Pitolisant: 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
AOTMIT (Poland), G-BA (Germany) and HIRA (South Korea), among others, recommended or restricted pitolisant, while AWMSG (Wales), CIPM (Spain) and NICE (England), among others, did not recommend it.
Assessment has run over 9.4 years, from 29 Jun 2016 at HAS (France) to 5 Nov 2025 at ZIN (Netherlands).
ZIN (Netherlands) changed its position: not recommended on 10 May 2022, recommended by 5 Nov 2025, after a resubmission.
No assessment is on file from PBAC (Australia) and PHARMAC (New Zealand), each among the eight highest-volume agencies here.
Not every gap is a refusal: for pitolisant, 2 submissions were never made — an outcome set by the company rather than the assessor.
The file is active: 8 of 22 records date from 2023 or later.
3 distinct indication wordings are recorded for pitolisant by the agencies that label one in English (AWMSG, NICE and SMC).
HAS (France) was first to assess pitolisant, on 29 Jun 2016; AOTMIT (Poland) did not open a file until 30 May 2023 — a wide spread of 6.9 years between the earliest and latest system to look at it.
The record arrives in waves: 8 separate years each carry two or more decisions, spread across 9 years in total.
Restriction is doing real work here: 4 of 16 decisive outcomes narrowed pitolisant to a subgroup rather than accepting or refusing it outright, at AOTMIT (Poland), G-BA (Germany) and HIRA (South Korea).
7 of the 11 agencies here assessed pitolisant more than once, HAS (France) 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 pitolisant.
The full ledger for pitolisant reads 7 not recommended, 5 recommended, 4 restricted and 2 non-submission, with 4 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 23 Apr 2025 | Re-assessment of SMR and ASMR | SMR substantial · ASMR V | source |
| NYE METODER (Norway) | 22 Sep 2024 | Forbedre våkenhet og redusere overdreven søvnighet på dagtid (EDS) hos voksne med obstruktiv søvnapné (OSA) hvis EDS ikk… | decision recorded | source |
| SMC (Scotland) | 11 Mar 2024 | To improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated b… | not recommended | source |
| G-BA (Germany) | 21 Sep 2023 | Wakix — benefit assessment §35a | added benefit: non-quantifiable (hint) | source |
| AOTMIT (Poland) | 30 May 2023 | Wakix reimbursement recommendation | recommended conditionally | source |
17 further decisions for pitolisant, across 10 agencies, are not shown here. They include the most recent record on file, 5 Nov 2025 from ZIN (Netherlands); its outcome is in the subscriber dataset. They link to 15 further source documents.
Related molecules
- tafamidis — same ATC class N07X — Other nervous system
- vutrisiran — same ATC class N07X — Other nervous system
- fampridine — same ATC class N07X — Other nervous system
- omaveloxolone — same ATC class N07X — Other nervous system
- patisiran — same ATC class N07X — Other nervous system
- tofersen — same ATC class N07X — Other nervous system
Coverage: 22 decisions for pitolisant from 11 agencies, 2016 to 2025. Data to 7 Sep 2026. ATC class N07X — Other nervous system. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.