tadalafil (Adcirca)

following a full submission

tadalafil (Adcirca®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of adults with pulmonary arterial hypertension (PAH) classified as World Health Organisation functional class (WHO-FC) II and III, to improve exercise capacity.

SMC restriction: To initiation by specialists working in the Scottish Pulmonary Vascular Unit or similar specialists.

Tadalafil demonstrated statistically significant improvement in 6 minute walking distance (6MWD) compared with placebo in patients with PAH, WHO-FC II or III.  Approximately half of the study patients were receiving a concomitant endothelin receptor antagonist.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tadalafil.  This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.