Opinion Inquiry by February 4...Implement on February 10
Health insurance will cover when Novartis Korea’s Rafinlar(dabrafenib) and Meqsel(trametinib) are used in combination to treat non-small cell lung cancer. The relevant procedure is nearing the end.
The Health Insurance Review and Assessment Service(HIRA) prepared revision of ‘Details on the criteria and methods of medical care benefits for drugs prescribed and administered to cancer patients’ and pre-announced this on January 28th.
Two types of Rafinlar capsules(50mg, 75mg) and two types of Meqsel tablets(0.5mg, 2mg) are approved by the Ministry of Food and Drug Safety for treatment of melanoma. Later in March 2018, it added an indication for BRAF V600E gene mutation-positive metastatic non-small cell lung cancer.
However, these two products approved as drugs that can be shown to be effective only in treating metastatic NSCLC patients with confirmed BRAF V600E mutation.
The revision established the health insurance coverage criteria for the added indication.
In other words, the reimbursement criteria newly established for ▲ The combination of dabrafenib + trametinib in non-small cell lung cancer(first-line, palliative) ▲ The combination of dabrafenib + trametinib in non-small cell lung cancer(second-line, palliative).
The pharmaceutical benefit standard division, which is part of the HIRA, said that the medical evidence was found after reviewing and discusssing textbooks, guidelines, and clinical papers on the combination of Rafinlar and Meqsel in the treatment of NSCLC.
In addition, the division explained because there was no alternative medicine(targeted treatment) for BRAF V600E mutation non-small cell lung cancer, the combination of Rafinlar and Meqsel was recognized as medicines necessary for medical treatment that reimbursed by insurance.
It also disclosed the response rate, median progression-free survival and median overall survival of phase 2 studies in patients with previously untreated BRAF V600E non-small cell lung cancer and in patients who had previously failed treatment, and presented the basis of establishing reimbursement criteria for the first-line and second-line of treatment.
HIRA plans to gather opinions on the revision by February 4th and implement it from Feb. 10 if there are no objections.