AUTH/2095/2/08: Actelion v Encysive – Thelin pilot risk-share scheme and Clause 18.1

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Key facts

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Case number	AUTH/2095/2/08
Case reference	Actelion v Encysive – Pilot study with Thelin
Complainant	Actelion Pharmaceuticals UK Ltd
Respondent/company	Encysive (UK) Limited
Product(s)	Thelin (sitaxentan); Tracleer (bosentan) mentioned as Actelion’s product
Material/channel	Pilot clinical and cost effectiveness scheme / risk-share arrangement using credit notes (commercial agreement; presentation referenced)
Key issue	Whether the scheme (credit note for failed treatment redeemable against future Thelin) constituted an inducement to prescribe/recommend and whether it was misleadingly presented as an evaluation
Dates (received/completed if stated)	Complaint received 5 February 2008; Case completed 23 April 2008
Appeal	Yes – Encysive appealed; appeal successful
Code year	Not stated
Breaches/clauses	Clause 18.1: Panel breach; Appeal Board no breach (narrow grounds). Clause 1.2 discussed (trade practice exemption rejected by Panel).
Sanctions	Panel required suspension of the pilot pending final outcome; Panel reported company to Appeal Board under Paragraph 8.2; Appeal Board took no further action regarding that report.

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

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Actelion Pharmaceuticals UK Ltd complained about a pilot clinical and cost effectiveness scheme run by Encysive (UK) Limited for Thelin (sitaxentan) in pulmonary arterial hypertension (PAH) patients classified as WHO functional class III and naïve to endothelin receptor antagonist (ETRA) therapy.
The scheme was offered for up to 20 patients at each prescribing centre and would run for 6 months from the date of first prescription at that centre.
If a patient discontinued Thelin within a 24-week evaluation period due to lack of efficacy and/or adverse events (endpoints determined by the physician and patient), Encysive would issue a credit note covering the cost of Thelin used to date.
The credit note was valid for one year (also described as 12 months) and could be used to offset the cost of Thelin for other patients; it could be transferred to another centre.
Actelion alleged the scheme was an inducement to prescribe and misleadingly presented as a “clinical and cost-effectiveness evaluation” despite lacking recognised standard criteria and formal cost-effectiveness evaluation.
Encysive submitted the scheme was a risk-sharing/outcome guarantee arrangement discussed at commissioning level, with prescribing decisions left to physicians, and argued it was akin to a financial trade practice/discounting measure.

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The Panel ruled the terms of the pilot scheme unacceptable and found a breach of Clause 18.1.
The Panel required Encysive to suspend the pilot pending the final outcome of the case and decided to report Encysive to the Code of Practice Appeal Board in accordance with Paragraph 8.2 of the Constitution and Procedure.
Encysive appealed.
The Appeal Board was extremely concerned about the scheme and considered it “not a model of good practice”, noting the title suggested clinical rigour that appeared to be missing (no protocol, steering group, predetermined endpoints, etc.).
On the narrow grounds of the complaint (Clause 18.1), the Appeal Board ruled no breach because the credit note was issued to a treatment centre and was not a gift/benefit/pecuniary advantage to any individual.
The appeal was successful and the Appeal Board decided to take no further action in relation to the Panel’s report to it under Paragraph 8.2.

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Clause 18.1 (inducements): Panel ruled breach; Appeal Board ruled no breach on the narrow grounds of the complaint.
Clause 1.2 (trade practices exemption): Panel did not accept Encysive’s submission that the pilot was exempt from the Code (outcome guarantee schemes not in wide use on 1 January 1993; scheme related to more than financial arrangements).

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