AUTH/3486/3/21 - Complainant v Sanofi

Alleged off-licence promotion of Suliqua

  • Received
    06 March 2021
  • Case number
    AUTH/3486/3/21
  • Applicable Code year
    2019
  • Completed
    06 October 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, non-contactable complainant who described him/herself as a health professional complained about the promotion of Suliqua (pre-filled pen of insulin glargine and lixisenatide) by Sanofi.

Suliqua was indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.

The complainant was perturbed to be notified of an out-of-licence formulary positioning of Suliqua which was not licensed to be used with basal insulin as could be found from its summary of product characteristics (SPC). The complainant was concerned that representatives might have/would have been having off-licence discussions/promotion, leading to this positioning. The complainant referred to a webpage of a local Area Prescribing Committee (APC) formulary for evidence.

The detailed response from Sanofi is given below.

The Panel noted that the APC formulary stated Suliqua was indicated for ‘Type 2 diabetes mellitus in combination with oral antidiabetic drugs (e.g. metformin, pioglitazone, or a sulfonylurea) or basal insulin, or both, when adequate glycaemic control has not been achieved with these drugs’ whilst the SPC for Suliqua stated that it was ‘indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors’.

The Panel noted Sanofi’s submission that although the SPC for Suliqua was updated in March 2020, neither the original nor updated licensed indication correlated with the inappropriately worded Suliqua listing which was determined by the local APC formulary. The Panel noted Sanofi's submission with regard to the interactions between it and the APC in relation to Suliqua. The Panel noted that Sanofi acknowledged that whilst the APC formulary position was not aligned with Suliqua’s licence, it was set independently of Sanofi and there had been no evidence that Sanofi influenced this position.

The Panel noted Sanofi’s submission that the complainant had provided no evidence that Sanofi provided any support to the local APC’s application(s). The Panel noted that Sanofi had only reviewed a sample of call records but noted its submission that from its broader investigations, it had found no evidence in its customer relationship management (CRM) system, nor from interviews with relevant staff members, that promotion outside of the Suliqua licence had taken place. The Panel further noted Sanofi’s submission that Sanofi’s formulary pack and its associated briefing document were aligned with the Suliqua indication. The Panel considered that the complainant had not demonstrated that Sanofi employees had engaged in off-licence discussions or promotion about Suliqua with health professionals leading to its off-licence listing as alleged and thus ruled no breaches of the Code.

The Panel did not consider that the complainant had raised an allegation in relation to briefing and therefore ruled no breach of the Code.

The Panel noted its comments and rulings of no breach above and consequently ruled no breaches of the Code, including no breach of Clause 2.