PBAC's latest decision on Everolimus: Recommended with restriction (2017). Considered for Adjunctive treatment of refractory seizures associated with tuberous sclerosis complex (TSC) in patients aged 2 years and older who have failed at least two anti-epileptic drugs and are not candidates for curative surgery.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
11
first 2010
Submissions
11
2010 → 2017
Eligible population
Patients aged ≥2 years with refractory epilepsy associated with tuberous sclerosis complex who have failed at least two anti-epileptic drugs, are not candidates for curative surgery, and have a minimum of two partial-onset seizures per week.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
366 patients
Key trials
EXIST-3
Comparator
best supportive care (placebo)
Economic model
CEA
ICER note
ICER not stated in public summary document; effective prices redacted (marked as '''''''''''''').
ICER (historical)
$45k/QALY–$105k/QALY across 7 submissions (2010–2014) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Jul 2010: Not recommended — ICER $75k/QALY
Nov 2011: Not recommended · Authority Required — ICER $75k/QALY
2012: Not recommended — ICER $45k/QALY
Nov 2012: Not recommended
Mar 2013: Not recommended · Authority Required — ICER $75k/QALY
Apr 2013: Not recommended · Authority Required — ICER $45k/QALY