Adcetris’s IPS requirement for reimb may be removed

green light lit for the fulfillment of the long yearning of patients

The reimbursement expansion application passes the Cancer Disease Review Committee review

Will the prescription restriction set for Stage IV Hddgkin's Lymphoma patients be finally removed?

A green light has been given for the removal of the IPS score requirement for Adcetris, which had been a long-standing wish of the patients.

 

According to industry sources, Takeda Pharmaceutical Korea’s reimbursement expansion application to remove the International Prognostic Score (IPS) score criteria for prescribing its Adcetris (brentuximab vedotin) in combination with chemotherapy (AVD, adriamycin+bleomycin+dacarbazine) in Hodgkin's lymphoma passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee review on the 17th.

 

Adcetris )’ was granted reimbursement as a first-line treatment for Hodgkin’s lymphoma in 2021, but a restriction of "IPS score of 4" was applied, meaning that the drug was only reimbursable for patients with severe disease.

 

As a result, patients with an IPS score of 2-3 have been prescribed an existing chemotherapy combination, ABVD (adriamycin+bleomycin+vinblastine+dacarbazine), instead of Adcetris.

 

Even patients with stage IV disease were unable to benefit from Adcetris and its better efficacy if they had a low IPS score.

 

However, when analyzing the results of the 1,344 patients in the ECHELON-1 trial, Adcetris demonstrated efficacy in high-risk patients who were Stage IV, male, younger, and had an IPS score of 4-7.

 

The National Comprehensive Cancer Network (NCCN) guidelines recommend Adcetris+AVD for the treatment of patients with stage III and IV disease, and the European guidelines allow Stage IV patients to be treated with Adcetris regardless of the IPS score.

 

Therefore, the medical community has been pushing for the removal of the IPS score requirement from Adcetris’s reimbursement criteria, and expectations are rising with its passage of the CDDC review this time.

 

However, it remains to be seen if Adcetris can clear the remaining hurdles, including the Drug Reimbursement Evaluation Committee and drug price negotiations, and remove the IPS score requirement from its reimbursement criteria.

 

In the Phase III ECHELON-1 trial, Adcetris demonstrated superior clinical efficacy compared to ABVD in previously untreated patients with stage III or IV classical Hodgkin lymphoma.

 

Its three-year progression-free survival (PFS) analysis showed that the Adcetris combination therapy (PFS rate 83.1%) reduced the risk of disease progression by 30%, compared with ABVD (PFS rate 76%).