Tillotts v Ferring: Pentasa cost comparison chart ruled misleading for not comparing like with like (AUTH/2724/7/14)

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Key facts

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Case number	AUTH/2724/7/14
Parties	Tillotts Pharma UK Limited v Ferring Pharmaceuticals Ltd
Product	Pentasa (mesalazine; 5-ASA)
Material	Cost comparison bar chart in e-detail aid (ref PA/283/2014/UK)
Headline claim	“Pentasa is less expensive than many other brands of 5-ASA”
Key issue	Comparison used Pentasa 1.5g/day dose (not specifically quantified in SPC) while comparator doses were SPC-quantified ranges; not like-for-like
Panel decision	Breach Clause 7.2; No breach Clause 3.2
Sanction	Undertaking received
Complaint received	30 July 2014
Case completed	9 September 2014
Appeal	No appeal
Applicable Code year	2014

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

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Tillotts complained about a cost comparison bar chart for Pentasa (mesalazine) in a Ferring e-detail aid (ref PA/283/2014/UK) titled: “Pentasa is less expensive than many other brands of 5-ASA”.
The chart compared annual acquisition costs of oral mesalazine products for maintenance of remission of mild to moderate ulcerative colitis (UC), including Octasa (Tillotts), Asacol, Mezavant and Salofalk.
For Pentasa, the chart used two daily doses: 1.5g/day and 2g/day (annual costs shown as £336.62 and £448.83 respectively).
Tillotts alleged the 1.5g/day maintenance dose was not supported/quantified in Section 4.2 of the Pentasa SPC (which stated: “Maintenance treatment: Individual dosage. Recommended dosage, 2g mesalazine once daily”).
Tillotts argued the chart implied Pentasa was the cheapest option and that the comparison was unfair because comparator products used only SPC-quantified maintenance dose ranges, while Pentasa used a dose derived from other sources (prescription data/guidelines/trials).
Ferring argued the chart was not intended to imply Pentasa was the cheapest and said 1.5g/day was commonly prescribed and consistent with “Individual dosage” plus guidelines and clinical studies.

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Breach found: Clause 7.2 (misleading/unfair comparison; did not compare like with like).
No breach: Clause 3.2 (1.5g/day not inconsistent with the SPC given “Individual dosage”, guidelines and studies).
No appeal.

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