Regorafenib: 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), DMC (Denmark) and HAS (France), among others, recommended or restricted regorafenib, while CIPM (Spain), CONITEC (Brazil) and PBAC (Australia) did not recommend it.

On the same population the two systems disagree outright: NICE (England) recorded restricted in TA866, while PBAC (Australia) recorded not recommended for “Colorectal cancer”.

Assessment has run over 11.3 years, from 14 May 2014 at HAS (France) to 26 Sep 2025 at CONITEC (Brazil).

NYE METODER (Norway) changed its position: not recommended on 18 Nov 2018, recommended by 28 Apr 2019, after a resubmission.

No assessment is on file from PHARMAC (New Zealand), which is among the eight highest-volume agencies here.

Not every gap is a refusal: for regorafenib, 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.

The file is active: 3 of 30 records date from 2023 or later.

The programme is broad: 13 distinct indication wordings are recorded for regorafenib by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).

4 of these 30 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.

HAS (France) was first to assess regorafenib, on 14 May 2014; CONITEC (Brazil) did not open a file until 26 Sep 2025 — an unusually long tail of 11.3 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 11 years in total.

9 of the 12 agencies here assessed regorafenib more than once, NICE (England) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.

regorafenib has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.

The full ledger for regorafenib reads 10 recommended, 7 not recommended, 5 restricted and 2 superseded, with 6 in other categories.

Decisions on file

AgencyDateIndication as recorded OutcomeSource
CONITEC (Brazil)26 Sep 2025Tratamento de indivíduos com tumor do estroma gastrointestinal avançado ou metastático, após falha ao imatinibe e suniti…not incorporatedsource
SMC (Scotland)9 Oct 2023Adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapiesacceptedsource
NICE (England)8 Feb 2023NICE TA866recommended (optimised)source
AWMSG (Wales)23 Dec 2022For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not …supersededsource
PBAC (Australia)2018REGORAFENIB is indicated for the treatment of patients with: | Metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irin…Resubmission to request an Authority Required (STREAMLINED) listing for the treatment of p…source

25 further decisions for regorafenib, across 11 agencies, are not shown here. They link to 19 further source documents.

Related molecules

Coverage: 30 decisions for regorafenib from 12 agencies, 2014 to 2025. Data to 7 Sep 2026. ATC class L01E — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.

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