Novartis: Entresto symposium video on learned society website lacked prescribing information and key initiation thresholds (AUTH/3654/5/22)

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Key facts

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Case	AUTH/3654/5/22
Complainant	Anonymous, contactable health professional
Company	Novartis Pharmaceuticals UK Ltd
Medicine	Entresto (sacubitril/valsartan)
Material	Promotional symposium video hosted on a learned society’s website post-conference (MLR ID 166435, November 2021)
Conference timing	September 2021
Applicable Code	2021
Complaint received	23 May 2022
Case completed	25 May 2023
Appeal	No appeal
Breach clauses	Clauses 5.1, 6.1, 12.1
No breach clauses	Clauses 2, 6.2, 8.1 (and additional “no breach” findings as listed in the case summary)
Key missing clinical statements (per Panel)	No reference that treatment should not be initiated if serum potassium level >5.4 mmol/l or if SBP <100 mmHg
Sanctions	Undertaking received; additional sanctions not stated

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

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A health professional complained about a Novartis promotional symposium video for Entresto (sacubitril/valsartan) hosted on a learned society’s website after a September 2021 conference (video MLR ID 166435, November 2021).
The complainant alleged the video contained no prescribing information and that a guideline algorithm slide was misleading because it did not clearly state key SPC thresholds (serum potassium and systolic blood pressure) and did not address hepatic considerations.
Novartis said the original slide decks and a pre-recorded “speaker presentations” video included prescribing information, but when a “full symposium” video (including live Q&A) was edited for post-conference hosting, the prescribing information was erroneously removed and this was missed at certification.
The Panel also noted that a chair slide with more detailed initiation considerations appeared to have been edited out of the hosted video.

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Breach of Clause 12.1 (prescribing information missing from the hosted promotional video).
Breach of Clause 6.1 (material misleading/not sufficiently complete): the video did not state that Entresto should not be initiated if serum potassium >5.4 mmol/l or if SBP <100 mmHg.
Breach of Clause 5.1 (high standards): concerns about editing and the failure to identify missing prescribing information and missing key clinical considerations in the final hosted video.
No breach of Clause 8.1 (the video had been certified, despite the error).
No breach of Clause 6.2 (no allegation that claims were incapable of substantiation).
No breach of Clause 2 (despite concerns, the Panel did not consider the video reduced confidence in or brought discredit upon the industry).
No appeal.

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Breach of Clause 6.1 Misleading material that was not sufficiently complete to enable viewers to form their own opinion of the therapeutic value of the medicine
Breach of Clause 12.1 Failing to include prescribing information
Breach of Clause 5.1 Failing to maintain high standards
No Breach of Clause 6.1 Requirement that information must not be misleading
No Breach of Clause 6.2 Requirement that information must be capable of substantiation
No Breach of Clause 8.1 Requirement to certify promotional material
No Breach of Clause 5.1 Requirement to maintain high standards
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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