BMS' Opdivo, Amgen's Repatha first on Japan's list for new price restrictions

Pharma, already smarting in Japan from new price controls imposed by the government, may now face additional limits on new breakthrough drugs. Up first for challenge are Bristol-Myers Squibb’s hot-selling cancer drug Opdivo and Repatha, the new-gen cholesterol fighter from Amgen.

Japan’s Health, Labor and Welfare Ministry will discuss its plans at an upcoming meeting and expects to have limits in place by the start of the next fiscal year in March 2017, the Nikkei Asian Review reports. Among other restrictions may be a limit on use of certain meds to only those patients which studies show are most likely to benefit.

Opdivo is said to be of particular concern because despite its success in extending life in cancer patients, it is estimated it would cost the government 1.75 trillion yen ($16.3 billion) for the 50,000 patients who might benefit. That sum amounts to 20% of the country's current spending on drugs, the newspaper said.

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Japan’s Ono Pharmaceuticals, which is BMS’ local partner for Opdivo, has said that sales of the cancer fighter were ¥21.2 billion ($200 million) in the last financial year, substantially exceeding its original forecast of ¥3.5 billion for the year. Next year, sales are expected to grow to ¥126 billion ($1.16 billion) for the lung cancer indication.

The new restrictions would be on top of price controls that Japan already has in place. It established a once-every-two-years price cut exercise, which kicked in earlier this year, to achieve savings of $1.5 billion. In addition, Japan's Central Social Insurance Medical Council--known as Chuikyo--implemented a formula for best-selling drugs that saw reimbursements cut as much as 50% for key products. The effects of the price cuts were a recurring theme in drugmakers’ Q1 reports.

- read the Nikkei Asian Review story

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