Ledipasvir / Sofosbuvir: 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
CONITEC (Brazil), G-BA (Germany) and HAS (France), among others, recommended or restricted ledipasvir / sofosbuvir, while AWMSG (Wales) did not recommend it.
On the same population the two systems disagree outright: SMC (Scotland) recorded restricted for “Treatment of chronic hepatitis C infection in adolescents aged 12 to < 18 years”, while AWMSG (Wales) recorded not recommended for “Ttreatment of chronic hepatitis C in adolescents aged 12 to < 18 years.”.
Where ledipasvir / sofosbuvir met resistance it was usually narrowed rather than refused: 7 of 15 decisive outcomes were recommendations with restrictions, against 2 outright refusals.
Assessment has run over 6.5 years, from 4 Mar 2015 at HAS (France) to 27 Sep 2021 at TLV (Sweden).
G-BA (Germany) changed its position: recommended on 21 May 2015, restricted by 21 Jan 2021.
No assessment is on file from PBAC (Australia), PHARMAC (New Zealand) and CIPM (Spain), each among the eight highest-volume agencies here.
Nothing has been added since 2021; on this evidence the file is dormant.
5 distinct indication wordings are recorded for ledipasvir / sofosbuvir by the agencies that label one in English (AWMSG and SMC).
HAS (France) was first to assess ledipasvir / sofosbuvir, on 4 Mar 2015; NYE METODER (Norway) did not open a file until 22 Nov 2020 — a wide spread of 5.7 years between the earliest and latest system to look at it.
Activity is concentrated rather than steady: 7 of 17 dated records fall in 2015 alone.
Restriction is doing real work here: 7 of 15 decisive outcomes narrowed ledipasvir / sofosbuvir to a subgroup rather than accepting or refusing it outright, at G-BA (Germany), SMC (Scotland) and TLV (Sweden).
5 of the 8 agencies here assessed ledipasvir / sofosbuvir more than once, AWMSG (Wales) most often at 3 entries — repeat review is the norm for this molecule rather than the exception.
8 of the 18 agencies in this archive hold a record for ledipasvir / sofosbuvir.
The full ledger for ledipasvir / sofosbuvir reads 7 restricted, 6 recommended, 2 not recommended and 1 superseded, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| TLV (Sweden) | 27 Sep 2021 | Harvoni granulat i dospåse ingår i läkemedelsförmånerna med begränsning | restricted subsidy | source |
| AWMSG (Wales) | 23 Jul 2021 | Treatment of chronic hepatitis C (CHC) in paediatric patients aged 3 to < 18 years and weighing above 17kg | not endorsed (non-submission) | source |
| HAS (France) | 2 Dec 2020 | Indication extension | SMR substantial · ASMR V | source |
| NYE METODER (Norway) | 22 Nov 2020 | Behandling av kronisk hepatitt C hos voksne og barn i alderen 3 år og eldre. | introduced | source |
| G-BA (Germany) | 21 May 2015 | Harvoni — benefit assessment §35a | added benefit: considerable (hint) | source |
12 further decisions for ledipasvir / sofosbuvir, across 7 agencies, are not shown here. They link to 10 further source documents.
Related molecules
- glecaprevir / pibrentasvir — divergent outcome (restricted vs recommended) on a shared indication
- sofosbuvir — divergent outcome (restricted vs recommended) on a shared indication
- letermovir — same ATC class J05A — Antivirals
- raltegravir — same ATC class J05A — Antivirals
- cabotegravir — same ATC class J05A — Antivirals
- tenofovir — same ATC class J05A — Antivirals
Coverage: 17 decisions for ledipasvir / sofosbuvir from 8 agencies, 2015 to 2021. Data to 7 Sep 2026. ATC class J05A — Antivirals. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.