PBAC's latest decision on Pasireotide: Recommended with restriction (2015). Considered for Treatment of acromegaly in patients inadequately controlled with either octreotide LAR 30mg or lanreotide autogel 120mg.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Adult patients with acromegaly inadequately controlled on maximum recommended doses of octreotide LAR 30mg or lanreotide ATG 120mg, with mean growth hormone level >2.5 micrograms per litre and IGF-1 >1.3 × ULN.
Therapy area
Endocrinology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
198 patients
Key trials
C2402 (PAOLA)
Comparator
octreotide LAR 30mg or lanreotide ATG 120mg
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission presented a cost-minimisation analysis rather than cost-utility analysis due to difficulties in quantifying benefits in QALYs.