Will ‘Keytruda’ be reviewed for reimbursement in May?

MDS Korea submits alternative plan proposing to bear the initial administration cost burden by adjusting reimbursement rate, etc.

MSD Korea, “Will do our best in discussions with the government to expand patient coverage”

MSD Korea threw a game-changer for the reimbursement expansion of the immunotherapy drug ‘Keytruda.’ According to industry sources, the company has once again submitted a revised cost-sharing proposal to the Health Insurance Review & Assessment Service (HIRA) to expand the reimbursement of ‘Keytruda (pembrolizumab)’ to cover first-line treatment of non-small cell lung cancer (NSCLC).

 

With the submission, the industry’s eyes are on whether the issue will put on the agenda for deliberation by the Cancer Drug Review Committee in May.

 

If selected, this will be the 8th discussion held by the Committee for Keytruda.

 

The decision for the drug was put on hold at the committee meeting in August last year as the committee determined that MSD Korea’s proposal lacked compromise on the company’s part.

 

In September of the same year, HIRA handed the proposal back to MSD Korea and requested a 're-revision.' A month later, MSD Korea submitted a re-revised proposal, which was discussed by the Reimbursement Standard Sub-committee meeting but to no avail.

 

The agenda of Keytruda’s reimbursement was not discussed by the Cancer Drug Review Committee.

 

So, once again, MSD Korea submitted a cost-sharing plan to HIRA this year.

 

The proposal submitted by MDS this time contains an offer equivalent to the company ‘covering the initial 3 cycles’ worth of administration cost’ through measures including adjusting the reimbursement rate.

 

If the new cost-sharing proposal is reviewed and, again, rejected by the Cancer Drug Review Committee, expanded reimbursement for Keytruda will likely be difficult to achieve.

 

An MSD official said, “Although we cannot share details as discussions with the government are still ongoing, we will do our best so that our patients in Korea can promptly receive the global standard-of-care treatment.” Meanwhile, MSD Korea has submitted additional applications to expand the indication of its PD-1 inhibitor Keytruda (pembrolizumab) ▲ as first-line treatment in patients with microsatellite instability-high (MSI-h) or mismatch repair deficient (dMMR) advanced colorectal cancer; and ▲ as first-line treatment in combination with platinum-based chemotherapy for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that is not amenable to surgical resection