sildenafil (Revatio) IV

following an abbreviated submission

sildenafil citrate 0.8mg/mL injection (Revatio®) is accepted for restricted use within NHS Scotland.

Indication under review: for the treatment of patients with pulmonary arterial hypertension who are currently prescribed oral sildenafil and who are temporarily unable to take oral medicine, but are otherwise clinically and haemodynamically stable.

SMC restriction: restricted to use on the advice of specialists in the Scottish Pulmonary Vascular Unit and from the Scottish Adult Congenital Cardiac Service.

Oral sildenafil is indicated for treatment of patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.  Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

SMC has previously accepted oral sildenafil in this orphan indication. The intravenous formulation is significantly more expensive than the oral preparation but it is intended only for short-term use (the estimated average duration of intravenous treatment is three days).