Merck’s Keytruda, Handok’s Pemazyre, and other immunotherapies under the microscope in recent oncology review.
The reimbursement criteria for Merck's immunotherapy drug, 'Keytruda' (containing the active ingredient pembrolizumab), in the United States, subject to an ongoing review for expanded indications, are now slated for further discussion. Among the 13 indications submitted for reimbursement expansion, a select few were evaluated in the review.
On October 11th, the Health Insurance Review and Assessment Committee (HIRA) convened for the 7th Oncology Review Committee for the year 2023. The primary agenda of this meeting was to deliberate upon the reimbursement criteria for anti-슬롯 머신 사이트 drugs.
In a prior development in June, Merck (MSD) sought to extend the reimbursement criteria for Keytruda to encompass 13 different 슬롯 머신 사이트 indications. These indications include early triple-negative breast 슬롯 머신 사이트, metastatic or recurrent triple-negative breast 슬롯 머신 사이트, metastatic or recurrent head and neck 슬롯 머신 사이트, advanced or metastatic esophageal 슬롯 머신 사이트, post-surgery adjuvant therapy for new cell 슬롯 머신 사이트, non-invasive bladder 슬롯 머신 사이트, persistent, recurrent, or metastatic cervical 슬롯 머신 사이트, advanced endometrial 슬롯 머신 사이트, high-frequency microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) metastatic endometrial 슬롯 머신 사이트, MSI-H or dMMR inoperable or metastatic colorectal 슬롯 머신 사이트 (KN-177), MSI-H or dMMR metastatic colon 슬롯 머신 사이트, MSI-H or dMMR metastatic ovarian 슬롯 머신 사이트, and MSI-H or dMMR metastatic pancreatic 슬롯 머신 사이트. These 슬롯 머신 사이트s are considered highly aggressive and present a significant threat to patient survival, often lacking viable alternative treatments or approved therapies, which underscores the unmet medical need, as explained by the company.
However, during the recent oncology review, the committee focused its discussions on the following specific indications:
① Use of Keytruda as the primary treatment for patients with inoperable locally advanced or metastatic esophageal 슬롯 머신 사이트 expressing positive PD-L1 (CPS≥10).
② Combination therapy involving platinum and fluoropyrimidine-based chemotherapy for patients with HER-2 negative junctional stomach 슬롯 머신 사이트, located at the epicenter of the lesion (1-5 cm above the gastroesophageal junction).
③ Treatment with Keytruda for patients with progressive endometrial 슬롯 머신 사이트, not exhibiting MSI-H or dMMR, where progression has been confirmed after prior systemic therapy, and surgical or radiation therapy is not a suitable option; this would involve combination therapy with lenvatinib.
④ Treatment with Keytruda for patients with inoperable or metastatic colorectal 슬롯 머신 사이트 exhibiting MSI-H or dMMR, involving combination therapy with regorafenib.
As a result, the committee has resolved to initiate a re-evaluation process. This re-evaluation will give priority to assessing the medical validity and clinical necessity for each of the numerous indications for which reimbursement expansion has been proposed. Additionally, an analysis of the financial impact of the pharmaceutical company's proposal on the overall reimbursement for established indications will be conducted, and discussions will ensue regarding the determination of reimbursement criteria. Furthermore, Handok’s 'Pemazyre' (containing the active ingredient Pemigatinib) is also scheduled for re-evaluation.
In parallel developments, Kyowa Kirin's 'Poteligeo' (containing the active ingredient mogamulizumab) and Pfizer's 'MyloTarg' (containing the active ingredient Gemtuzumab Ozogamicin) have successfully had their reimbursement criteria established. Poteligeo serves as a therapeutic agent for patients with mycosis fungoides or Sézary syndrome who have previously undergone one or more systemic therapies, while MyloTarg is a treatment designed for newly diagnosed adult CD33-positive acute myeloid leukemia (AML) patients.