Roche and Chugai: complaint about allegedly out-of-date RoActemra prescribing information (no breach)

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Key facts

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Case numbers	AUTH/3379/9/20 and AUTH/3380/9/20
Parties	Complainant v Roche Products Ltd and Chugai Pharma UK Ltd
Product	RoActemra (tocilizumab)
Channel/material	Guidelines in Practice sponsored supplement/product review (print insert and online version)
Allegation	Out-of-date prescribing information vs SPC updates; missing special warnings (SPC 4.4) and altered indication
PI date referenced	October 2019
Panel decision	No breach
Clauses considered	2, 4.1, 7.2, 9.1
Applicable Code year	2019
Complaint received	6 September 2020
Case completed	4 March 2021
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A UK health professional complained about a sponsored product review on the Guidelines in Practice website about RoActemra (tocilizumab) for giant cell arteritis (GCA) in adults, published by Roche Products Ltd and Chugai Pharma UK Ltd.
The complainant alleged the prescribing information (PI) linked/embedded in the online review and in a PDF version was created in October 2019 and therefore out of date because the RoActemra SPC had been updated twice since then.
The complainant alleged the SPC updates included significant changes to the indication and additions to SPC section 4.4 (special warnings and precautions) that were missing from the PI, potentially confusing or misleading prescribers.
Roche and Chugai said RoActemra has multiple indications across adult and paediatric populations and they used separate PI for adults vs paediatrics.
They said the material in question was about adult GCA only (not a paediatric indication) and that there had been no post-October 2019 SPC updates relevant to adults that required updating the adult PI used in the supplement/online review.
They noted paediatric PI had been updated in April 2020 to reflect paediatric-relevant SPC changes (including approval of a pre-filled pen/auto-injector for certain paediatric arthritis indications).

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No breach of the Code was ruled.
The Panel found no evidence that the PI in the product review (online or PDF) failed to include the relevant adult GCA indication and warnings as alleged.
The Panel found no evidence readers would be misled, and no evidence that high standards were not maintained.

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