COA Issues Policy Statement on Step Therapy in Cancer Care

Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, jeopardizes the health of patients with cancer by delaying treatment and creating unnecessary barriers, according to a recent position statement from the Community Oncology Alliance (COA).

Step therapy, or so-called “fail-first” policies, are common in chronic conditions such as for autoimmune disorders or diabetes, but for patients with cancer who may not have the luxury of time, it can create unnecessary delays or denials; COA said that, unlike some other conditions, with cancer “the wrong choice as initial therapy can be life-threatening.” In addition, there are few therapeutic and generic-to-brand substitutes in oncology treatments, COA said.

“Patients on fail-first step therapy are forced to receive potentially inferior or incorrect treatment options that their treating physicians considered and specifically did not prescribe,” COA said.

COA called insurers and pharmacy benefit managers (PBMs) “third-party middlemen” and said step therapy “forces patients and their physicians to try cheaper, often older, treatments before they are allowed access to state-of-the-art, newer therapies, which are often more expensive. This is despite the recommendation of the treating physician who believes the cheaper treatment would not work.”

Although plans include an appeal process in step therapy programs, they are insufficient, COA said, because step therapy stops patients from receiving evidence-based treatment and presents burdensome hurdles to patients and providers.

While step therapy is common in commercial insurance, it became part of HHS’ strategy to control costs this year when Medicare Advantage began allowing it as well. A bipartisan group of senators recently introduced a bill to curb the use of step therapy.

Instead of focusing on medical needs, the goal of step therapy is to zero in on financial interests to maximize profits and control costs, COA said. Some reports have cited step therapy as a way to increase uptake of biosimilars; earlier this year, COA released a position statement about biosimilars, saying it would work with stakeholders to support the acceptance of biosimilars as well as work to close knowledge gaps.