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PMCPA Case

Bayer Eylea promotion: misleading implied comparison with unlicensed Lucentis dose in DMO e-detailer (AUTH/2785/8/15)

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2785/8/15
CompanyBayer plc
ComplainantAnonymous, non-contactable consultant
ProductEylea (aflibercept)
Comparator referencedLucentis (ranibizumab) (marketed by Novartis Pharmaceuticals UK)
Therapy areaOphthalmology (wAMD, DMO, retinal vein occlusion mentioned)
Main issue upheldMisleading implied comparison with Lucentis involving unlicensed Lucentis dosing in DMO e-detailer; inadequate briefing material
Material at issueDMO e-detailer (available from Jan 2015) and representatives’ briefing material
Breach clauses7.2, 7.3, 9.1, 15.2, 15.9
No breach clauses2, 3.2
Complaint received3 August 2015
Case completed20 October 2015
AppealNo appeal
SanctionsUndertaking received; additional sanctions not stated
Sourcehttps://www.pmcpa.org.uk/cases/completed-cases/auth2785815-anonymous-consultant-v-bayer

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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  • An anonymous, non-contactable consultant complained about Bayer’s promotion of Eylea (aflibercept), alleging discussions comparing Eylea with Lucentis (ranibizumab) using off-licence/off-label data (including Protocol T, VIVID/VISTA, RISE/RIDE).
  • The complainant alleged Bayer staff implied Eylea was superior to Lucentis without explaining that Protocol T used an unlicensed 0.3mg Lucentis dose in the UK, and worried a forthcoming meeting would promote that unlicensed dose.
  • The Panel did not accept the alleged 18-month pattern of discussions (Feb 2014–Jan 2015) as established, given Eylea was not licensed for DMO until Aug 2014 and DMO field materials were not issued until Jan 2015.
  • However, the Panel reviewed Bayer’s DMO e-detailer (available from Jan 2015) and associated representatives’ briefing material. The e-detailer compared data from RESTORE (Lucentis), VIVID/VISTA (Eylea) and RISE/RIDE (Lucentis) and referenced unlicensed Lucentis dosing in study design.
  • Small-print text stated Lucentis dosing in the cited studies did not represent current UK posology and referred readers to the Lucentis SPC, but the Panel considered this did not negate the misleading impression.
  • The Panel noted it only became apparent that RISE/RIDE outcome results shown related to the licensed 0.5mg dose if the representative “tapped” to reveal an additional dialogue box—information not otherwise apparent and potentially optional to disclose.
  • The representatives’ briefing material cautioned about cross-study comparisons but did not clearly flag the unlicensed Lucentis dose status or clarify that the results shown were for the licensed dose only.
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Outcome

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  • Breach of Clause 7.2 and Clause 7.3: the implied comparison of Eylea with an unlicensed dose of Lucentis was misleading.
  • No breach of Clause 3.2 in relation to Lucentis dosing: Lucentis is marketed by Novartis, and Bayer could not be found to be promoting another company’s medicine under Clause 3.2 in these circumstances.
  • Breach of Clause 15.9: significant omission in the representatives’ briefing material (failure to make unlicensed dose status clear and to clarify which Lucentis dose the results related to) likely to lead to discussions contrary to the Code.
  • Breach of Clause 15.2: in so much as a representative used the material provided, this was a breach.
  • No breach in relation to alleged Protocol T discussions (Clauses 3.2, 7.2, 7.3) and no breach of Clause 15.2/15.9 regarding the Protocol T briefing material.
  • Breach of Clause 9.1: Bayer was found not to have maintained high standards.
  • No breach of Clause 2: the Panel did not consider the breaches merited particular censure.
  • No appeal.
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