Volanesorsen: 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
AIFA (Italy) and G-BA (Germany) recommended or restricted volanesorsen, while CIPM (Spain) and HAS (France) did not recommend it.
Assessment has run over 5.2 years, from 5 Jul 2019 at AWMSG (Wales) to 9 Sep 2024 at SMC (Scotland).
AIFA (Italy) changed its position: recommended on 20 Feb 2021, restricted by 20 Feb 2021.
No assessment is on file from PBAC (Australia), PHARMAC (New Zealand) and TLV (Sweden), each among the eight highest-volume agencies here.
Not every gap is a refusal: for volanesorsen, 1 submission was never made — an outcome set by the company rather than the assessor.
AWMSG (Wales) was first to assess volanesorsen, on 5 Jul 2019; SMC (Scotland) did not open a file until 9 Sep 2024 — a wide spread of 5.2 years between the earliest and latest system to look at it.
The record arrives in waves: 3 separate years each carry two or more decisions, spread across 5 years in total.
Restriction is doing real work here: 2 of 5 decisive outcomes narrowed volanesorsen to a subgroup rather than accepting or refusing it outright, at AIFA (Italy) and G-BA (Germany).
AIFA (Italy) is the only agency to have returned to volanesorsen, recording 2 separate entries.
8 of the 18 agencies in this archive hold a record for volanesorsen.
The full ledger for volanesorsen reads 2 not recommended, 2 restricted, 1 non-submission and 1 other, with 3 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| SMC (Scotland) | 9 Sep 2024 | As an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet an… | not recommended | source |
| NYE METODER (Norway) | 11 Feb 2024 | Som tilskudd til kosthold hos voksne pasienter med genetisk bekreftet familiært kylomikronemisyndrom (FCS) og med høy ri… | decision recorded | source |
| ZIN (Netherlands) | 13 Jan 2022 | GVS-advies volanesorsen (Waylivra®) bij de behandeling van genetisch bevestigd familiair chylomicronemiesyndroom (FCS) | advice published (GVS) | source |
| CIPM (Spain) | 30 Sep 2021 | Indicaciones terapéuticas autorizadas: WAYLIVRA está indicado como complemento a la dieta en pacientes adultos con síndr… | not financed by the SNS · art. 92 c, d | source |
| AIFA (Italy) | 20 Feb 2021 | WAYLIVRA è rimborsato in pazienti adulti affetti da sindrome da chilomicronemia familiare (FCS) confermata geneticamente… | innovative, since expired | source |
4 further decisions for volanesorsen, across 4 agencies, are not shown here. They link to 3 further source documents.
Related molecules
- evolocumab — same ATC class C10A — Lipid modifying agents
- alirocumab — same ATC class C10A — Lipid modifying agents
- rosuvastatin — same ATC class C10A — Lipid modifying agents
- inclisiran — same ATC class C10A — Lipid modifying agents
- evinacumab — same ATC class C10A — Lipid modifying agents
- ezetimibe — same ATC class C10A — Lipid modifying agents
Coverage: 9 decisions for volanesorsen from 8 agencies, 2019 to 2024. 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.