Reimb for 'Padcev' combo as a 1st-line treatment reapplied

Astellas has applied for reimbursement for both monotherapy and combination therapy…aiming to be considered for the upcoming Cancer Disease Review Committee in September

Unusual case of 'new drug + new drug' combination therapy…a methodological agreement between the company and gov't may be necessary

Will 'Padcev+Keytruda' combination therapy overcome the reimbursement hurdle in the area of metastatic urothelial cancer, where the first-line treatment option had not been available?

 

In terms of treatment effectiveness, there is no disagreement among experts that, in the long term, it is a first-line standard treatment option.

 

With Astellas now taking proactive steps, reimbursement entry will ultimately be the key factor.

 

Astellas Pharma Korea held a press conference on August 18 to celebrate the first anniversary of the domestic approval of Padcev (enfortumab vedotin) in combination therapy for first-line metastatic urothelial carcinoma

Astellas Pharma Korea held a press conference on August 18 to celebrate the first anniversary of the domestic approval of Padcev (enfortumab vedotin) in combination therapy for first-line metastatic urothelial carcinoma and shared its future strategy.

 

The Padcev + Keytruda combination therapy was approved by the Ministry of Food and Drug Safety (MFDS) last July for the first-line treatment of locally advanced or metastatic urothelial carcinoma.

 

The basis for the approval was the Phase 3 KEYNOTE-A39/EV-302 clinical trial.

 

The results, which evaluated the efficacy of the Padcev + Keytruda combination therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma, showed that it approximately doubled both the overall survival (OS, 31.5 months) and the progression-free survival (PFS, 12.5 months) compared to platinum-based chemotherapy.

 

Professor Jeong Min Cho of the Department of Oncology at Ewha Womans University Mokdong Hospital explained, "Metastatic urothelial carcinoma is a type of cancer with a very low survival rate of 14.3%, giving it a poor prognosis similar to highly fatal lung cancer." She added, "Due to its aggressive nature and the high proportion of elderly patients, the patient's condition often deteriorates rapidly during the early stages of treatment."

Professor Jeong Min Cho of the Department of Oncology at Ewha Womans University Mokdong Hospital

Professor Cho continued, "The Padcev first-line combination therapy has been confirmed to show therapeutic effects similar to those in clinical studies in clinical practice, establishing itself as an option that can provide a powerful treatment response in the early stages of treatment." A year after its approval, the demand from the field for the Padcev + Keytruda combination therapy is for expanded access through reimbursement.

 

On this day, Professor Cho said, "In clinical practice, we are constantly getting inquiries from patients about whether it's covered by insurance." In addition to the drug's efficacy, hurdles such as the cost burden create apparent limitations in treatment access.

 

Professor Cho emphasized, "It is often difficult to recommend to patients due to the high cost burden, and I feel heavy-hearted that we cannot provide the best treatment opportunity on time." She stressed, "As Padcev is recommended as the top first-line option in major global guidelines, institutional support is urgently needed in Korea as well." Currently, Astellas has reportedly re-applied to the health authorities for reimbursement for both the Padcev + Keytruda combination therapy and Padcev monotherapy for first-line and later treatment of metastatic urothelial carcinoma.

 

It is also known to have proactively submitted a proposal for sharing financial burdens.

 

This is interpreted as a move to secure reimbursement for both combination therapy and monotherapy simultaneously, in preparation for submission to the upcoming Cancer Disease Review Committee in September.

 

However, a view exists that a company's strategy is crucial because it is a combination of two new drugs still acts as a stumbling block.

 

Baek So-young, Managing Director of Medical Affairs at Astellas, stated, "One might think that reimbursement would be faster for second-line or later treatments, but in reality, it takes a long time to get cancer drug reimbursement in Korea." She explained, "We applied for first-line reimbursement because we believe it provides an opportunity to save more patients." Baek added, "In terms of opening a new path for combination therapy of new drugs, the company is open to all options," and concluded, "If there is a will to reimburse Padcev, a methodological agreement can be reached through negotiation.

 

As of now, the company has not set any restrictions."