Darzalex SC, Polivy move closer to reimbursement, while Verzenio faces another setback
Janssen Korea's Darzalex SC (daratumumab) and Roche Korea's Polivy (polatuzumab vedotin)” have surmounted the first hurdle toward health insurance coverage by passing the Cancer Disease Review Committee (CDRC), five years after receiving approval from the Ministry of Food and Drug Safety (MFDS).
The immunotherapy drug Tecentriq (atezolizumab) and the CDK4/6 inhibitor Verzenio (abemaciclib)’ were reviewed for reimbursement as adjuvant therapy for early-stage lung cancer and breast cancer patients, respectively, but the outcomes were mixed.
On Wednesday, the Health Insurance Review and Assessment Service (HIRA) held a CDRC meeting and approved reimbursement criteria for certain indications of Darzalex and Polivy.
Darzalex SC and Polivy, approved by the MFDS in June and October 2020, respectively, finally cleared the CDRC threshold after five years, but only partially.
Darzalex SC is a subcutaneous injection developed to improve the convenience of administration compared to the existing intravenous injection, the CD38 antibody Darzalex. Janssen Korea has applied for reimbursement for Darzalex SC for treating “light chain (AL) amyloidosis,” an indication exclusive to Darzalex SC, in addition to the five indications (DVMP, DVTd, DRd, DVd, and monotherapy) for which the intravenous formulation is currently reimbursed.
However, the CDRC has only approved reimbursement criteria for the combination therapy of bortezomib, cyclophosphamide, and dexamethasone in patients newly diagnosed with AL amyloidosis.
Roche Korea also applied for reimbursement for Polivy’s two therapies (Pola-R-CHP and Pola-BR) indicated for treating diffuse large B-cell lymphoma (DLBCL). However, the CDRC approved reimbursement criteria only for the combination therapy of rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone (Pola-R-CHP) for adult patients with DLBCL who have not previously received treatment.
Roche Korea's Tecentriq has become the first anti-PD-(L)1 immunotherapy to receive reimbursement criteria for adjuvant therapy in patients with early-stage non-small cell lung cancer following surgery. The reimbursement criteria are set as “adjuvant therapy administered after resection and platinum-based chemotherapy for patients with stage 2-3A non-small cell lung cancer with a PD-L1 expression rate of 50 percent or higher in tumor cells (TC).”
On the other hand, Lilly Korea's attempt to reapply for reimbursement for its Verzenio adjuvant therapy was also unsuccessful this time. Verzenio is the only CDK4/6 inhibitor approved for use as adjuvant therapy after surgery in patients with hormone receptor-positive (HR+/HER2-) breast cancer, the most common subtype, who have a high risk of recurrence, such as lymph node-positive patients.
Still, reimbursement was not granted once again despite repeated requests from relevant academic societies.
However, under the recently revised reimbursement principles for combination therapy with anticancer agents, endocrine therapy used in combination is eligible for partial reimbursement (5/100) as before, and Verzenio can be used at the patient's full expense.
The proposal to expand reimbursement for Amgen Korea's Blincyto (blinatumomab) and the neutropenia treatment component pegfilgrastim, such as Neulasta by Kyowa Kirin Korea, has been approved by the CDRC.
Blincyto establishes its reimbursement criteria for indications in the consolidation therapy of adult and pediatric patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL). At the same time, pegfilgrastim-containing formulations received coverage for treating febrile neutropenia and reducing the duration of neutropenia in patients undergoing cytotoxic chemotherapy for malignant tumors.