1.1 Naldemedine is recommended, within its marketing authorisation, as an option for treating opioid-induced constipation in adults who have had laxative treatment.
Why the committee made these recommendations
The treatment of opioid-induced constipation depends on whether the opioid is the only cause of the constipation (pure opioid-induced constipation) or if there are other contributing factors (mixed aetiology constipation). Treatment may include a peripherally acting mu-opioid receptor antagonist (PAMORA) alone. But, commonly a PAMORA and a conventional laxative are used together. Naldemedine is an oral PAMORA for adults who have had laxative treatment.
The clinical evidence shows that naldemedine increases the frequency of bowel movements compared with no treatment and other PAMORAs.
The cost-effectiveness evidence includes naldemedine in several clinical scenarios, for both pure opioid-induced constipation and mixed aetiology constipation. In all scenarios, the most likely cost-effectiveness results are within what NICE normally considers an acceptable use of NHS resources. Therefore, naldemedine is recommended for opioid-induced constipation in adults who have had laxative treatment.