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New HTA Decisions in France
March 2021
Drug name
MONOXYDE D’AZOTE SOL FRANCE (nitrogen monoxide)
Company
SOL FRANCE
Decision date
20/01/2021
Therapeutic area
Cardiovascular conditions
Therapeutic sub area
Hypertension
Official notice date
21/01/2021
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
Indicated in the treatment of persistent pulmonary arterial hypertension in newborns and in the treatment of pulmonary arterial hypertension associated with cardiac surgery in children and adults.
Decision Type
New technology assessment
Summary
The committee consider the actual benefit of MONOXYDE D'AZOTE SOL FRANCE (nitrogen monoxide) to be 'important' in combination with assisted ventilation and conventional treatment for the treatment of newborns of gestational age = 34 weeks, presenting with respiratory distress hypoxemia associated with clinical or echocardiographic signs of pulmonary arterial hypertension, with the aim of improving oxygenation and avoiding the use of oxygenation by extracorporeal circulation. It is indicated also in the treatment of flare-ups of peri and postoperative pulmonary arterial hypertension as part of cardiac surgery, in adults, newborns, infants, children and adolescents aged 0 to 17 years, with the aim of selectively lowering pulmonary arterial pressure to improve right ventricular function and tissue oxygenation. MONOXYDE D'AZOTE SOL FRANCE does not improve the actual benefit (ASMR V) compared to other specialties based on nitric oxide.