Acalabrutinib: 14 agencies, 2020–2026

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

HAS (France) has been harder on acalabrutinib than on its own caseload: it refused 2 of 5 decisive submissions here (40%), against a base rate of 11% across everything it has assessed.

Assessment has run over 6.1 years, from 2020 at PBAC (Australia) to 19 Aug 2026 at NICE (England).

PBAC (Australia) changed its position: not recommended in 2020, recommended by 2026, after a resubmission.

Every one of the eight highest-volume agencies in this archive has a record for acalabrutinib.

The file is active: 29 of 52 records date from 2023 or later.

The programme is broad: 12 distinct indication wordings are recorded for acalabrutinib by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).

11 of these 52 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.

PBAC (Australia) was first to assess acalabrutinib, in 2020; AIFA (Italy) did not open a file until 5 Jun 2026 — a wide spread of 5.9 years between the earliest and latest system to look at it.

The record arrives in waves: 6 separate years each carry two or more decisions, spread across 7 years in total.

Restriction is doing real work here: 12 of 40 decisive outcomes narrowed acalabrutinib to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland), DMC (Denmark) and NICE (England) among others.

12 of the 14 agencies here assessed acalabrutinib more than once, PBAC (Australia) most often at 11 entries — repeat review is the norm for this molecule rather than the exception.

acalabrutinib has been through 14 of the 18 agencies in this archive — among the most widely assessed molecules on file.

The full ledger for acalabrutinib reads 19 recommended, 12 restricted, 9 not recommended and 6 no benefit, with 6 in other categories.

Decisions on file

AgencyDateIndication as recorded OutcomeSource
NICE (England)19 Aug 2026NICE TA1185published appraisalsource
AWMSG (Wales)30 Jul 2026In combination with venetoclax for the treatment of previously untreated chronic lymphocytic leukaemiaexcluded, NICE appraisedsource
ZIN (Netherlands)14 Jul 2026Advies - alleen vergoeden na prijsdaling acalabrutinib (Calquence®) voor de behandeling van lymfeklierkankerreimburse only after price negotiation (sluis)source
PBAC (Australia)2026Mantle cell lymphoma (MCL)Recommendedsource
AIFA (Italy)5 Jun 2026Calquence in monoterapia è indicato per il trattamento di pazienti adulti con linfoma a cellule mantellari (MCL) recidiv…innovative status not granted · reimbursed class Hsource

47 further decisions for acalabrutinib, across 14 agencies, are not shown here. They include the most recent record on file, 19 Aug 2026 from NICE (England); its outcome is in the subscriber dataset. They link to 34 further source documents.

Related molecules

Coverage: 52 decisions for acalabrutinib from 14 agencies, 2020 to 2026. Data to 7 Sep 2026. ATC class L01E — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.

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