NHS patients in Wales will now have access to a first-in-class pharmaceutical treatment for irritable bowel syndrome with constipation (IBS-C). The positive recommendation by the All Wales Medicines Strategy Group (AWMSG) of Constella (linaclotide) will offer a treatment option to people in Wales who live with this chronic, relapsing disorder.
Linaclotide is an oral, once-daily guanylate cyclase-C receptor agonist (GCCA), licensed for the symptomatic treatment of moderate-to-severe irritable bowel syndrome with constipation (IBS-C) in adults. The AWMSG has recommended its use in adults whose symptoms remain uncontrolled and who have tried antispasmodics and/or laxatives.
It is estimated that approximately 10.5% (255,000) of the adult Welsh population live with irritable bowel syndrome (IBS), of which about a third will have IBS-C. IBS is a chronic, gastrointestinal disorder5 and is characterised by recurrent abdominal pain or discomfort at least three days per month in the last three months, associated with improvement with defecation, and onset associated with a change in frequency or form of stool6. The specific indicators of IBS-C include hard or lumpy stools in 25% or more of bowel movements and loose (mushy) or watery stools in less than 25% of bowel movement.
For some patients IBS can lead to multiple physician visits, multiple medication usage, potentially avoidable diagnostic tests, medical procedures and, in some cases, surgery. All of these contribute to higher medical costs for the economy – both directly via the use of healthcare resources (estimated to cost the NHS over £200 million per year) and indirectly, for example, reduced productivity and loss of earnings due to illness.
Linaclotide has a dual mechanism of action that targets abdominal pain, bloating and constipation. It acts locally in the gastrointestinal tract and is not absorbed into the body, but attaches to receptors called guanylate cyclase C on the surface of the tract. By attaching to these receptors, it blocks the sensation of pain and allows liquid to enter from the body into the gut, thereby loosening the stools and increasing bowel movements.
Until now, current treatment options for IBS-C have been limited to drugs that target individual symptoms, for example antispasmodics, which are used to treat symptoms such as pain and spasm, off-label low-dose antidepressants for the pain, and laxatives for constipation.
“This is a very positive decision from the AWMSG which we broadly welcome. This product will be a valuable asset to those people in Wales that currently have to endure the chronic pain that commonly affects people suffering from IBS. It presents a real opportunity for them to enjoy life without the burden of pain,” said Ian Semmons, Chairman, Action on Pain.