New cancer drug provokes heated debate in Japan


OSAKA -- Opdivo, a revolutionary cancer drug developed by Japan's Ono Pharmaceutical, has been increasingly popular among cancer patients since its release in 2014 in Japan. Some who take the drug, also known as nivolumab, have seen their cancer cells disappear completely. The medical breakthrough, however, is a headache for Japan's government: While Opdivo may be highly effective, it is also very expensive, and debate over the drug's price is growing fierce. The recent controversy started with a cost estimate submitted to the Finance Ministry's Fiscal System Council in April. If Opdivo's popularity keeps growing, the nation's health care costs will rise infinitely, the analysis said. For example, if the drug were prescribed to 50,000 of the 77,000 patients in Japan who succumb every year to nonsmall cell lung cancer -- which accounts for 80% of lung cancer cases in the nation -- the annual cost of the drug alone would total 1.75 trillion yen ($17 billion). The government approved Opdivo for treating this type of cancer last December. According to the health and welfare ministry, Japan spends about 40 trillion yen on health care. The amount increased steadily for 12 years until fiscal 2014. About a quarter was covered by the government in fiscal 2013. If the government expands the use of the drug to include other forms of cancer such as gastric cancer -- on top of its current approval for treating malignant melanoma and advanced nonsmall cell lung cancer -- it would increase spending significantly. Ono Pharmaceutical is not happy with the estimate. "Realistically speaking, [sales of Opdivo] are estimated to be 126 billion yen in the current fiscal year through March 2017," President Gyo Sagara said at an earnings conference at the Osaka Exchange in May. That is less than one-10th of the government's estimate, he said. Ono Pharmaceutical says the government is overestimating the number of patients who will actually use Opdivo. The company believes only a fraction of patients suffering from advanced nonsmall cell lung cancer will qualify for the drug: those who have failed to get better through chemotherapy and are terminally ill, without the option of surgery. Based on this assumption, the company projects some 15,000 patients will start using the drug -- far fewer than the 50,000 estimated by the government.