GSK misleadingly implied NICE endorsement for Anoro Ellipta and blurred licensed indication context (AUTH/3175/3/19)

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3175/3/19
ComplainantAnonymous, non-contactable individual (described as a health professional)
CompanyGlaxoSmithKline UK Limited
MedicineAnoro Ellipta (umeclidinium/vilanterol)
MaterialTwo-page advertisement (ref UK/UCV/0028/18) in February 2019 edition of Guidelines in Practice
Key issueProminent “NICE 2018” circle and layout implied NICE specifically recommended Anoro; page two implied an exacerbation-reduction indication without firm licensed-indication context
Applicable Code year2016
Complaint received22 March 2019
Case completed18 October 2019
Breach clausesClause 3.2; Clause 7.2; Clause 9.1
No breach clausesClause 2
SanctionsUndertaking received; Additional sanctions: Not stated
AppealNo appeal

Download the full case report (PDF)


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

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What happened

  • An anonymous health professional complained about a two-page Anoro Ellipta advertisement (ref UK/UCV/0028/18) in the February 2019 edition of Guidelines in Practice.
  • Each page featured a prominent blue circle stating “NICE 2018” and a prominent depiction of the Anoro Ellipta device.
  • The complainant alleged the “NICE 2018” circle placed close to the product/device imagery implied NICE had recommended Anoro Ellipta specifically.
  • The complainant also alleged page two’s wording about “reducing the risk of moderate to severe exacerbations” implied an indication Anoro did not have (licensed for maintenance bronchodilator treatment to relieve symptoms in adults with COPD).
  • The Panel assessed each page separately because the pages were not facing; each page had to be non-misleading when read in isolation.
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Outcome

  • Breach of Clause 7.2 (misleading) in relation to page one: the prominence of “NICE 2018” plus the Anoro device image could give an immediate impression that NICE specifically recommended Anoro, which was not the case.
  • Breach of Clause 7.2 (misleading) in relation to page two: layout, colour-coding, “NICE 2018” badge, and “Start with Anoro Ellipta” could lead readers to assume Anoro was NICE’s LAMA/LABA of choice, which was not so.
  • Breach of Clause 3.2: page two’s exacerbation-risk reduction message was not set firmly in the context of the licensed indication (maintenance therapy to relieve symptoms), implying Anoro was licensed to reduce exacerbations.
  • Breach of Clause 9.1: high standards were not maintained.
  • No breach of Clause 2: the Panel did not consider the matter brought discredit upon or reduced confidence in the industry.
  • No appeal (as per case listing).
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