TOKYO -- The Japanese health ministry will issue guidelines to promote appropriate administration of groundbreaking but expensive treatments, starting with the Opdivo cancer drug, aiming to rein in rising health care costs.

Revolutionary new treatments can cost hundreds of dollars or more per dose, with some earning pharmaceutical companies billions of dollars a year. When such treatments are used, government health insurance funded by taxes and premiums eases the blow to the patient's wallet.

The Health, Labor and Welfare Ministry expects public funds to cover more of these costs in the future. The new guidelines will aim to hold down spending as well as ensure that medical institutions can respond to unexpected side effects.

Hospitals using treatments covered by the new rules will have to meet such requirements as staying open around the clock to deal with emergencies, for example. Conditions will be imposed on patients as well, though the guidelines will not discriminate by age. The ministry will consider requiring studies to determine which patients a given drug is most likely to work on and limiting its use to those groups.

The ministry will discuss the topic at an upcoming meeting of the Central Social Insurance Medical Council. Guidelines will be drawn up by the end of fiscal 2016 and take effect as early as fiscal 2017.

Opdivo, an immunotherapy drug, will be the first treatment covered by the new rules. Opdivo can have dramatic results in terminally ill patients with inoperable cancer. But administering it to 50,000 people for a year would cost 1.75 trillion yen ($16.3 billion) for the drug alone -- equivalent to 20% of the country's annual pharmaceutical spending. The Japan Medical Association warned that such expenses could threaten universal health coverage.

The health ministry will also work on guidelines for Repatha, a treatment for high blood cholesterol. The drug, launched in April, costs 22,948 yen per kit. But it must be administered repeatedly, so the cost to patients can mount rapidly.

Pharmaceutical spending in Japan totaled 8.5 trillion yen in fiscal 2012, up 2 trillion yen from a decade earlier. The past few years have seen the emergence of a number of costly new drugs, such as the Sovaldi hepatitis C treatment. This trend is starting to dent the health care system's finances. The Japan Health Insurance Association, which covers employees of small and midsize businesses, saw benefit payout costs climb 6.3% in fiscal 2015.

(Nikkei)