Japan's push on innovative drugs gets a budget boost

Japan Health Minister Yasuhisa Shiozaki

Japan's cabinet gave the nod to a draft of next year's budget in a Christmas Eve meeting that saw the Ministry of Health, Labor and Welfare (MHLW) get funds outlined in September to promote development of innovative drugs and medical devices--and paves the way for compassionate clinical trial approvals.

The effort will receive ¥82.5 billion ($690 million) for the fiscal year starting April 1, according to a ministry spokesman, as part of other spending outlines that included ¥126.5 billion, up by 1.3%, for the Japan Agency for Medical Research and Development related to overall R&D in healthcare.

Genomic work is a key focus of the spending on innovative medicine and was flagged last year with plans to pool data from medical research hospitals with a focus on cancer and refractory diseases.

According to the spokesman, drugmakers will be eligible for a reduction in clinical trial consultation fees of as much as 90% for compassionate use cases approved by the Pharmaceutical and Medical Devices Agency (PMDA).

On specific oncology-related spending, an increase of 10% to ¥35.6 billion is slated to promote screening and research.

Japan in 2015 moved to spur drug innovation and in October, MHLW named 6 drugs in its first announcement on the new "sakigake" fast-track review system, a pilot project outside of the full-review process. Any products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world, PMDA said in April.

However, cuts to reimbursement for widely prescribed drugs are slated by Japan's Central Social Insurance Medical Council, known as Chuikyo, that could see some innovative drugs get a price cut of as much as half.

Chuikyo looks at sales volumes and pricing as part of a formula set against forecast targets of demand.

Cutting-edge cardiovascular and oncology drugs that draw around $1 billion in reimbursement funding during the fiscal year are a particular target if sales increase 1.5 times more than forecast.

Chuikyo also looks to boost prescriptions of generic drugs, though pressure there was highlighted in the budget to curb costs of products that face limited competition.

- here's the MHLW website