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on the Guidelines in Practice website by Roche Products Ltd and Chugai Pharma UK Ltd which he/she alleged contained out-of-date prescribing information.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.
CASES AUTH/3379/9/20 AND AUTH/3380/9/20 NO BREACH OF THE CODE
COMPLAINANT v ROCHE AND CHUGAI
Alleged out-of-date prescribing information for RoActemra
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.
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 provided a link to the online product review (ref RCUKACTE1980a) and what the complainant described as a pdf copy of it (ref RCUKACTE01980, date of preparation February 2020).
COMPLAINT
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 (4.4) 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.
When writing to Roche and Chugai, the Authority asked them to consider the requirements of Clauses 2, 4.1, 7.2 and 9.1 of the Code.
RESPONSE
Roche and Chugai submitted identical responses and stated that they had very high standards for materials and robust processes in place to ensure that all materials were accurate and met the requirements of the Code. Both companies stated that they took patient safety extremely seriously and as such were very aware of the obligations they were required to meet regarding updating prescribing information following significant changes to an SPC.
Roche and Chugai submitted that as per Clause 4.2, the requirement to include certain elements about a medicine in prescribing information was an area that they considered very carefully. As per the stipulation, they must include at least one authorised indication consistent with the SPC. As RoActemra had a number of different indications for both adults and paediatrics, Roche and Chugai had separate prescribing information for those two populations.
Roche and Chugai noted that the complaint had referred to a sponsored supplement in Guidelines in Practice, that featured a printed (ref RCUKACTE01980) and an online (ref RCUKACTE01980a) version of the article that discussed the use of RoActemra in giant cell arteritis in adults.
The print version was certified in March 2020 and subsequently published later that month as a loose insert in the March edition of Guidelines in Practice that was distributed to UK health professional subscribers.
The online version was certified and went live on the Guidelines in Practice website in early May 2020. This was intended for UK health professionals registered on the site and an email notification was sent to those who had consented for such communications (ref RCUKACTE01980b).
All materials were certified by both Roche and Chugai medical final signatories, all of whom were registered medical practitioners or pharmacists registered in the UK (details were provided).
The prescribing information within the print supplement and online version dated October 2019 (ref RCUKMEDI00027(5)) was the correct version, as the supplement 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. That prescribing information was still in use on relevant materials as there had been no further SPC updates since October 2019 related to adults that had necessitated the need to update it. As such, neither Roche nor Chugai considered that they had breached Clauses 4.1 or 7.2.
Roche and Chugai explained that the paediatric prescribing information was updated in April 2020 (ref RCUKMEDI00026(7)) 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. As such, Roche and Chugai were confident that they had fully met their obligations for updating prescribing information in line with significant changes to the SPC.
Roche and Chugai reiterated that they prided themselves on the maintenance of the highest standards and took patient safety extremely seriously. Both companies hoped that the above addressed the Panel’s and complainant’s concerns in this matter. Neither Roche nor Chugai considered that they had breached Clauses 4.1 or 7.2 and therefore neither Clauses 9.1 or 2 of the Code.
PANEL RULING
The Panel noted the complainant’s allegation that since the prescribing information was created in October 2019, the SPC had been updated twice, once where the indication for the product had been extensively altered and significant additions to the special warnings section (4.4) which was missing from the prescribing information both on the website and the supplement at issue. 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 Clause 4.2 required prescribing information to include, inter alia, at least one authorized indication for use consistent with the summary of product characteristics and a succinct statement regarding precautions relevant to the indication in question. 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 in the prescribing information.
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 (ref RCUKMEDI00026(7)) 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 the prescribing information 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 (ref RCUKMEDI00027(5)) 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 Clause 4.1. The Panel did not consider that there was evidence to show that that readers of the prescribing information would be misled as alleged and no breach of Clause 7.2 was ruled.
The Panel considered that the complainant had not established that Roche and Chugai had failed to maintain high standards and no breach of Clause 9.1 was ruled. The Panel noted its rulings above and ruled no breach of Clause 2.
Complaint received 6 September 2020
Case completed 4 March 2021
