Step Therapy in Medicare Part D Oncology Drugs

Executive Summary

Escalating drug costs in the United States are placing pressure on both the federal government and health plans to implement strategies aimed at controlling drug expenditures and optimizing utilization. Utilization management (UM) tactics are frequently used in Medicare Part D, by both Medicare Advantage-Prescription Drug plans (MA-PDs) and standalone Prescription Drug Plans (PDPs), to control prescription drug spending. While UM is used to lower plan spending and premiums for beneficiaries, it can also make it more difficult for patients to access the prescriptions they need, especially high-cost oncology drugs.

To better understand how UM is used in Medicare, the American Cancer Society Cancer Action Network (ACS CAN) engaged Avalere to conduct an analysis to understand the extent to which step therapy restrictions exist for certain drugs that treat breast cancer, cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors. The CDK 4/6 class includes four drugs: Ibrance, Kisqali, Kisqali Femara co-pack, and Verzenio. Results indicate there were few differences in formulary tiering and UM across the four drugs evaluated; however, there were differences in tiering and UM by plan type. Differences in tiering occurred within Special Needs Plans (SNPs), which placed the four drugs on the specialty tier 45% of the time and the preferred brand tier 55% of the time.[1] All non-SNP MA-PDs and all standalone PDPs placed the four drugs on the specialty tier 100% of the time.

While no plans explicitly require step therapy (ST) in the formulary design, Avalere evaluated the detailed restrictions policies to understand whether ST requirements were embedded within prior authorization (PA) requirements for all Part D plans. Many plans included ST embedded within their PA criteria, with step edits dependent on patient characteristics or treatment choice. Kisqali and Kisqali Femara co-pack included ST requirements embedded within PA requirements that were dependent on beneficiary characteristic or treatment choice 23% of the time, while Ibrance and Verzenio included ST requirements 23% and 82% of the time, respectively. For Ibrance, step therapy requirements were dependent on treatment type, and for Kisqali, Kisqali-Femara co-pack and Verzenio, step requirements were dependent on both patient characteristics and treatment type.