Appendix B: Sources of evidence considered by the Committee

A The Evidence Review Group (ERG) report for this appraisal was prepared by Kleijnen Systematic Reviews:

  • Riemsma R, Maiwenn J et al. Mannitol dry powder for inhalation for the treatment of cystic fibrosis, Kleijnen Systematic Reviews (April 2011).

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:

  • Pharmaxis

II Professional/specialist and patient/carer groups:

  • Association of Respiratory Nurse Specialists

  • British Thoracic Society

  • Cystic Fibrosis Trust

  • Royal College of Nursing

  • Royal College of Paediatrics & Child Health

  • Royal College of Physicians

  • United Kingdom Clinical Pharmacy Association

III Other consultees:

  • Department of Health

  • Sandwell PCT

  • Welsh Assembly Government

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

  • British National Formulary

  • Commissioning Support Appraisals Service

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

  • NHS Quality Improvement Scotland

  • Roche Products

C The following individuals were selected from clinical specialists and patient expert nominations from the non-manufacturer/sponsor consultees and commentators. They gave their expert personal view on mannitol by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Mrs Penny Agent, Deputy Director of Rehabilitation & Therapies, Royal Brompton & Harefield HS Foundation Trust, nominated by Pharmaxis – clinical specialist

  • Dr Diana Bilton, Consultant Physician, Royal Brompton Hospital, nominated by Pharmaxis – clinical specialist

  • Mrs Emma Lake, Senior Clinical Care Patient Advisor, the Cystic Fibrosis Trust, nominated by the Cystic Fibrosis Trust – patient expert

D The following individuals were nominated as NHS Commissioning experts by the selected PCT allocated to this appraisal. They gave their expert/NHS commissioning personal view on mannitol by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Dr Alexis Macherianakis, Consultant in Public Health Medicine, Sandwell PCT, selected by Sandwell PCT – NHS Commissioning expert

E 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.

  • Pharmaxis

  • National Institute for Health and Care Excellence (NICE)