Boehringer Ingelheim: Ofev (nintedanib) supply/discount programme – no breach (AUTH/2775/6/15) | PMCPA Case

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Key facts

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Case	AUTH/2775/6/15
Complainant	Anonymous, non-contactable pharmacist (hospital pharmacist)
Company	Boehringer Ingelheim
Medicine	Ofev (nintedanib)
Indication referenced	Adults with idiopathic pulmonary fibrosis (IPF)
Issue	Free/discount supply programme pre-NHS reimbursement; alleged inducement/switch programme/disguised promotion; lack of clarity/protocol concerns
Applicable Code	2015
Clauses considered	2, 9.1, 12.1, 12.2, 18.1, 19.1
Panel decision	No breach
Complaint received	22 June 2015
Case completed	15 July 2015
Appeal	No appeal
Sanctions	None

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

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An anonymous, non-contactable complainant (described as a hospital pharmacist) raised concerns about a Boehringer Ingelheim programme supplying Ofev (nintedanib) free of charge/at a confidential discount while it was licensed (Jan 2015) but not yet reimbursable on the NHS.
The complainant alleged the programme resembled historic “free medicine then charge the NHS later” practices.
The complainant believed the programme was aimed at patients who had “failed” on Esbriet (pirfenidone) and queried the criteria for switching.
The complainant described meeting a company medical representative, did not believe it was a clinical trial, and said no protocol was provided.
Boehringer said it could not identify the alleged interaction due to the complainant’s anonymity, but believed the complaint related to a confidential discount (“Patient in Need Programme” / Ofev Supply Programme) for ILD specialist centres commissioned to treat IPF.
Boehringer stated the programme was intended to bridge the gap between marketing authorisation and reimbursement, for patients unable to access Esbriet (contraindication or outside reimbursement criteria), and was agreed with NHS England to avoid additional NHS expense.
Company materials stated the programme was medical-led; commercial teams were briefed not to raise it proactively and to direct enquiries to medical; and there was no associated promotional material.

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No breach of the Code was found.
The Panel found the programme was not a switch programme (it applied to patients who could not take Esbriet, not those who had “failed” it).
The Panel found no evidence the programme constituted an inducement to prescribe/supply/buy/sell Ofev.
The Panel found the programme was non-promotional and not disguised promotion or a promotional activity disguised as a clinical assessment/experience programme.
The Panel found no evidence that high standards were not maintained and no basis for a Clause 2 breach.
No appeal.

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