Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement for the treatment of:

  • newborn infants of > 34 weeks’ gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;
  • episodes of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, aged 0-17 years in conjunction with heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.

No clinical added value of the new forms compared to the forms already available.


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of KINOX 800 ppm mol/mol (nitric oxide) medicinal gas, compressed is substantial in the MA indications.


Clinical Added Value

no clinical added value

This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the forms already listed.


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