REGULATORY
Expert Panel Talks over Yakkasa, Revamp of Price Revision Method; Fixed Margin, Claw-Back Mooted
By Yoshinori Sagehashi March 20, 2023
Japan’s current drug price revision mechanism inevitably creates a gap between an NHI price and a market price, called yakkasa, which has effectively become a source of revenue particularly for pharmacies. Many members of a…

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March 22, 2023
A health ministry panel on March 17 approved 184 additional health damage claims following COVID-19 vaccinations for compensation. The applicants will be eligible for medical benefits upon official approval by the health minister.A total of 213 claims were reviewed at…
March 22, 2023
The Japanese health ministry on March 17 approved two regenerative medicine products including Japan Tissue Engineering’s (J-TEC) autologous cultured epidermal cell sheet Jacemin for the treatment of vitiligo.Jacemin was approved for vitiligo for which nonsurgical therapy is ineffective or not…
March 22, 2023
Eisai said on March 20 that it has published the updated results from its social value estimate for its Alzheimer’s treatment Leqembi (lecanemab) in the peer-reviewed journal Neurology and Therapy.The findings reported in the paper were used for the pricing…
By Eric Persoff

The healthcare supply chain in Japan, as in all major markets, consists of biopharmaceutical manufacturers selling to wholesalers who in turn sell to hospitals, clinics, and pharmacies, where the drugs are finally dispensed to patients. Each party ideally contributes value…

By Yoshinori Sagehashi

The health ministry’s key expert panel on February 15 agreed on the need to consolidate the Japanese generic sector to…

By Yoshinori Sagehashi

“Balance” seems to be the keyword for the next drug pricing reform in FY2024. Japan now appears ready to seek a better balance between evaluating innovative medicines and taking tough measures against companies dependent on long-listed products (LLPs) and generic…

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…

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