The American Medical Association (AMA), American Society of Clinical Oncology (ASCO), American Society for Radiation Oncology (ASTRO), the American Society of Hematology (ASH), and 90 other medical societies cosigned a letter on September 7, 2018, calling on the US Centers for Medicare & Medicaid Services (CMS) to reconsider its decision to allow Medicare Advantage plans to use “step therapy” or “fail first” cost-control programs for Part B drugs.1
Step therapy allows insurers to require physicians to prescribe less expensive medications as a first step; the patient is required to try certain medications before progressing to more expensive treatments.
Participating plans will not be required to submit their step-therapy criteria for affected Part B drugs to CMS and can require off-label use of drugs before allowing access to on-label, FDA-approved treatments when off-label indications are “supported by widely used treatment guidelines or clinical literature that CMS considers to represent best practices,” according a CMS document.2
Describing the policy change as part of President Trump’s efforts to negotiate better prices and foster competition in the drug marketplace, CMS announced the change “empowers patients with more choices when picking a Medicare Advantage plan.”3
In their letter, the medical societies expressed concern about the use of step therapy to guide treatment decisions, stating that it could endanger patients undergoing treatment for cancer and other life-threatening diseases.
“While step-therapy protocols are problematic for many patients on a variety of therapies, they are particularly concerning where physician-administered drugs are concerned,” the letter states. “In many cases, patients receiving drugs covered under Part B are especially vulnerable, many with serious or life-threatening conditions. Many cancer therapies, for example, are covered under Part B. For cancer patients, selecting the proper personalized treatment as quickly as possible can be critical to survival.”
The new policy would take effect in January 2019. The medical societies asked CMS to abandon the change and stick with a 2012 policy that stops Medicare Advantage plans from using step therapy.
Details are scarce, and it is not yet clear exactly how the policy will be implemented — or what the implications will be for oncology formularies.
Just before the policy was announced, Department of Health and Human Services Secretary Alex Azar, who oversees CMS, met with ASCO officials and others. He acknowledged that there exists limited drug interchangeability in oncology and said he did not expect to see step therapy be a significant issue for patients with cancer, according to ASCO Vice President of Clinical Affairs Stephen Grubbs, MD, FASCO.
“We’ve had that discussion and he said in no way does he want these policy changes to affect or delay treatment for patients with cancer,” Dr Grubbs said of his conversation with Azar. “He asked that if we find the policy delays therapy, we [should] report that immediately to him personally.”
Particularly with increasingly rapid cancer drug approvals, it will be important to carefully monitor step-therapy restrictions, and to make sure appeals processes are quick, Dr Grubbs said.
“The physician’s responsibility is to always pick the right drug for the right patient at the right time,” Dr Grubbs said. “In-class drug difference nuances can make one drug more appropriate for a given patient. […] Appeals have to be done in a timely fashion.”