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DDNC Position Statement on Access to Biologics
January 2018

The Digestive Disease National Coalition (DDNC) is an advocacy organization comprised of 40 of the major national voluntary and professional societies concerned with digestive diseases. DDNC focuses on improving public policy and increasing public awareness with respect to these diseases. The coalition was founded in 1978 and is based in Washington, DC.

DDNC works cooperatively to improve access to and the quality of digestive disease health care in order to promote the best possible medical outcome and quality of life for current and future patients with digestive diseases.

Choosing the appropriate biological therapy is not "one size fits all". This process requires individualization based on the patient and disease characteristics, a risk/benefit discussion of the available options, adherence, and other factors. Furthermore, use of the right biologic at the right time with the right concomitant therapies is critical to optimizing clinical benefits while controlling costs. Even within the same class of biologics, important clinical differences exist and should be taken into account in choosing the appropriate agent.

Health benefits coverage (whether from an insurer and/or a pharmacy benefits manager) implementing a standardized treatment approach to individual cases forces patients to use certain therapies first before gaining access to the prescribed therapy and could result in unnecessary harm to the patient without saving costs. Additionally, patients are often switched off of their prescribed therapy for non-medical reasons, resulting in further harm. Steering patients toward one biologic over another may be justified only after literature demonstrates a disparity in efficacy, as well as a risk/benefit analysis, when comparing agents. In the absence of unequivocal clinical data, the treating physician and the patient are best suited to make the appropriate drug selection.

DDNC supports any policy that prioritizes the relationship between a medical provider and their patient to choose the appropriate biologic and encourages all insurers to provide open access to biologics based on GI Society guidelines and Food and Drug Administration (FDA) labeling without step therapy requirements, fail-first protocols, or non-medical switching. Additionally, DDNC supports any policy that makes biologic medicines more affordable, and opposes the practice of specialty tiering.