Under the Oncology Care Model (OCM), a Medicare value-based care program aimed at transforming care quality and reducing total cost, drugs receiving new US Food and Drug Administration (FDA) approvals for cancer treatment were deemed “novel therapies” for up to two years. Led by Puneeth Indurlal, MD, MS, MBBS, a recent study presented at the 2024 National Comprehensive Cancer Network Annual Conference analyzed six years of OCM claims data from 14 practices within The US Oncology Network, assessing novel therapy utilization and expenditures.

Over the OCM period, 127 unique drugs spanning 85 drug classes earned novel therapy status, driven by 309 FDA approvals across various cancer indications. Nearly all cancer types (18 out of 20) benefited from novel therapies, contributing to 20% of total care costs. Competition emerged among 22 drug classes with multiple novel therapy drugs and overlapping indications. Pembrolizumab stood out with 22 approvals, particularly in lung cancer, over the entire OCM duration.

The study revealed diverse criteria for novel therapy designation, including novel formulations, drugs using the 505(b)(2) pathway, and approvals based on patient age. However, inconsistencies were noted in applying the status, with some similar agents, biosimilars, and generics being left out. Legacy drugs and non-chemotherapy agents also secured novel therapy status for newer indications.

The study underscores the rapid evolution of oncologic therapeutics and the impact of FDA approvals, especially on immuno-oncology drugs. It highlights the need for consistent application of novel therapy status, especially regarding drug parity considerations for biosimilars and generics. The findings emphasize the complexity of novel therapy designation and its implications for oncology care and cost management.

Source:

Indurlal P, Wilfong LS. Novel therapies in the oncology care model: a profile in review. Presented at the 2024 National Comprehensive Cancer Network Annual Conference; April 5-April 7, 2024. Orlando, Florida, and virtual.