CMS Says Its Step Therapy Plan May See More Patients Using Biosimilars

CMS this week announced a policy that will allow Medicare Advantage (MA) plans to negotiate drug prices for physician-administered and other Part B drugs by allowing plans to employ the utilization management strategy known as step therapy to newly diagnosed patients.

Step therapy—which is widely used in the private sector but was prohibited for access to Part B drugs and services under a 2012 CMS policy—requires patients to start treatment with less expensive drugs. Only after failing to respond adequately to those options do patients become eligible for more expensive treatments.

Opponents of step therapy often refer to the policy as “fail first,” arguing that forcing patients to take a potentially older, less effective treatment intrudes on the physician—patient relationship and can lead to prolonged illness, reduced quality of life, and higher overall healthcare costs.

Click here to learn more about the patient perspective on step therapy.

In its announcement, CMS indicated that one way in which MA plans may use step therapy is to ensure that “a senior who is newly diagnosed with a condition begin treatment with a cost-effective biosimilar before progressing to a more costly drug therapy” if treatment with the biosimilar is ineffective.

The statement did not specify whether patients could be stepped up to the biosimilars’ reference products (a biosimilar and its reference are expected to have no clinically meaningful differences) or whether patients could be required to begin treatment with a biosimilar of one therapy before being allowed to step up to a different biologic product altogether. It did note, however, that step therapy would apply to new patients only, a fact that may allay some patients' concerns about being switched to a biosimilar. CMS did not immediately respond to a request for clarification about the step-up from The Center for Biosimilars^®.

In contrast with CMS’ suggestion that biosimilars could be used as a first step, among commercial plans, experience thus far has shown that biosimilars are not typically used first. As described in a recent Avalere report that assessed use of biosimilars in step therapy, among plans that had available documents related to infliximab, 10 plans required the use of the reference product first and only 1 plan required the use of a biosimilar first. Furthermore, in some cases, a biosimilar would only qualify for coverage if the patient first failed to respond to the reference product—a practice that contradicts the European League Against Rheumatism’s recommendations that switching to another drug—not a biosimilar of the same drug—may be appropriate in the case of treatment failure.

CMS indicated that MA plans that use step therapy will be required to pass savings generated to plan members, and emphasized that plans would still be required to cover all medically necessary Part B drugs that patients can access through the exceptions process. Plans will also be subject to penalties if they do not put a minimum of 85% of their savings toward healthcare services and quality improvement.

Today, the American College of Rheumatology (ACR) voiced what it called “extreme disappointment” with the decision. In a statement, David Daikh, PhD, MD, president of the ACR, said, “Put simply, this policy change is a gross affront to America’s sickest Medicare patients—individuals living with diseases like inflammatory arthritis and cancer —who depend on timely access to safe, affordable, and high-quality treatments.” He added that “At the same time that medical research is showing that early institution of effective treatment prevents such damage, CMS is instituting a policy that will make it much more difficult for patients to get this treatment in time. We urge CMS to reconsider this policy and ensure that all Americans continue to have access to the most appropriate and effective therapy as determined by their health care team.”

In a follow-up interview with The Center for Biosimilars^®, Angus Worthing, MD, FACP, FACR, chair of ACR’s Government Affairs Committee, said of the new plan, “Two potentially positive outcomes could be that biosimilar use could be encouraged in order to reduce costs and improve access to treatment (especially given the very poor coverage of biologics by MA plans currently), and also that the savings from biosimilars could be passed on to patients." However, he added, "It's unfortunate that step therapy would take patients and doctors out of the driver's seat regarding treatment decisions. It would be better to allow patients to share in the savings and improve access to treatment while maintaining patient and physician autonomy.”