Big Pharma threatens to sue U.K. fund as officials nix Novartis, Sanofi and Eisai meds

U.K. officials have decided which drugs to toss off the Cancer Drug Fund (CDF), which pays for drugs rejected by cost-effectiveness gatekeepers. Reportedly, Novartis ($NVS), Sanofi ($SNY) and Eisai treatments are among them.

Eisai CEO Haruo Naito

Drugmakers are threatening to sue over the decisions, prompted by a budget crunch at the CDF. Eisai CEO Haruo Naito has publicly said he'll fight back; he's expecting Halaven, the Japanese company's breast cancer drug, to be struck off the coverage list.

Naito called the National Health Service's move an "unfair and arbitrary decision," the Financial Times reports. "There is no arbitration mechanism so the only option that will remain is to go to court," Naito told the FT. Other pharma companies privately say they could do the same, the paper says.

Novartis' Afinitor, which the CDF covers for breast, pancreatic and kidney cancer, is likely to get the ax as well. Health officials broke the news in a meeting this week, Pharmafile reports. In a statement to the U.K. publication, the Swiss drugmaker called the NHS' assessment process "unacceptable as it is insufficiently robust and transparent." The cost portion of the evaluation "does not reflect the true value of cancer drugs," Novartis added.

According to BBC News, Sanofi's Jevtana is off the list in second and third-line prostate cancer, and Zaltrap won't be covered for advanced colon cancer. "We are hugely shocked and disappointed at this decision against Jevtana," U.K. manager Tarja Stenvall said, calling the coverage review "fundamentally flawed."

Plenty of other drugs were in danger, though there's no word yet on their fate. A list of drugs to be reassessed was released in November, and it included Roche's ($RHHBY) new breast cancer drugs Perjeta and Kadcyla; Pfizer's ($PFE) leukemia treatment Bosulif and lung cancer drug Xalkori; and Bayer and Amgen's ($AMGN) colon cancer drug Stivarga. The full list of rejected meds will be released Monday, the BBC says.

The CDF, ironically enough, was the U.K.'s answer to outcry over cancer drug rejections by the National Institute for Health and Care Excellence, whose evaluation process is exhaustive and very public. In fact, the agency recently suggested that, if the NHS was planning to review drugs for the cancer fund, then it should use NICE's own processes.

U.K. officials announced last year that the CDF was running out of money quickly. They expected the fund to overrun its £200 million annual budget ($422 million) by £100 million by the end of the fiscal year. The government promised an additional £160 million infusion over two years, but to avoid tapping out completely, granted the fund power to reassess its drug list.

"We need to get maximum value for every pound we spend," CDF Chairman Peter Clark said Thursday. "We can no longer sustain a position where we are funding drugs that don't offer sufficient clinical benefit when drugs that will do more for patients are coming on stream."

Not everyone is outraged at the CDF's decision-making, either. As the BBC points out, some patient advocates and doctors have said the fund itself is a bad idea, because it creates a backup plan for drugmakers that don't want to offer cut-rate prices to NICE. "The drug companies have behaved badly with their pricing and we support the Fund going back to try to reduce costs," said Eric Lowe, chief of Myeloma U.K. (as quoted by the news service).

- check out the FT piece
- get more from Pharmafile
- read the BBC News coverage

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