Following a full submission, the Scottish Medicines Consortium (SMC) has accepted sildenafil citrate (Revatio®) for restricted use within NHS Scotland for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II, to improve exercise capacity. It is restricted to initiation by specialists working in the Scottish Pulmonary Vascular Unit or similar specialists.
The drug advice notes that efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. This is an orphan indication for sildenafil with limited clinical evidence from post-hoc analysis of a short-term clinical trial.