riociguat (Adempas)

following a full submission considered under the end of life/orphan medicine process.

riociguat (Adempas®) is accepted for restricted use within NHS Scotland.

Indication under review: Chronic thromboembolic pulmonary hypertension (CTEPH): Treatment of adult patients with World Health Organisation (WHO) functional class II to III with
• inoperable CTEPH,
• persistent or recurrent CTEPH after surgical treatment,
to improve exercise capacity.

SMC restriction: for patients in whom a PDE5 inhibitor is inappropriate, not tolerated, or ineffective.  It is restricted to prescribing by specialists in the Scottish Pulmonary Vascular Unit.

Riociguat demonstrated significant improvement compared with placebo in exercise capacity, in terms of 6-minute walk distance, in patients with inoperable CTEPH or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of riociguat.  This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Riociguat is also indicated for use in pulmonary arterial hypertension. The company submitted  clinical and cost-effectiveness evidence for its use in CTEPH only.