Cladribine: 12 agencies, 2009–2025
This page collects every recorded health technology assessment decision for one molecule across the agencies in our archive, and compares them. The comparison is the point: each agency publishes its own verdict, none publishes how that verdict sits against the others.
What the record shows
The file has been open for more than a decade: 16.2 years separate the first record, 9 Mar 2009 at SMC (Scotland), from the most recent, 9 Jun 2025 at SMC (Scotland).
PBAC (Australia) changed its position: recommended in 2018, not recommended by 2023.
No assessment is on file from CIPM (Spain), which is among the eight highest-volume agencies here.
The file is active: 6 of 26 records date from 2023 or later.
The programme is broad: 10 distinct indication wordings are recorded for cladribine by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
5 of these 26 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
SMC (Scotland) was first to assess cladribine, on 9 Mar 2009; PHARMAC (New Zealand) did not open a file until 28 Mar 2024 — an unusually long tail of 15 years between the earliest and latest system to look at it.
The record arrives in waves: 5 separate years each carry two or more decisions, spread across 11 years in total.
Restriction is doing real work here: 5 of 18 decisive outcomes narrowed cladribine to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland), NICE (England) and SMC (Scotland) among others.
7 of the 12 agencies here assessed cladribine more than once, HAS (France) most often at 5 entries — repeat review is the norm for this molecule rather than the exception.
cladribine has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for cladribine reads 10 recommended, 5 restricted, 3 not recommended and 3 no benefit, with 5 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| SMC (Scotland) | 9 Jun 2025 | Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease as defined by clinical or imaging features. | accepted (restricted) | source |
| HAS (France) | 14 May 2025 | Re-assessment following post-listing study results | SMR low | source |
| NICE (England) | 15 Apr 2025 | NICE TA1053 | recommended | source |
| AWMSG (Wales) | 12 Mar 2025 | Treatment for active relapsing forms of multiple sclerosis | excluded, NICE appraised | source |
| PHARMAC (New Zealand) | 28 Mar 2024 | relapsing-remitting multiple sclerosis | PTAC advice: Cost Neutral | source |
21 further decisions for cladribine, across 11 agencies, are not shown here. They link to 14 further source documents.
Related molecules
- teriflunomide — divergent outcome (recommended vs restricted) on a shared indication
- adalimumab — same ATC class L04A — Immunosuppressants
- upadacitinib — same ATC class L04A — Immunosuppressants
- secukinumab — same ATC class L04A — Immunosuppressants
- tocilizumab — same ATC class L04A — Immunosuppressants
- ustekinumab — same ATC class L04A — Immunosuppressants
Coverage: 26 decisions for cladribine from 12 agencies, 2009 to 2025. Data to 7 Sep 2026. ATC class L04A — Immunosuppressants. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.