New standard for Adcetris combination has been established

Non-Hodgkin lymphoma/Hodgkin's lymphoma can be applied for the first dose

The HIRA, scheduled to take effect on April 1st

Takeda's antibody-drug conjugate (ADC) and Adcetris (Brentuximab) are now available in combination with chemotherapy during the first-line administration of patients with non-Hodgkin lymphoma and Hodgkin lymphoma.

 

The HIRA announced on the 17th that the revised bill 'Details on the criteria and methods for applying medical care benefits to drugs prescribed and administered to cancer patients' was released and that opinion inquiry will be conducted by the 25th.

 

The scheduled enforcement date is April 1.

 

The revised bill of this announcement contains the new and changed reimbursement standards for combination therapy including Adcetris, a lymphoma treatment.

 

◆Non-Hodgkin's lymphoma= It is recognized when Adcetris and chemotherapy drugs (Cyclophosphamide, Doxorubicin, Prednisone) are administered in combination with CD30-positive peripheral T-cell lymphoma that have not been treated before (sALCL).

 

In the case of ALK-positive sALCL, it is possible by limiting to 'IPI (international prognostic index) ≥ 2 points' included in the clinical literature.

 

As a result of reviewing textbooks, there is a mention of a clinical study of Adcetris combination therapy for sALCL, and NCCN recommends ALK-positive sALCL as a preferred regimen category 1A and other peripheral T-cell lymphoma as category 2A.

 

In a randomized phase 3 clinical trial, it was confirmed that progression-free survival was increased as a result of comparison with CHOP (Cyclophosphamide, Doxorubicin, Vinblastine, Prednisone), an alternative therapy.

 

◆Hodgkin's lymphoma= Adcetris and chemotherapy drugs (Doxorubicin, Vinblastine, Dacarbazine) in combination therapy for stage 3 or 4 Hodgkin lymphoma that have not been treated before are recommended for NCCN.

 

Reflecting the expert opinion that it is difficult to establish objective standards and prove relevance as symptomatic improvement, it was decided to be reimbursed only for 'IPS (international prognostic score) ≥ 4 points'.

 

In the case of non-Hodgkin's lymphoma and Hodgkin's lymphoma combination therapy, it was decided to classify it as a therapy with a risk of febrile neutropenia exceeding 20%, reflecting the NCCN guidelines, related clinical trials (ECHELON-2), and expert opinions.