MSD/Schering-Plough Ezetrol ‘New NICE technology appraisal’ ad in Pulse: no breach (AUTH/2180/11/08, AUTH/2181/11/08)

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Key facts

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Case numbers	AUTH/2180/11/08 and AUTH/2181/11/08
Complainant	Associate Director Pharmacy Policy & Prescribing at a teaching primary care trust
Company	Merck Sharp & Dohme Limited and Schering-Plough Limited
Product	Ezetrol (ezetimibe)
Material	Journal advertisement in Pulse (ref 08-09 EZT.08.GB.751108.J)
Main claim at issue	“New NICE technology appraisal recommends ezetimibe alone or in combination with initial statin therapy”
Key references discussed	NICE Technology Appraisal 132 (Nov 2007); NICE Clinical Guideline 67 (May 2008)
Applicable Code	2006
Clauses considered	7.2 and 7.4
Panel decision	No breach
Complaint received	3 November 2008
Case completed	23 December 2008
Appeal	No appeal

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

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An Associate Director (Pharmacy Policy & Prescribing) at a teaching primary care trust complained about a Pulse journal advertisement for Ezetrol (ezetimibe) issued by Merck Sharp & Dohme and Schering-Plough.
The ad headline stated: “New NICE technology appraisal recommends ezetimibe alone or in combination with initial statin therapy”.
The supporting reference (in a footnote near the prescribing information) was NICE Technology Appraisal (TA) 132 (Nov 2007): Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia.
The complainant argued readers might assume “New NICE” referred instead to NICE Clinical Guideline (CG) 67 (May 2008) on lipid modification, which gave ezetimibe a less prominent role, and that the ad did not refer to familial hypercholesterolaemia.
The Authority asked the companies to respond under Clauses 7.2 and 7.4 (2006 Code; same wording in 2006 and 2008 Codes).

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The Panel ruled the headline was not misleading because it clearly referred to a “technology appraisal” and the cited document was TA132.
The Panel accepted that TA132 recommended ezetimibe alone or with initial statin therapy and that the claim could be substantiated.
The Panel considered the prescribing information adequately stated the licensed indications (including primary heterozygous familial and non-familial hypercholesterolaemia), so the ad was not misleading for not mentioning familial hypercholesterolaemia in the main body.
No breach of the Code was ruled.

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