Utilization Management in Breast Cancer and Hepatocellular Carcinoma

Executive Summary

Utilization management (UM) refers to a variety of practices that health plans and pharmacy benefit managers employ to confirm the use of specific drugs or services aligns with the payer’s policy. Plans can use UM to shift utilization between therapeutically equivalent products to ensure that a prescribed drug is medically necessary, or to limit utilization of high-priced, specialty medications. UM use in oncology may have unintended consequences to patient care, such as delaying patient access to medication or increased administrative burden for the patient and provider.

Prior to 2019, Medicare Advantage Prescription Drug (MA-PD) plans were only allowed to use step therapy (ST) for provider-administered drugs (i.e., drugs available via the medical benefit) if the local Medicare Administrative Contractor had a local coverage determination requiring ST. Starting in 2019, MA-PD plans were allowed to apply ST to provider-administered drugs for patients initiating treatment, which may require patients to step through another provider-administered (i.e., medical benefit) drug, or step through a self-administered drug available via the pharmacy benefit.

Avalere conducted an analysis to understand the extent to which ST restrictions exist in MA for a subset of oncology drugs for breast cancer and hepatocellular carcinoma (HCC), a form of liver cancer. For breast cancer, Avalere reviewed the extent to which MA-PD plans require ST among provider-administered innovator and biosimilar products. For HCC, Avalere reviewed the extent to which MA-PD plans require ST through one brand drug, whether provider- or self-administered, to receive another brand drug.

Apart from biosimilars Kanjinti and Trazimera, most analyzed breast cancer drugs require ST in MA (70-95% of the time); most plans increased their use of step therapy from 2023 to 2024, particularly for innovator products Herceptin and Herceptin Hylecta. Fewer than 20% of plans required step therapy for Kanjinti or Trazimera in both 2023 and 2024.

Five of the HCC products analyzed are innovator biologic products (provider-administered) and two are oral products (self-administered). Under the medical benefit, plans did not require ST for Imfinzi or Tecentriq in 2023 or 2024. Keytruda, Opdivo, and Yervoy have ST approximately 30% of the time in 2024. Among the drugs analyzed, ST is most often required for Avastin, at 71% of the time in 2024. Avastin is the only product, of the drugs analyzed, that has a double ST requirement, which is present about 9% of the time.