AUTH/3365/7/20 - Complainant v Norgine

Promotion of Feraccru

  • Received
    14 July 2020
  • Case number
  • Applicable Code year
  • Completed
    15 March 2021
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK heath professional, complained about the email promotion of Feraccru capsules (ferric maltol) by Norgine Ltd. Feraccru was indicated in adults for the treatment of iron deficiency.

The email had been sent on behalf of Norgine from Guidelines in Practice and the subject line of the recipient’s inbox read ‘Managing patients with iron deficiency anaemia in hospital (promotional information from Norgine)’. The email itself was headed ‘Real World Economic Evaluation of Feraccru vs IV Iron’ and was referenced to Lovato et al (2018).

The complainant noted that below the heading of the email it was stated that researchers at a named NHS trust reported on ‘…the potential health economic benefit of using Feraccru in Inflammatory Bowel Disease (IBD) patients who would otherwise have been considered for IV iron therapy*’. The asterisk took the reader to much smaller text that‘Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBD patients with haemoglobin (Hb) levels <9.5g/dL.’ The complainant stated that apart from this small wording, this special warning was not made clear and it was also not clear if the patients in the audit followed that warning.

The complainant submitted that the data appeared to be based on 28 patients in one small hospital and was conducted almost as a narrative with the absence of a primary endpoint, inclusion criteria, exclusion criteria, any attempt to quantify the values that were used, and a mix of prospective and retrospective data. The complainant stated that that was the only data upon which the whole piece was based, apart from further in-house extrapolation.

The complainant noted that the nursing time was estimated to be 75 minutes per patient although how that was estimated was not stated. In that regard the complainant submitted that two of the most widely used IV irons took 15 minutes to administer, that still left a further hour of time to be accounted for. Cannulation took minutes at most, and of course there was time to set up a giving set but still the time was unaccounted for. The patient might have to be observed for 30 minutes post-infusion, but this did not require a nurse or one-to-one care. The cost of both nursing time and the IV infusion were not specified (there were several treatment options and all had different costs).

The length of treatment was set at three months. The complainant noted that the studies mentioned in the Feraccru summary of product characteristics (SPC) stated that 90% or 68% of patients gained 1g of haemoglobin (Hb) in 16 weeks. If that was so there was a considerable percentage of the patients who would not have had sufficient treatment after 3 months - so again the costs of Feraccru were artificially low. The complainant did not know how low and noted that treatment could be required for perhaps months if the patient required an increase of more than 1g Hb. The complainant acknowledged that the same might be true of those treated with IV iron - there was not prespecified criteria of what ‘treatment’ was to be.

The complainant noted that the email concluded that according to the authors using Feraccru in their NHS trust was cost-effective, reduced costs and saved nursing time. The complainant referred to the actual conclusion and that the key limitations had been removed - such as underestimating those that needed IV iron, patients might refuse treatment and of course finally patients might be excluded as having too low a Hb or active IBD or needed oral treatment over 3 months - which was highly likely.

The complainant further noted that extrapolated costing based on no evidence ended with ‘**Number of appointments for iron infusion could have been overestimated as some of the patients could have been admitted.’ The complainant alleged that this was misleading as well as being unsupported by any evidence.

The complainant alleged that when the data had been extrapolated to 100 patients there were several errors that had not been taken into account: what percentage would be unsuitable due to special warnings?; how many might refuse?; how many might require IV iron after treatment? In essence the data was insufficient to draw any meaningful conclusions and should not be used promotionally to clinicians.
The detailed response from Norgine is given below.

The Panel noted that the email was sent to prescribers, commissioners and relevant NHS decision makers and included two boxed sections detailing costs and nursing times. The first section was based on a small study of 28 patients over 9 months at one NHS trust (Lovato et al) available as an abstract from the European Haematology Association open access library. The authors had reported that of the 28 patients in the study, four (14%) had to be switched to IV iron. The authors calculated the cost if all patients had been treated with IV iron, although the IV iron was not specifiedand that using Feraccru could have led to savings of £8,955 and 3.75 days of nursing time.

The figure for nursing time saved in the email referred to a footnote directly below which stated that the number of appointments for iron infusion could have been overestimated as some patients could have been admitted. The Panel noted that this also appeared in the abstract as one of the study’s limitations. Included within the published abstract, although not in the email, the authors noted that limitations also included the possibility that the number of patients who needed IV iron could have been under-estimated. The authors also noted that not all patients with IBD would be able to have oral therapy and some might refuse it. The authors concluded that further data were needed to better estimate the real impact of using Feraccru.

Despite the limitations and conclusion set out by the authors, a second section of the email, labelled ‘Modelling/projected costs over 12 months’, was referenced to ‘Norgine Data on file’. On examination of that Data on file, although not obvious to the reader, it appeared that the company had simply extrapolated the data from 28 patients over 9 months to 100 patients over 12 months and noted that if all these IBD patients received IV therapy, treatments costs would have been £57,068 vs £25,031 if Feraccru had been used and still assuming 14% would need IV iron, with a potential saving of 13.4 days of nursing time.

Overall, the Panel did not consider that Lovato et al and the company’s Data on file was sufficiently robust as to support the claim of over 50% cost saving with a potential saving of 13.4 days of nursing time if 100 IBD patients over 12 months were started on Feraccru versus IV iron; in the Panel’s view, the email made too much of too little. Neither the preliminary nature of Lovato et al nor all of the study limitations had been communicated to the reader of the email and there was no indication as to how the estimated 75 minutes of nursing time for each infusion had been calculated by the authors or which IV iron was used. Further, readers would be unaware that ‘Norgine Data on file’ referred to a basic in-house calculation by marketing. Overall, the Panel considered that the email was not sufficiently complete to allow the recipient to fully understand the basis and significance of the data. A breach of the Code was ruled. The comparison with IV iron was misleading and a breach of the Code was ruled. The Panel considered that what appeared to be unequivocal claims regarding potential savings could not be substantiated and a breach of the Code was ruled.

The Panel further noted that Lovato et al was an evaluation of Feraccru vs IV iron only in terms of reduction in treatment cost and nursing time; there was no clinical evaluation of the comparative efficacy and safety of the two regimens. The email, however, included the claim ‘The authors concluded that using Feraccru in their NHS trust was cost-effective, reduced costs and saved nursing time’ and while the Panel noted that the authors did indeed conclude that Feraccru had been cost effective reducing costs and saving nursing time, it considered that the term ‘cost-effective’ encompassed more than just a cost comparison; other factors such as relative efficacy and incidence of side effects needed to be taken into account. The Panel thus considered that the claim that, compared with IV iron, Feraccru was cost effective was misleading and could not be substantiated. Breaches of the Code were ruled.

The Panel noted thatit appeared from the email that for any IBD patient it was a simple choice between IV iron or Feraccru which was not so. An asterisk in the first paragraph led the reader to a footnote which stated that Feraccru should not be used in patients with inflammatory bowel disease flare or in IBD patients with haemoglobin (Hb) levels <9.5g/dL. The Panel noted that claims must be capable of standing alone and that in general, claims should not be qualified by the use of footnotes and the like. The Panel considered that the restrictions on the use of Feraccru in some IBD patients had not been clearly and adequately communicated and a breach of the Code was ruled.

Overall the Panel considered that in using data from a very small, preliminary study as the basis for bold promotional claims and not informing readers about all the relevant limitations, high standards had not been maintained. A breach of the Code was ruled.

Clause 2 was a sign of particular censure and reserved for such use. The Panel noted that it was not clear from the study, and therefore not clear from the promotional email, how the estimated 75 minutes of nursing time for each infusion had been calculated or which specific IV iron was used. The Panel was further concerned by the use of the term cost-effective in the email as noted above.

The Panel noted that it was crucial that health professionals and others could rely upon the industry to provide them with robust and accurate information to aid their decision making. The Panel noted its comments above and considered that the information in the email was not based on robust data and that it encouraged use of Feraccru in all IBD patients when not all of those patients would be suitable for such therapy. Overall, the Panel considered that the material brought discredit upon, and reduced confidence in, the industry. A breach of Clause 2 was ruled.