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Bayer takes on Actavis in ABPI code conduct breach

Published on 26/11/15 at 02:46pm

The Prescription Medicines Code of Practice Authority (PMCPA) has ruled in favour of Bayer in a case brought against Actavis.

Bayer complained that Actavis had breached the ABPI Code of conduct - the regulations by which pharmaceutical companies operating in the UK are expected to abide- by misleading patients over the suitability for more women of its contraceptive system Levosert, compared to Bayer’s own Mirena implant.

Bayer’s complaint centred on the information leavepiece for Levosert, issued by Actavis UK. Levosert and Mirena were both intrauterine delivery systems (IUSs) containing 52mg levonorgestrel; both were indicated as long-acting, reversible contraceptives and of particular use in women with heavy menstrual bleeding who required contraception.  

Levosert was effective for three years and should then be removed, while Mirena was effective for five years before removal was necessary. Mirena was additionally indicated for protection from endometrial hyperplasia during oestrogen replacement therapy and was effective in that regard for four years, after which it should be removed.

Bayer alleged that the leavpiece’s claim, ‘can a single IUS be suitable for so many women?’ was ambiguous, misleading, did not encourage the rational use of Levosert and could not be substantiated; it implied that Levosert was suitable for the majority of women/more women than other IUSs, when in fact, as Bayer noted, Levosert had a more limited licence than Mirena, with fewer indications and a shorter licensed duration of use, limiting its suitability for some women.  

The Panel noted that although the title of the leavepiece - ‘Can a single IUS be suitable for so many women?’ was presented as a question, the claim implied that Levosert was suitable for more women than other IUSs. As a contraceptive, Levosert was contraindicated in more women than Mirena as it could not be used in those with active or previous severe arterial disease such as stroke or myocardial infarction.

After considering evidence, the PMCPA panel considered that the claim implied inaccurately that Levosert had a broader use than other IUSs, and so ruled a breach of the ABPI Code.

Bayer further alleged that the claim ‘Levosert is available at a low acquisition cost.  25% saving compared to Mirena’ was inaccurate and misleading.  Levosert could not be compared with other IUSs and that the comparison with Mirena in particular could mislead by placing undue emphasis on the acquisition cost saving, without clearly stating that it had different licensed indications and duration of use.  It was not a like-for-like comparison.  For five years Mirena cost less per year than Levosert.  

An additional complaint from Bayer was Actavis’s statement on the leavepiece- ‘All these benefits at a competitive price’, and the claim that contraception with Levosert would always be 25% less than with Mirena, which was not so.  In the Panel’s view the claim did not provide enough information for the prescriber to make a well-informed decision, and so ruled a breach of the Code.

The final claim, that Actavis had not maintained high standards, was also upheld. In all, the PMCPA ruled breaches of clauses 7.2, 7.4, 7.10 and 9.1.

Joel Levy

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