AUTH/3432/12/20 - Complainant v GlaxoSmithKline

Promotion of respiratory medicines

  • Received
    28 November 2020
  • Case number
    AUTH/3432/12/20
  • Applicable Code year
    2019
  • Completed
    16 November 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    No appeal

Case Summary

An anonymous, contactable complainant raised concerns about the promotion of respiratory medicines by GlaxoSmithKline UK Limited. The complainant referred to four medicines: Trelegy (fluticasone/umeclidinium/vilanterol), Anoro (umeclidinium/vilanterol), Incruse (umeclidinium) and Relvar (fluticasone/vilanterol), that were each delivered via the Ellipta device. Seretide (fluticasone/salmeterol) and Serevent (salmeterol) were also referred to on one of the materials at issue. All of the medicines were variously indicated for chronic obstructive pulmonary disease (COPD) and/or asthma.

The detailed response from GlaxoSmithKline is given below.

1 Invitation to a promotional meeting on inhaler techniques and devices

The complainant alleged that an invitation to a respiratory promotional meeting lacked the mandatory information. The complainant noted that at the bottom of the page, Trelegy, Anoro, Relvar and Incruse were mentioned but the generic names were not listed for any of the medicines and more importantly there was no adverse event reporting statement or black triangles which were needed for Incruse, Anoro and Trelegy. The complainant did not consider that the material appeared to have been certified given the lack of mandatory information.

The Panel noted that the bottom right-hand corner of the invitation to a respiratory promotional meeting titled ‘Inhaler Technique & Devices Workshop’ provided by GlaxoSmithKline listed the brand names for Trelegy, Anoro, Relvar and Incruse but did not include the corresponding non-proprietary names or an inverted black triangle for Trelegy, Anoro and Incruse. Breaches of the Code were ruled as acknowledged by GlaxoSmithKline. Relvar Ellipta did not need a black triangle and thus the Panel ruled no breach of the Code in relation to Relvar Ellipta. The Panel noted that whilst the adverse event reporting statement was included within the prescribing information, which was hosted on external links from the invitation, there was no reference to it on the meeting invitation itself. The Panel considered that this was particularly important given that three of the four products were subject to additional monitoring, and therefore it ruled a breach of the Code; In reaching its decision on this point, the Panel did not consider that a separate adverse event reporting statement was needed for each product promoted as alleged.

The Panel noted that both the certificate for the Asthma and COPD promotional meetings invite template and the final invitation to the meeting provided by GlaxoSmithKline included the same job bag number and date of preparation (PM-GB-UCV-BRF-190006, September 2019). This gave the impression that the final populated template had been approved but from GlaxoSmithKline’s response that was not so.

The Panel noted that it was not unacceptable to use certified templates for invitations but the arrangements must be such that the company could be confident that the completed template complied with the Code. Instructions to representatives were important in this regard. In the Panel’s view, altering fields such as the agenda, which was likely to be directly relevant to whether material was Code compliant and might meaningfully change the nature of the original certified invitation template, was different to the population of fields related to administrative details. In the Panel’s view, in the particular circumstances of this case, the final invitation had not been certified prior to being issued and a breach of the Code was ruled.

The Panel ruled a breach of the Code as high standards had not been maintained.

The Panel noted its rulings above and although it considered that it was unacceptable to omit the adverse event reporting statement and black triangle, where relevant within the invitation in question, they could, nonetheless, be viewed when the prescribing information was accessed from the links within the invitation. The Panel considered that the rulings of breaches adequately covered this matter and an additional ruling of a breach of Clause 2 would be disproportionate in the particular circumstances of this case. A ruling of a breach of Clause 2 was used as a sign of particular censure and reserved for such use. The Panel, on balance, ruled no breach of Clause 2.

2 Invitation to a promotional meeting on asthma control

The complainant alleged that another promotional meeting invitation to a meeting titled ‘Optimising asthma control in your practice’, implied that Trelegy Ellipta was licensed for asthma but it was only licensed for COPD.

The Panel noted GlaxoSmithKline’s submission that the digital invitation at issue was intended to be printed and distributed to health professionals. It appeared to the Panel that, if printed the invitation was a 6 page gate-folded booklet and that the front cover of the invitation included an image of a pair of lungs, the title ‘Optimising asthma control in your practice’ and the Trelegy Ellipta brand logo at the bottom of the page.

The Panel noted that the agenda on the invitation listed two separate sessions, one titled ‘Optimising asthma control in your practice’ and one titled ‘Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol): The only single daily inhalation triple therapy for COPD’.

In the Panel’s view, it was not unreasonable to consider that a busy health professional reading the first page of the invitation might assume that Trelegy Ellipta was a treatment option for asthma, given the heading. It would have only been upon reading the agenda that one might have been made aware from the session ‘Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol): The only single daily inhalation triple therapy for COPD’ that Trelegy Ellipta was licensed for COPD. The Panel also considered that the impression from the agenda might have led health professionals to believe that Trelegy was licensed for both asthma and COPD.

In the Panel’s view, the invitation implied that Trelegy was licensed for asthma which was not so; a breach of the Code was ruled.

The Panel ruled a breach of the Code as high standards had not been maintained. The Panel considered that any reference to Trelegy on an invitation for an asthma-focussed meeting was wholly inappropriate given that Section 4.4, Special warning and precaution for use of the Trelegy SPC, stated that it should not be used in patients with asthma since they had not been studied in that patient population. The Panel considered that the implied suggestion otherwise was such as to reduce confidence in the pharmaceutical industry. A breach of Clause 2 was ruled.

The Panel noted that it was not unacceptable to use certified templates for invitations but the arrangements must be such that the company could be confident that the completed template complied with the Code. Instructions to representatives were important in this regard. In the Panel’s view, altering fields such as the agenda, which was likely to be directly relevant to whether material was Code compliant and might meaningfully change the nature of the original certified invitation template, was different to population of fields related to administrative details. In the Panel’s view, in the particular circumstances of this case, the final invitation had not been certified prior to being issued and a breach of the Code was ruled.

3 On-demand webinar

The complainant noted that an on-demand webinar entitled ‘Winter is Coming – COPD patient optimisation in the context of COVID-19’ (ref PM-GB-UCV-VID-200012, September 2020 could be accessed via a Google search and it was important to note the route of access within the context of the first mention of generic names. The complainant stated that when Trelegy Ellipta was first mentioned three times it did not have a generic name or black triangle anywhere next to the three mentions on the slide. Anoro and Relvar were also first mentioned on the same slide but again there was no generic name or black triangle for Anoro.

The Panel noted GlaxoSmithKline’s submission that the on-demand video could be searched for via Google, however when landing on the page via a Google search, the first mention of the product was within the video-on-demand and at that point, the black triangle and the non-proprietary name were clearly displayed.

The Panel further noted that the complainant referred to a slide at 29 minutes and 31 seconds into the webinar, which mentioned Trelegy Ellipta three times with no generic name or black triangle and did not include the generic name or black triangle for Anoro Ellipta either.

The Panel noted that a screenshot of the video at 26 seconds provided by GlaxoSmithKline, described as Slide 2, included the licensed indications, non-proprietary names, and inverted black triangles, where relevant, for Trelegy Ellipta, Anoro Ellipta, Relvar Ellipta, Incruse Ellipta, Seretide and Serevent. The Panel noted that the complainant bore the burden of proof and that he/she had not established that the required obligatory information was not included as alleged. No breaches of the Code were ruled in relation to each medicine. The Panel consequently ruled no further breaches of the Code including Clause 2 in this regard.

4 Patient resource material

The complainant noted that on the GSKPro website, there was, within the patient resources, a one-page leaflet on how to use the Ellipta device available in different languages. However, none of the five pdf guides included the adverse event reporting details as required by the Code, which was of concern as patients might take the Ellipta device with one of the black triangle Ellipta products (eg Anoro, Incruse) but yet were not provided with information on how to report adverse effects.

The Panel noted that the patient leaflet at issue was intended to provide instructions for patients on how to use the Ellipta inhaler.

The Panel noted that whilst the leaflet did not refer to a specific medicine and thus the black triangle which was related to a specific medicines was not required to be included, the ultimate audience of the leaflet was members of the public who had been prescribed one of the four licensed medicines used with an Ellipta device and thus, in the Panel’s view, the leaflet should have included an adverse event reporting statement and a breach of the Code was ruled.

5 Claim for Trelegy

The complainant further referred to claims regarding exacerbation reduction for Trelegy Ellipta within the GSKPro website (ref PM-GB-FVU-WCNT-200013, September 2020). The complainant noted that on the first part of the page, there was a claim that Trelegy Ellipta delivered superior reduction in annual rate of moderate/severe exacerbations vs an inhaled corticosteroid/long-acting beta agonist (ICS/LABA); there was a bubble next to the bar chart which stated 44% reduction. The complainant alleged that that was relative risk reduction and not absolute risk reduction which had to be shown.

The Panel noted that the relative risk reduction was in a bubble, to the right of the graph. The Panel noted GlaxoSmithKline’s submission that the graph represented the absolute values from the referenced clinical study (Lipson et al 2017); the absolute values on each bar of the chart were of the same size and prominence as the relative risk reduction.

The Panel considered that the graph included the absolute values with similar prominence to the relative risk reduction and therefore no breaches of the Code was ruled. The Panel noted its rulings above and did not consider that high standards had not been maintained.

6 Claim about the cost-effectiveness of Trelegy

The complainant alleged thatthe claim that Trelegy was a cost-effective single inhaler triple therapy, on the GSKPro website, was not accurate as no cost-effective analysis had been done and the reference provided for the claim (MIMS) was purely the price of the inhaler as opposed to actual cost-effectiveness which was much broader than simply the price of a product.

The Panel noted that the webpage at issue had the heading ‘Trelegy Ellipta Price’ beneath which was a graph which compared Trelegy Ellipta with other branded multiple inhaler triple therapy combinations in COPD; the graph was a bar chart which was headed ‘A cost-effective single inhaler triple therapy for COPD’ and illustrated the price differential between Seretide, Fostair, Symbicort and Trelegy; Trelegy was markedly lower visually.

The Panel noted GlaxoSmithKline’s submission that in July 2019, the National Institute for Health and care Excellence (NICE) updated its guideline on the diagnosis and management of COPD, which also took into account clinical and cost-effectiveness outcomes of a treatment. The Panel noted GlaxoSmithKline’s submission that two Trelegy Ellipta COPD studies had been included in the review and whilst it did not make a recommendation in favour of single or multiple inhaler devices, NICE did state that using a single inhaler device was more cost-effective than using more than one inhaler to deliver triple therapy. The section headed ‘Cost effectiveness and resource use’ discussed indirect costs and the application of its economic model.

The Panel noted that the complainant bore the burden of proof and considered that, on the evidence before it, the complainant had not established that there was no cost-effective analysis as alleged. Based on the very narrow allegation, the Panel thus ruled no breach of the Code.