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New HTA Decisions in England
September 2020
Drug name
RIZMOIC® (naldemedine)
Company
Shionogi
Decision date
27/08/2020
Therapeutic area
Digestive tract conditions
Therapeutic sub area
Constipation
Decision
Recommended
Indication
Naldemedine is recommended, within its marketing authorisation, as an option for treating opioid-induced constipation in adults who have had laxative treatment.
Decision Detail
Summary
Clinical evidence for naldemedine was based on 4 pivotal randomised trials (COMPOSE-1, -2 -3 and -4) and 3 supportive open-label safety studies (COMPOSE-5, -6 and -7). COMPOSE-1, -2 and -4 suggested a significantly greater proportion of people who had spontaneous bowel movements in the naldemedine arm compared with placebo. The committee agreed that treatment with naldemedine will likely result in an ICER below £20,000 per QALY gained compared with the relevant comparators for all the subpopulations. Therefore, naldemedine is recommended for opioid-induced constipation in adults who have had laxative treatment.