AUTH/3701/10/22: Astellas v Janssen — Nurse support service for Erleada (apalutamide) offered as a package deal (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3701/10/22
Parties	Astellas Pharma Ltd v Janssen-Cilag Limited
Medicine / therapy area	Erleada (apalutamide) — prostate cancer
Issue	Nurse support service offered as part of a package deal; alleged inducement to prescribe
Applicable Code	ABPI Code of Practice 2021
Complaint received	24 October 2022
Case completed	3 August 2023
Appeal	No appeal
Clauses considered	2, 5.1, 19.1
Decision	No breach of Clauses 2, 5.1, 19.1
Sanctions	None stated

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

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Astellas complained about Janssen’s provision of a nurse support service for Erleada (apalutamide) in prostate cancer, offered as part of a package deal.
Astellas alleged the service was an inducement to prescribe Erleada, particularly given NHS capacity pressures and the perception that nurses previously supporting Zytiga (abiraterone) patients were “switched” to support Erleada patients.
Astellas argued there were no additional monitoring requirements in the Erleada SPC beyond standard prostate cancer management, so the package deal was not justified and could influence prescribing choices.
Astellas said inter-company dialogue (ICD) failed because Janssen would not share the “explicit rationale” and full details of the nurses’ work as embedded clinic members.
Janssen denied any inducement, stated the Zytiga and Erleada programmes were separate/independent, and said the Erleada service was relevant to SPC safety warnings (eg seizure, falls/fractures, ischaemic heart disease/cerebrovascular disorders, SJS/TEN) with additional monitoring particularly in the first 6 months.
Janssen also argued Astellas provided no documentary evidence and appeared to be seeking confidential commercial agreement details.

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No breach of Clause 19.1.
No breach of Clause 5.1.
No breach of Clause 2.
The Panel considered Astellas had not demonstrated the package deal was inappropriate or offered as an inducement to prescribe Erleada.

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Clause 2 — Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (No breach).
Clause 5.1 — Requirement to maintain high standards (No breach).
Clause 19.1 — Requirement that no gift, pecuniary advantage or benefit may be supplied, offered or promised to health professionals or to other relevant decision makers in connection with the promotion of medicines or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. (No breach).

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