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Cystic fibrosis (pseudomonas lung infection) - colistimethate sodium and tobramycin [ID342]

Colistimethate sodium and tobramycin dry powders for inhalation for treating pseudomonas lung infection in cystic fibrosis

Status: History
Expected date of issue: March 2013
Referral date: June 2010
Process: MTA
Notes:

Scoped within Batch 11

Topic area:
  • Digestive system
  • Respiratory
 

NICE project team

Executive Lead: Gillian Leng
Technical Lead: Helen Tucker
Communications manager: Katie Williamson
Project manager: Kate Moore
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Provisional schedule

Closing date for invited submissions / evidence submission: 12 May 2011
1st appraisal committee meeting: 25 September 2012
2nd appraisal committee meeting: 27 November 2012
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Consultees and commentators

Consultees

 

Commentators (no right to submit or appeal)

 

Manufacturers/sponsors

  • Forest Laboratories UK (colistimethate sodium powder for inhalation)
  • Novartis (Tobramycin inhalation powder and podhaler)

Patient/carer groups

  • Cystic Fibrosis Trust

Professional groups

  • 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

Others

  • Department of Health
  • Welsh Government

General

  • 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

Comparator manufacturer(s)

  • Forest Laboratories UK (colistimethate sodium for nebulised inhalation)
  • Gilead (aztreonam)
  • Novartis (tobramycin for nebulised inhalation)
  • Profile Pharma (colistimethate sodium for nebulised inhalation)

Relevant research groups

  • None

Assessment group

  • National Institute for Health Research Health Technology Assessment Programme
  • School of Health & Related Research Sheffield (ScHARR)

Associated guideline groups

  • None

Associated public health groups

  • None

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Project history

Date Update
18 July 2012

NICE has requested further information from the manufacturers of colistimethate sodium powder and tobramycin powder for inhalation (as per 3.4.9-10 of the NICE MTA process guide) and the Assessment Group will be performing additional analyses.

As a consequence, the first committee discussion has been delayed from 23 August to 25 September 2012. The rescheduled discussion will take place regardless of any further developments. The second discussion for this appraisal remains scheduled for 27 November 2012.

2 May 2012

 

The first Appraisal Committee meeting discussion of this topic was due to be held on 23 May 2012.  As a consequence of further information from the manufacturers of colistimethate sodium powder and tobramycin (Forest Laboratories and Novartis Pharmaceuticals), this discussion has now been cancelled. We will provide further information in due course to confirm when this topic has been rescheduled into the appraisals work programme.

 

9 February 2012

 

We are in a position to update you on the Assessment Report Consultation for this appraisal. We anticipate sending the Assessment Report to consultees and commentators for a 20 day consultation around late March / early April 2012. Further updates on timings will follow soon.

26 August 2011

Following on from advice received from the manufacturer of colistimethate, Forest Laboratories, this appraisal has been rescheduled to align with latest regulatory expectations.  The committee meetings for this appraisal have therefore been rescheduled for 23 May 2012 and 25 July 2012. The assessment report for this appraisal was due to be sent to consultees and commentators in early September 2011. As NICE will not make public, or circulate among consultees and commentators, any documents for consultation before the technology has received regulatory approval (Section 3.2.15, Guide to the multiple technology appraisal process), this consultation will also be rescheduled. We will issue an update in due course.

 

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Key documents

This page was last updated: 19 April 2013

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Selected, reliable information for health and social care in one place

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.