Japanese government to set new controls on specialty drugs: report
- Japan's Health, Labor and Welfare Ministry plans to implement new price restrictions on certain specialty drugs as early as March 2017, according to Nikkei Asian Review.
- Under the proposed guidelines, use of drugs such as Bristol-Myers Squibb's Opdivo and Amgen's Repatha could be limited only to patients that are most likely to respond, the report said. These guidelines would come on top of price cuts for commonly used new drugs earlier this year.
- Japan has a centralized healthcare system, which has been under strain lately as expenditures have increased, due partly to increased benefit payouts from Japan's Health Insurance Association. Demographics are also a disadvantage, as Japan's population is aging rapidly.
The country's centralized healthcare system covers 127 million people and is funded from taxes and premiums. Increased availability and coverage for specialty drugs, hoewver, is beginning to tax Japan's healthcare budget.
Take Opdivo, which is marketed by Ono Pharmaceuticals in Japan and was first approved in that market in July 2014. The drug launched successfully and sales look set to acclerate quickly.
Japanese sales of Opdivo were ¥21.2 billion, or roughly $200 million, in FY 2016 (ended March 31). Next year sales are expected to reach ¥126 billion ($1.16 billion) on the back of its approved indication in lung cancer.
But if Opdivo was given to 50,000 people in Japan, it would cost 20% of Japan's healthcare budget to fund it, according to the Nikkei Asian Review.
And Japan is aiming to increase the use of generic drugs dramatically to limit costs, especially as an older population needs more medication for chronic conditions.
The new guidelines aimed at limiting coverage for specialty drugs like Opdivo are expected to be drawn up this year and launched in fiscal year 2017.