Leo Pharma: Picato ‘Dear Dr’ template letter pad alleged to bypass non-formulary status (AUTH/2633/8/13) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2633/8/13
Complainant	Medicines management pharmacist (CCG)
Company	Leo Pharma
Medicine	Picato gel (ingenol mebutate)
Material	Pad of 30 pre-printed A4 forms / “Dear Dr” template letter (ref 4340a/000526) with prescribing information on reverse
Allegation	Forms used to get around non-formulary status; potentially misleading about formulary position
Clauses considered	Clause 7.2 and Clause 9.1
Panel notes (context)	Promotion of non-formulary medicines not necessarily prohibited; local arrangements must be observed (Panel referenced Clause 15.4 in its reasoning)
Decision	No breach of Clause 7.2; No breach of Clause 9.1
Complaint received	13 August 2013
Case completed	27 September 2013
Applicable Code year	2012
Appeal	No appeal

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

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A medicines management pharmacist complained about Leo Pharma promotional material for Picato gel (ingenol mebutate): a pad of 30 pre-printed A4 forms (ref 4340a/000526).
The form was a pre-printed letter addressed “Dear Dr” designed as a template for dermatologists/specialists to communicate prescribing recommendations to GPs.
It included spaces for patient/clinical details, Picato’s indication, phase III clinical trial information, a clinician signature area, and prescribing information on the reverse.
The complainant said a form reached a GP surgery; a GP asked whether to prescribe Picato. The complainant was advised by the local commissioning support unit that Picato was not on the formulary (as the request was initiated by Leo rather than via a dermatologist as customary) and advised the GP to prescribe an alternative first-line option (Solaraze).
The concern was that the forms were being used across the local health economy to get around Picato’s non-formulary status.
Leo said the forms were certified for promotional use and offered in face-to-face meetings to appropriate recipients (dermatologists, specialist registrars, and four GPs with a special interest in dermatology), and that representatives checked local NHS restrictions before distribution.

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No breach of Clause 7.2.
No breach of Clause 9.1.
The Panel considered the material did not comment on, or imply anything about, Picato’s formulary status and was not misleading in that regard.
The Panel did not consider Leo failed to maintain high standards given the local guidance and the company’s submissions about local arrangements.

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