Will Keytruda’s reimbursement standards be set this time?

Keytruda will receive its first CDDC review this year

First CDDC review for Keytruda to be held on the 12th…will discuss 17 indications

MFDS submitted an additional fiscal sharing plan last year…fiscal sharing remains a task

Third year since MSD first submitted Keytruda’s reimbursement extension application…how the company will seek to progress further after CDDC review gains attention

Keytruda, for which MSD had submitted reimbursement applications to extend its coverage to 17 indications, is gaining industry attention as it is expected to be presented to the Cancer Disease Deliberation Committee for the first time this year.

 

Pic of Keytruda

According to industry sources, MSD Korea's Keytruda (pembrolizumab) will be presented to the Korea Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee (CDDC) on the 12th.

 

Keytruda received a redeliberation decision for the two indications of gastric cancer at the 9th CDDC meeting in December.

 

There were hopes that a conclusion could be reached last October when MSD Korea submitted a new financial sharing proposal to expand coverage to 17 indications, including gastric cancer, but the year had passed with no solid results.

 

In particular, there were various interpretations of the fact that only the 2 additional gastric cancer indications were discussed at the CDDC meeting, as the company applied for coverage of 17 indications.

 

However, with Keytruda expected to be presented at the first CDDC meeting this year, industry eyes are on whether the tables will turn this time.

 

Keytruda is currently approved in 33 indications for 17 different cancers and has applied for reimbursement for 17 of those indications.

 

After applying for reimbursement for 13 indications in 2023, the company added four more indications last year: ▲ MSI-H gastric cancer, ▲MSI-H biliary tract cancer, ▲HER2-positive gastric cancer, and ▲HER2-negative gastric cancer.

 

The issue is how CDDC will view MSD's proposed fiscal sharing plan.

 

It is understood that the agency has asked MSD to provide additional data beyond its financial sharing plan.

 

Given that the last review only discussed gastric cancer, it will be interesting to see how the government will regard the cost burden of applying the additional reimbursement to the 17 indications.

 

At this point, it is unlikely that the CDDC will pass or fail review for individual indications.

 

The CDDC had reviewed all indications at the same time, with the exception of the gastric cancer indication, which was added last December after MSD filed for Keytruda's reimbursement in bulk.

 

This means that the decision is likely to be an all-or-nothing proposition.

 

This has led some to speculate that MSD may take on a different strategy if Keytruda's reimbursement extension is not approved in this CDDC review.

 

While there are advantages to applying for reimbursement extensions for many indications at once, the downside is that it is difficult to get feedback on individual indications.

 

Considering how even if the application passes CDDC review, there are still procedures such as the Drug Reimbursement Evaluation Committee and the National Health Insurance Service’s drug pricing negotiations, MSD may well worry about the lack of progress if there is no change in its third year of application.

 

“As it has been three years since MSD applied for the reimbursement extension, MSD would be contemplating on setting a specific strategy to overcome the current situation,” said an industry official.

 

”As MSD has stated that it submitted the reimbursement for multiple indications at once to not marginalize certain cancer types, I expect there will be discussions on various strategies depending on the results of the upcoming CDDC review.”