The Ethics of Step Therapy: Next Steps Investigation findings prove why public officials and health care stakeholders must unite to curb the existing step therapy protocol.   Discussions regarding the needs of the current state of health care, as well as its continued expansion into the future, must result in patient care being placed back in the hands of the health care providers who are educated and ethically obligated to treat them.  


In today’s world where innovation is ever-evolving and the patient population requiring access to advanced treatments in order to sustain an acceptable quality of life continues to expand, it is imperative that the relationship between individual patient and provider remain intact so that only health care professionals familiar with a patient's personal medical history and uniqueness are making treatment decisions.  As we usher in an era of personalized medicine, patient-focused research and patient-centric care, step therapy must be updated to keep pace with biomedical innovation and to ensure ethical responsibilities are being met.

The Ethics of Step Therapy project was made possible thanks to a grant award from Celgene Corporation.

In 2015, IFAA led a six month investigation into the ethics of step therapy, which 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.  IFAA was assisted by bioethicist consultants and Kathleen Arntsen, President & CEO of the Lupus & Allied Diseases Association, Inc. (LADA) as the public policy advisor. The team met in person in New York City, NY (pictured below) to discuss ethical principles for insurers, practitioners, and the healthcare system.  Learn more about the Team

ethics of step therapy investigation: Next Steps 

Next Step Solutions


Step Therapy

After further the bioethicists provided their overview of the ethical principles that apply to step therapy, Ms. Westrich-Robertson spent several months analyzing the data and made some groundbreaking findings.  This included realizing that while both payers and providers have an ethical responsibility to treat based on cost control and proven research, the payers base their decisions on what works best for the “general patient population” whereas the provider has a specific ethical obligation to treat to the individual uniqueness of the patient if they do not meet the general patient population standard.  Step therapy essentially ignores the provider’s ethical responsibilities if the patient is atypical and thus many individuals with rare and/or chronic, complicated conditions like autoimmune and other diseases of unmet need fit this scenario.


IFAA concluded that the research used by payers to justify forcing use of preferred drugs is biased towards patients who meet general patient population standards, and does not account for patients who present atypical or have comorbidities. Therefore, the treating practitioner, who is ethically bound to treat based on a patient’s individual characteristics, should be able to override a payers recommendation if they patient is not representative of a traditional patient who is diagnosed with the same condition.   


read an overview of the paper


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