The following written comments were submitted by IFFGD president, Ceciel T. Rooker, to the US Department of Defense (DoD) in connection with a January 10, 2019 meeting of the TRICARE Beneficiary Advisory Panel (BAP) regarding the Uniform Formulary and, specifically, review of gastrointestinal agents:

The International Foundation for Gastrointestinal Disorders (IFFGD) commends TRICARE and the Beneficiary Advisory Panel (BAP) for ensuring that those who have pledged themselves in service to the American people and their families are provided with access to necessary treatments and medical care.

Established in 1991, IFFGD is a patient-driven nonprofit organization dedicated to assisting individuals affected by chronic gastrointestinal (GI) illnesses by providing education and support for patients, the family members, healthcare providers, and the public. IFFGD also works to advance critical research aimed at broadening our understanding of the basic mechanisms and clinical care of these conditions and providing patients with better treatment options, and perhaps one day, cures. IFFGD has worked closely with the Department of Defense (DoD) to encourage and support research into GI illnesses affecting active service personnel and veterans, including the Gulf War Illness Research Program (GWIRP).

Today, I am writing to you regarding Docket No. 2018-26188 for “Uniform Formulary Beneficiary Advisory Panel; Notice of Federal Advisory Committee Meeting” to discuss the TRICARE formulary, including “Gastrointestinal-2 Agents – Miscellaneous” and “Gastrointestinal-2 Agents – CIC and IBS-C.”

We applaud the efforts of the BAP to provide advice and recommendations on the development of the TRICARE Uniform Formulary and the drugs and supplies covered by this program. We are especially grateful for the guidance of the BAP regarding drugs and other therapies for GI illnesses, including constipation predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC). IBS-C and CIC are among the most common GI disorders in the general population, striking all demographic groups and resulting in significant human suffering and disability. As “functional disorders,” IBS-C and CIC affect the way the muscles and nerves of the bowel work, but the bowel itself does not appear to be damaged on medical tests. Without a definitive diagnostic test, many cases of IBS-C and CIC go undiagnosed or misdiagnosed, sometimes for years. It is not uncommon for those affected to undergo unnecessary treatment courses or even surgical procedures before receiving a proper diagnosis and appropriate care. And even after diagnosis, treatment options are limited, and treatment effectiveness varies widely from patient to patient or even for a single patient over his or her lifespan. Adding to the complexity of these conditions, comorbidities affecting both the GI tract and other systems are common in IBS and CIC. Other functional GI disorders, including functional chest pain, heartburn, dyspepsia, and/or abdominal pain, are common in individuals with IBS-C and CIC and those with IBS-C are more likely to also have other pain-related disorders, including migraine headache, fibromyalgia, and chronic pelvic pain compared with the general population (Whitehead WE, et al. 2002. https://doi.org/10.1053/gast.2002.32392; Frissora CL & Koch KL. 2005. https://doi.org/10.1007/s11894-005-0018-9).

Because of the heterogenous nature of these disorders, research has found that patients respond best to a personalized approach tailored to their predominant symptoms, symptom severity, responsiveness to treatment, and vulnerability to adverse effects (Chey WD, et al. 2015. https://doi.org/10.1001/jama.2015.0954; Ford AC, et al. 2017; https://doi.org/10.1056/NEJMra1607547).
No one treatment pathway will effectively address the needs of all patients, and long-term solutions often require a combination of treatment approaches. For this reason, it is critical that patients have access to a variety of approved treatments, both brand name and generic.

We urge the BAP to consider the complexity, heterogeneity, and impact of chronic GI disorders, such as IBS-C and CIC, when evaluating the drugs and supplies covered by the TRICARE Uniform Formulary and ensure that a wide range of drugs and other treatments are covered.

We thank you for the consideration of our comments and welcome the opportunity to work in conjunction with the DoD and TRICARE to obtain input from patients on issues of coverage for military personnel, retirees, and their families.