The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
REGULATORY
MOF Panel Urges Govt to Use Economic Evaluations for Reimbursement Decisions: FY2019 Budget Recommendation
The Fiscal System Council submitted its recommendation paper for FY2019 budget formulations to Finance Minister Taro Aso on November 20, calling on the government to use economic evaluations when it makes go/no-go decisions on the reimbursement of drugs and other…
To read the full story
Related Article
- MOF Panel Leery of Pricey Drugs for Huge Patient Population: FY2020 Budget Recommendation
November 26, 2019
- MOF Panel Paper Reiterates Copay Raise for “Small-Risk” Disease Treatments
June 20, 2019
- CEFP Finalizes Govt Reform Timeline Urging FY2019 Debate on “Economic Evaluations” for Reimbursement Decisions
December 21, 2018
- Govt’s Draft Reform Timeline Prods MHLW to Discuss Use of “Economic Evaluations” in Reimbursement Decisions in FY2019
December 11, 2018
- MOF Reiterates Drug Cost Optimization, but Makes No Fresh Proposal: Fiscal System Council
October 10, 2018
REGULATORY
- MHLW Set to Approve Label Expansions for Kadcyla, Keytruda, Imfinzi and More
July 7, 2020
- Japan Govt Likely to Stick to 2020 Off-Year Drug Re-Pricing Plan in Honebuto Paper
July 6, 2020
- Create Cross-Bureau Scheme at MHLW to Fuel Rx-to-OTC Switches: Regulatory Reform Panel
July 6, 2020
- MHLW Donates Nearly 200 Million Yen to GARDP to Combat Antimicrobial Resistance
July 6, 2020
- Key MOF Panel Passes on Typical Budget Recommendation amid COVID-19
July 3, 2020
When Jiho surveyed drug makers on the non-sales criteria they use to evaluate reps’ performance, it received a variety of…
Nearly a year after the introduction of the Ministry of Health, Labor and Welfare’s (MHLW) drug promotion guidelines in April…
Advancements in modified oligonucleotide technologies has been the key driver behind a spate of approvals in the oligonucleotide therapeutics space…
Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…
The Ministry of Health, Labor and Welfare (MHLW) on November 27 added to the NHI price list Japan’s first biosimilars of Avastin (bevacizumab), Nesp (darbepoetin alfa), and Forteo (teriparatide). The NHI prices of first biosimilars are set at 70% of…
A total of 51 new drugs joined the NHI price list in 2019, which are expected to generate combined peak sales of 373 billion yen, according to Jiho’s tally of data submitted to a key reimbursement policy panel. The relatively…
Some seven years in the making, Japan’s Ministry of Health, Labor and Welfare (MHLW) finally rolled out a cost-effectiveness assessment…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…
In a change striking to the very core of the traditional Japanese salaryman, “We are seeing the coronavirus ushering in a new way of working… and I think it’s about time,” says Ivan Tselichtchev, Professor of Economics at the Niigata…