PBAC's latest decision on Riociguat: Deferred (2016). Considered for Treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent CTEPH subsequent to pulmonary endarterectomy (PEA) in adult patients with WHO functional class II-IV symptoms.
PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
$75k/QALY
Range: $15k/QALY–$75k/QALY
Submissions
4
first 2014
Submissions
4
2014 → 2016
Eligible population
Adult patients with inoperable CTEPH or persistent CTEPH following PEA with WHO functional class II, III, or IV symptoms, with documented PVR >300 dyn·sec·cm⁻⁵ and PAPmean >25 mmHg or right ventricular dysfunction on echocardiography.
Therapy area
Cardiovascular
Line of therapy
Any
Evidence base
RCT
Primary endpoint
6MWD, WHO functional class
Pivotal trial size
261 patients
Key trials
CHEST-1, CHEST-2
Comparator
placebo
Economic model
CUA
ICER note
ICER range varies by patient cohort: inoperable patients $15,000–$45,000; persistent patients $45,000–$75,000. Corrected base case ICER $45,000–$75,000.
Submission history
Mar 2014: Recommended with restriction · Authority Required
Nov 2014: Noted · Authority Required
Jul 2015: Not recommended · Authority Required
Mar 2016: Deferred · Authority Required — ICER $75k/QALY