Appendix B: Sources of evidence considered by the Committee

Appendix B: Sources of evidence considered by the Committee

A The assessment report for this appraisal was prepared by the School of Health and Related Research (ScHARR):

  • Tappenden P, Harnan S, Uttley L et al., Colistimethate sodium powder and tobramycin powder for inhalation for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, March 2012

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, assessment report and the appraisal consultation document (ACD). Organisations listed in I, II and III were also invited to make written submissions and have the opportunity to appeal against the final appraisal determination.

I Manufacturers/sponsors:

  • Forest Laboratories UK

  • Novartis

  • PH&T Pharma

II Professional/specialist and patient/carer groups:

  • Cystic Fibrosis Trust

III Other consultees:

  • Association of Respiratory Nurse Specialists

  • British Thoracic Society

  • Chartered Society of Physiotherapy

  • Royal College of Nursing

  • Royal College of Paediatrics & Child Health

  • Royal College of Pathologists

  • Royal College of Physicians

  • United Kingdom Clinical Pharmacy Association

  • Department of Health

  • Welsh Government

IV Commentator organisations (without the right of appeal):

  • British National Formulary

  • Commissioning Support Appraisals Service

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

  • Healthcare Improvement Scotland

  • Medicines and Healthcare products Regulatory Agency

  • Forest Laboratories UK

  • Gilead

  • Novartis

  • Profile Pharma

  • National Institute for Health Research Health Technology Assessment Programme

C The following individuals were selected from clinical specialist and patient expert nominations from the non-manufacturer/sponsor consultees and commentators. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee's deliberations. They gave their expert personal view on colistimethate sodium powder and tobramycin powder for inhalation for the treatment of pseudomonas lung infection in cystic fibrosis by attending the initial Committee discussion and/or providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Professor Andrew Greening, nominated by Healthcare Improvement Scotland – clinical specialist

  • Dr Robert Ian Ketchell, nominated by Forest Laboratories UK – clinical specialist

  • Emma Lake, nominated by The Cystic Fibrosis Trust – patient expert

  • Nikki Samsa, nominated by The Cystic Fibrosis Trust – patient expert

D Representatives from the following manufacturers/sponsors attended Committee meetings. They contributed only when asked by the Committee chair to clarify specific issues and comment on factual accuracy. They were also invited to comment on the ACD.

  • Forest Laboratories UK

  • Novartis

  • National Institute for Health and Care Excellence (NICE)