AUTH/2148/7/08 AstraZeneca v Trinity-Chiesi: Fostair cost comparison chart (no breach)

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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 (beclometasone 100mcg/formoterol 6mcg); comparators referenced: Symbicort 200/6; Seretide 125/25
Material/channel	Advertisement in Pulse (June 2008; published 25 June 2008; ref TRF0S20080298) and detail aid (prepared April 2008; ref TRF0S20080198)
Key issue	Whether a cost comparison chart was incomplete, unfair and misleading by comparing only one Symbicort strength/regimen and presenting annual 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)
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 UK Limited 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, annual cost saving per patient with Fostair, and percentage annual saving.
The chart stated a 23% annual saving versus Symbicort 200/6 and a 20% annual saving versus Seretide.
The chart appeared in a detail aid prepared in April 2008 (ref TRF0S20080198) and in an advertisement in Pulse in June 2008 (published 25 June 2008; ref TRF0S20080298).
AstraZeneca alleged the chart was incomplete and misleading because Symbicort was available in three strengths but only one was shown, and because other dosing regimens (including Symbicort SMART) and presentations could be cheaper than Fostair.
AstraZeneca also alleged Trinity-Chiesi continued to use the chart despite inter-company dialogue and assurances it would be amended/withdrawn.
Trinity-Chiesi responded that the dosages used were taken from two published head-to-head studies (Papi et al 2007a and 2007b) and that it amended the chart heading in the advertisement to reference those studies; it did not consider it necessary or appropriate to include other Symbicort strengths/regimens.

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The Panel considered 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.
The Panel did not consider it necessary to include other strengths or dosage regimens for Symbicort in that context and ruled the chart was not incomplete, unfair or misleading as alleged.
No breach of Clauses 7.2 and 7.3 was ruled for the Pulse advertisement.
For the detail aid, the Panel noted the Papi et al study results were presented on preceding pages and, taking all circumstances into account, ruled no breach of 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 which would not necessarily be so, and requested Trinity-Chiesi be advised of its concerns.

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