NICE in the United Kingdom Gives Positive Recommendation for Eluxadoline (Truberzi) for IBS-D

July 31, 2017

Today, via the social media of the IBS Network, the U.K. charity for irritable bowel syndrome, IBS Impact received the following linked press release from Allergan, the pharmaceutical company for eluxadoline, which is known in the U.K. and throughout the European Union by the brand name Truberzi. This is the same medication which is known in the U.S. and Canada by the brand name Viberzi. It is a twice-daily oral medication for irritable bowel syndrome with diarrhea (IBS-D)

According to the press release, dated July 27, 2017, the National Institute of Health and Care Excellence, still known by its former acronym, NICE, issued a Final Appraisal Determination that the National Health Service (NHS) make eluxadoline available to adults with IBS-D who have not responded to, or for medical reasons, cannot use other IBS treatment interventions usually offered. If there is no appeal to this determination, this guidance will be published in August, and availability under the NHS is expected sometime this fall.

Eluxadoline was originally approved for use in the EU by the European Commission in September 2016, by the Food and Drug Administration (FDA) in the United States in May 2015 and by Health Canada in March 2017. It has been used successfully by many people with IBS-D throughout North America and the European Union in that time frame, but as reported by this blog on March 15, 2017, the FDA issued a warning to U.S. physicians that eluxadoline should not be prescribed to patients who do not have a gallbladder because of reports of many cases of serious pancreatitis and two deaths in that subgroup. We advise anyone considering any specific IBS medication or treatment to read available evidence-based information, to familiarize themselves with the benefits and risks, and to consult their own doctors as to if the given intervention is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular interventions, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.

Representative Hastings of Florida Co-Sponsors HR 1187 for Functional Gastrointestinal and Motility Disorders

July 14, 2017

According to IFFGD and the official Congressional legislative database, Representative Alcee Hastings (D-FL-20) signed on yesterday as a co-sponsor of of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.

Representative Hastings is serving his thirteenth term in the House of Representatives. His current district, the 20th Congressional District of Florida, encompasses parts of Broward and Palm Beach Counties, including parts of Miramar, Fort Lauderdale, and West Palm Beach.  Representative Hastings has a long record of supporting a wide range of health issues and is currently a member of the Congressional caucuses for numerous other specific chronic medical conditions and disabilities as seen on his official house website.

In officially supporting HR 1187, Representative Hastings joins Representative F. James Sensenbrenner, Jr. (R-WI-5), who is the initial sponsor, and co-sponsors, Representatives Mark Pocan (D-WI-2), Eliot Engel (D-NY-16),and Dave Loebsack (D-IA-2)  If you are a constituent of any of these legislators, please take a few minutes to call, write, or contact him on social media to thank him for his  support of the functional gastrointestinal and motility disorders community.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 1187, please see the previous post from March 21, 2017 for links to the bill and more details on how to do so.  Often, it takes multiple attempts to elicit any interest from legislators, so if you do not receive a reply, do not hesitate to try again or to switch contact methods until you attract attention. Keep in mind that your Representative may be different from before because of the 2016 elections, district boundaries that may have been re-drawn, or if you have moved.

Your personal experiences as a person with IBS and/or other functional GI/motility disorders, or as a concerned family member, friend or colleague, are most effective in communicating to legislators and their staff that there are real human beings behind the statistics. However, even general expressions of support are helpful.

HR 1187 is bipartisan legislation (supported by members of both parties) and according to IFFGD discussions with IBS Impact,  is “revenue-neutral,” meaning that there will be no additional taxes or spending added to the current federal deficit if it is enacted. Discretionary funds are available at the National Institutes of Health to be allocated if Congress directs NIH, through this Act, that functional gastrointestinal and motility disorders are a priority. Congress will only do so if we, as a community, are able to show them the importance of the research, education and FDA coordination provided for in HR 1187.

NIH grants funding to researchers throughout the world, not just in the U.S., so in the long run, enactment of this Act may also benefit readers with IBS in other countries. Medical research also sometimes involves multinational teams of scientists, and in any case, study results are usually published globally, adding to the cumulative knowledge worldwide.

It is IBS Impact’s understanding that HR 1187 will not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 218 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 115th,  the necessary number of sponsor/cosponsors must be reached by December 2018. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 1187 has not passed by that time,  a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering co-sponsors anew. This is what occurred with HR 2239 in 2012, HR 842 in 2014 and HR 2311 in 2016. While it is quite common for legislation of various sorts to take several Congresses to pass, our continuing advocacy now can increase awareness, build momentum and perhaps accelerate passage. It is in our hands.

Check back on this blog or join IBS Impact’s Facebook page or Twitter feed for further updates on HR 1187 as they occur. Links to the social media sites can be found on the right sidebar of the blog.