Step Therapy Policy Alarms Cancer Leaders

Andrew D. Smith
Published: Tuesday, Oct 16, 2018
Stephen S. Grubbs, MD

Stephen S. Grubbs, MD

A policy change that allows step therapy provisions in Medicare Advantage insurance plans is setting off alarm bells among oncology leaders, who have joined medical associations from across the country in objecting to the revision. The controversy has been mounting since the Centers for Medicare and Medicaid Services (CMS) announced in August that step therapy would be permitted for drugs covered under Medicare Part B.

Step therapy, a form of prior authorization, will enable Medicare Advantage plans, starting January 1, 2019, to require that preferred drugs be prescribed first and used until they prove ineffective before physicians can try other, potentially higher-cost agents. The policy reverses a prohibition on step therapy for Medicare Advantage plans established in 2012.1

Anticancer drugs currently covered under Part B include infused drugs, such as chemotherapy, chimeric antigen receptor T-cell therapies, and, in some cases, other types of immunotherapy. Additionally, oral anticancer drugs that are also available as injectables are covered by Part B.

As it stands now, oncology experts do not expect the Medicare Advantage step therapy provision to have a large impact on treatment protocols because anticancer agents can rarely be substituted for one another. However, that’s not the case with supportive care drugs, said Stephen S. Grubbs, MD, vice president of clinical affairs for the American Society of Clinical Oncology (ASCO).

Based on prior experience with private payer policies, “It’s rare for step therapy to force changes in tumor treatment, but it often forces us to change supportive medications we prescribe patients with cancer for problems such as peripheral neuropathy. You start with a less expensive medication that often fails and work your way up to a more effective drug, which delays the benefit of therapy. And there are times when step therapy requirements do prevent you from getting your patients the right drug at the right dose at the right time. That’s just not acceptable, and that is why ASCO opposes this decision by CMS.”

In September, ASCO joined more than 90 state and national professional societies in urging CMS to reconsider its decision in a letter that the American Medical Association circulated.2 The letter also was signed by the American Society of Hematology, the American Society for Radiation Oncology, the Society of Gynecologic Oncology, and the American Urological Association. The Community Oncology Alliance (COA) also is opposing the policy.

ASCO and the other physician groups have urged CMS to reverse the step therapy decision on grounds that such requirements could end up denying a significant number of patients with cancer timely access to medications their doctors deem best suited for them, based on assessments of each patient’s unique circumstances. “While a particular drug or therapy might be generally considered appropriate for a condition, the presence of comorbidities, potential drug-drug interactions, or patient intolerances, for example, may necessitate the selection of an alternative drug as the first course of treatment,” the AMA letter states.


In explaining the rationale for the revised policy, CMS said that it will incentivize drug manufacturers and distributors to negotiate drug prices with Medicare Advantage plans much as they do for private payers that employ step therapy. The agency projects a median value of $1 billion in potential savings. In addition, CMS said, more than 50% of the savings achieved through step plans must be returned to Medicare beneficiaries in the form of gift cards or other noncash transfers.1

The changes “should not result in increased costs to enrollees,” CMS said in its memo. Although the new step therapy guidelines compel plans to share at least half of any savings with patients, the competitive market for Medicare Advantage plans in many areas might pressure them to pass more savings to enrollees via lower premiums. Moreover, CMS officials said, regulatory safeguards would prevent access problems for patients. Patients and their doctors will have the ability to challenge step therapy decisions and policies, and reviews of those challenges must be completed swiftly, CMS said. Plans will have 14 days to address regular requests and 72 hours to adjudicate expedited requests.1

CMS has encouraged Medicare Advantage plans to use their Part D protocols as templates for determining when it is appropriate to use step therapy for drugs in Part B. Part D drugs include self-administered prescription drugs, such as immunosuppressants and anticancer oral drugs. As part of the policy change, CMS emphasizes that physicians can be required to use lower-cost Part D drugs before being allowed to try a Part B drugs, which are often more expensive.

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