Will Polivy secure reimbursement approval this year?

a new blood cancer drug

Polivy is expected to be presented to the 1st Cancer Disease Review Committee in 2024 this week

After an unsuccessful attempt to secure listing as a third-line treatment, Polivy re-applied for approval as a first-line treatment last year

Roche Korea’s Polivy (polatuzumab vedotin)

The question of whether ‘Polivy,’ a B-cell lymphoma treatment, will be listed for insurance reimbursements this year is garnering significant attention.

 

According to industry sources, Roche Korea’s Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be presented to the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st.

 

Previously, in 2021, Polivy made an initial attempt to obtain reimbursement listing for its third-line treatment as a combination therapy with BR therapy (bendamustine/rituximab).

 

However, Polivy did not receive approval from the Cancer Disease Review Committee.

 

In the first half of last year, Roche applied for reimbursement as a first-line treatment, in combination with other pharmaceuticals, including rituximab plus cyclophosphamide, doxorubicin, and prednisone.

 

As the first CD79b-directed antibody-drug conjugate (ADC), Polivy received approval for its indication as a first-line treatment in Korea in November 2022.

 

This approval was granted approval based on the demonstrated efficacy in Phase 3 POLARIX clinical trial results.

 

The POLARIX trial conducted follow-up of all patients for more than 24 months.

 

During the 28.2-month follow-up period, patients with DLBCL treated with first-line Polivy and R-CHP combination therapy showed a 27% reduction in the risk of disease progression or death compared to those treated with R-CHOP.

 

Among the most commonly reported adverse reactions of Polivy combination therapy, with a frequency of more than 30%, are peripheral neuropathy (52.9%), nausea (41.6%), neutropenia (38.4%), and diarrhea (30.8%).

 

DLBCL, which is an aggressive form of blood cancer, is the most common type of non-Hodgkin lymphoma.

 

In Korea, approximately 5000 patients are newly diagnosed with DLBCL every year.

 

DLBCL falls into the category of aggressive lymphoma, which requires immediate treatment due to the fast progression of the disease.

 

About half of the patients reach remission following treatment due to their positive responsiveness to the therapy.

 

However, approximately 30-40% of the patients are still non-responsive to the standard therapy, R-CHOP, or experience remission after receiving first-line treatments.

 

Most patients with relapsed or refractory DLBCL experience recurrence within two years, and the duration of survival after recurrence is estimated to be only six months.

 

Despite these critical conditions, not many effective treatment options are available for patients with relapsed or refractory DLBCL.