AUTH/2822/2/16: Bayer v Daiichi-Sankyo — Lixiana leavepiece claims on VTE initiation and 30‑day pill-burden comparison | PMCPA Case

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Key facts

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Case number	AUTH/2822/2/16
Complainant	Bayer Healthcare
Respondent	Daiichi-Sankyo UK Limited
Product	Lixiana (edoxaban)
Material	Six-page gate-fold leavepiece (ref EDX/15/0090, June 2015), used by sales team with health professionals at meetings/face-to-face (ESC meeting, London)
Main issues upheld	VTE “initiation” dose-transition claim lacked clarity about ≥5 days’ heparin lead-in; 30-day pill-burden graph misleading/unfair vs SPC minimum treatment duration and overall burden
Breach clauses	3.2; 7.2; 7.4; 7.8; 7.10; 9.1
Sanction	Undertaking received
Complaint received	23 February 2016
Case completed	16 May 2016
Appeal	No appeal
Code year	2016

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

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Bayer complained about a six-page gate-fold leavepiece promoting Lixiana (edoxaban) (ref EDX/15/0090, June 2015), used by the sales team with health professionals at the European Society of Cardiology meeting in London.
Allegations focused on multiple claims/graphics, including: a crossed-out INR-style device with “No regular anticoagulation level monitoring required”; a VTE dosing claim “No scheduled high-to-low dose transition at initiation in VTE patients”; “Superior reduction” bleeding claims vs warfarin; “Once-daily Lixiana is simple and convenient”; and a graph comparing “dosing transitions and pill burden in the first 30 days”.
The Panel ruled most items were not in breach, but found breaches for (1) the VTE “initiation” dose-transition claim (insufficiently clear about the required ≥5 days’ heparin lead-in) and (2) the 30-day pill-burden comparison/graph (misleading and unfair given SPC minimum treatment duration and overall burden).

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No breach for the crossed-out anticoagulation monitoring graphic/claim (Panel considered it referred to anticoagulation monitoring, not “no blood tests at all”).
Breach for the claim “No scheduled high-to-low dose transition at initiation in VTE patients” (misleading/unclear, not substantiable in the implied sense, inconsistent with SPC, did not promote rational use, and high standards not maintained).
No breach for “Superior reduction in major bleeding vs well-controlled warfarin” (NVAF) and “Superior reduction in clinically relevant bleeding vs well-controlled warfarin” (VTE) (qualified sufficiently by “vs well-controlled warfarin”; not disparaging; not a hanging comparison).
No breach for “Once-daily Lixiana is simple and convenient” / “...for patients and prescribers” (on balance, sufficiently clear it referred to once-daily dosing; heparin lead-in stated elsewhere, though Panel noted visibility concern on a pull-tab section).
Breach for the 30-day pill-burden/dosing-transition graph (misleading and unfair emphasis on 30 days vs SPC minimum 3 months; not fair/balanced; inconsistent with SPC; high standards not maintained; and ruled to fail to promote rational prescribing due to omission of the minimum treatment duration context).
Sanction recorded: Undertaking received.
No appeal.

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