Novartis breached Clause 6.1 and 5.1 over ‘1st line’ Entresto guideline claim lacking HFrEF definition (AUTH/3665/6/22)

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Key facts

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Case	AUTH/3665/6/22
Complainant	Anonymous, contactable health professional
Company	Novartis
Medicine	Entresto (sacubitril/valsartan)
Channel	Company website (health.novartis.co.uk) promotional webpages aimed at UK healthcare professionals / NHS relevant decision-makers
Main upheld issue	Claim “National guidelines support ENTRESTO as a 1st line treatment option in chronic HFrEF” lacked clarification of reduced ejection fraction threshold for a broad audience
Applicable Code year	2021
Complaint received	24 June 2022
Case completed	1 August 2023
Appeal	No appeal
Breach clauses	Clause 6.1; Clause 5.1
Sanction	Undertaking received

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

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An anonymous, contactable health professional complained about promotional claims for Entresto (sacubitril/valsartan) on Novartis’ health.novartis.co.uk website (UK | October 2021 materials).
The complaint challenged four claims across Entresto webpages, alleging they were misleading/unqualified and relied on secondary or post-hoc analyses without clear prominence.
The key upheld issue related to the claim: “National guidelines support ENTRESTO as a 1st line treatment option in chronic HFrEF”—the complainant argued the guideline recommendation was tied to a specific LVEF threshold (<40%).
The Panel focused on whether the claim was sufficiently complete for the broad certified audience (including “Physician; Pharmacist; Payor / Health Insurance / Nurse / Other Healthcare Stakeholder”).

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Breach for the guideline/“1st line” claim (Claim 2): the Panel found the claim was not sufficiently complete without clarifying the degree of reduced ejection fraction, given the broad audience.
No breach findings for the other challenged claims (Claims 1, 3 and 4) on the grounds alleged, including allegations about reliance on secondary/post-hoc analyses and use of an asterisk.
No breach of Clause 2 across the case (Panel noted Clause 2 is a sign of particular censure and was not warranted here).

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Breach of Clause 6.1 Requirement that material must be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine
Breach of Clause 5.1 Failure to maintain high standards
No Breach of Clause 6.2 Requirement that claims must be capable of substantiation
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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