AUTH/2148/7/08 AstraZeneca v Trinity-Chiesi: Fostair cost comparison chart

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Key facts

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Case number	AUTH/2148/7/08
Case reference	Fostair cost comparison chart
Complainant	AstraZeneca UK Limited
Respondent/company	Trinity-Chiesi Pharmaceuticals Ltd
Product(s)	Fostair; Symbicort; Seretide
Material/channel	Advertisement in Pulse (June 2008; ref TRF0S20080298); detail aid (prepared April 2008; ref TRF0S20080198)
Key issue	Whether a cost comparison chart was incomplete, unfair, and misleading by including only one Symbicort strength/regimen and presenting annualised savings
Dates (received/completed if stated)	Complaint received 28 July 2008; case completed 5 September 2008
Appeal	Not stated
Code year	2008 (considered under the 2008 Constitution and Procedure; clauses cited same as 2006 Code)
Breaches/clauses	No breach of Clauses 7.2 and 7.3
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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AstraZeneca complained about a cost comparison chart used by Trinity-Chiesi Pharmaceuticals Ltd to promote Fostair (beclometasone 100mcg/formoterol 6mcg) for asthma.
The chart compared Fostair (two puffs twice daily) with Seretide 125/25 (two puffs twice daily) and Symbicort 200/6 (two puffs twice daily), and presented 30-day NHS price, annual NHS price, and annual/percentage savings with Fostair (23% vs Symbicort 200/6; 20% vs Seretide).
The chart appeared in a detail aid prepared in April 2008 (ref TRF0S20080198) and an advertisement in Pulse in June 2008 (ref TRF0S20080298) as part of a double-page spread.
AstraZeneca alleged the chart was incomplete because Symbicort was available in other strengths (eg 100/6 and 400/12) and other dosing regimens (including SMART), some of which could be cheaper than the comparator used.
Trinity-Chiesi said the doses used were taken from two head-to-head studies (Papi et al 2007a/b) and that it amended the chart heading to reference those studies; it did not agree it needed to include other Symbicort strengths/regimens.

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The Panel ruled that, in the context of the Pulse advertisement discussing Papi et al (2007a), it was not unreasonable to use a cost comparison chart based on those results and it was not necessary to include other Symbicort strengths or dosage regimens.
No breach was ruled for the Pulse advertisement under Clauses 7.2 and 7.3.
No breach was ruled for the detail aid under Clauses 7.2 and 7.3.
The Panel queried the validity of extrapolating three-month clinical data at maximum doses to one-year financial data, noting the chart implied continuous use of two puffs twice daily; the Panel requested Trinity-Chiesi be advised of these concerns.

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