Ethics of Step Therapy Investigation

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Step therapy is an insurance company policy whereby patients must try a less costly treatment first and fail it before the insurer will cover a more expensive treatment. In other words, the patient is stepped up to the costlier treatment after failing the cheaper one, thus the term step therapy.

The Team

International Foundation for AiArthritis
  • Project Manager and Author of White Paper: Tiffany Westrich-Robertson, CEO
  • Assistants:  Volunteer Representatives Monica Johnson, Kerry Wong, Laura Schaaf
Advisors
  • Bioethicists: M. Sara Rosenthal, Ph.D., Professor and Director, University of Kentucky Program for Bioethics, Department of Internal Medicine;  Michael A. Santoro, Ph.D, Professor, Department of Management and Global Business, Rutgers Business School-Newark and New Brunswick, Ph.D in Public Policy, Harvard University. 
  • Public Policy: Kathleen Arntsen, President and CEO of Lupus and Allied Diseases Association, Inc.


Overview. In 2015, our CEO researched the evolution of step therapy, worked with bioethicists to investigate the ethical guidelines that insurers and providers must follow, and consulted with a public policy expert to report current legislative efforts that are impacted by the protocol.

Conclusion.  Based on these reports, an assessment into the history of the century old protocol, and her personal experience as an "atypical" patient who was not able to participate in the same clinical trials insurers cite to justify preferred treatments, she concluded research - in particular data proving efficacy in "atypical" patient subgroups - is they key component in potentially step therapy practices. 

While insurers have an ethical obligation to recommend the use of the lowest cost therapy before approval of a higher cost prescription, forcing use of preferred drugs is biased towards patients who meet general patient population standards and does not account for patients who present non-traditionally or who have co-morbidities. If research were present to demonstrate elevated efficacy in these sub-populations, then the treating practitioner, who is ethically bound to treat based on a patient's individual characteristics, should be able to override a payer's recommendation if the patient is not representative of a traditional patient that is diagnosed with the same condition.



Author Opinions
Tiffany Westrich-Robertson

What began as a successful measure to contain healthcare costs in a time when innovation had yet to
flourish, step therapy has become a model unable to withstand the continued advancements in both science and the growing community of patients who require access to specialty pharmaceuticals to sustain an acceptable quality of life. While the equation ‘research + safety = justifiable cost’ has been an acceptable method to ensure patients receive the best care at a price that contributes to rationing resources for all people, its current implementation challenges ethical boundaries. The bottom line is research holds the key to justifying costs. If we focus on expanding research past only the “general patient population” and consider the perhaps larger “typical atypical” patient subgroups equally, we can begin to truly measure long-term costs and start to develop real measures of value for all. Precision medicine, or even N of 1 trials, have the potential to produce the research we need to do this.

The truth is we have stretched the quarter-century-old protocol of step therapy beyond its ethical limits. Now it
is time to devise a new strategy that will take into account the current state of healthcare, as well as its continued
expansion into the future, and put patient care back into the hands of the doctors who are educated and ethically
obligated to treat them. 


Next Steps

Legislative.  The Ethic of Step Therapy Investigation "atypical" patient argument has been used often in legislative discussions nationwide; we hope other organizations continue to refer to this paper to help advance all issues related to the need for continuity of care and practitioner-recommended treatment protocols.

Research Advocacy. Finding the right biologic often results in trial-and-error, causing long-term costs for the healthcare system and less chance for improvement for the patient. This delay is partly due to step therapy practices, which reference clinical trial and post-market surveillance to justify low cost treatment preferences. If patients are to gain access to the best option for their disease journey, clinical trials should prepare for the age of precision medicine so robust data can trump current insurance protocols.  

Our organization is working on projects to prepare for precision medicine clinical trials and to establish longitudinal profiles of “Typical Atypical” patient subgroups. We hope these efforts will produce data that can be used in conjunction with policy efforts to influence step therapy legislation.


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