Otsuka Pharmaceutical Co., Ltd.

September 1, 2022

Otsuka Measurement Kit to be Covered by National Health Insurance in Japan for
Philadelphia-Chromosome-Positive, Acute Lymphoblastic Leukemia

- Reimbursement now extended to the Major-type BCR-ABL mRNA-based measurement kit, following reimbursement initiation for the minor-type BCR-ABL measurement kit in November 2021

Otsuka Pharmaceutical Co., Ltd. announces that for the Otsuka Major BCR-ABL mRNA Measurement Kit, insurance coverage is to be provided by the National Health Insurance system in Japan for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-positive ALL) with Major BCR-ABL. The insurance coverage commences on Septermber 1.

This in-vitro measurement kit is used to assist in diagnosis and to monitor treatment effectiveness for Ph-positive ALL.

The Otsuka Major BCR-ABL mRNA Measurement Kit already is marketed in Japan and covered by the National Health Insurance system as a diagnostic aid and as a treatment-response-monitoring marker for chronic myeloid leukemia (CML).

In patients with ALL, lymphocytes (a type of white blood cell) become malignant at an early stage of differentiation and proliferate unrestrainedly without maturing into functional lymphocytes. Early diagnosis and treatment initiation are important because symptoms can appear suddenly and the condition progresses rapidly. The number of patients in Japan was reported to be about 5,000 in a survey by the Japanese MHLW in 2017.

Until now, there has been no in-vitro diagnostic product that can quantitatively measure Major BCR-ABL mRNA in Ph-positive ALL, and the development of such a product has been desired in clinical practice.

Otsuka Pharmaceutical has been engaged for many years on research and development related to this disease, for which is difficult to conduct clinical trials due to the small number of patients, and as a result, the insurance coverage has now been further extended. In addition to the previously approved minor type, the Major type of BCR-ABL mRNA can now be measured, and is under insurance reimbursement, making the test available to most Ph-positive ALL patients.

The Diagnostic Division of Otsuka has launched Otsuka's WT1 mRNA Measurement Kit II Otsuka and Major BCR-ABL mRNA Measurement Kit Otsuka as in-vitro diagnostic agents for blood cancers. Otsuka will continue to contribute to medical treatment with the aim of developing diagnostic agents that can maximize the capabilities of therapeutic agents.