PBAC's latest decision on Selpercatinib: Recommended with restriction (2024). Considered for Advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adults aged 18 years or older.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2023
Submissions
2
2023 → 2024
Eligible population
Adults aged 18 years or older with histologically and cytologically confirmed advanced or metastatic NSCLC who are RET fusion-positive, with ECOG performance status of 0 to 2, receiving selpercatinib orally until disease progression.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Key trials
LIBRETTO-001, LIBRETTO-431, KN-189
Comparator
pembrolizumab in combination with platinum-based doublet chemotherapy
Economic model
CUA
ICER note
The ICER value is not stated in the public text. The PBAC considered the economic model unreliable and uncertain due to indirect comparison uncertainties and noted that the ICER remained highly uncertain. The resubmission did not use clinical outcomes from the LIBRETTO-431 trial in the economic model as requested.
Submission history
Jul 2023: Recommended with restriction · Authority Required
Jul 2024: Recommended with restriction · Authority Required