Grünenthal: Versatis budget impact brochure misled on “Total NHS cost” comparison (AUTH/1959/2/07)

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Key facts

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Case	AUTH/1959/2/07
Company	Grünenthal Ltd
Complainant	Medicines information pharmacist
Material	12-page brochure: “Overview and Budget Impact Bulletin: Versatis (5% lidocaine medicated plaster) for localised pain of post-herpetic neuralgia [PHN]” (ref 064/GRTUK/VERS 12/06-12/08)
Product	Versatis (5% lidocaine medicated plaster)
Main issue	Table comparing “Total NHS cost” of Versatis vs gabapentin was not sufficiently clear and was misleading
Key figures in dispute	Versatis £845 vs gabapentin £718 over 6 months (difference £128)
Panel finding	Misleading presentation/insufficient clarity of “Total NHS cost”
Breach clauses	Clause 7.2
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	05/06 February 2007 (dates reported as 5 Feb and 6 Feb 2007)
Case completed	19/20 March 2007 (dates reported as 19 March and 20 March 2007)
Appeal	No appeal
Applicable Code year	2006

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

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A medicines information pharmacist complained about a 12-page brochure: “Overview and Budget Impact Bulletin: Versatis (5% lidocaine medicated plaster) for localised pain of post-herpetic neuralgia [PHN]” (ref 064/GRTUK/VERS 12/06-12/08) issued by Grünenthal.
The brochure was mailed to PCT and hospital budget holders after marketing authorisation and used in a formulary pack by representatives.
A table titled “Results of the Base Care Analysis (Per Patient)” compared Versatis with gabapentin, including “Total NHS cost” over six months: Versatis £845 vs gabapentin £718 (difference £128).
The complainant alleged the gabapentin figure was misleading because gabapentin capsules at high dose (800mg three times daily) would cost about £280 for six months (Drug Tariff Feb 2007), suggesting the brochure used a more expensive form (tablets).
Grünenthal responded that the table was not medicine acquisition cost alone; “Total NHS cost” included medicine plus other treatment costs (eg consultations, additional medication, switch medication, referrals) derived from a health economic (Markov) model and Delphi panel inputs.
The Panel found the table did not make clear what “Total NHS cost” meant and that surrounding text reinforced an acquisition-cost interpretation.

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Breach found: the table was misleading because “Total NHS cost” was not sufficiently clearly defined and could be read as acquisition cost only.
The Panel also queried whether Versatis costs were calculated on a comparable basis to gabapentin (including whether using 1.89 plasters/day was appropriate given practical use), and asked that these concerns be drawn to Grünenthal’s attention.
No appeal.

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