9 Sources of evidence considered by the Committee

9 Sources of evidence considered by the Committee

A The Evidence Review Group (ERG) report for this appraisal was prepared by BMJ Technology Assessment Group (BMJ-TAG):

  • Edwards SJ, Karner C, Trevor N et al. Mirabegron for the treatment of symptoms associated with overactive bladder. (January 2013)

B The following organisations accepted the invitation to participate in this appraisal as consultees and commentators. They were invited to comment on the draft scope, the ERG report and the appraisal consultation document (ACD). Organisations listed in I were also invited to make written submissions. Organisations listed in II and III had the opportunity to give their expert views. Organisations listed in I, II and III also have the opportunity to appeal against the final appraisal determination.

I Manufacturer/sponsor:

  • Astellas Pharma (mirabegron)

II Professional/specialist and patient/carer groups:

  • Association for Continence Advice

  • Bladder and Bowel Foundation

  • British Association of Urological Surgeons

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians

III Other consultees:

  • Department of Health

  • Welsh Government

IV Commentator organisations (did not provide written evidence and without the right of appeal):

  • BMJ Technology Assessment Group (BMJ-TAG)

  • Commissioning Support Appraisals Service

  • Department of Health, Social Services and Public Safety for Northern Ireland

  • Health Care Improvement Scotland

  • Medicines and Healthcare products Regulatory Agency

  • National Clinical Guidelines Centre

  • National Institute for Health Research Health Technology Assessment Programme

  • Pfizer (fesoterodine fumarate, oxybutynin hydrochloride, tolterodine tartrate)

C The following individuals were selected from clinical specialist and patient expert nominations from the consultees and commentators. They gave their expert personal view on mirabegron by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Mrs Cath Williams, ACA Executive Committee/Clinical and Operational Lead, Bladder and Bowel Service, nominated by organisation representing Association for Continence Advice – clinical specialist

  • Mrs Suzie Venn, Consultant Urological Surgeon, nominated by organisation representing British Association of Urological Surgeons – clinical specialist

  • Mrs Debbie Stuart, Clinical Manager, nominated by organisation representing Bladder and Bowel Foundation – patient expert

  • Mrs June Rogers, PromoCon Team Director, nominated by organisation representing National Clinical Guidelines Centre – patient expert

D Representatives from the following manufacturer/sponsor attended Committee meetings. They contributed only when asked by the Committee chair to clarify specific issues and comment on factual accuracy.

  • Astellas Pharma

  • National Institute for Health and Care Excellence (NICE)