NICE now backs Colobreathe, Tobi Podhaler

The U.K.'s NICE issued final appraisal determinations recommending Colobreathe colistimethate sodium from Forest Laboratories Inc. (NYSE:FRX) and TOBI Podhaler from Novartis AG (NYSE:NVS; SIX:NOVN) to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients. The decisions are contingent on the companies providing their respective therapies at an undisclosed discount under a patient access scheme. Colobreathe, which is inhaled colistimethate delivered with a dry powder inhaler, is recommended if nebulized colistimethate, a generic antibiotic, is not tolerated. The recommendation reverses draft guidance issued last October.

At the time, NICE said that Colobreathe "showed potential for cost savings" compared with nebulized tobramycin, which Novartis markets as TOBI. However, the committee said clinical evidence was "not robust enough to conclusively show" that Colobreathe was a cost-effective use of NHS resources. In the FAD, the committee said that "despite uncertainties associated with the clinical- and cost-effectiveness evidence" for Colobreathe, the product has "substantial cost savings" compared to TOBI in patients who are intolerant of nebulized colistimethate. ...