Sanofi breached ABPI Code over Lyxumia cost comparison vs Bydureon in basal-insulin leavepiece (AUTH/2638/9/13, AUTH/2639/9/13)

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Key facts

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Case numbers	AUTH/2638/9/13 and AUTH/2639/9/13
Parties	Bristol-Myers Squibb and AstraZeneca v Sanofi
Product	Lyxumia (lixisenatide)
Material	Leavepiece ref GBIE.LYX.13.04.14
Main claim at issue	“LYXUMIA can lower your GLP-1 prescribing costs” and associated “savings with Lyxumia” percentages (including 26% vs Bydureon)
Core issues upheld	Needle costs excluded for Lyxumia vs included for Bydureon; comparator not licensed for add-on to basal insulin in context of the leavepiece; 26% saving vs Bydureon not substantiated
Applicable Code year	2012
Complaint received	10 September 2013
Case completed	08 November 2013
Appeal	No appeal
Findings	No breach: Clause(s) 7.2 and 7.3 (in part). Breach: Clause(s) 7.2 (x3), 7.3 (x3) & 7.4
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Bristol-Myers Squibb and AstraZeneca complained about a Sanofi promotional leavepiece for Lyxumia (lixisenatide) (ref GBIE.LYX.13.04.14) focused on adding Lyxumia to basal insulin.
The leavepiece included a table headed “LYXUMIA can lower your GLP-1 prescribing costs” showing 28-day acquisition costs and percentage “savings with Lyxumia” versus Byetta, Bydureon and Victoza.
The complainants alleged the cost claims were misleading/unbalanced and not like-for-like, particularly versus Bydureon, and could not be substantiated.
Key issues raised included: (a) Lyxumia pen needles had to be prescribed separately (extra NHS cost) while Bydureon kits included needles; (b) Bydureon was not licensed for add-on to basal insulin while the leavepiece’s primary message was add-on to basal insulin; (c) broader arguments that cost comparisons should consider efficacy/safety (Panel did not accept this as a requirement for acquisition-cost comparisons).
Sanofi stated the table was intended as a price (acquisition cost) comparison, not an economic evaluation, and that headings made this clear.

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No breach for presenting acquisition costs as such: the Panel considered it sufficiently clear the table showed acquisition costs only (not cost-effectiveness).
Breach because the Lyxumia vs Bydureon comparison was misleading and unfair due to omission of needle costs for Lyxumia while Bydureon included needles.
Breach because the 26% saving claim vs Bydureon was misleading and not capable of substantiation.
Breach because, in the context of a leavepiece promoting add-on to basal insulin, comparing with Bydureon (not licensed for use with basal insulin) was misleading even though the table indicated licensing status.
No breach regarding failure to include titration costs in the first 28 days (dose stated as 20mcg once daily; Panel said it would have been helpful to state maintenance doses were used, but not misleading).
No breach for not including clinical efficacy/safety data alongside an acquisition-cost comparison.

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