Suggested remit: To appraise the clinical and cost effectiveness of romosozumab within its marketing authorisation for preventing osteoporotic fragility fractures in adults with severe osteoporosis at high risk of fracture.
 
Status In progress
Process STA 2018
ID number 3936

Provisional Schedule

Committee meeting: 2 17 February 2022

Project Team

Project lead Shonagh D'Sylva

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews Ltd

Consultees

Companies sponsors UCB Pharma (romosozumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Royal Osteoporosis Society
Professional groups British Society for Rheumatology
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Comparator companies Accord Healthcare (alendronate, ibandronate, zoledronate, risedronate, raloxifene) - not participating
  Actavis UK (alendronate, ibandronate, risedronate, zoledronate) - not participating
  Amgen (denosumab)
  Atnahs (ibandronate) - not participating
  Aspire Pharma (risedronate, ibandronate, raloxifene) - not participating
  Aurobindo (alendronate, risedronate) - not participating
  Consilient Health (ibandronate) - not participating
  Creo Pharma (alendronate) - not participating
  Dr Reddy’s Laboratories (zoledronate) - not participating
  Eli Lilly (teriparatide) - not participating
  Mylan UK (alendronate, ibandronate, zoledronate) - not participating
  Novartis Pharmaceuticals (zoledronate) - not participating
  Radius Health (abaloparatide) - not participating
  Rosemont (alendronate) - not participating
  Sandoz (risedronate, ibandronate) - not participating
  Seacross Pharmaceuticals (zoledronate) - not participating
  Sun Pharmaceuticals (ibandronate, zoledronate) - not participating
  Thornton and Ross (Alendronate) - not participating
  Vygoris Limited (raloxifene) - not participating
  Zentiva (alendronate, ibandronate) - 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 None

Timeline

Key events during the development of the guidance:

Date Update
25 November 2021 - 16 December 2021 Appraisal consultation: 1
04 November 2021 Committee meeting
01 September 2021 The Department of Health and Social Care has asked NICE to produce guidance on the above technology in the NHS in England. Over the past few months NICE has been working with the company and evidence review group on the evidence submission and critique. We have experienced some technical challenges during this process, which all parties have worked to resolve. These technical challenges have led to delays in the evidence generation. Therefore, to avoid further delay NICE, following discussion with the company, have decided not to hold a technical engagement for this appraisal. To avoid further delay we will proceed directly to a discussion at the scheduled committee meeting on 4 November 2021. We will endeavour to keep stakeholders informed if there are any further updates ahead of the committee meeting.
20 April 2021 In progress. Topic in progress
22 March 2021 - 12 April 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
20 April 0021 Invitation to participate

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