REGULATORY

Chuikyo Defers Coverage for SaMD for Breast Cancer Recurrence Risk Assessment; Software Remains Incomplete

December 3, 2021
The Central Social Insurance Medical Council (Chuikyo) on December 1 agreed to defer insurance coverage for Exact Sciences’ software as a medical device (SaMD) used to assess the risk of breast cancer recurrence. The company says that program development had…

To read the full story

Related Article

REGULATORY

By Tatsuya Otsuka

A bill to amend the Pharmaceutical and Medical Devices (PMD) Law is expected to be submitted to the ordinary session of the Diet this year, which was convened on January 17 for a 150-day run. The proposed amendment is for…

A total of 15 new drugs (APIs) joined the NHI price list in 2021 with peak sales forecasts topping at 10 billion yen, many of them in the area of orphan diseases and with few mega launches, according to a…

Japan’s all-important reimbursement policy panel on December 22 approved an outline of the next drug pricing reform scheduled for April 2022, which embraces plans to reward innovative new indications and introduce a grace period for so-called “spillover” re-pricing.The reform outline…

By Philip Carrigan

Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…

By Yoshinori Sagehashi

Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…

Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…