Taking a Stand on Step Therapy: Treating Patients With the Right Therapy at the Right Time

Heather Hylton, MS, PA-C

On August 7, 2018, the Center for Medicare and Medicaid Services  (CMS) announced Medicare Advantage Plans would be permitted to apply a step therapy approach to Part B drugs starting in 2019. This action effectively rescinds a September 17, 2012 memo that prohibited the imposition of step therapy for Part B drugs.

Step therapy, a utilization management tool, is a construct in which patients must try—and be failed by—one, often less expensive, medication before progressing to a subsequent, typically more expensive, medication.

At a high level, there could be some positives in this approach under certain circumstances; however, a deeper dive reflects a grimmer reality for several reasons. 

First, financial considerations are more likely to drive the first-line drug offered rather than the best available evidence.  This can subsequently lead to suboptimal outcomes, additional toxicity to the patient, and delays for patients to access the treatment they need. 

Second, the broad stroke of step therapy application fails to recognize the uniqueness of each patient’s clinical picture and overall well-being.  For example, how will the first-line drug impact a patient’s other medical conditions or medications the patient takes to manage those conditions?  How will the first-line drug impact a patient’s quality of life?  What if the patient tried the first-line drug under another health plan and did not have a desired outcome?

While CMS does have a graduated appeals process, patients should not have to experience delays in receiving the treatment they need for their cancer.

If Medicare Advantage plans implement step therapy, patients and providers should have an expedited, transparent pathway to request an upfront exception that would allow for circumventing step therapy altogether under specified circumstances, such as those detailed in the Restoring the Patient’s Voice Act of 2017 which includes:

  • The treatment is contraindicated (or)

  • The treatment is expected to be ineffective (or)

  • The treatment will cause or is likely to cause an adverse reaction to the individual (or)

  • The treatment is expected to decrease the individual’s ability to either  perform daily activities or occupational responsibilities or adhere to the treatment plan

Furthermore, the timeliness of a response to an appeal is paramount, and it is not unreasonable, if a patient were to meet any of the aforementioned conditions, to receive a response to that request in <24 hours for emergent requests and <72 hours for all other requests.

Third, with the nod from CMS to Medicare Advantage plans to incorporate step therapy, a form of prior authorization, it seems this action is effectively introducing incremental administrative burden, seemingly a philosophical contradiction to CMS’s Patients Over Paperwork initiative.

Lastly, the memo issued by Administrator Verma on August 7, 2018 encourages Medicare Advantage plans that are incorporating step therapy to boost patient participation in drug management care coordination programs by offering a portion of the savings to be passed along to patients as rewards in the form of gift cards or other items of value in exchange for their participation.  The optics of this seemingly pose a challenge to the bioethical principle of patient autonomy:  If a patient’s being offered what could be an inferior therapy but is being incentivized to take that therapy by having a portion of the savings returned in the form of gift cards or other items of value, couldn’t this be seen as an undue influence that might impact meaningful, informed choice?

Although not all Medicare Advantage plans may opt to apply a step therapy approach to Part B drugs, the hope is that CMS will reconsider last week’s decision.  Placing restrictions on patients’ access to the care they need is disruptive to the patient-provider relationship, places our patients at risk for suboptimal outcomes, and is not congruent with high-quality, patient-centered care.  

More information on the Restoring the Patient’s Voice Act of 2017 can be found at the ASCO Advocacy Center.