Following the recent cancellation of the committee meeting, NICE does not consider that this appraisal, within the current format, will add value to the existing published guidance. Therefore, NICE has decided to suspend this appraisal from its current work programme..
 
Status Suspended
Decision Selected
Process MTA
ID number 901

Project Team

Project lead Shonagh D'Sylva

Email enquiries

External Assessment Group School of Health and Related Research, University of Sheffield

Stakeholders

Companies sponsors Amgen (denosumab, romosozumab)
  Consilient Health (raloxifene) not participating
  Daiichi Sankyo (raloxifene)
  Eli Lilly (teriparatide)
  Gedeon Richter (teriparatide)
  Internis Pharmaceuticals (teriparatide)
  Mylan UK (raloxifene) – not participating
  Sandoz (raloxifene) – not participating
  UCB (romosozumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups National Osteoporosis Society
Professional groups Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  United Kingdom Clinical Pharmacy Association
Comparator companies Accord Healthcare (alendronate, ibandronate, zoledronate) not participating
  Actavis UK (alendronate, ibandronate, risedronate, zoledronate) not participating
  Amneal Pharma Europe (zoledronate) not participating
  Aurobindo (alendronate, risedronate) not participating
  Consilient Health (ibandronate) not participating
  Creo Pharma (alendronate) not participating
  Dr Reddy’s Laboratories (zoledronate) not participating
  Hospira UK (zoledronate) not participating
  Internis (alendronate) not participating
  Intrapharm Laboratories (zoledronate) not participating
  Medac (zoledronate) not participating
  Merck Sharp & Dohme (alendronate) not participating
  Mylan UK (alendronate, ibandronate, zoledronate) not participating
  Novartis Pharmaceuticals (zoledronate) not participating
  Ranbaxy (ibandronate, zoledronate) not participating
  Rosemont (alendronate) not participating
  Sandoz (risedronate) not participating
  Seacross Pharmaceuticals (zoledronate) not participating
  Warner Chilcott UK (risedronate) 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
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Bone Research Society

Timeline

Key events during the development of the guidance:

Date Update
02 March 2021 Suspended. Following the recent cancellation of the committee meeting, NICE does not consider that this appraisal, within the current format, will add value to the existing published guidance. Therefore, NICE has decided to suspend this appraisal from its current work programme..
31 January 2021 The Committee discussion scheduled for 7 January 2021 has been cancelled. During the preparation for the Committee meeting, NICE has considered whether this appraisal will add value to the existing published guidance and how best to advise the NHS on the use of romosozumab.
22 September 2020 In progress. This appraisal was delayed due to COVID-19 but has now been rescheduled.
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.
02 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.
29 January 2019 All of the drugs in this Technology Appraisal must have received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) before the first Appraisal Committee meeting. This will not have happened before the current scheduled meeting in February, therefore we will reschedule this appraisal and the first Committee meeting will take place on 24 April 2019.
15 January 2019 Assessment report sent for information
18 May 2018 Invitation to participate
18 December 2017 - 22 January 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
17 June 2016 Further details regarding the timings of this MTA will be available in due course.
01 March 2016 Referral

For further information on our processes and methods, please see our CHTE processes and methods manual