AUTH/3923/6/24: Complainant v GSK — Trelegy sales aid alleged off-label promotion (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3923/6/24
Company	GSK UK Limited
Complainant	Anonymous, contactable health professional (later non-contactable)
Medicine	Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol)
Material type	Representatives’ electronic sales aid(s)
Main allegation	Off-label/unlicensed promotion: Trelegy promoted for patients not adequately treated on multiple inhaler triple therapy (MITT)
Applicable Code	2021
Clauses considered	2, 5.1, 11.2
Panel decision	No breach of Clauses 11.2, 5.1, 2
Appeal	No appeal
Complaint received	9 June 2024
Case completed	17 July 2025
Sales aids referenced by GSK (examples provided)	Primary care Anoro/Trelegy combined eDA (V4) in use 29/3/2023–26/6/2023; Primary care Trelegy Real-World Effectiveness and Device deck (V2) in use 14/9/2023–11/11/2023; Secondary care Trelegy sales aid (V3) in use 29/3/2023–26/6/2023; Combined primary/secondary Trelegy sales aid (V2) in use from 11/11/2023

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

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An anonymous, contactable complainant (health professional) alleged that GSK COPD representatives’ Trelegy sales aid(s) used throughout 2023 promoted Trelegy Ellipta for an unlicensed indication.
The allegation: the materials promoted Trelegy for COPD patients “not adequately treated on multiple (open) triple therapy” (MITT), e.g., patients using an ICS/LABA inhaler plus a separate LAMA inhaler.
The complainant argued Trelegy’s indication was limited to patients not adequately treated on dual therapy (ICS/LABA or LABA/LAMA), so MITT-focused promotion would be off-label.
The complainant did not provide the specific sales aid or specific wording; the complainant later became non-contactable.
GSK explained that in 2023 it used four electronic sales aids (with multiple versions due to updates) and provided four examples representing the longest duration of use.
The Panel assessed the general principle of promoting a switch from MITT to Trelegy (SITT), given the lack of a specific piece/claim to assess.

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No breach of Clause 11.2 (promotion in accordance with marketing authorisation/SmPC).
No breach of Clause 5.1 (high standards).
No breach of Clause 2 (no discredit to the industry).
No appeal.

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