Japan will raise reimbursement prices for selected essential and clinically valuable drugs in April, while cutting back prices for a higher than usual number of other products through the broad application of market expansion repricing rules. The overall regular revision will see prices cut by 4.7% on average.
In a long-running effort to balance growth in national healthcare costs in a rapidly ageing society and promote stability in a flat pharmaceutical market, Japan has announced details of its annual drug reimbursement price revision under the National Health Insurance (NHI) scheme for the fiscal year starting 1 April.
The average price reduction for drugs listed in the reimbursement tariff will be 4.67%, which is estimated to reduce the...
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
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A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
