PBAC's latest decision on Alemtuzumab: Not recommended (2018). Considered for Relapsing remitting multiple sclerosis (RRMS); specifically the resubmission sought reimbursement of up to two additional courses of treatment for patients experiencing relapses or MRI lesion activity after initial two courses.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2014
Submissions
3
2014 → 2018
Eligible population
Adult patients with relapsing remitting multiple sclerosis; two subpopulations: (1) those who do not experience relapses or new/enlarging brain or spinal cord lesions after two PBS-subsidised courses, and (2) those who experience one or more relapses or two or more new/enlarging lesions after two PBS-subsidised courses.
CARE-MS I, CARE-MS II, CAMMS03409 (CARE-MS extension study)
Comparator
Fingolimod, natalizumab, ocrelizumab, cladribine, or other PBS-listed RRMS disease modifying therapies; for patients remaining relapse-free, continuous use of fingolimod or natalizumab over six years
Economic model
Cost-minimisation
ICER note
No ICER stated. The resubmission presented a cost-minimisation analysis but PBAC found it inadequate; no incremental cost-effectiveness ratio was calculated or provided in the public document.
Why PBAC said no
Reasons cited in the latest PSD: Comparator nominated by sponsor was the intervention itself and therefore inappropriate; cost-minimisation analysis based on assumption of equivalent sustained benefit in all patients was unreasonable given that additional courses indicate differential treatment benefit; absence of cost-utility analysis to account for differences in risk/benefit profile; PBAC required data comparing up to two additional courses against alternative RRMS medicines or no further treatment rather than against the initially funded two courses
Submission history
Jul 2014: Recommended with restriction · Authority Required
Nov 2014: Recommended with restriction · Authority Required