Lenacapavir: 9 agencies, 2022–2025
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 record spans 3 years, opening at PBAC (Australia) in 2022 and running to 2025.
PBAC (Australia) changed its position: not recommended in 2022, recommended by 2025, after a resubmission.
No assessment is on file from PHARMAC (New Zealand), TLV (Sweden) and G-BA (Germany), each among the eight highest-volume agencies here.
Not every gap is a refusal: for lenacapavir, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 8 of 12 records date from 2023 or later.
4 distinct indication wordings are recorded for lenacapavir by the agencies that label one in English (AWMSG, PBAC and SMC).
3 of these 12 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 lenacapavir, in 2022; NYE METODER (Norway) did not open a file until 27 Apr 2025 — a moderate spread of 2.8 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 4 years in total.
2 of the 9 agencies here assessed lenacapavir more than once, PBAC (Australia) most often at 3 entries — repeat review is the norm for this molecule rather than the exception.
9 of the 18 agencies in this archive hold a record for lenacapavir.
The full ledger for lenacapavir reads 5 recommended, 2 not recommended, 1 other and 1 non-submission, with 3 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2025 | Human immunodeficiency virus (HIV) | In November 2025, the PBAC extended its November 2023 recommendation for this drug for a f… | source |
| NYE METODER (Norway) | 27 Apr 2025 | Behandling av multiresistent humant immunsviktvirus (HIV-1) infeksjon. | decision recorded | source |
| SMC (Scotland) | 8 Jul 2024 | Film-coated tablets: in combination with other antiretroviral(s) for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possibl… | not recommended | source |
| CIPM (Spain) | 21 Feb 2024 | Indicación terapéutica autorizada: Sunlenca comprimido, en combinación con otro(s) fármaco(s) antirretroviral(es), está … | not financed by the SNS (financed 2024-05) | source |
| AIFA (Italy) | 19 Aug 2023 | SUNLENCA compresse, in associazione con altri antiretrovirali, è indicato per il trattamento degli adulti con infezione … | innovative status not granted · reimbursed class H | source |
7 further decisions for lenacapavir, across 6 agencies, are not shown here. They link to 5 further source documents.
Related molecules
- raltegravir — divergent outcome (recommended vs restricted) on a shared indication
- bictegravir / emtricitabine / tenofovir alafenamide — divergent outcome (recommended vs restricted) on a shared indication
- sofosbuvir — same ATC class J05A — Antivirals
- letermovir — same ATC class J05A — Antivirals
- cabotegravir — same ATC class J05A — Antivirals
- tenofovir — same ATC class J05A — Antivirals
Coverage: 12 decisions for lenacapavir from 9 agencies, 2022 to 2025. Data to 7 Sep 2026. ATC class J05A — Antivirals. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.