Reason for request


Low clinical benefit in the treatment of pulmonary arterial hypertension (PAH) in functional class III, in triple therapy, but no clinical benefit demonstrated in the management of this disease

Insufficient clinical benefit to justify its inclusion on the list of reimbursable productsfor the treatment of PAH in WHO functional class II or III in monotherapy or dual therapy



  • UPTRAVI has a Marketing Authorisation in the treatment of pulmonary arterial hypertension (PAH) in WHO functional class II-III, in combination, in patients inadequately controlled by an endothelin receptor antagonist (ERA) and/or by a phosphodiesterase type 5 (PDE5) inhibitor, and in monotherapy in patients who are not candidate for these therapies.
  •  Its efficacy, alone or in combination with an ERA and/or a PDE5 inhibitor, has been demonstrated only compared with placebo, after a median duration of 15 to 17 months, primarily on the reduction of worsening of PAH. No difference wasobserved  on mortality compared with placebo.
  • It is a PAH medicine that uses the prostacyclin pathway. Its use is required in PAH from functional class III and only in patients inadequately controlled by a dual therapy with ERA/PDE5 inhibitor, as part of a triple therapy with these two substances.



Clinical Benefit




Clinical Added Value

no clinical added value


Therapeutic use


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