Leukemia treatment ‘Venclexta’ to be reimbursed

in combination with MabThera as second line treatment

HIRA announces revision of cancer patient drug notice … to be implemented from June 7th

In the revision, standards were newly added for response evaluation of ‘Afinitor,’ a treatment for CNS cancer

‘Venclexta (venetoclax)’ in combination with ‘MabThera (rituximab)’ will be reimbursed as second-line treatment for patients with chronic lymphocytic leukemia.

 

The Health Insurance Review and Assessment Service (HIRA) has been conducting an opinion inquiry on its proposed revision of the ‘Notices required according to drugs prescribed and administered to cancer patients.’ If no objections are raised during this period, the revision will be applied and enforced from June 7th.

 

Venclexta was approved in combination with rituximab for ‘adult patients with chronic lymphocytic leukemia (CLL) who had at least one prior treatment.’ HIRA reviewed the reimbursement expansion based on information from textbooks, guidelines, and clinical papers.

 

As a result, the combination’s clinical efficacy was demonstrated in the randomly assigned, open-label, Phase III MURANO trial through progression-free survival (PFS), etc., in adult patients with relapsed or refractory chronic lymphocytic leukemia.

 

In addition, the interval required for response evaluation of Afinitor (everolimus), a treatment for central nervous system cancer, was extended.

 

Under general principles, the response of patients with solid cancers and malignant lymphoma should be evaluated every 2-3 cycles or 2-3 months.

 

However, a request had been filed to extend the evaluation interval for Afinitor in tuberous sclerosis complex (TSC) patients who are in need of therapeutic interventions but have a brain tumor called subependymal giant cell astrocytoma (SEGA), in which the tumor cannot be removed completely by surgery.

 

HIRA's textbook review showed that the interval should be 3-6 months for the first 3-5 years, followed by at least once a year.

 

The U.K.

 

guidelines also recommend patients to check responses in 1-3 years if they are asymptomatic, and more frequently so if they have symptoms.

 

Considering the evidence that shows that the imaging tests may be conducted in an interval of 1 year at maximum, HIRA decided to recognize the 3 to 12 month interval as the response evaluation interval for Afinitor depending on the patient's condition.