Immunotherapies have become so effective and popular that some cancer patients were cured. However, they are still a hot potato for the Korean authorities to decide whether to give them insurance benefits because of their low response rates and high prices.
Recently, the government suggested “performance-based reimbursement criteria” to pharmaceuticals, allowing reimbursements only to immunotherapies with meaningful drug response to give cancer patients easier access to immunotherapies and minimize the government’s spending.
“Immunotherapies show good therapeutic effects in patients with a response. However, their efficacy remains for a very short time, or they don’t work at all in patients without any response,” the Health Insurance Review and Assessment Service (HIRA) said. “We could not give insurance coverage to all of the patients who meet the current standard of PD-L1 (programmed death-ligand 1) response rate. That is why we came up with this measure.”
Critics said PD-L1, the criteria for approval of an immunotherapy and insurance benefit, was a poor biomarker because it showed different determinant power depending on the types of cancer and patients’ sensitivity.
HIRA’s proposal to give insurance benefits according to treatment results after injecting immunotherapies was aiming at both guaranteeing patient’s accessibility to treatment and reducing the government’s financial burden.
However, only Roche (Tecentriq, atezolizumab) agreed on the government’s proposal among immunotherapy makers including MSD (Keytruda, pembrolizumab) and Ono Pharmaceutical‧BMS (Opdivo, nivolumab).
Whether the HIRA’s scheme will be ever feasible is uncertain because the firms selling the two leading drugs (Keytruda, Opdivo) that arrived in Korea first did not accept the government’s suggestion.
The pharmaceutical firms would have thought there was no reason to narrow down the patient group for the immunotherapies and pay more for the drugs because they have already obtained approval.
However, I do not think accepting the government’s proposal will harm the drugmakers.
First of all, I am convinced that immunotherapies will be used more widely. It is highly likely that their targets will be expanded from lung cancer to bladder, gastric, and liver cancer. The treatment period is being advanced from the fourth stage to the third, or earlier. Clinical studies on pre-operative adjuvant therapies are underway.
More extensive use of immunotherapies means a rapid increase in the government’s financial burden. So, the government is likely to apply more strict criteria for expanding drugs’ targeted patient groups or the period of drug use.
If reimbursement is available on the condition of efficacy, patients and physicians will demand access to immunotherapies more actively. Then, the government will find it difficult to ignore their demands. Such a scenario is possible because single-agent immunotherapy can treat various cancer diseases.
“The performance-based reimbursement criteria” is not completely new or innovative. We can refer to it as “risk-sharing agreement for immunotherapies.” So, it could create a new problem or become a meaningless additional measure.
However, the government’s proposal came after a thorough review to promote the use of immunotherapies.
I hope that just like late-runner Roche agreed with the government on the new reimbursement criteria for immunotherapies, other companies, including MSD, will follow suit.