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
Medicine	Lixiana (edoxaban)
Material	Six-page gate-fold leavepiece (ref EDX/15/0090, June 2015), used at ESC meeting (London) and by sales team with health professionals
Main issues upheld	Unclear/misleading VTE “initiation” dosing-transition claim; misleading/unfair 30-day pill-burden comparison and lack of fair balance; inconsistency with SPC; high standards
Clauses breached	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
Applicable 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 for Lixiana (edoxaban) (ref EDX/15/0090, June 2015) used by Daiichi-Sankyo UK at the European Society of Cardiology meeting and by the sales team with health professionals.
Allegations focused on multiple claims/graphics, including: a crossed-out INR-style monitor (“No regular anticoagulation level monitoring required”); a VTE claim (“No scheduled high-to-low dose transition at initiation in VTE patients”); “Superior reduction” bleeding claims vs warfarin; “simple and convenient” once-daily claims; and a graph comparing dosing transitions and pill burden in the first 30 days.
The Panel accepted some context/qualifiers were sufficient (eg, anticoagulation monitoring vs blood tests; “vs well-controlled warfarin” qualifiers), but found two areas where the leavepiece was misleading and/or unfair when viewed as standalone pages/claims.

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No breach was ruled for the crossed-out anticoagulation monitoring graphic/claim (including no breach of Clauses 7.2, 7.10, 7.8, 3.2 and 9.1 in relation to that allegation).
Breach was ruled for the VTE claim “No scheduled high-to-low dose transition at initiation in VTE patients” (misleading/unclear about required ≥5 days heparin lead-in before starting Lixiana for VTE).
No breach was ruled for the “Superior reduction … vs well-controlled warfarin” claims in NVAF and VTE populations (qualified sufficiently by “vs well-controlled warfarin”; not disparaging; not a hanging comparison).
No breach was ruled for “Once-daily Lixiana is simple and convenient” / “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 concerns with a pull-tab).
Breach was ruled for the 30-day pill-burden/dosing-transition graph: misleading and unfair emphasis on 30 days where Lixiana VTE treatment was indicated for at least 3 months; not fair/balanced; inconsistent with SPC; and high standards not maintained.
Sanction recorded: Undertaking received. No appeal.

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