AUTH/2391/2/11: Takeda v AstraZeneca – Zoladex price reduction letter and “No other LHRHa…” survival claim (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2391/2/11
Parties	Takeda v AstraZeneca
Product/material	Zoladex (goserelin) price reduction letter (ref CZ004482-ZOLA)
Main issue	Comparative survival claim: “No other LHRHa has demonstrated survival benefits in all 3 stages of prostate cancer”
Audience	NHS budgetary stakeholders (including PCT pharmacists, practice managers and other payers); sent to medical information sources (EMIS, BNF, MIMS), Department of Health and other purchasing organisations; used with appropriate health professionals
Applicable Code year	2008
Clauses cited	Clause 7.2, Clause 7.3, Clause 7.10
Panel decision	No breach
Complaint received	28 February 2011
Case completed	5 May 2011
Appeal	No appeal

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

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Takeda complained about an AstraZeneca letter titled “Zoladex (goserelin) price reduction from 1st October 2010” sent to NHS budgetary stakeholders and used with appropriate health professionals.
The letter highlighted a 12% price reduction for Zoladex 10.8mg and stated Zoladex 3.6mg was the least expensive one-month LHRHa.
The disputed comparative efficacy statement was: “In addition to the savings Zoladex has demonstrated survival benefits in all 3 stages of prostate cancer (localised, locally advanced and metastatic). No other LHRHa has demonstrated survival benefits in all 3 stages of prostate cancer.”
Takeda alleged the “No other” claim was absolute, exaggerated, unbalanced, and misleading; and that AstraZeneca’s evidence base used strict inclusion/exclusion criteria (UK licensed dose, monotherapy trials; excluding combined androgen blockade and abstracts).
AstraZeneca argued the claim reflected the evidence base and differences in SPC wording for Zoladex vs other LHRH analogues, and that the claim would be understood as referring to single-agent (monotherapy) use.

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No breach of the Code was ruled.
The Panel considered Takeda did not provide data demonstrating survival benefits in all three stages for Prostap (leuprorelin) when used as monotherapy.
The Panel accepted the claim reflected differences in the SPCs and was not misleading in context (including the cost/price-reduction context).
The Panel found there was no footnote qualifying the claim, so the footnote-related allegation could not succeed.

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