U.K. gatekeepers toughest on cancer meds--and getting tougher all the time

NICE CEO Sir Andrew Dillon

The U.K.'s cost gatekeeper is notoriously strict when it comes to approving drugs, shooting down meds based on strict cost-effectiveness standards or saddling them with restrictions. But cancer drugs face the toughest road ahead, as a new report shows that the National Institute for Health and Care Excellence is less likely to green-light oncology meds compared to other classes of drugs. And the agency is getting even tougher on cancer meds as time goes by.

A recent analysis from Context Matters weighed NICE's reimbursement decisions against the European Medicines Agency (EMA) market authorizations for oncology and nononcology drugs, and found that cancer drugs were 56% more likely to be rejected by the cost-effectiveness gatekeepers than noncancer meds, which were only turned down 16% of the time. NICE's stance on cancer drugs has grown increasingly stringent over time as well, with fewer approvals overall and and more restrictions on meds that did win approval.

The numbers raise a few questions, the analysis notes, including whether NICE is passing the buck on cancer drugs to the U.K.'s Cancer Drugs Fund (CDF). The fund, which is designed to cover oncology meds stiff-armed by NICE, faces budget constraints of its own, and it's planning to reconsider previous payment approvals at a meeting next month. The CDF plans to examine two dozen top-selling cancer drugs, including Roche's ($RHHBY) breast-cancer treatments Perjeta and Kadcyla, Pfizer's ($PFE) leukemia treatment Bosulif and Sanofi's ($SNY) Zaltrap. Low funds and skyrocketing drug prices could prevent the CDF from covering as many drugs--which could in turn prompt drugmakers to make new offers to win NICE's approval.

Meanwhile, NICE continues to face pushback from pharma companies and patients who take issue with the watchdog's cancer drug rejections. In August, the U.K. gatekeeper drew fire when it turned down Roche's breast cancer treatment Kadcyla due to pricing concerns. In October, NICE provoked outcry when it rejected Celgene's ($CELG) multiple myeloma treatment Imnovid in preliminary guidance, saying that the drug's benefits did not justify its high price tag.

But NICE says it's not to blame for the repeated rejections. Over the summer, agency CEO Andrew Dillon pinned the watchdog's rejections on drugmakers, telling the Financial Times that the NHS isn't "a bottomless pit" and that "we shouldn't mislead ourselves into thinking that there is some world we will reach … where everything that could conceivably make a difference to us, whatever its price, is going to be available."

- read the Context Matters blog post

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