Making Step Therapy Work for Patients, Providers, and Payers

The use of step therapy protocols by payers to manage pharmacy costs has increased significantly over the past several years. According to Health Strategies Group, in 2015, 39% of health plans used step therapy in at least 12 classes of medications—an increase of 35% over the prior year.

At its core, step therapy is about trying to ensure the right patients are getting the right medications at the right point in the care continuum, while also ensuring that lower net cost products are used earlier while higher net cost products are reserved for later lines of care. Step therapy protocols should be built both on clinical evidence and cost considerations. Unfortunately, this is not always the case.

Clinicians and patient advocates argue that step therapy protocols are “one-size-fits-all” and many require patients to take less efficacious products or products that are not appropriate for their disease before moving on to the therapy their prescriber has determined is best. In some cases, patients need to fail multiple medications. Patients’ illnesses may be prolonged or progress while waiting to gain access to the medication they were originally prescribed.

Clinicians further argue even if there are exceptions, these appeals take additional staff time and time away from patient care. The inconsistency both within and across plans’ processes adds to this administrative burden. According to the Coalition for State Rheumatology Organizations, the average physician spends three weeks per year interacting with health plans. This is in addition to 23 weeks of nursing time and 44 weeks of clerical time.

Is There a Better Way?

Most would agree that if certain patient-centered protections were put in place, step therapy could be supported by patients, physicians, and manufacturers. Key elements of a physician- and patient-friendly step therapy program include:

  • Policies based predominately on medical criteria and long-term cost of care versus yearly budget considerations.
  • Policies established that avoid situations in which a patient may not receive the most appropriate treatment—e.g., contraindications or previous treatment failure.
  • Providers able to cite medically necessary reasons why a patient should not need to step through other therapies.
  • An appropriate “grandfathering” timeframe so a patient need not fail a previously tried product just because of plan changes.
  • Patient access to an expedient, fair, easily accessible, transparent, and independent process for requesting an exception to a step therapy protocol.

Does Recent New York Legislation Show the Way?

At the kick-off of 2017, New York passed a new law that adopts a number of criteria that insurers must adhere to when implementing step therapy protocols. Two important provisions being (1) the protocol needs to be based on clinical evidence and practice guidelines versus solely on cost and, (2) an expedient appeals process must be in place—no longer than 72 hours for non-emergent cases. This legislation keeps intact step therapy as a tool to manage cost, but does so in a more physician- and patient-friendly way.

Balancing healthcare costs and patient access to the medicines they need should be a top priority for state houses across the U.S.—legislation like that recently passed in New York provides a great framework for other states to follow.

  • Richard Ascroft

    Richard C. Ascroft, RPh, JD is Vice President, Managed Markets and Government Affairs at Takeda Pharmaceuticals USA, Inc. Rick is responsible for Managed Markets and Government and External Affairs and serves as a member of the Takeda Pharmaceuticals U.S.A, Inc. Executive Team. Prior to joining Takeda in 2015, Rick worked for Eli Lilly and Company for 22 years in a variety of clinical research, commercial, market access, and corporate affairs roles.


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