Progress preserved

The drug pricing reforms from Japan’s Ministry of Health, Labour and Welfare, set to take effect on April 1, largely preserve the regulatory innovations put in place by PMDA. But changes to the price maintenance premium have industry crying foul and calling for other healthcare players to share in the cost-cutting.

The premium, introduced in 2010, is meant to encourage therapeutic innovation by exempting companies with qualifying drugs from the standard procedure of having to adjust prices to within 2% of wholesale every two years, which typically results in price lowering. The premium lasts for 15 years or until generics enter, and applies to all indications the drug is approved for, not only the initial ones. ...