A Menarini misleading cost messaging and email permission failures in payer promotion for Adenuric (AUTH/2755/5/15)

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Key facts

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Case	AUTH/2755/5/15
Complainant	Head of medicines optimisation
Company	A Menarini Farmaceutica Internazionale SRL
Product	Adenuric (febuxostat)
Issue	Misleading cost/budget messaging vs allopurinol; email promotion without prior permission; out-of-date mailing list; high standards
Audience	Payers, formulary committees, prescribing advisors, medicines management teams
Key claims/content	29% increase in allopurinol average unit cost; projection that annual allopurinol expenditure would rise by ~£2.6m; references to planning long-term expenditure; graph of allopurinol unit cost
Notable pricing cited	Adenuric £24.36/28 tablets vs allopurinol £1.43/28 tablets (Feb 2015 figures referenced)
Emails sent / bounces	170 individuals; 31 undelivered (as stated by the company)
Applicable Code	2015
Breach clauses	7.2, 7.8, 9.1, 9.9, 11.3
No breach clauses	2, 11.1, 12.1, 12.2
Sanction	Undertaking received
Complaint received	06 May 2015
Case completed	15 July 2015
Appeal	No appeal

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

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A head of medicines optimisation complained about a promotional email sent by A Menarini to payers, formulary committees, prescribing advisors and medicines management teams.
The email/attachment highlighted a 29% increase in generic allopurinol average unit cost and claimed that if the trend continued, annual allopurinol expenditure would rise by ~£2.6 million.
The attachment (“Generic Bulletin – Urate Lowering Therapies [ULTs]”) introduced Adenuric (febuxostat) as another ULT and referred to planning “long-term expenditure costs”.
A graph depicted the rise in allopurinol average unit cost; the complainant argued the scale exaggerated minimal variation and did not present Adenuric’s cost comparably.
Adenuric’s price was only shown in small type within prescribing information, while the allopurinol price increase was emphasised more prominently.
The complainant also raised concerns about email/data handling: recipients were openly copied, there were broken/legacy addresses, and some addresses appeared linked to organisations that no longer existed (eg, primary care trusts).
A Menarini accepted the email was not correctly balanced and conceded breaches of Clauses 7.2 and 7.8, but argued recipients could interpret the information themselves and that permission to email was “implied” by having addresses and offering opt-out.

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Breach of Clauses 7.2 and 7.8: the material (including the graph) was misleading and did not provide a clear, balanced view of relative costs and implied cost advantages from switching to Adenuric.
Breach of Clause 9.9: the company could not show prior permission to send promotional emails; permission could not be implied from possession of an email address or lack of opt-out.
No breach of Clause 11.1: the complainant did not demonstrate on the balance of probabilities that the email was circulated to those with no need for or interest in the content.
Breach of Clause 11.3: the email list was not up-to-date.
No breach of Clauses 12.1 and 12.2: the email was not disguised promotion and the studies-related provision was not relevant.
Breach of Clause 9.1: high standards were not maintained; the Panel cited poor quality material, concerning submissions, and potential NHS budget impact.
No breach of Clause 2: the Panel did not consider the circumstances warranted this particular censure.
No appeal.

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