AUTH/3379/9/20 and AUTH/3380/9/20 - Complainant v Roche and Chugai

Alleged out-of-date prescribing information for RoActemra

  • Received
    06 September 2020
  • Case number
    AUTH/3379/9/20 and AUTH/3380/9/20
  • Applicable Code year
  • Completed
    04 March 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant, who described him/herself as a concerned UK health professional, referred to a product review about the use of RoActemra (tocilizumab) in the treatment of giant cell arteritis published on the Guidelines in Practice website by Roche Products Ltd and Chugai Pharma UK Ltd which he/she alleged contained out-of-date prescribing information.

The complainant noted that on the Guidelines in Practice website, the link for which was provided, there was an online copy of the product review and a link to the prescribing information; in both cases the prescribing information was created in October 2019. Since then the summary of product characteristics (SPC) had been updated twice, once which was very significant where the indication for the product had been extensively altered. The updates included significant additions to the special warnings section which was missing from the prescribing information on the website as well as the supplement. This could be confusing or, worst case scenario, misleading for physicians.

The response from Roche and Chugai is given below.

The Panel noted that the complainant had provided no details about the indications or warnings that, in his/her view, should have been included in the prescribing information as a result of the two SPC updates.

The Panel noted that the general principle was that prescribing information (defined by Clause 4.2) must be up-to-date, must comply with Clauses 4.1 and 4.2 and must not be inconsistent with the SPC. The Panel noted that at least one authorized indication for use consistent with the SPC and a succinct statement regarding precautions relevant to the indication in question were required to be included in prescribing information. The Panel further noted that some changes to an SPC might not necessarily have to be reflected in the prescribing information. For example, information relevant only to an indication not being promoted might not need to be included.

The Panel noted Roche and Chugai’s submission that as RoActemra had a number of different indications for both adults and paediatrics, Roche and Chugai had separate prescribing information for those populations. According to Roche and Chugai the paediatric prescribing information was updated in April 2020 to reflect some significant changes to the SPC specifically relevant to paediatrics, in particular, the approval of the pre-filled pen (auto-injector) formulation for the treatment of systemic juvenile idiopathic arthritis and polyarticular idiopathic arthritis in patients 12 years of age or older.

The Panel noted that the product review in question clearly related to the use of RoActemra in the treatment of giant cell arteritis in adults. The Panel noted that the prescribing information on the pdf document provided by the complainant and on the product review, accessed via the link provided by the complainant, included both the intravenous (IV) and subcutaneous (SC) indications. The indications stated SC: For the treatment of Giant Cell Arteritis (GCA) in adult patients. The Panel noted Roche and Chugai’s submission that the prescribing information within the printed product review and online version dated October 2019 was the correct version, as the product review in question referred to the use of RoActemra in giant cell arteritis in adults only; giant cell arteritis was not a licensed indication for paediatrics. The prescribing information was still in use on relevant materials as there had been no further SPC updates since October 2019 which related to adults that had necessitated the need to update it.

The Panel considered that given the content of the product review as published on the Guidelines in Practice website, or within the product review pdf, there was no evidence that the RoActemra prescribing information on either did not include the relevant indication and warnings as alleged and so, in that regard, it ruled no breach of the Code. The Panel did not consider that there was evidence to show that that readers of the prescribing information would be misled as alleged or that high standards had not been maintained. No breaches of the Code were ruled including Clause 2.