Step therapy, also known as “fail first” therapy, is not a new concept in healthcare. Originally introduced into the care process by health insurance plans, step therapy was aimed at lowering costs, improving quality of life, and ensuring that patients received the most preferred therapy. The process requires prior authorization by a patient’s health insurer to determine if the patient’s plan will cover a prescribed drug or require that the patient be treated first with another therapy. Historically, Medicare Advantage plans were not permitted to implement step therapy. However, in August 2018, the Centers for Medicare & Medicaid Services (CMS) issued a memo announcing new guidance that allowed Medicare Advantage plans to implement step therapy for Part B drugs effective January 1, 2019.
In May 2019, CMS issued a final rule that expanded step therapy to Medicare Part B drugs but specified that antineoplastics are to remain among the “protected classes,” and that insurers could impose prior authorization and step therapy requirements for new patients only.
As cancer treatments have become increasingly targeted and complex, the potential for increased utilization of step therapy in oncology presents unique challenges for patients and providers. This lecture series explores the implications of implementation of step therapy in Medicare Advantage plans, which cover more than 20 million Medicare beneficiaries, and for the delivery of patient-centered care.
Disclosure: Dr. Fonseca is a consultant with Amgen, BMS, Celgene, Takeda, Bayer, Janssen, AbbVie, Pharmacyclics, Merck, Sanofi, Kite, and Juno; has served on the scientific advisory board for Adaptive Biotechnologies; and Mayo Clinic holds the patent in his name for the prognostication of MM based on genetic categorization of the disease.
This project is sponsored by Amgen.
