Suggested remit: To appraise the clinical and cost effectiveness of tanezumab within its marketing authorisation for treating moderate to severe chronic pain caused by osteoarthritis.
On 16 September 2021 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of marketing authorisation for the medicinal product Raylumis (tanezumab), intended for the treatment of pain associated with osteoarthritis. NICE have therefore suspended the appraisal. We will continue to monitor any developments and will update interested parties if the situation changes.
 
Status Suspended
Process STA 2018
ID number 1603

Project Team

Project lead Thomas Feist

Email enquiries

Evidence Review Group / Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Consultees

Companies sponsors Pfizer
Others Department of Health and Social Care
  Welsh Government
Patient carer groups British Society for Rheumatology
Professional groups Royal College of Physicians
  UK Clinical Pharmacy Association

Commentators

General commentators All Wales Therapeutic and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
23 November 2021 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of tanezumab for treating moderate to severe chronic pain caused by osteoarthritis [ID1603]. The company has informed NICE that it is withdrawing the evidence submission for this appraisal as it will be discontinuing the global clinical development programme for tanezumab following negative outcomes of both the FDA (Food and Drugs Administration) and EMA (European Medicines Agency) reviews of regulatory submissions. Therefore, this topic will remain indefinitely suspended on the NICE work programme.
13 October 2021 Suspended. On 16 September 2021 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of marketing authorisation for the medicinal product Raylumis (tanezumab), intended for the treatment of pain associated with osteoarthritis. NICE have therefore suspended the appraisal. We will continue to monitor any developments and will update interested parties if the situation changes.
26 October 2020 Invitation to participate
26 October 2020 In progress. STA
03 August 2020 - 01 September 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

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