Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
 
Status Schedule affected by COVID-19
Process STA 2018
ID number 1189

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews Ltd

Consultees

Companies sponsors Shionogi (naldemedine)
Others Department of Health & Social Care
  NHS England
  Welsh Government
Patient carer groups None
Professional groups Association of Cancer Physicians
  British Society of Gastroenterology
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
  UK Clinical Pharmacy Association

Commentators

Comparator companies Kyowa Kirin (naloxegol) (CAU form signed, participating)
  Norgine Pharmaceuticals (sterculia/ frangula, macrogol, docusate sodium enema) (CAU form signed, participating)
  Novartis (senna) – (CAU not signed, not participating)
  Orbis Consumer Products (glycerol suppositories) – (CAU not signed, not participating)
  Pinewood Healthcare (sodium citrate enema) – (CAU not signed, not participating)
  Reckitt Benckiser Healthcare (senna) – (CAU not signed, not participating)
  Sandoz (lactulose) – (CAU not signed, not participating)
  Sanofi (bisacodyl, docusate, macrogol sodium picosulfate) – (CAU not signed, not participating)
  Stirling Anglian (macrogol) – (CAU not signed, not participating)
  Swedish Orphan Biovitrum (methylnaltrexone bromide) – (CAU not signed, not participating)
  Teva UK (lactulose) – (CAU not signed, not participating)
  Thornton & Ross (macrogol, magnesium hydroxide, glycerol suppositories, senna) – (CAU not signed, not participating)
  UCB Pharma (sodium citrate enema, docusate) – (CAU not signed, not participating)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
05 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
07 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide updates as and when this information becomes clear.
18 March 2020 Committee meeting: 1
05 April 2019 Invitation to participate
05 April 2019 In progress. To appraise the clinical and cost effectiveness of Suggested remit - To appraise the clinical and cost effectiveness of Naldemedine for treating opioid-induced constipation.
23 February 2018 The Department of Health has asked the Institute to conduct an appraisal of naldemedine for treating opioid-induced constipation which was due to start in mid-January 2018. We have been informed by the company of a delay to the licensing application, therefore, NICE will suspend and reschedule this appraisal in line with the new timings.

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance