE's role, but those plans reportedly have been delayed, Pharmafile notes.
- read the Pharmafile story
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