Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…
REGULATORY
Zolgensma to Get Japan’s Highest List Price 167 Million Yen, but Peak Sales Put at Just 4 Billion Yen
Novartis’ spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec) is expected to join the NHI reimbursement list on May 20 with Japan’s highest price tag of 167 million yen, people familiar with the matter have told Jiho. The price…
To read the full story
Related Article
- Will Zolgensma Delay Spur Revision of Sakigake Designation System?
June 11, 2020
- Zolgensma Hits Japan Market with Stringent Conditions Attached
May 21, 2020
- Hodanren Criticizes Zolgensma’s High NHI Price as “Result of a Money Game”
May 18, 2020
- Chuikyo Members Frown on Zolgensma’s Sakigake Premium; Topic Up for 2022 Pricing Debate
May 14, 2020
- Japan Regulators Upped Zolgensma Price after Novartis Complaints: Chuikyo Paper
May 13, 2020
- Novartis Offers Free Access Program for Zolgensma Diagnostic
May 11, 2020
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
- Drug Pricing Rules to Be Applied to Zolgensma: Chuikyo
March 25, 2020
- (Update) Japan Approves Novartis’ SMA Gene Therapy Zolgensma; 15-20 Patients Expected Annually
March 19, 2020
REGULATORY
- MHLW Proposes Setting Key Drugs as Category Separated from Bundled Trades
September 29, 2023
- Guidelines Should Urge Drug Makers to Explain Solo-Wholesaler Decisions: Panel Members
September 29, 2023
- MHLW Expert Panel Draws Up New Cancer Research Strategy
September 28, 2023
- As Chuikyo Begins Pricing Debate of Leqembi, Panelists Urge Safety, Fair Access
September 28, 2023
- Japan PM Asks Health Minister to Reform Pricing of Potential Blockbusters
September 28, 2023
A doctor member of the Central Social Insurance Medical Council (Chuikyo) on September 20 traded barbs with pharma leaders over…
The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies…
IntroductionCommercial transformation is a top priority for pharma leaders in Japan and rightfully so. In a market with low single…
In the run-up to FY2024 budget requests this summer, there were growing hopes in the pharmaceutical industry that the government's de-facto cap on increases in social security spending would finally be lifted. That did not happen, despite strong calls from…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…