AUTH/3649/5/22 - Health professional v Daiichi Sankyo

SMC 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 Scottish Medicines Consortium (SMC) Guidelines summary card for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe), produced as promotional material by Daiichi Sankyo.

The Panel ruled a breach of the following Clauses of the 2021 Code for failing to make immediately apparent to health professionals in the body of 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, and for failing to comply with an undertaking given in Case AUTH/3504/4/21:

Breach of Clause 3.3

Failure to comply with an undertaking

Breach of Clause 6.1

Misleading impression provided

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 Clauses of the 2021 Code as the complainant had not established that the material was incapable of substantiation nor that the omission in the body of the material of the contraindication for Nustendi when co-administered with a statin in patients with active liver disease or unexplained persistent elevations in serum transaminases meant the material was misleading, given the material did not imply there were no liver disease considerations:

No Breach of Clause 6.1

Requirement that claims must not be misleading

No Breach of Clause 6.2

Requirement that claims must be capable of substantiation

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