Bezlotoxumab: where the agencies disagree
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
G-BA (Germany), HAS (France) and NYE METODER (Norway) recommended or restricted bezlotoxumab, while AWMSG (Wales) and PBAC (Australia) did not recommend it.
The record spans 3 years, opening at PBAC (Australia) in 2017 and running to 2020.
No assessment is on file from PHARMAC (New Zealand), TLV (Sweden) and CIPM (Spain), each among the eight highest-volume agencies here.
Not every gap is a refusal: for bezlotoxumab, 1 submission was never made — an outcome set by the company rather than the assessor.
Nothing has been added since 2020; on this evidence the file is dormant.
3 distinct indication wordings are recorded for bezlotoxumab by the agencies that label one in English (AWMSG, PBAC and SMC).
3 of these 10 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 bezlotoxumab, in 2017; G-BA (Germany) did not open a file until 20 Sep 2018 — a moderate spread of 1.2 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 5 of 10 dated records fall in 2017 alone.
2 of the 7 agencies here assessed bezlotoxumab more than once, PBAC (Australia) most often at 3 entries — repeat review is the norm for this molecule rather than the exception.
7 of the 18 agencies in this archive hold a record for bezlotoxumab.
The full ledger for bezlotoxumab reads 3 recommended, 2 other, 2 no benefit and 2 not recommended, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2020 | Bezlotoxumab is indicated for the prevention of recurrence of Clostridium difficile | infection (CDI) in adult patients 18 years or older at high risk for recurrence of C… | Resubmission to request a Section 100 (Highly Specialised Drugs Program) Authority require… | source |
| G-BA (Germany) | 20 Sep 2018 | Zinplava — benefit assessment §35a | added benefit: minor (indication) | source |
| AIFA (Italy) | 2 Jul 2018 | ZINPLAVA è indicato per la prevenzione della recidiva dell’infezione da Clostridium difficile(CDI) negli adulti ad alto … | innovative status not granted · reimbursed class H | source |
| SMC (Scotland) | 11 Dec 2017 | Prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI. | not recommended | source |
| NYE METODER (Norway) | 19 Nov 2017 | Behandling ved vedvarende clostridium difficile infeksjon | introduced | source |
5 further decisions for bezlotoxumab, across 4 agencies, are not shown here. They link to 2 further source documents.
Related molecules
- nirsevimab — same ATC class J06B — Immune sera and immunoglobulins
- human normal immunoglobulin — same ATC class J06B — Immune sera and immunoglobulins
- palivizumab — same ATC class J06B — Immune sera and immunoglobulins
- sotrovimab — same ATC class J06B — Immune sera and immunoglobulins
- patiromer — also decided by G-BA in 2018Q3
- ipilimumab — also decided by G-BA in 2018Q3
Coverage: 10 decisions for bezlotoxumab from 7 agencies, 2017 to 2020. Data to 7 Sep 2026. ATC class J06B — Immune sera and immunoglobulins. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.