Will the non-reimb status of 'Padcev' change this year?

The industry closely monitors whether Padcev will be considered for the the Cancer Disease Review Committee in February

Astellas will proceed with reimbursement for monotherapy·combination therapy at the same time

Product photo of Padcev

The industry is paying attention to the progress of reimbursing monotherapy·combination therapy of 'Padcev,' the new ADC drug for bladder cancer.

 

Astellas Korea's Antibody-Drug Conjugates (ADC) Padcev (enfortumab) is expected to be considered for the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) in February.

 

At the end of last year, Astellas applied for reimbursement of Padcev for the monotherapy of adult patients with locally advanced or metastatic urothelial carcinoma who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors, and also applied for reimbursement of Padcev in combination with Keytruda (pembrolizumab), a PD-1 inhibitor, as a first-line treatment of advanced or metastatic urothelial carcinoma.

 

The monotherapy passed the Cancer Disease Review Committee in February 2024 but after the economic evaluation, its reimbursement is being postponed due to disagreement between the government and the pharmaceutical company over the cost-effectiveness.

 

Astellas plans to submit a supplement of the monotherapy while applying for reimbursement of the combination therapy.

 

Padcev is recommended as a Category 1 preferred treatment option in the National Comprehensive Cancer Network (NCCN), and a novel treatment option for patients with urothelial cancer who have disease progression or relapsed following cancer immunotherapy and platinum-containing chemotherapy and are not eligible for previous standard-of-care treatment options.

 

In South Korea, Padcev was approved in March 2023 as a monotherapy for patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors.

 

Consequently, the industry is closely monitoring whether the status of Padcev, which remained a non-reimbursed drug for two years following its domestic approval, will change.

 

Astellas representative stated, "Padcev combination therapy has changed the paradigm of the first-line treatment of metastatic urothelial carcinoma after 30 years and a demonstrated therapy with superior clinical benefits.

 

We will strive to closely talk with the government and interested parties so that Korean patients with metastatic urothelial carcinoma receive benefits." The efficacy of Padcev monotherapy was demonstrated through the global EV-301 Phase 3 clinical study, which compared Padcev to existing chemotherapy in 608 patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors.

 

The study results have shown that Padcev treatment lowered the death risk by approximately 30% compared to the existing chemotherapy, and the Padcev treatment group had a median overall survival (OS) of 12.9 months, significantly improving the OS compared to the 9.0 months of those treated with chemotherapy.

 

The efficacy of Keytruda combination therapy was demonstrated through the EV-302 clinical study presented during the 2023 Congress of the European Society for Medical Oncology (ESMO Congress 2023).

 

EV-302 is a randomized Phase 3 clinical study evaluating the effectiveness of Padcev+Keytruda combination therapy compared to platinum-based chemotherapy in 886 patients in 25 countries.

 

Based on the study, at the median follow-up of 17.2 months, the patients had a median OS of 31.5 months, extending the OS by approximately twofold compared to the platinum-based chemotherapy group, and reduced death risk by 53%.