Baxter Healthcare v Novo Nordisk: NovoSeven leavepiece cost-effectiveness claim found misleading (Clause 7.3)

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Key facts

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Case	AUTH/2385/2/11
Parties	Baxter Healthcare Ltd v Novo Nordisk Ltd
Product	NovoSeven (eptacog alfa (activated))
Material	NovoSeven leavepiece (ref UK/NV7/0809/0125a)
Main issue	Cost-effectiveness claim vs FEIBA/pd-aPCC based on older efficacy inputs; alleged selective/out-of-date evidence
Key claim cited	“A systematic review based on 2001 prices found that on-demand treatment with NovoSeven was cost-effective compared to treatment with pd-aPCC”
Applicable Code year	2008
Complaint received	11 February 2011
Case completed	11 July 2011
Breach clause(s)	Clause 7.3
Appeal	Appeal by respondent; unsuccessful
Sanctions applied	Undertaking received; Additional sanctions: Not stated
Other Panel concern	Percentage price-change graph could mislead about absolute acquisition cost differences (concern raised; breach not stated)

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

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Baxter complained about a Novo Nordisk promotional leavepiece for NovoSeven (eptacog alfa (activated)) (ref UK/NV7/0809/0125a), specifically a page headed “How can NovoSeven help you cut costs?”.
The leavepiece stated: “A systematic review based on 2001 prices found that on-demand treatment with NovoSeven was cost-effective compared to treatment with pd-aPCC” (referenced to Knight et al (2003)).
The cost-effectiveness message relied on an indirect comparison using efficacy inputs of 92% for NovoSeven (from Key et al (1998)) and 79% for FEIBA (from Hilgartner et al (1990)).
Baxter argued the supporting evidence was out-of-date and selective, noting more recent comparative studies (Astermark et al (2007) and Young et al (2008)) and a 2010 Cochrane review concluding the trials did not show superiority of one treatment over the other.
Novo Nordisk said the leavepiece was for key account managers, focused on home treatment and cost effectiveness, and stated the item was withdrawn from circulation on 8 November 2010.
Novo Nordisk appealed the Panel’s decision; the Appeal Board considered whether Knight et al (2003) was robust enough to be relied upon in 2011.

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Breach found: the cost-effectiveness claim was ruled misleading because it was not a fair reflection of the totality of the evidence.
The Panel ruled a breach of Clause 7.3.
The Appeal Board upheld the Panel’s ruling; the appeal was unsuccessful.
The Panel also raised a concern (not recorded as a breach) that a graph showing percentage price changes could mislead about absolute acquisition cost differences.

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