New Regulations Take Effect in August! National Health Insurance to Cover $11.2 Million Hemophilia Drug; Court Approval Required for Involuntary Hospitalization

Starting in August, the Ministry of Health, Labour and Welfare (MHLW) will implement several new policies, including expanded national health insurance coverage for new medications. These include a new formulation for treating postherpetic neuralgia, with an estimated annual drug cost of approximately JPY 33,000 per patient, and a new injectable drug for the preventive treatment of hemophilia, with an annual cost of approximately JPY 11.2 million per patient. Additionally, amendments to the Mental Health Act will take effect, shifting the authority for involuntary hospitalization of severely mentally ill patients from review boards to court rulings, under the principle of 'judicial reservation,' and introducing an expert panel review system.

The National Health Insurance will provisionally cover medications containing fitusiran sodium, specifically QFITLIA Solution for subcutaneous injection 20 mg vial and 50 mg prefilled pen (Fan-te-ning subcutaneous injection). The National Health Insurance Administration states that the drug is indicated for the preventive treatment of severe hemophilia A or B in patients aged 12 and above, regardless of inhibitor status, offering a convenient treatment option with subcutaneous injection every two months. The estimated number of patients receiving treatment in the first to fifth years ranges from 115 to 252, with projected drug costs between JPY 1.288 billion and JPY 2.822 billion, and financial impact estimated at JPY 354 million to JPY 843 million. The annual drug cost per patient is approximately JPY 11.2 million.

The National Health Insurance will also provisionally cover medications containing pregabalin, specifically Regalin Oral Solution 20 mg/mL (Li-jia-ning). The Administration states that this medication can be used to treat neuropathic pain caused by diabetic peripheral neuropathy, postherpetic neuralgia, as an adjunctive treatment for adult partial epilepsy, fibromyalgia, and neuropathic pain caused by spinal cord injury. Currently, pregabalin-containing medications in Japan are only available in capsule or tablet form. The addition of an oral solution provides a new clinical option for patients who have difficulty swallowing. The estimated number of patients in the first to fifth years ranges from 1,896 to 2,471, with projected drug costs between JPY 4.37 million and JPY 5.69 million. The financial impact is expected to result in savings of JPY 600,000 to JPY 790,000. For example, in treating postherpetic neuralgia, the annual drug cost per patient is approximately JPY 33,000.

Under the revised Mental Health Act, effective August 1, the authority for ordering involuntary hospitalization of severely mentally ill patients will shift from the 'Mental Health Review Board for Involuntary Evaluation and Community Treatment' to the courts, adopting the 'judicial reservation' principle and introducing an 'expert panel participation' system. This change aims to ensure more comprehensive consideration of patients' medical needs and social support systems during the adjudication process.

Under the new system, the first-instance panel will consist of one presiding judge, one designated psychiatrist, and one patient rights representative, totaling three members. Decisions will be made by majority vote. The goal is to ensure that patients requiring hospitalization receive proper treatment, while those who do not can live with dignity in the community.