Lundbeck Migraine Preceptorship: alleged pre-licence promotion of eptinezumab (Vypeti) at internal training – No breach (AUTH/3510/5/21) | PMCPA Case

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Key facts

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Case number	AUTH/3510/5/21
Parties	Complainant v Lundbeck
Allegation	Alleged promotion of Vypeti (eptinezumab) at a Lundbeck-funded event; inappropriate “exciting/innovative” wording; alleged excessive speaker payments; alleged inaccurate sponsorship/declaration statement
Event	“Migraine Preceptorship” (24–25 November 2020)
Medicine / area	Vypeti (eptinezumab); migraine; CGRP class
Complainant	Anonymous, contactable
Applicable Code year	2019
Clauses considered	2, 3.1, 7.2, 7.10, 9.1, 9.10, 18.1, 23.1
Panel decision	No breach
Appeal	No appeal
Complaint received	27 April 2021
Case completed	1 April 2022
Notable Panel comment	Panel queried appropriateness of “innovative” and “exciting” for a yet-to-be-licensed medicine given MSL attendance; Lundbeck to be advised of concerns

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

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What happened

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An anonymous, contactable complainant alleged that a Lundbeck-funded event (“Migraine Preceptorship”, 24–25 Nov 2020) promoted the unlicensed medicine Vypeti (eptinezumab) and/or the CGRP class to health professionals, a patient organisation representative and an expert patient.
The agenda included the wording: “The future of migraine treatments; how do clinicians, patients and patient organisations view new treatments (and CGRPs), is this exciting and innovative? What impact will they have?” (UK-VYEP-0001, Date of Preparation: October 2020).
The complainant alleged the terms “exciting” and “innovative” were used to increase interest and that discussion of a pipeline product/class was inappropriate given Lundbeck’s pipeline medicine.
The complainant also alleged speakers (health professionals) were paid far above normal market rate and that this was connected to promotion/inducement.
The complainant alleged the sponsorship/declaration statement on invitations was inaccurate: “This activity had been funded by Lundbeck. Whilst Lundbeck has selected key topics for discussion, content has been ultimately determined by [named academy]”.
Lundbeck stated the event was internal training for Lundbeck UK and Business Area North internal medical/market access staff; no sales representatives attended; access was restricted/verified; external individuals (clinicians, expert patient, patient organisation representative) attended as contracted speakers via a named academy.

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Outcome

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No breach of the Code was found.
The Panel ruled the complainant had not established, on the balance of probabilities, that the alleged promotion, inappropriate payments, or inaccurate declaration occurred.
The Panel nevertheless expressed a concern (not a breach finding) about the appropriateness of using “innovative” and “exciting” in relation to a yet-to-be-licensed medicine, noting MSLs who might be asked about unlicensed medicines attended; Lundbeck was to be advised of the Panel’s concerns.

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Lundbeck Migraine Preceptorship: alleged pre-licence promotion of eptinezumab (Vypeti) at internal training – No breach (AUTH/3510/5/21)

Key facts

What happened

Outcome

Clauses

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