13 of Keytruda’s indications await ‘redeliberation’

but Keytruda’s reimbursement journey has just begun in Korea

The final 6 indications remain pending after deliberation at first DREC meeting in the new year

Company’s supplementary measures, including a fiscal-sharing plan, gain attention

The first result for the reimbursement for the remaining 13 indications of Keytruda was ultimately a collective ‘hold.’ However, the reimbursement journey for 'Keytruda' has just begun.

 

The Health Insurance Review and Assessment Service held its first Cancer Disease Deliberation Committee meeting of the new year on January 31st and reviewed the reimbursement of the remaining 6 indications for MSD Korea's PD-1 inhibitor immuno-oncology drug Keytruda (pembrolizumab) that were not reviewed last year, and issued another re-deliberation decision.

 

This completes the first round of reviews for Keytruda’s 13 indications for which the company applied for reimbursement in June last year.

 

3 indications were presented in October, 4 in November, and 6 in the most recent CDDC meeting.

 

At the time, MSD applied to extend reimbursement to 13 indications for its Keytruda.

 

The indications 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, ▲advanced 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 A re-deliberation decision is not a rejection.

 

It literally means that the agenda will be given a second look.

 

MSD Korea had applied for a large-scale reimbursement expansion for its Keytruda, which was an unprecedented event in the history of Korea's insurance benefits system.

 

Due to its large scale, the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, which are conducting the review, also need to take their time for serious deliberation and preliminary discussions.

 

In other words, the first re-deliberation decision was probably inevitable.

 

It would be more accurate to say that the first review was more of a preliminary review of the medical validity and necessity of reimbursing the 13 indications.

 

In fact, MSD appears to be quickly preparing for the redliberation process.

 

A company official said, "Through the first round of discussions, we completed discussions on the need for the reimbursement and clinical utility of Keytruda’s 13 indications.

 

MSD will now focus on building on the discussions made during the 3 rounds of deliberations and prepare additional measures to expand reimbursement, including a fiscal-sharing plan.”