Regulatory Focus™ > News Articles > Novartis' and Forrest's Cystic Fibrosis Drugs Green Lighted by NICE

Novartis' and Forrest's Cystic Fibrosis Drugs Green Lighted by NICE

Posted 28 March 2013 | By Louise Zornoza 

The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has recommended reimbursement for tobramycin (Tobi Podhaler, Novartis) and colistimethate sodium (Colobreathe, Forest Laboratories UK) dry powders for inhalation (DPI) as options for treating lung infections in patients with cystic fibrosis.  

The recommendation for each drug is limited to clearly defined circumstances.

Novartis' tobramycin DPI is recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in patients with cystic fibrosis only if:

  • Nebulised tobramycin is considered an appropriate treatment, that is, when nebulised colistimethate sodium is contraindicated, not tolerated or has not produced an adequate clinical response; and
  • The manufacturer provides tobramycin DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS.

Forrest's colistimethate sodium dry powder for inhalation (DPI) is recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in patients with cystic fibrosis, only if:

  • They would clinically benefit from continued colistimethate sodium but do not tolerate it in its nebulised form and thus tobramycin therapy would otherwise be considered; and
  • The manufacturer provides colistimethate sodium DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS

Tags: Novartis, UK

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