NICE now backs Xarelto to treat blood clots; negative on Bronchitol for CF

In final draft guidance published today (1 June 1), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended German drug major Bayer’s (BAYN: DE) Xarelto (rivaroxaban) as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism in adults diagnosed with acute deep vein thrombosis (DVT) on the National Health Service.

Publication of the draft recommendation follows receipt of further information from the manufacturer that had been requested by NICE in its previous draft guidance, when the agency asked Bayer to provide further evidence relating to the drug’s clinical and cost effectiveness of the drug in these indications (The Pharma Letter March 13).

Commenting on the recommendation, Carole Longson, the NICE’s Health Technology Evaluation Centre Director, said: "For many people, using warfarin is difficult because of the need for regular monitoring with blood tests, dosing adjustments, and the need to be careful about their diet because of warfarin’s interaction with certain foods. The independent Appraisal Committee was initially unable to recommend rivaroxaban based on the data presented by the manufacturer because it did not adequately demonstrate the drug’s clinical and cost effectiveness in the context of UK clinical practice. We are pleased to say that, following the submission of additional information and analysis from the manufacturer during consultation, the committee is able to recommend rivaroxaban as a cost-effective option for treating DVT and preventing recurrent DVT and PE in adults."