AGA’s position: patients should be given a clear, equitable and transparent appeals process when subjected to step therapy protocols.

In step therapy treatment, also known as ‘fail first,’ insurers require patients to try and fail medications before agreeing to cover the initial therapy prescribed by their health care provider. This practice jeopardizes the physician-patient relationship, since it bypasses what the physician believes is the best treatment for their patient. Although step therapy is used by insurers as a cost-containment mechanism, it has been shown not to save money in the long run due to complications that patients suffer, which can require additional physician visits, emergency department visits or even costly hospitalizations. With the increase of biologics to treat diseases like inflammatory bowel disease (IBD), more and more patients with digestive diseases are subject to this policy.

Impact of Step Therapy on Patients

Requiring patients to cycle through different treatments can take time and delay access to the right treatment. These delays can ultimately lead to disease progression and even put patients at risk. In fact, a 2015 study found that 18 health plans representing 97 million lives required patients who rely on biologics or immunologic drugs to step through one or more therapies with black box safety warnings before they were able to access a safer treatment.(1)

Appealing step therapy protocols can be very timely and burdensome for the physician and the patient, and can take months to resolve. Some physician practices have a full-time employee devoted to navigating this process for patients, but not all practices have the resources to devote to this administrative burden.

AGA is advocating for enactment of H.R. 2077, Restoring the Patients Voice Act that would give patients and providers a clear, equitable and timely appeals process when subjected to step therapy protocols.

AGA has been working closely with our patient, provider and industry partners in advocating in support of H.R. 2077 and raising awareness how step therapy impacts patients and their ability to get the right treatment at the right time to manage their disease. Step therapy protocols also are a tremendous burden on physician practices since appealing step therapy protocols require time that takes away from caring for patients. Some physician practices have full time employees devoted to appealing step therapy or other utilization management policies but not all practices have the resources to do so.

AGA looks forward to continuing to work with our partners in educating Congress and policymakers on how disruptive step therapy is to patients and how harmful it is to the management of chronic conditions like IBD.

(1) Branning, G., et al. “Formulary Management of Branded Drugs With And Without Boxed Warnings Within Therapeutic Categories.” Value in Health 18.3 (2015): A100.