AUTH/3464/1/21 - Complainant v Novartis

Beovu video

  • Received
    26 January 2021
  • Case number
  • Applicable Code year
  • Completed
    05 August 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A named contactable complainant, who described him/herself as a healthcare practitioner and wished to remain anonymous, complained about the promotion of Beovu (brolucizumab) by Novartis Pharmaceuticals UK Limited. The material at issue was a video of a health professional discussing his early experiences with Beovu; the video titled ‘First experience in [country]: Patient cases and implementation’ was available on a promotional Beovu website.

Beovu was presented as a pre-filled syringe for intravitreal injection, for use in adults for the treatment of neovascular (wet) age-related macular degeneration (nAMD).

The complainant explained that in July 2020, he/she had remotely attended a Novartis meeting about Beovu. One of the presenters discussed his/her experience with the medicine which included stressing the need for caution after the reports from the US of retinal vasculitis and occlusions post Beovu use which had emerged in February 2020.

The complainant stated that in the December/January 2021 issue of Eye News, Novartis had an advertisement with a QR code linking to a Novartis website which included a link to the presentation.

The complainant submitted that if the material was viewed, one would see all the positive aspects of the presentation but then at the end it just faded out; the complainant alleged that Novartis had purposefully cut out the ‘negative’ parts. The wider UK ophthalmology audience accessing the site, having not seen the original full presentation, would be misled by this blatant editing designed to alter the presenter’s view; all balance had been lost and the complainant regarded it as blatant misrepresentation.

The detailed response from Novartis is given below.

The Panel noted that the original live webinar in July 2020 was entitled ‘Experience sharing with Beovu (brolucizumab). An innovation in the treatment of Wet AMD Webinar’. The webinar lasted just over an hour and included three presentations and a Q&A session at the end; the presentation ‘Beovu: patient cases and implementation in [country]’, lasted about 22 minutes during which the presenter shared his/her experience of treating patients with Beovu and discussed a series of case studies.

The Panel noted that the presenter made a number of positive comments about his/her clinical experience with Beovu including describing the very positive effects seen in a patient 2 weeks after an injection. The Panel noted that at the end of the presentation, within a section titled ‘What are we doing now? July 2020’, the presenter referred to what was being done based on the discussions of intraocular inflammation and that clinicians needed to be aware of the relevant data that was available. In that regard, he/she cautioned that he/she would not treat eyes which previously had uveitis or ‘better seeing eye conditions’ and explained that in his/her country controls were put in place at two weeks after an injection to rule out any signs of inflammation/endophthalmitis which would be treated accordingly. At that point another presenter took over the webinar. At the end of the webinar, in a Q&A session, the presenter was asked whether in the 47 patients he/she had treated, had there been an increase in intraocular inflammation; the presenter stated that he/she had not noticed an increase but that intraocular inflammation needed to be taken seriously and that clinicians particularly needed to look for signs of it.

The Panel noted that according to the Beovu SPC (date of revision of the text 14 October 2020), Section 4.2 stated that the recommended dose was 6mg brolucizumab (0.05ml solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, the physician might individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. The Panel further noted that Section 4.4 Special warnings and precautions for use stated 'Intravitreal injections, including those with Beovu, have been associated with endophthalmitis, intraocular inflammation, traumatic cataract and retinal detachment (see section 4.8). Proper aseptic injection techniques must always be used when administering Beovu. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Beovu (see sections 4.3 and 4.8). In patients developing these events, treatment with Beovu should be discontinued and the events should be promptly managed. Patients should be instructed to report any symptoms suggestive of the above-mentioned events without delay’. The Panel noted Novartis’ submission that when the webinar took place (July 2020) this safety signal had not been incorporated into the SPC but had been included by the time the website containing the video was created (November 2020).

The Panel noted Novartis’ submission that the live webinar initially seen by the complainant and the video available on the website were two different activities. Novartis explained that it did not provide any on-demand access to the webinar but that it had produced an excerpt of the webinar, resulting in the video, which formed part of the promotional Beovu website it had created separately. The Panel noted Novartis’ submission that that website was the relevant standalone promotional material against which compliance with the Code should be assessed and that the edited video (certified in November 2020) was not intended to be viewed in isolation or as a standalone item and could only be viewed as part of the broader website in its entirety which included directions to the prescribing and safety information.

The Panel noted that the Code did not prohibit extracts of recorded promotional presentations being included in other promotional material, such as on a website, provided that it complied with the Code.

The Panel noted that an email from Novartis to the presenter in October 2020 stated ‘Following your talk at the UK Beovu webinar in July we have had a number of clinicians ask us if they could watch the Beovu webinar as they could not make the live event. As you know we recorded the webinar for the purpose of sharing with clinicians. Please could we kindly request your permission to share the recording both by email and on our Beovu UK website, this is a closed website only available to HCPs. We have reviewed the videos and edited in line with the code’. It appeared to the Panel that, contrary to Novartis’ email to the presenter, the website did not provide on-demand access to the July 2020 webinar per se, rather it featured edited extracts from that webinar in the form of individual videos from each of the speakers which formed part of the broader promotional website. There was no video of the Q&A section from the webinar. Nonetheless, the presenter was sent a link to the video for review to which he replied, ‘OK from my side’.

The Panel noted that readers were directed to the promotional website via a QR code in a Beovu journal advertisement. On the landing page of the website within a section titled ‘Beovu (brolucizumab): on-demand webinars’, was the video in question described as: ‘…[full name and place of practice] provides valuable insights into how Beovu is being used in clinics in [country] and early treatment outcomes in patients’. The video was an edited version of the original presentation delivered at the July 2020 webinar. The Panel noted that a statement at the bottom of the opening slide of the video read, ‘This promotional meeting was organised and funded by Novartis UK’. It was thus apparent that the recording had come from a presentation at a Novartis promotional meeting. The presenter’s positive comments about Beovu including in relation to patient case studies presented at the July 2020 webinar were retained in the edited video on the promotional website, including the case study where he/she referred to the positive effects on a patient after 2 weeks. There was, however, contrary to the description of the video and reference to ‘implementation’ in the title, not all of the information as to how Beovu was being used in clinical practice for example, that the presenter put controls/checks in two weeks after Beovu injections to look for any signs of intraocular inflammation had been omitted from the video.

The Panel noted Novartis’ submission that during the production of the webinar in July 2020, Novartis acknowledged the need to proactively communicate safety information and it was included in the Q&A section. Novartis submitted, however, that technically it could not know at that time what information would be included in the SPC and discussions based on the personal opinions of health professionals prior to the definitive inclusion of the safety information in the SPC were edited out to reduce the risk of any potential information being shared that was inconsistent with the final wording within the SPC. In that regard, the Panel further noted Novartis’ submission that the safety signal had been incorporated into the SPC by the time the website was created and was in Novartis’ view appropriately incorporated into the website.

The Panel queried whether all of the information that had been edited from the July 2020 presentation needed to be removed when creating the video to comply with the Code. In the Panel’s view, information related to the presenter’s clinical practice of managing the risk of intraocular inflammation gave a balanced view of his/her early experience of using Beovu and put his/her presented case reports into context.

The Panel noted its comments above and considered that focusing on the presenter’s experience of the positive effects of Beovu without including his caution in relation to intraocular inflammation within a video about his/her first experiences and implementation of Beovu was thus misleading. Novartis had failed to maintain high standards and breaches of the Code were ruled.

In the Panel’s view, the video at issue was not a quotation as such and thus it ruled no breach of the Code in this regard.