Japan’s regulatory authorities have decided to grant reimbursement to Novartis AG/AveXis Inc.’s gene therapy Zolgensma (onasemnogene abeparvovec) under the national health insurance scheme, marking a watershed in drug pricing in the country, although the annualized cost will be less than many other big-selling products.
Japan To Reimburse Zolgensma – But At Lower Price Than US
NHI Scheme Grants Coverage
Novartis gene therapy gets insurance coverage at record price although small patient population will limit system costs.
More from Japan
• By
Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
• By
Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
More from Asia
• By
South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.
• By
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
• By
A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.