The Korean Health Insurance Review and Assessment Service (HIRA) said Monday that it would cancel reimbursement expansion for malignant melanoma treatment Zelboraf (ingredient: vemurafenib).

Zelboraf, co-developed by Roche’s subsidiary Genentech and Plexxikon, is a B-Raf enzyme inhibitor to treat late-stage melanoma. The drug first gained insurance coverage last July when used in the “first administration phase” to treat patients with BRAF V600E mutated melanoma who cannot undergo surgery or have had the tumor spread to other parts of the body.

HIRA’s cancellation of expanded coverage aims to remedy procedural errors in trying to expand reimbursement, it said. Because Zelboraf was insured without an economic evaluation, expanded coverage would require additional drug negotiations or a company proposal that proves the drug’s cost-effectiveness.

Roche did not submit further proof of the drug’s efficacy against the cost, HIRA said. The health agency said it left a grace period until Thursday to survey opinions.

Regarding the decision to cancel expanded coverage, Roche Korea said that it hoped HIRA reaches a “reasonable” conclusion to improve patient access to medical treatment opportunities.

yjc@docdocdoc.co.kr

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