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
MHLW Proposes Continued Discussions for Cell & Gene Therapy Pricing
The Ministry of Health, Labor and Welfare (MHLW) on November 22 proposed continued deliberations on a pricing rule specific to cell and gene therapies, including on whether such rule should be created in the first place. No objection was raised…
To read the full story
Related Article
- MHLW Floats 2 Rules to Address Unreasonable Price Rises for Listed Generics
November 26, 2019
- Chuikyo Members Remain Divided over Timing of Comparator PMP Removal
November 25, 2019
- MHLW Wants to Subject Innovative Add’l Use to PMP, but No Price Raise
November 25, 2019
- MHLW Wants to Ease Unfairness Concerns by Adding New Innovation Gauge to PMP Company Criteria
November 25, 2019
- Industry Urges Careful Approach to Creating Special Rule for Indication Change Re-Pricing: Chuikyo
November 25, 2019
- No Change to Essential Drug Rule in 2020 Reform: MHLW
November 25, 2019
- MHLW Proposes Earlier Price Cuts for Off-Patent Drugs with 80%-Plus Gx Rates, but Chuikyo Questions 2-Year Grace Period
November 25, 2019
- Chuikyo Agrees on Need to Look at More Examples to Craft Pricing Models for Cell & Gene Therapies
September 12, 2019
REGULATORY
- LDP Lawmakers Irked as Govt Stands Fast on Off-Year Re-Pricing/Survey Plan; Honebuto Text Tweak Unclear
July 10, 2020
- MHLW’s OTC Panel Begins Discussions toward Interim Report; to Seek Solutions for Problems in Switch-OTC Approval
July 10, 2020
- Original Plan Remains Unchanged for Off-Year Drug Re-Pricing, Survey: Minister
July 9, 2020
- AnGes’ COVID-19 Vaccine Given Some Safety Confirmation Before Clinical Trial: MHLW Official
July 9, 2020
- LDP Lawmakers’ League to Launch Group to Protect People against HPV
July 8, 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…