Internists Warn Against the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety

Washington, DC (November 30, 2020) — In a new policy paper released today, The American College of Physicians (ACP) warned against the potential negative impact that cost-cutting step therapy policies and nonmedical switching of prescription drugs can both have on patient safety. The new paper titled “Mitigating the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety: An American College of Physicians Position Paper” also offered detailed recommendations about how to mitigate restrictions on patient access to care.

Step therapy policies, commonly called “fail-first” policies, require patients to be initiated on lower-priced medications before being approved for originally prescribed medications. Carriers can also change coverage in an attempt to force patients off their current therapies for cost reasons in a practice known as nonmedical drug switching.

If designed improperly, step therapy, nonmedical drug switching, and other cost-curbing formulary designs can challenge the medical expertise of physicians and fail to effectively account for the individual characteristics and needs of patients, including comorbid conditions, concurrent medications, and demographic factors, all of which can impact a medication’s effectiveness and lead to potentially dangerous side effects for the patient.

“A patient’s individual needs should be our primary concern in any care we provide,” said Jacqueline W. Fincher, MD, MACP, president, ACP. “Insurance company policies, like step therapy and nonmedical drug switching, that prioritize cost-curbing over patient needs and a physician’s medical judgement can seriously compromise patient safety.”

ACP offered the following recommendations to help ensure that moving forward, all step therapy and nonmedical drug switching policies are designed with patient needs at the center:

  1. ACP recommends all step therapy and medication switching policies should aim to minimize care disruption, harm, side effects, and risks to the patient.
  2. ACP recommends all step therapy and nonmedical drug switching policies be designed with patients at the center, taking into account unique needs and preferences.
  3. ACP recommends all step therapy and nonmedical drug switching protocols be designed with input from frontline physicians and community pharmacists; feature transparent, minimally burdensome processes that consider the expertise of a patient’s physician; and include a timely appeals process.
  4. ACP recommends that data concerning the effectiveness and potential adverse consequences of step therapy and nonmedical drug switching programs should be made transparent to the public and studied by policymakers. Alternative strategies to address the rising cost of prescription drugs that do not inhibit patient access to medications should be explored.

“All decisions on patient care, including prescription medication coverage, must factor in a physician’s clinical expertise as well as each patient’s unique medical needs,” continued Dr. Fincher. “Implementing the recommendations we offer in this paper will help insurers, pharmacy benefit managers, and policymakers to not only better protect patient safety but also minimize unnecessary administrative burdens on physician practices. If physicians and their practice staff can spend less time navigating the current maze of formulary restrictions, they can redirect time and resources to patient care, which is important now more than ever during the COVID-19 pandemic.”


About the American College of Physicians
The American College of Physicians is the largest medical specialty organization in the United States with members in more than 145 countries worldwide. ACP membership includes 163,000 internal medicine physicians (internists), related subspecialists, and medical students. Internal medicine physicians are specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness. Follow ACP on Twitter, Facebook, and Instagram.

Contact: Taneishia Bundy, (202) 261-4523,