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Step Therapy (Fail First)

NORD supports policies to reform step therapy and protect patients by requiring that protocols are based on clinical criteria, clear exceptions processes exist, and certain automatic exceptions are outlined and respected.

Step therapy is a procedure by which insurers (public or private) require patients to take one or more alternative medications before they can access the medicine prescribed by their provider. While this is done by insurers as an attempt to control health care costs, step therapy has been increasingly applied to patients with little regard for their medical situation or treatment history.

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The Impact of Step Therapy

When used inappropriately, step therapy protocols can delay necessary treatment and lead to adverse reactions that ultimately increase health care costs, not lower them. For example, patients changing insurance plans may be required to go off a successful treatment and take a less effective medicine because it is less expensive. For rare disease patients, the use of step therapy protocols is particularly concerning as it can take years to find a diagnosis and a treatment that works.

As the use of step therapy has increased (at least 60% of commercial health plans have now implemented it), so has the need for states to ensure that these requirements do not interfere with appropriate care for patients. It is important to note that, in seeking to reform step therapy protocols, NORD does not advocate for ending the practice of step therapy entirely. Instead, the goal of these reforms is to bolster protections for patients, while enabling health plans to achieve the cost-saving benefits, when appropriate.

Approximately half of states have instituted protections around the use of step therapy to ensure patients obtain the care and treatment they need at the right time. In general, these protections:

  1. Ensure step therapy protocols are based on medical criteria and clinical guidelines developed by independent experts;
  2. Create a simple and accessible exceptions process for providers and patients to challenge the use of step therapy;
  3. Establish a clear and expedited timeline for decisions for both emergency and non-emergency situations, to ensure patients do not experience delays in treatment; and
  4. Establish a basic framework for when it is most appropriate to exempt patients from step therapy.

Grading Methodology

NORD’s State Report Card grades states separately on the following four categories and an overall state grade for step therapy was determined by taking the average of these four separate grades:

  1. Step Therapy Protocol Based on Clinical Practice: Step therapy protocols should be based on clinical practice to ensure the interests of the patient are front and center. States received a higher grade if they mandate that protocols be based on clinical practice.
  2. Timeline: A clear and expedited timeline, for both emergency and non-emergency situations, is important. This ensures patients have access to the prescription drugs they need without experiencing any delays in treatment. States received a higher grade if they specify timelines for both in their statutes.
  3. Clarity of Exceptions Process: A clear exceptions process is crucial for both the provider and the patient. States received a higher grade if they had a clear process for both the provider and patient.
  4. Categories of Exceptions: There are five automatic exceptions from step therapy that states may require, and states received a higher grade if they included all five exceptions. The five exceptions include: (1) the required prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the patient; (2) the required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen; (3) the patient has tried the required prescription drug while under their current or a previous health insurance or health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event; (4) the required prescription drug is not in the best interest of the patient, based on medical necessity; and (5) the patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan.

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