Tolvaptan: 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
NICE (England), NYE METODER (Norway) and PHARMAC (New Zealand), among others, recommended or restricted tolvaptan, while AOTMIT (Poland), CIPM (Spain) and DMC (Denmark), among others, did not recommend it.
On the same population the two systems disagree outright: NICE (England) recorded restricted in TA358, while PBAC (Australia) recorded not recommended for “Autosomal dominant polycystic kidney disease”.
The file has been open for more than a decade: 13.9 years separate the first record, 30 Jun 2009 at AWMSG (Wales), from the most recent, 21 May 2023 at NYE METODER (Norway).
HAS (France) changed its position: recommended on 2 Dec 2015, not recommended by 10 Jul 2019.
No assessment is on file from G-BA (Germany), which is among the eight highest-volume agencies here.
Not every gap is a refusal: for tolvaptan, 1 submission was never made — an outcome set by the company rather than the assessor.
5 distinct indication wordings are recorded for tolvaptan by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
5 of these 21 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 tolvaptan, on 30 Jun 2009; NYE METODER (Norway) did not open a file until 21 May 2023 — an unusually long tail of 13.9 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 10 years in total.
6 of the 12 agencies here assessed tolvaptan more than once, PBAC (Australia) most often at 5 entries — repeat review is the norm for this molecule rather than the exception.
tolvaptan has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for tolvaptan reads 8 not recommended, 5 recommended, 2 restricted and 2 deferred, with 4 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| NYE METODER (Norway) | 21 May 2023 | Til å bremse utvikling av cyster og nyreinsuffisiens hos voksne med autosomal dominant polycystisk nyresykdom (ADPKD). B… | introduced | source |
| CIPM (Spain) | 3 Feb 2022 | Indicaciones terapéuticas autorizadas: Jinarc está indicado para ralentizar la progresión del desarrollo de quistes y la… | not financed by the SNS · art. 92 c, d | source |
| AOTMIT (Poland) | 4 Jan 2021 | Jinarc reimbursement recommendation | not recommended | source |
| PHARMAC (New Zealand) | 22 Nov 2019 | Polycystic chronic kidney disease | PTAC advice: High · decision reached | source |
| HAS (France) | 10 Jul 2019 | Indication extension | SMR insufficient · ASMR IV | source |
16 further decisions for tolvaptan, across 9 agencies, are not shown here. They link to 11 further source documents.
Related molecules
- eptinezumab — also decided by NYE METODER in 2023Q2
- dalbavancin — also decided by NYE METODER in 2023Q2
- cannabidiol — also decided by NYE METODER in 2023Q2
- ibrutinib — also decided by NYE METODER in 2023Q2
- ipilimumab — also decided by NYE METODER in 2023Q2
- risdiplam — also decided by NYE METODER in 2023Q2
Coverage: 21 decisions for tolvaptan from 12 agencies, 2009 to 2023. Data to 7 Sep 2026. ATC class C03X — Diuretics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.