Human Normal Immunoglobulin: 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
AOTMIT (Poland) and TLV (Sweden) recommended or restricted human normal immunoglobulin, while AWMSG (Wales) did not recommend it.
AWMSG (Wales) has been harder on human normal immunoglobulin than on its own caseload: it refused 8 of 8 decisive submissions here (100%), against a base rate of 49% across everything it has assessed.
The file has been open for more than a decade: 15.3 years separate the first record, 22 Jun 2006 at TLV (Sweden), from the most recent, 25 Oct 2021 at AWMSG (Wales).
Coverage is thin among the largest agencies: 6 of the eight highest-volume bodies — HAS (France), PBAC (Australia) and SMC (Scotland) among them — hold no record for human normal immunoglobulin at all.
Nothing has been added since 2021; on this evidence the file is dormant.
Against its own class, human normal immunoglobulin is an outlier: 33% of its decisive outcomes were positive, where molecules sharing ATC class J06B average 75%.
The programme is broad: 9 distinct indication wordings are recorded for human normal immunoglobulin by the agency that label one in English (AWMSG).
TLV (Sweden) was first to assess human normal immunoglobulin, on 22 Jun 2006; AOTMIT (Poland) did not open a file until 29 Jan 2020 — an unusually long tail of 13.6 years between the earliest and latest system to look at it.
The record arrives in waves: 4 separate years each carry two or more decisions, spread across 10 years in total.
2 of the 3 agencies here assessed human normal immunoglobulin more than once, AWMSG (Wales) most often at 10 entries — repeat review is the norm for this molecule rather than the exception.
Coverage is narrow: only 3 of the 18 agencies here have assessed human normal immunoglobulin.
The full ledger for human normal immunoglobulin reads 8 not recommended, 3 recommended, 2 not assessed and 1 restricted.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AWMSG (Wales) | 25 Oct 2021 | Replacement therapy in adults, children and adolescents (0‑18 years) in secondary immunodeficiencies (SID) in patients w… | outside AWMSG criteria | source |
| AWMSG (Wales) | 25 Oct 2021 | Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaire… | outside AWMSG criteria | source |
| AOTMIT (Poland) | 29 Jan 2020 | Hizentra reimbursement recommendation | recommended conditionally | source |
| AWMSG (Wales) | 23 Jul 2018 | Treatment of patients with chronic inflammatory demyelinating polyneuropathy as maintenance therapy after stabilization … | not endorsed (non-submission) | source |
| TLV (Sweden) | 17 Feb 2015 | HyQvia ingår i högkostnadsskyddet | general subsidy | source |
9 further decisions for human normal immunoglobulin, across 2 agencies, are not shown here. They link to 9 further source documents.
Related molecules
- nirsevimab — same ATC class J06B — Immune sera and immunoglobulins
- bezlotoxumab — 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
- cefazolin — also decided by AWMSG in 2021Q4
- cannabidiol — also decided by AWMSG in 2021Q4
Coverage: 14 decisions for human normal immunoglobulin from 3 agencies, 2006 to 2021. 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.