(317) Similarities of oral oncology drugs excluded by large pharmacy benefit managers (PBMs)

Background: : Since formulary exclusions were introduced in 2012, the number of excluded products has grown considerably from less than 100 products to well over 600 products in 2025 across CVS Health, Express Scripts (ESI) and OptumRx alone. While exclusions aim to decrease healthcare spend by encouraging the use of lower cost alternatives, they also limit provider choice and patient access.

Objective: : Understand the similarities of oral oncology drugs selected for formulary exclusion and identify trends among the exclusions that shape the current treatment landscape.

Methods: : Formulary exclusions were gathered from publicly available formulary listing and categorized by cancer type, mechanism of action (MOA), indication, and the presence of black box warnings. A descriptive analysis was conducted of 2025 Commercial formulary exclusions for CVS Health, ESI, and OptumRx, to isolate exclusions specific to oral oncolytics.

Results: : 34 oral oncolytics are excluded on one or more commercial formularies for CVS Health, Express Scripts and OptumRx; of these products, only 1 is excluded by all three PBMs. While exclusions have historically been placed on brands with a generic alternative, 82% of the oral oncology agents excluded are single source products without a generic alternative.

Common cancers are more likely to face access restrictions than rare conditions, where there may be a limited number of treatment options available. Cancer types most often targeted in formulary exclusions were NSCLC (5 products), Prostate (5 products), and Renal Cell Carcinoma (4 products). Other common cancer types include breast, CML, AML and GIST.

NCCN recommendations, mechanism of action, presence of mutations, black box warnings, orphan designation and accelerated approval all impact the potential for exclusion. NCCN recommendations have a variable influence; the majority of excluded agents (62%) have one or more Category 1 NCCN recommendations. Kinase inhibitors make up the majority of products identified (59%), followed by PARP inhibitors (9%) and CYP17 inhibitors (6%). 39% of the excluded agents are targeted therapies for specific mutations, while only 24% of the excluded agents carry a black box warning. 65% of excluded drugs have orphan drug designation and 24% have at least one indication with an accelerated approval.

Conclusions: : While crowded classes and common cancers seem to be correlated with more frequent exclusions, factors like guideline recommendations and single-source status are insufficient to protect oral oncolytics from exclusion.

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