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PMCPA Case

Norgine breached ABPI Code over Feraccru email claiming major cost and nursing-time savings vs IV iron

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/3365/7/20
CompanyNorgine Ltd
ProductFeraccru capsules (ferric maltol)
MaterialPromotional email sent via Guidelines in Practice; subject line “Managing patients with iron deficiency anaemia in hospital (promotional information from Norgine)”; email headed “Real World Economic Evaluation of Feraccru vs IV Iron”
AudiencePrescribers, commissioners and relevant NHS decision makers
Main issueBold cost/nursing-time savings claims based on a small preliminary abstract (n=28) plus in-house extrapolation (“Norgine Data on file”), with insufficient limitations and unclear assumptions; restrictions for some IBD patients not clearly communicated
Applicable Code year2019
Complaint received14 July 2020
Case completed15 March 2021
AppealNo appeal
Breach clauses2, 7.2, 7.3, 7.4, 9.1
SanctionsUndertaking received; Advertisement

Download the full case report (PDF)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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  • A UK health professional complained about a promotional email for Feraccru (ferric maltol) sent via Guidelines in Practice to prescribers, commissioners and NHS decision makers.
  • The email headline and content promoted a “Real World Economic Evaluation of Feraccru vs IV Iron” (Lovato et al, 2018 abstract) and included boxed claims about cost and nursing-time savings.
  • The email stated potential health economic benefit in IBD patients who would otherwise have been considered for IV iron, with an asterisk leading to small text: “Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBD patients with haemoglobin (Hb) levels <9.5g/dL.”
  • The first boxed section was based on 28 patients over 9 months at one NHS trust; it suggested savings of £8,955 and 3.75 days of nursing time, but did not specify which IV iron was used or how 75 minutes nursing time per infusion was calculated.
  • A second boxed section, “Modelling/projected costs over 12 months”, referenced “Norgine Data on file”; the Panel found this was essentially an in-house marketing extrapolation from 28 patients/9 months to 100 patients/12 months, claiming costs £57,068 (IV) vs £25,031 (Feraccru) and 13.4 days nursing time saved.
  • The email did not communicate the preliminary nature of the abstract and did not include all relevant limitations from the abstract (including that IV-iron need might be under-estimated; not all IBD patients qualify for oral therapy; some might refuse; further data needed).
  • The email used the term “cost-effective” in a way the Panel considered went beyond a simple cost comparison (no comparative clinical efficacy/safety evaluation was provided).
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Outcome

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  • Breach found: the email was not sufficiently complete to allow recipients to understand the basis and significance of the data.
  • Breach found: the comparison with IV iron was misleading.
  • Breach found: claims about potential savings (including “cost-effective”) could not be substantiated.
  • Breach found: restrictions on use in some IBD patients were not clearly and adequately communicated (footnote/asterisk in small text was insufficient).
  • Breach found: high standards were not maintained.
  • Breach found: the material brought discredit upon, and reduced confidence in, the industry (Clause 2; sign of particular censure).
  • No appeal.
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