Bulevirtide: 11 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
Where bulevirtide met resistance it was usually narrowed rather than refused: 5 of 12 decisive outcomes were recommendations with restrictions, against 1 outright refusal.
Assessment has run over 5.7 years, from 14 Oct 2020 at AWMSG (Wales) to 24 Jun 2026 at DMC (Denmark).
PBAC (Australia) changed its position: not recommended in 2024, recommended by 2025, after a resubmission.
No assessment is on file from PHARMAC (New Zealand), which is among the eight highest-volume agencies here.
The file is active: 12 of 15 records date from 2023 or later.
4 distinct indication wordings are recorded for bulevirtide by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
3 of these 15 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
AWMSG (Wales) was first to assess bulevirtide, on 14 Oct 2020; DMC (Denmark) did not open a file until 24 Jun 2026 — a wide spread of 5.7 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 6 years in total.
Restriction is doing real work here: 5 of 12 decisive outcomes narrowed bulevirtide to a subgroup rather than accepting or refusing it outright, at NICE (England), NYE METODER (Norway) and SMC (Scotland) among others.
3 of the 11 agencies here assessed bulevirtide more than once, PBAC (Australia) most often at 3 entries — repeat review is the norm for this molecule rather than the exception.
11 of the 18 agencies in this archive hold a record for bulevirtide.
The full ledger for bulevirtide reads 6 recommended, 5 restricted, 1 no benefit and 1 deferred, with 2 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| G-BA (Germany) | 19 Feb 2026 | Hepcludex — benefit assessment §35a | added benefit: not proven | source |
| PBAC (Australia) | 2025 | Chronic hepatitis D (CHD) | Recommended | source |
| HAS (France) | 11 Jun 2025 | Indication extension | SMR substantial · ASMR IV | source |
| TLV (Sweden) | 25 Mar 2025 | Hepcludex får utökad subvention | restricted subsidy | source |
| NYE METODER (Norway) | 25 Aug 2024 | Behandling av kronisk infeksjon med hepatitt D-virus (hepatitt deltavirus, HDV) hos voksne og barn ≥3 år som veier ≥10 k… | introduced with conditions | source |
10 further decisions for bulevirtide, across 9 agencies, are not shown here. They include the most recent record on file, 24 Jun 2026 from DMC (Denmark); its outcome is in the subscriber dataset. They link to 7 further source documents.
Related molecules
- sofosbuvir — same ATC class J05A — Antivirals
- letermovir — same ATC class J05A — Antivirals
- raltegravir — same ATC class J05A — Antivirals
- cabotegravir — same ATC class J05A — Antivirals
- tenofovir — same ATC class J05A — Antivirals
- darunavir — same ATC class J05A — Antivirals
Coverage: 15 decisions for bulevirtide from 11 agencies, 2020 to 2026. Data to 7 Sep 2026. ATC class J05A — Antivirals. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.