Besremi passes cancer drug reimbursement panel in 2nd try

PharmaEssentia's polycythemia vera (PV) drug Besremi (rofeginterferon alfa-2b), which is rechallenging for insurance coverage, has passed the first gateway of the Cancer Disease Review Committee (CDRC).

HK inno.N's application for a new benefit for the antinausea and antivomiting drug Akynzeo (fosnetupitant/palonosetron) and expanding the benefit standard for capecitabine anticancer drugs, including Boryung's Xeloda also passed the threshold.

The Health Insurance Review and Assessment Service (HIRA) released the results of the deliberations on the reimbursement standards for drugs used for cancer patients, including improved reimbursement standards reflecting clinical reality, at this year’s fifth CDRC meeting on Wednesday.

Three new drugs were reviewed for new reimbursement -- Besemi, Akynzeo, and Roche's blood cancer drug Columvi (glofitamab).

Of the three, Besemi and Akynzeo succeeded in setting the reimbursement threshold.

Besremi, which tried again a year after its failure at CDRC in July of last year, crossed the threshold this time around, three years after receiving approval from the Ministry of Food and Drug Safety (MFDS).

The reimbursement standard was set for "treating patients with PV without symptomatic splenomegaly in the low-risk (only for those requiring cytoreductive therapy) and high-risk group.

Akynzeo, imported and marketed by HK inno.N, won the MFDS’ approval in October 2022, with the reimbursement criteria set for "prevention of acute and delayed nausea and vomiting induced by initial and repeated treatment with moderately or severely emetogenic anticancer chemotherapeutic agents.

Columvi, which received MFDS’ approval last December, failed its first reimbursement challenge. Columvi is a bispecific antibody that targets both CD20 and CD3 and won the nod for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies.

Besides, capecitabine-based anticancer drugs, including Boryung’s Xeloda, Roche's Tecentriq (atezolizumab), and Janssen's Erleada (apalutamide) were also tabled for coverage expansion.

Of these, only Xeloda set reimbursement standards for "postoperative adjuvant treatment of stage 3 (Dukes' C) colorectal cancer," while Tecentriq and Erleada failed to do so.

Roche Korea added supplemental overall survival (OS) data to expand coverage for Tecentriq as an adjuvant in early-stage NSCLC, but the second challenge was also unsuccessful.

Janssen Korea tried to expand coverage for Erleada’s added indication of "treating high-risk non-metastatic castration-resistant prostate cancer (nmCRPC)" in April last year but failed.

Meanwhile, HIRA continuously reviewed the improvement proposals requested by medical associations, including the Korean Medical Association and the Korean Hospital Association, last December by forming an anticancer drug task force, and disclosed the deliberations results on four items reviewed by the CDRC.

First, a request for an expanded dose level for Inlyta (axitinib) in urothelial cancer was granted. As a result, Inlyta monotherapy in clear cell carcinoma will be expanded from the current regimen dose level of second-line to second-line or higher.

In urologic cancers, other changes include refinements to IMDC, a prognostic indicator for kidney cancer, and a request to allow "muscle infiltration" to be defined by imaging rather than biopsy for patients receiving prior chemotherapy for urothelial cancer.

In addition, the request to recognize the RANO criteria for brain tumor response assessment in brain tumors was accepted.