Koselugo gains committee approval, Tagrisso coverage expands

2023-09-11     Hyeokgi Lee, Newsmp

[Newsmp] South Korea's Drug Reimbursement Evaluation Committee under the Health Insurance Review and Assessment Service (HIRA) has approved three drugs, including Koselugo for neurofibromatosis.

During the 10th committee meeting on the 7th, HIRA has passed insurance coverage of four drugs, including an extension of coverage, while two were granted conditional approval, and one was determined to remain uncovered.

Tagrisso (osimertinib) from AstraZeneca Korea, which applied for expanded coverage, was approved by the committee.

Furthermore, AstraZeneca Korea's Koselugo Capsule (selumetinib hydrogen sulfate) 10mg and 25mg has been granted insurance coverage for neurofibromatosis type 1 with plexiform neurofibromas.

Novartis Korea's Luxturna (voretigene neparvovec) has been approved for reimbursement for the treatment of inherited retinal dystrophy caused by biallelic RPE65 mutations, and GSK's Nucala (mepolizumab) has also received approval for reimbursement to treat severe eosinophilic asthma.

On the other hand, AstraZeneca Korea's Fasenra Pre-filled Syringe (benralizumab), applied for severe eosinophilic asthma like Nucala, has been determined to be non-reimbursable.

The drugs granted conditional approval for reimbursement are Pfizer Korea's Zavicefta Inj. 2g/0.5g (ceftazidime/avibactam)' and Bosulif Tab. (bosutinib monohydrate)' in 100mg, 400mg, and 500mg.

Zavicefta and Bosulif have been approved for reimbursement when the evaluation cost remains under a certain threshold. Zavicefta has proven its effectiveness in managing three conditions: complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Hospital-acquired pneumonia (HAP), which includes ventilator-associated pneumonia (VAP). Bosulif has demonstrated its treatment efficacy for Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

The drugs that passed the committee will be covered by insurance if the price is negotiated with the National Health Insurance Service and approved by the Health Insurance Policy Deliberation Committee.