AUTH/2789/8/15: Roche/PMCPA Director v Merck Serono — CDF presentation alleged to breach undertaking (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2789/8/15
Parties	Roche/PMCPA Director v Merck Serono
Complaint type	Alleged breach of undertaking
Product	Erbitux (cetuximab)
Comparator mentioned	Avastin (bevacizumab)
Setting	Presentation to Cancer Drugs Fund (CDF) panel (July 2015) with pre-submitted slides and wider evidence pack
Key studies referenced	CRYSTAL, OPUS, FIRE-3, CALGB/SWOG
Alleged clauses	Clause 2; Clause 9.1; Clause 29
Applicable Code year	2015
Outcome	No breach
Complaint received	14 August 2015
Case completed	3 November 2015
Appeal	No appeal
Panel note (governance)	Panel queried whether CDF panel was within Clause 1.2-type exemption and whether materials ought to have been certified; Merck Serono to be advised of concerns

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

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Roche alleged Merck Serono breached an undertaking given in an earlier case (AUTH/2705/3/14) about how FIRE-3 clinical trial data for Erbitux (cetuximab) should be presented.
The new material was a July 2015 presentation to a Cancer Drugs Fund (CDF) panel meeting, submitted in advance with a wider evidence pack, and delivered in a time-limited slot (15 minutes for three indications).
Roche argued the presentation over-emphasised FIRE-3 overall survival, omitted key context (including that OS was a secondary endpoint and that the study did not meet its primary endpoint), and did not adequately contextualise FIRE-3 against CALGB/SWOG data.
Roche also alleged the setting included lay observers and other companies, increasing the need for high standards and non-misleading presentation.
Merck Serono denied breach, arguing the Erbitux licence had materially changed since the 2013 press release (now restricted to RAS wild-type mCRC), the presentation aligned with the SPC (which included RAS wild-type FIRE-3 results), and CALGB/SWOG data was included across multiple slides.
The complaint was taken up in the name of the PMCPA Director because it concerned an alleged breach of an undertaking.

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No breach of the Code was ruled.
The Panel found the CDF presentation was not “closely similar” to the earlier press release and therefore was not caught by the prior undertaking.
No breach was ruled of Clause 29 (undertakings), and consequently no breach of Clauses 9.1 or 2.
The Panel queried whether the CDF body was truly within the Clause 1.2 exemption (national public organisations) and raised concerns about whether the submission/presentation ought to have been certified; Merck Serono was to be advised of these concerns.

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