PBAC's latest decision on Selexipag: Recommended with restriction (2020). Considered for Triple agent sequential add-on therapy with an endothelin receptor antagonist (ERA) and a phosphodiesterase-5 inhibitor (PDE-5i) for patients with World Health Organisation (WHO) Functional Class III or IV pulmonary arterial hypertension (PAH) demonstrating an inadequate clinical response or deterioration whilst on stabilised doses of an ERA and a PDE-5i.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
3
first 2016
Submissions
3
2016 → 2020
Eligible population
Adult patients with WHO Functional Class III or IV PAH who have received prior dual therapy with a phosphodiesterase-5 inhibitor (PDE-5i) and an endothelin receptor antagonist (ERA) and are demonstrating inadequate clinical response or deterioration whilst on stabilised doses of both agents.
Therapy area
Cardiovascular
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
OS
Key trials
GRIPHON
Comparator
placebo
Economic model
CUA
ICER note
ICER values are redacted (shown as '''''''''''''') in the public summary document. The document states 'A new a cost utility analysis was presented based on results of GRIPHON trial subgroup with WHO FC III PAH on dual therapy with an ERA and a PDE-5i at baseline. Results presented as costs per QALY gained in the model.' However, the actual numeric ICER is not disclosed.
Risk sharing
Risk-sharing arrangement in place — Special Pricing Arrangement (SPA) proposed for all maintenance packs of selexipag as well as the 800 mcg strength initiation pack with a flat pricing structure.
Submission history
Mar 2016: Recommended with restriction · Authority Required
Mar 2017: Recommended with restriction · Authority Required
Jul 2020: Recommended with restriction · Authority Required