Reimb extensions for Keytruda to be rediscussed later

Results of the CDDC deliberations

Will analyze the impact of the financial sharing plan for indications with proven necessity

Reimbursement standards for Kyowa Kirin's 'Portelligio', Poteligeo Inj.’ and Pfizer Korea’s ‘Mylotarg Inj.’ have been established

MSD Korea's immunotherapy drug 'Keytruda (pembrolizumab)', which applied for a large-scale reimbursement extension, was unable to pass the first hurdle and was determined in need of rediscussions.

 

The authorities plan to first receive the pharmaceutical company's financial sharing plan and then decide whether to set a reimbursement standard.

 

The Health Insurance Review and Assessment Service announced that it decided to rediscuss the agenda of expanding the reimbursement standard for Keytruda at the 7th 2023 Cancer Disease Deliberation Committee meeting that was held on the 11th.

 

The indications for Keytruda that were deliberated for reimbursement extensions were ▲ as a first-line treatment in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either who express programmed death ligand 1 (PD⁠-⁠L1) [combined positive score (CPS) ≥10]; ▲ for use in combination with lenvatinib to treat patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation; and ▲the treatment of patients with unresectable or metastatic MSI⁠-⁠H or dMMR colorectal cancer (CRC).

 

The CDDC explained, “We plan to first review the medical feasibility and medical necessity for each indication among the many indications the company applied to extend Keytruda’s reimbursement to and receive the pharmaceutical companies' financial sharing plan (drafts) for the overall finances of proven indications to determine their impact before setting the reimbursement standards.” Keytruda is an anti-PD-1 immunotherapy drug, that is currently being reimbursed for 7 indications for 4 cancer types in Korea.

 

Last year, its reimbursement was extended to include its use as a first-line treatment for non-small cell lung cancer.

 

Keytruda has 38 indications in 18 cancers approved under the US Food and Drug Administration (FDA).

 

In Korea, the company applied to extend reimbursement to 13 of the indications in June.

 

The 13 indications Keytruda applied for are as follows: ▲ 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 This time, the government deliberated on extending reimbursement to 3 of the indications.

 

Meanwhile, the reimbursement standards for 2 new anticancer drugs have been established.

 

Kyowa Kirin Korea’s ‘Poteligeo Inj.’ and Pfizer Korea’s ‘Mylotarg Inj.’ are the beneficiaries.

 

However, the government decided to rediscuss the reimbursement of Handok’s ‘Pemazyre Tab.’ Also, Folfirinox (oxaliplatin + irinotecan + leucovorin + 5-FU), which has sought to expand reimbursement as neoadjuvant chemotherapy for borderline resectable pancreatic cancer, succeeded in setting reimbursement standards.