Health insurance coverage for the colon cancer drug Braftovi (encorafenib) is unlikely to be available this year.
The National Health Insurance Service (NHIS) and Ono Pharmaceutical recently decided to extend the drug price negotiations for Braftovi after failing to reach a deal by the deadline.
Braftovi is a targeted therapy used in combination with cetuximab in patients with previously treated BRAF V600E-mutated metastatic colorectal cancer. Its phase 3 trial demonstrated a survival benefit over the widely used irinotecan/FOLFIRI+cetuximab combination. It is the only agent leading global guidelines recommend to treat BRAF V600E-mutated colorectal cancer.
After receiving approval for Braftovi from the Ministry of Food and Drug Safety (MFDS) in August 2021, Ono Pharmaceutical immediately applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA). It quickly passed the Cancer Disease Review Committee in January 2022, but it was not until last August that the Pharmaceutical Reimbursement Evaluation Committee recognized the appropriateness of the reimbursement.
It took two years to clear the drug evaluation panel after receiving approval from the MFDS. In the meantime, patients have been paying more than 12 million won ($9,280) monthly for the treatment. They posted a petition on the National Assembly's petition board to appeal for a speedy review for reimbursement.
It once seemed that Braftovi's reimbursement would be accelerated after its recent passage of the drug evaluation committee. In the end, however, the NHIS and the pharmaceutical company could not narrow their differences and failed to end the negotiation by the deadline.
The news has raised the anxiety of patients once again.
Patients have been waiting for nearly two years for the drug to be reimbursed after passing the cancer screening panel and are worried that the drug price negotiations would collapse.
A patient surnamed Chung, who started a petition drive early this year, emailed Korea Biomedical Review recently, saying that "every month poses a very big financial burden on patients."
"Given they have come this far, we hope there won't be a deal collapse,” the patient said. "I have gotten used to waiting but still find it very painful to think of such a possibility."
What frustrates these patients most is they cannot know the reimbursement status of the drugs they are waiting for.
"Sixty days have passed since an order was given to negotiate the drug price, but there is no way to confirm if the negotiation has been concluded," Chung said.
An official from Ono Pharmaceutical acknowledged the extension of the drug price negotiation.
"We are in a situation where we need separate approval and discussion with the headquarters,” the official said. “It seems that (Braftovi’s reimbursement) will be delayed for about a month longer than expected."