Nivolumab Drug Price Adjustment Information

• November 18, 2016
• Read time: 2 minutes

Sharing observations from Japan: around the end of July this year, Japan's Central Social Insurance Medical Council under the Ministry of Health, Labour and Welfare discussed pricing for many high-cost drugs in Japan. As many are aware, the ever-increasing drug prices place a considerable financial burden on both patients and the government. Accordingly, discussions were held regarding the drug pricing system ("yakka seido"), covering topics such as new drug recognition methods and dosing information, to build an appropriate environment for new drug use — resulting in the formulation of "Optimal Use Promotion Guidelines" (literally, "guidelines for the most appropriate use"). Japan's current drug pricing system did not account for market expansion following post-marketing efficacy updates; as a result, a new standard was developed for drugs such as nivolumab, allowing future price adjustments based on this criterion.

To elaborate: nivolumab was initially targeted at patients with unresectable malignant melanoma, with an estimated maximum of 470 users, and was launched in September 2014. Drug pricing was designed based on manufacturing costs, research and development expenses, and projected patient numbers. At the time, the price was set at 152,000 yen for 20 mg and 729,849 yen for 100 mg, resulting in an estimated annual cost of approximately 35 million yen per lung cancer patient. Then in December 2015, it was approved for non-small cell lung cancer patients, with projected users increasing to 15,000. With kidney cancer now also an eligible indication and more cancer types becoming applicable, the estimated number of users has continued to rise.

Japan's current system allows drug prices to be adjusted when market growth occurs. However, nivolumab's market growth was too rapid after its launch, making it unable to become a target for price adjustment in 2016. Given the impact on Japan's national finances, the Japanese government required the pharmaceutical company to explore a price reduction special case before 2018. Drug prices are typically determined on a biennial basis when medical fees are revised. However, on November 16, the Central Social Insurance Medical Council recommended a 50% price reduction beginning the following February.

Ono Pharmaceutical stated that they had initially anticipated a drug price adjustment in fiscal year 2018 (Heisei 30), and that this sudden requirement caused harm to their company, requesting that the government revise the system once more. As of that writing, Ono Pharmaceutical was still considering whether to submit a dissenting opinion to the Ministry of Health, Labour and Welfare on November 22.

Currently, prices are also changing in Taiwan. Whether it is appropriate, how to administer it, and what dosage to use — these decisions still need to be made by medical professionals. Whether prices are uniform depends on the quotation from each medical institution. The information we provide is for reference only.

Reference: NHK http://www3.nhk.or.jp/news/html/20161116/k10010771151000.html

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

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Related Cancer Information

• Melanoma
• Lung cancer