[Reporter’s View]Kudos to Keytruda for filing 13 reimb apps

MSD applied for the reimbursement of 13 indications for Keytruda

A truly extraordinary case has emerged.

 

MSD Korea has applied for the reimbursement of 13 Keytruda indications at once.

 

This is an unprecedented event, the first time such a large amount of applications had been filed for a single drug since the positive list system was implemented for drug reimbursement in Korea.

 

After submitting the applications, MSD explained “Cancer is in itself an aggressive and life-threatening condition, and we saw that there was a dire need for improved access to Keytruda in the field due to the lack of alternatives or reimbursed latest treatment options.

 

To address the need, the company decided to apply for the extended reimbursement of Keytruda to cover indications with high clinical need or reimbursement.

 

We seek to improve treatment access to all patients that can benefit from Keytruda.” We should first applaud the company for its effort.

 

Considering the rising number of non-reimbursed immuno-oncology drug indications piling up in the field, MSD duly served its mission as a pharmaceutical company by applying for the reimbursements, regardless of success or failure.

 

Keytruda is currently reimbursed for 7 indications in 4 cancer types in Korea.

 

Applying for the reimbursement of 13 indications is not an easy task.

 

As a drug under the Risk Sharing Agreement scheme, its each and every indication must undergo an evaluation process comparable to that of a new drug to extend reimbursement.

 

Pharmacoeconomic evaluations must be performed for indications that were approved based on a Phase III trial to demonstrate cost-effectiveness, and those approved based on a Phase II trial must undergo negotiations to receive pharmacoeconomic evaluation waivers.

 

The relevant health authorities including the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service also have a lot on their hand as they must concurrently evaluate numerous indications of a single drug.

 

Therefore, the reimbursement extension process will also require considerable effort on the government’s part.

 

Considering how this is an unprecedented situation and that the pharmaceutical companies would not have applied for the reimbursement of 13 indications without prior discussion with the government, anticipation is rising on how the results will turn out for Keytruda.

 

In an era where a single drug owns multiple indications, I hope Keytruda’s case will set a milestone and serve to resolve the rising issues in Korea’s reimbursement extension process.

 

Meanwhile, the 13 indications Keytruda applied for were: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer, ▲persistent, recurrent, or metastatic cervical cancer, ▲ advanced endometrial carcinoma, ▲metastatic endometrial carcinoma that is microsatellite instability-high (MSI⁠-⁠H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI⁠-⁠H or dMMR colorectal cancer ▲metastatic MSI⁠-⁠H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer.