Step Therapy, also known as “Fail-First” policy, is used by health insurance plans as way to control costs. This cost-management strategy requires patients to try and document failure for one or more “preferred” treatment options before pursuing another treatment option. Many times, these fail-first requirements are not part of the medications FDA labeling and are added into the prior-authorization process by health plans based on their own internal research or financial analysis. 

Video courtesy of Alliance for Patient Access.

To join the conversation about Step Therapy, visit our Infusion Confusion Community post.


Step Therapy requirements can often undermine a healthcare provider’s ability to care for their patient by overruling their recommendation to pursue the prescribed treatment before trying one or more “preferred” treatments required by the health plan. 

Step Therapy is successful if the patient experiences therapeutic benefit from one of the “preferred” medications at a cost less than the originally prescribed medication(s). However, many biologics, IVIG, and specialty injectables, are administered less frequently and take a long time to establish a therapeutic benefit. Patients with chronic conditions cannot afford to waste time on health plan preferred medications if they are ineffective and NICA believes that the patient and their physician are better equipped than the health plan to select the best treatment plan. For patients with serious debilitating disease like Rheumatoid Arthritis, Crohn’s Disease, or Ulcerative Colitis, every day they don’t get relief is a day spent suffering through long term harm to their body. Delays in symptom and disease relief can result in serious complications and the need for more invasive intervention like surgery and hospitalization. 

Denying patients access to the medications they need to improve their quality of life while wasting thousands of dollars on medications that don’t work is a lose-lose situation for the patient, provider and insurer. After all, the most cost effective and efficacious medication is usually the one that works.


NICA believes health plans should consider Step Therapy policies for drugs only when reasonable according to the following criteria – when the COST of failure is LOW, the TIME to fail is SHORT, and the clinical RISK of failing preferred drugs is LOW.

Criteria for Step Therapy Requirements

NICA agrees with many of our partner patient and disease advocacy organizations and believes that the decision as to which biological therapy is best suited for a particular patient should be a collaborative determination by healthcare providers and patients on an individual patient basis, not a blanket requirement for all patients implemented by the health plan. Therefore, we find it impractical, wasteful, and possibly even harmful that accessing many physician-prescribed biologics would require failing one or more “preferred” biologics. NICA supports responsible access to biologics so providers and patients can safely and more cost-effectively find the best biologic therapy – the one that works.

NICA is maintaining an ongoing campaign for reasonable Step Therapy guidelines in alignment with our criteria: when the COST to fail is LOW, the TIME to fail is SHORT, and the clinical RISK to fail is LOW. We have meet with several health plans regarding their Step Therapy policies and continue to collaborate in the development of all-win solutions.

Check out some of the letters we've sent to payers about inappropriate Step Therapy policies


If you or someone you know has experienced medication access barriers because of Step Therapy or Fail-First policies, please reach out to us.

Additionally, please reach out to your legislative representatives and encourage them to work with NICA to establish and enforce reasonable Step Therapy guidelines.

Find your representative(s) here.


Thank you for your interest in NICA. We are eager to connect with you and to discuss the exciting work of increasing patient access to infusible and injectable therapies.

If you have questions or concerns, please send us an email and a member of our team will contact you shortly.


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