The U.K.’s National Institute for Health and Care Excellence (NICE) issued a final draft guidance that recommends the anticoagulant rivaroxaban (Xarelto, Janssen Pharmaceuticals/Bayer Healthcare) in the treatment of pulmonary embolism (PE) and prevention of recurrent deep vein thrombosis (DVT) and PE after acute PE in adults.
NICE determined that rivaroxaban was a clinically and cost-effective treatment. For the initial treatment of acute PE, the recommended dosage of rivaroxaban is 15 mg twice daily for the first 21 days followed by 20 mg once daily for continued treatment and prevention of recurrent venous thromboembolism.
Duration of treatment is based on individual risk of recurrent DVT or PE, as well as the risk of bleeding. In the U.K., the usual duration of treatment is six months or more but high-risk patients may be given indefinite treatment with anticoagulants to prevent further episodes.
Carole Longson, director of the NICE Health Technology Evaluation Centre, said the committee evaluated the benefit and risk of rivaroxaban compared with warfarin; the latter requires monitoring and dose adjustment and may interact with other medications and foods. “Rivaroxaban therefore represents a significant potential benefit for people with PE and DVT because it avoids the need for initiation with heparin and the subsequent transition to warfarin,” she said in a release.
The final draft guidance was sent to Bayer Healthcare, organizations representing patients and healthcare professionals and others who have 15 working days to appeal it or notify NICE of potential errors. Final guidance is expected to be published in May.