Difelikefalin: 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
DMC (Denmark), NICE (England) and SMC (Scotland) recommended or restricted difelikefalin, while CIPM (Spain) and NYE METODER (Norway) did not recommend it.
On the same population the two systems disagree outright: SMC (Scotland) recorded restricted for “Treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis.”, while PBAC (Australia) recorded not recommended for “Chronic kidney disease (CKD) associated pruritus”.
CIPM (Spain) has been harder on difelikefalin than on its own caseload: it refused 5 of 5 decisive submissions here (100%), against a base rate of 63% across everything it has assessed.
The record spans 3.2 years, opening at AWMSG (Wales) on 24 Mar 2022 and running to 21 May 2025.
PBAC (Australia) changed its position: not recommended in 2023, recommended by 2023, after a resubmission.
No assessment is on file from HAS (France), PHARMAC (New Zealand) and TLV (Sweden), each among the eight highest-volume agencies here.
The file is active: 11 of 13 records date from 2023 or later.
Against its own class, difelikefalin is an outlier: 36% of its decisive outcomes were positive, where molecules sharing ATC class V03A average 77%.
3 distinct indication wordings are recorded for difelikefalin by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
2 of these 13 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 difelikefalin, on 24 Mar 2022; DMC (Denmark) did not open a file until 19 Jun 2024 — a moderate spread of 2.2 years between the earliest and latest system to look at it.
The record arrives in waves: 4 separate years each carry two or more decisions, spread across 4 years in total.
2 of the 8 agencies here assessed difelikefalin more than once, CIPM (Spain) most often at 5 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 difelikefalin.
The full ledger for difelikefalin reads 7 not recommended, 2 recommended, 2 restricted and 1 no benefit, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| CIPM (Spain) | 21 May 2025 | SECRETARIA DE ESTADO DE SANIDAD 28 MINISTERIO DE SANIDAD Indicación terapéutica autorizada: Tratamiento del prurito de m… | not financed by the SNS · art. 92 c, d | source |
| DMC (Denmark) | 19 Jun 2024 | Behandling af moderat til svær pruritus i forbindelse med kronisk nyresygdom hos voksne patienter i hæmodialyse | Anbefalet | source |
| SMC (Scotland) | 12 Feb 2024 | Treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis. | accepted (restricted) | source |
| NYE METODER (Norway) | 21 Jan 2024 | Behandling av moderat til alvorlig kløe (pruritus) ved kronisk nyresykdom hos voksne pasienter som får hemodialyse. | not introduced | source |
| PBAC (Australia) | 2023 | Chronic kidney disease (CKD) associated pruritus | Not Recommended | source |
8 further decisions for difelikefalin, across 5 agencies, are not shown here. They link to 7 further source documents.
Related molecules
- sevelamer — same ATC class V03A — Other therapeutic products
- deferasirox — same ATC class V03A — Other therapeutic products
- patiromer — same ATC class V03A — Other therapeutic products
- deferiprone — same ATC class V03A — Other therapeutic products
- naloxone — same ATC class V03A — Other therapeutic products
- andexanet alfa — same ATC class V03A — Other therapeutic products
Coverage: 13 decisions for difelikefalin from 8 agencies, 2022 to 2025. Data to 7 Sep 2026. ATC class V03A — Other therapeutic products. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.