PBAC's latest decision on Pemetrexed disodium: Not recommended (2005). Considered for in combination with cisplatin for the treatment of patients with malignant pleural mesothelioma; and for the treatment of patients with un-resectable locally advanced or metastatic malignant pleural mesothelioma.
PBAC outcome
Not recommended
2005
ICER (AUD/QALY)
$105k/QALY
Range: $45k/QALY–$105k/QALY
Submissions
1
first 2005
Submissions
1
2005 → 2005
Eligible population
patients with un-resectable locally advanced or metastatic malignant pleural mesothelioma
Therapy area
Oncology
Evidence base
RCT
Primary endpoint
OS
Key trials
H3E-MC-JMCH; Vogelzang, NJ et al, 2003
Comparator
cisplatin
Economic model
CUA
ICER note
PBAC preferred estimate using mean survival (ITT, fully supplemented patients) with quality adjustment at nominal utility 0.7, yielding $45,000 to $105,000 per QALY. Base-case median survival estimate was $15,000 to $75,000 per life-year.
Why PBAC said no
Reasons cited in the latest PSD: unacceptable cost-effectiveness, concerns about reliability of sub-group analysis (multiple post hoc analyses with multiplicity issues), implausible reversal of treatment effect in Stage I/II patients, use of median rather than mean survival in economic evaluation, lack of demonstrated improvement in quality of life, difficult and unreliable disease staging for proposed restriction