PBAC's latest decision on Cladribine: Not recommended (2023). Considered for Treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
6
first 2011
Submissions
6
2011 → 2023
Eligible population
Patients with relapsing-remitting multiple sclerosis (RRMS)
Therapy area
Neurology
Line of therapy
Any
Evidence base
Registry
Primary endpoint
ARR
Pivotal trial size
699 patients
Key trials
GLIMPSE, Magalashvili 2022, CLARENCE
Comparator
fingolimod
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design
ICER (historical)
$105k/QALY–$200k/QALY in an earlier submission (2011) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Why PBAC said no
Reasons cited in the latest PSD: Clinical claim of non-inferior comparative efficacy and safety over four years not adequately justified; surrogate outcomes (treatment switch, discontinuation) poorly correlated with relapse; non-randomised data with significant baseline imbalances; propensity score matching did not fully address confounding; limited number of patients with four years of cladribine treatment data (only 9% of cladribine cohort received four years of treatment versus 52% of fingolimod cohort); unknown if all important confounders captured
Submission history
Mar 2011: Not recommended — ICER $200k/QALY
Nov 2017: Recommended with restriction · Restricted