Chuikyo, Japan’s Central Social Insurance Medical Council, plans to increase the National Health Insurance drug price premium rates for certain drugs. These products include drugs that are innovative, drugs that demonstrate increased usefulness, pediatric medicines, orphan drugs, and kits.
The premium rate for innovativeness will increase from 50-100% to 70-120%. Examples of innovative products include those demonstrating increased efficacy or safety compared to similar products, or those containing a clinically useful new mechanism of action.
The premium rate for usefulness group (I) will increase from 25-40% to 35-60% while the premium rate for usefulness group (II) will increase from 5-20% to 5-30%. The difference between the two groups is that drugs under usefulness (I) will have to satisfy two of three requirements while drugs under usefulness (II) only have to satisfy one or more requirements. These requirements are very similar to those outlined for innovative products.
The premium rate for pediatric medicines will increase from 3-10% to 5-20%. Chuikyo also plans to revise the requirements for drugs listed under this category. The first requirement stating that the indications and efficacy are specifically for children will not change. However, the second requirement will be revised. Drug products must also have comparable products that did not receive any pediatric medicine reimbursement in the past. Drugs must fulfill both of these requirements to be categorized into this group.
The category for orphan drugs also has two subgroups. The premium rate for orphan drugs (I) will increase from 10% to 10-20% while the premium rate for orphan drugs (II) will increase from 3% to 5%. The main difference between the two groups is that drugs under orphan drug (I) must satisfy Article 77-2 of the Japan Pharmaceutical Affairs Law, while drugs under orphan drug (II) must satisfy a drug efficacy classification listed in the Japan Standard Commodity Classification.
The premium rate for kits will increase from 3% to 5%. Products under this category should reduce the chance of infection, reduce risk of mistakes during drug preparation, increase ease of use or increase quality of treatment when administered compared to similar products.