AUTH/3611/2/22 - Complainant v Daiichi Sankyo

Electronic guidelines card for Nilemdo and Nustendi

  • Received
    14 February 2022
  • Case number
  • Applicable Code year
  • Completed
    23 February 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to a NICE technology appraisal summary card for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe), produced as promotional material by Daiichi Sankyo, which allegedly did not mention the contraindication with simvastatin >40mg nor the importance of seeing Sections 4.2, 4.3, and 4.4 of the Summary of Product Characteristics (SPC).

The Panel ruled a breach of the following Clause(s) of the 2021 Code for failing to make immediately apparent to health professionals in promotional material which referred to the therapeutic use of Nilemdo or Nustendi in combination with a statin that there was a
contraindication regarding concomitant use with simvastatin >40mg daily:

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

The Panel ruled no breach of the following Clause(s) of the 2021 Code based on the complainant not having established, on the very narrow allegation, that there was ‘no mention at all anywhere on the card about the contraindication with simvastatin >40mg’, nor that by not instructing the reader to view Sections 4.2, 4.3 and 4.4 of the SPC meant that Nilemdo and Nustendi had been promoted outside the terms of their licences as alleged:

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

This summary is not intended to be read in isolation.
For full details, please see the full case report