Daiichi Sankyo: NICE TA694 summary card for Nilemdo/Nustendi failed to make simvastatin >40mg contraindication immediately apparent (AUTH/3611/2/22)

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Key facts

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Case number	AUTH/3611/2/22
Company	Daiichi Sankyo
Complainant	Health professional (as described)
Material	Electronic NICE TA694 summary card for Nilemdo and Nustendi (4 pages; PI on pages 3–4)
Products	Nilemdo (bempedoic acid); Nustendi (bempedoic acid and ezetimibe)
Job code / date	BEM/21/0086; May 2021
Where used	Hosted on guidelines.co.uk (Guidelines website) for UK health professionals; launched 4 June 2021; removed 3 December 2021
Main issue	Contraindication with simvastatin >40mg daily not made immediately apparent in the main body where use with a statin was referenced
Applicable Code	2021
Complaint received	14 February 2022
Case completed	23 February 2023
Appeal	No appeal
Breach clauses	Clause 2; Clause 5.1; Clause 6.1; Clause 6.2
No breach clauses	Clause 6.1; Clause 11.2
Sanctions	Undertaking received; Advertisement

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

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A health professional complained about an electronic NICE technology appraisal (TA694) summary card for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe), commissioned and funded by Daiichi Sankyo (dated May 2021; job code BEM/21/0086).
The card was hosted on a UK health professional website (guidelines.co.uk), intended for GPs, payors and policy makers; launched 4 June 2021 and removed 3 December 2021 (scheduled 6 months).
The first two pages summarised NICE TA694 and, in a parallel section, presented the products’ licensed indications (broader than the NICE recommendation) including therapeutic use in combination with a statin.
The last two pages contained prescribing information (PI) for Nilemdo and Nustendi, including the contraindication: “concomitant use with simvastatin >40mg daily”.
The complaint alleged (1) there was no mention anywhere on the card of the simvastatin >40mg contraindication and (2) the card failed to highlight the SPC instruction to see sections 4.2, 4.3 and 4.4, allegedly promoting outside the SPC and misleading readers into thinking any simvastatin dose was suitable.
The Panel accepted the contraindication was present in the PI, but found that because the body of the material referred to use with a statin, the simvastatin >40mg contraindication needed to be immediately apparent in the main body; relying on PI in small text on later pages was not sufficient to correct the overall impression for a busy health professional.

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Breach found for failing to make immediately apparent that there was a contraindication regarding concomitant use with simvastatin >40mg daily when referring to use with a statin.
No breach found on the narrow allegation that there was “no mention at all anywhere on the card” of the contraindication (because it was included in the PI).
No breach found that the material promoted outside the SPC by not instructing readers to view SPC sections 4.2, 4.3 and 4.4.

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Breach of Clause 6.1 Misleading impression provided
Breach of Clause 6.2 Misleading impression incapable of substantiation
Breach of Clause 5.1 Failure to maintain high standards
Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
No Breach of Clause 6.1 The requirement to not mislead either directly or by implication, by distortion, exaggeration or undue emphasis
No Breach of Clause 11.2 The requirement for promotion to not be inconsistent with the SPC

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