Novartis voluntary admission: representative discussions about Piqray (alpelisib) pre-licence ruled promotional

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Key facts

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Case number	AUTH/3399/10/20
Company	Novartis Pharmaceuticals UK Limited
Product	Piqray (alpelisib)
Issue type	Conduct of a representative; pre-authorisation discussions/insight gathering ruled promotional
Trigger	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
CHMP positive opinion	28 May 2020 (published 29 May 2020)
European Commission approval	27 July 2020
HCPs involved	2 clinicians (two meetings held; four meetings scheduled)
Complaint received	07 October 2020
Case completed	05 March 2021
Applicable Code year	2019
Breach clauses	2; 3.1; 9.1
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal

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

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Novartis voluntarily admitted that a representative failed to maintain high standards in discussions about Piqray (alpelisib) with two clinicians.
In June 2020, the representative proactively held two separate conversations with clinicians about the CHMP published recommendation/wording for Piqray before it had an EMA/European Commission licence.
The stated intention was to gather clinician insights on interpretation of the CHMP wording.
A marketing employee (and their line manager) had been involved in planning introductory meetings with clinicians to introduce marketing and gather insights.
After a medical adviser said the activity should not be undertaken by commercial roles pre-licence, the marketing employee texted the representative to “hold off”, using wording such as “might”.
Despite this, four meetings were scheduled; two meetings went ahead in June with the representative alone, and the representative asked clinicians for insights on the clinical implications of the CHMP recommendation.
The issue came to light via a medical adviser (during a medical advisory board on 8 July) and separately via an MSL report, after clinicians referenced prior discussions with the representative.

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The Panel ruled that alpelisib had been promoted prior to the grant of its marketing authorisation.
The Panel ruled that high standards had not been maintained.
The Panel ruled that the activity brought discredit upon, and reduced confidence in, the industry.
No appeal.

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