Reimb expansions of Keytruda have failed the 4th CDRC

In addition to the 13 already included in the initial application, two additional indications were included for the review at once

The first assessment of MSD Korea's financial contribution proposal…“Yet insufficient”

MSD Korea’s cancer immunotherapy drug

Keytruda’s reimbursement expansion item did not cross the Cancer Disease Review Committee (CDRC) threshold for the fourth time following its expansion in June last year.

 

The analysis is that this attempt is particularly significant as all 15 indications were reviewed by the CDRC, and MSD’s financial contribution proposal was discussed for the first time.

 

During the 3rd CDRC in 2024, held on April 17th, the reimbursement expansion of MSD Korea’s cancer immunotherapy drug 'Keytruda (pembrolizumab)' was reviewed but failed in securing reimbursement expansion.

 

The CDRC announced during the meeting, it decided to postpone setting reimbursement criteria for 15 indications, including endometrial cancer.

 

It was decided that the setting of reimbursement criteria would be reconsidered upon the additional submission of financial contribution proposal.

 

All 15 indications included in the reimbursement expansion application were reviewed.

 

In June of last year, MSD Korea submitted Keytruda’s reimbursement expansion application to the Health Insurance Review and Assessment Service (HIRA) for 13 indications with high unmet needs in medical fields in Korea.

 

MSD's application includes 13 indications: ▲ Early-stage triple-negative breast cancer ▲ Metastatic or recurrent triple-negative breast cancer ▲ Metastatic or recurrent head and neck cancer ▲ Advanced or metastatic esophageal cancer ▲ Adjuvant therapy after renal cell carcinoma surgery ▲ Non-invasive bladder cancer ▲ Persistent, recurrent, or metastatic cervical cancer ▲ Advanced endometrial cancer ▲ Metastatic endometrial cancer with MSI-H or dMMR ▲ Metastatic rectal cancer with MSI-H or dMMR that cannot be removed with surgery ▲ Metastatic small intestine cancer with MSI-H or dMMR ▲ Metastatic ovarian cancer with MSI-H or dMMR ▲ Metastatic pancreatic cancer with MSI-H or dMMR.

 

The company recently added two additional indications.

 

It was reported that MSD applied for the reimbursement expansion of two indications last December: gastric cancer with MSI-H and bile duct cancer with MSI-H.

 

Three indications were assessed at the CDRC meeting in October last year, where Keytruda's reimbursement expansion was first discussed.

 

Then, 4 indications were assessed in November of the same year, and 6 indications were assessed in January of this year.

 

The CDRC said at each review, “We will prioritize reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion.

 

Upon receiving the pharmaceutical companies' financial contribution proposal towards proven indications, we have decided to analyze its impacts to establish reimbursement criteria.” Furthermore, during this CDRC review, 15 indications, including the previously discussed 13 and the two additional indications applied for in December, were all brought to the review table.

 

This indicates that the CDRC prioritized reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion.

 

In other words, the initial assessment of indication has been completed.

 

The committee will discuss establishing final reimbursement criteria for the next step after reviewing the pharmaceutical companies' financial contribution proposal.

 

It was reported that the financial contribution proposal submitted by MSD Korea was added as an additional agenda item just two days before the CDRC review.

 

This suggests that pharmaceutical companies deliberated on their financial contribution proposals until the last minute.

 

However, it has been reported that members of the CDRC were not satisfied with the financial contribution proposal submitted by MSD.

 

Keytruda's reimbursement expansion in the future depends on how much MSD is willing to compromise in their financial proposal.

 

“Keytruda is reimbursed for 7 indications, and its domestic sales reach KRW 400 billion,” an industry expert explained.

 

He added, “If the pharmaceutical company does not submit a new financial contribution proposal, it may not be possible to reimburse all 15 indications at once.”