Tisagenlecleucel: 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), G-BA (Germany) and NICE (England), among others, recommended or restricted tisagenlecleucel, while AOTMIT (Poland) and CIPM (Spain) did not recommend it.
Assessment has run over 6.2 years, from 8 Aug 2018 at AWMSG (Wales) to 23 Oct 2024 at CIPM (Spain).
ZIN (Netherlands) changed its position: recommended on 18 Dec 2018, not recommended by 7 Mar 2019.
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Not every gap is a refusal: for tisagenlecleucel, 1 submission was never made and 2 were withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 14 of 37 records date from 2023 or later.
The programme is broad: 8 distinct indication wordings are recorded for tisagenlecleucel by the agencies that label one in English (AWMSG, NICE and SMC).
AWMSG (Wales) was first to assess tisagenlecleucel, on 8 Aug 2018; CIPM (Spain) did not open a file until 19 Jun 2024 — a wide spread of 5.8 years between the earliest and latest system to look at it.
The record arrives in waves: 7 separate years each carry two or more decisions, spread across 7 years in total.
11 of the 12 agencies here assessed tisagenlecleucel more than once, HAS (France) most often at 7 entries — repeat review is the norm for this molecule rather than the exception.
tisagenlecleucel has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for tisagenlecleucel reads 15 recommended, 9 not recommended, 3 restricted and 3 deferred to NICE, with 7 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| CIPM (Spain) | 23 Oct 2024 | Indicaciones terapéuticas autorizadas: Leucemia linfoblástica aguda (LLA) de células B refractaria, en recaída post-tras… | not financed by the SNS · art. 92 d | source |
| NYE METODER (Norway) | 25 Aug 2024 | Behandling av voksne med residivert eller refraktært follikulært lymfom (FL) etter to eller flere systemiske behandlinge… | decision recorded | source |
| NICE (England) | 15 May 2024 | NICE TA975 | recommended (optimised) | source |
| AWMSG (Wales) | 9 Apr 2024 | Treatment of paediatric and young adult patients up to 25 years of age with B‑cell acute lymphoblastic leukaemia that is… | excluded, NICE appraised | source |
| DMC (Denmark) | 30 Jan 2019 | Akut lymfatisk leukæmi | Anbefalet | source |
32 further decisions for tisagenlecleucel, across 12 agencies, are not shown here. They link to 24 further source documents.
Related molecules
- loncastuximab tesirine — divergent outcome (recommended vs not recommended) on a shared indication
- polatuzumab vedotin — divergent outcome (recommended vs not recommended) on a shared indication
- selinexor — divergent outcome (recommended vs not recommended) on a shared indication
- atezolizumab — same ATC class L01X — Antineoplastics
- olaparib — same ATC class L01X — Antineoplastics
- durvalumab — same ATC class L01X — Antineoplastics
Coverage: 37 decisions for tisagenlecleucel from 12 agencies, 2018 to 2024. Data to 7 Sep 2026. ATC class L01X — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.