Inclisiran: 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
AWMSG (Wales), CHUIKYO (Japan) and DMC (Denmark), among others, recommended or restricted inclisiran, while CIPM (Spain) did not recommend it.
Where inclisiran met resistance it was usually narrowed rather than refused: 5 of 14 decisive outcomes were recommendations with restrictions, against 4 outright refusals.
The record spans 4.6 years, opening at ZIN (Netherlands) on 4 May 2021 and running to 8 Dec 2025.
PBAC (Australia) changed its position: not recommended in 2023, recommended by 2024, after a resubmission.
No assessment is on file from HAS (France) and TLV (Sweden), each among the eight highest-volume agencies here.
Not every gap is a refusal: for inclisiran, 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 11 of 18 records date from 2023 or later.
5 distinct indication wordings are recorded for inclisiran by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
4 of these 18 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
ZIN (Netherlands) was first to assess inclisiran, on 4 May 2021; PHARMAC (New Zealand) did not open a file until 8 Dec 2025 — a wide spread of 4.6 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 5 years in total.
Restriction is doing real work here: 5 of 14 decisive outcomes narrowed inclisiran to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland), AWMSG (Wales) and NICE (England) among others.
5 of the 11 agencies here assessed inclisiran more than once, PBAC (Australia) most often at 4 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 inclisiran.
The full ledger for inclisiran reads 5 recommended, 5 restricted, 4 not recommended and 1 appraised, with 3 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| AOTMIT (Poland) | 25 Jul 2025 | programu lekowego B.101 „Leczenie pacjentów z zaburzeniami lipidowymi (ICD-10: E78.0, I21, I22, I25) | not recommended | source |
| ZIN (Netherlands) | 29 Aug 2024 | Advies - Uitbreiding vergoedingsvoorwaarden inclisiran (Leqvio®) en bempedoïnezuur (Nilemdo®) | conditions amended | source |
| PBAC (Australia) | 2024 | Familial heterozygous hypercholesterolaemia (FHeH) and Non-familial hypercholesterolaemia (non-FH) | Recommended | source |
| CHUIKYO (Japan) | 15 Nov 2023 | レクビオ: cost-effectiveness evaluation (new product, high price or high sales) | evaluation completed, price adjustment decided | source |
| CIPM (Spain) | 24 Jul 2023 | Indicación terapéutica autorizada: Leqvio está indicado en adultos con hipercolesterolemia primaria (heterocigótica fami… | not financed by the SNS · art. 92 d | source |
13 further decisions for inclisiran, across 11 agencies, are not shown here. They include the most recent record on file, 8 Dec 2025 from PHARMAC (New Zealand); its outcome is in the subscriber dataset. They link to 10 further source documents.
Related molecules
- alirocumab — divergent outcome (recommended vs restricted) on a shared indication
- bempedoic acid — divergent outcome (recommended vs not recommended) on a shared indication
- evolocumab — same ATC class C10A — Lipid modifying agents
- rosuvastatin — same ATC class C10A — Lipid modifying agents
- evinacumab — same ATC class C10A — Lipid modifying agents
- ezetimibe — same ATC class C10A — Lipid modifying agents
Coverage: 18 decisions for inclisiran from 11 agencies, 2021 to 2025. Data to 7 Sep 2026. ATC class C10A — Lipid modifying agents. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.