Semblex and Onurex to Negotiate, Bidamax at Threshold of Negotiation

Semblex and Onurex to Negotiate, Bidamax at Threshold of Negotiation

The Korea Institute of Drug Safety & Risk Management has decided that the anti-leukemic drug Semblex (active ingredient Asciminib) and the anti-allergy drug Onurex (active ingredient Azacitidine) are deemed appropriate for reimbursement, and will move on to negotiation stages.

Regarding the RET targeted therapy drug Lenvatinib (active ingredient Selvocarcinib), discussion of its appropriateness for reimbursement will be revisited after supplementary data has been submitted.

On the 6th of January 2023, the Korea Institute of Drug Safety & Risk Management held the 4th evaluation committee meeting for medicine reimbursement, and assessed the appropriateness of healthcare benefits for the drugs under consideration.

Novartis's Semblex, used in treating Philadelphia chromosome-positive chronic myelogenous leukemia, was evaluated as appropriate for reimbursement. Last month, the drug was approved by the Serious Illness & Cancer Evaluation Committee and is swiftly undergoing the reimbursement process.

Onurex, which has shown efficacy and effects in maintenance therapy following induction therapy in adult patients with acute myelogenous leukemia, was also deemed appropriate for reimbursement. Accordingly, Semblex and Onurex will proceed to the next stage of the reimbursement process and negotiate with the National Health Insurance Corporation upon the Ministry of Health and Welfare's negotiation order.

Lilly Korea's Lenvatinib, a RET targeted therapy drug, has been decided for re-evaluation. The company is required to submit supplementary data for the evaluation. Lenvatinib is one of the 'life-threatening or serious therapeutic' products approved through the Ministry of Food and Drug Safety's expedited review system. RET gene mutations are found in about 2-6% of non-small cell lung cancer cases, and it is known that patients with metastatic RET fusion-positive non-small cell lung cancer may experience brain metastases of up to 50% throughout their lifetime.

Kyowa Kirin's Nepocsil capsule (active ingredient Ferrous Succinate), a treatment for hyperphosphatemia in chronic kidney disease patients undergoing hemodialysis, is conditionally reimbursed. If the acceptance price is below the evaluation amount, it will be recognized as appropriate for reimbursement.

Korea's Vutimex capsule (active ingredient Tafamidis), a treatment for wild-type or genetic transthyretin amyloid cardiomyopathy (ATTR-CM), was evaluated as not appropriate for reimbursement.

Novartis's another new drug application, Tabrecta (active ingredient Capmatinib), was also evaluated as not appropriate for reimbursement. It is indicated for locally advanced or metastatic MET exon 14 skipping-positive non-small cell lung cancer.