An anonymous complainant, who described him/herself as a health professional complained about the mobile version of the Roche Resources website, https://www.rocheresources.co.uk.
The complainant alleged that the Roche Resources website had not been certified for mobile use and had clear and obvious differences versus the desktop format of the website.
The complainant further alleged that a prominent prescribing information statement was not available on the mobile version of the webpage and both desktop and mobile versions of the webpage did [not] contain a prominent adverse events statement.
The complainant stated that similar issues were present on the medicines page (https://www.rocheresources.co.uk/roche-medicines.html).
The complainant stated that the company showed a lax knowledge and understanding of certification and important requirements in following principles and alleged a breach of Clause 2.
The complainant was concerned that a Polivy webpage, claimed that the medicine was recommended by NICE and SMC which was misleading as NICE and SMC recommended it as an option only if polatuzumab vedotin was provided according to the commercial arrangement. In addition, the claim ‘time to appreciate life’ was not appropriate as the medicine would require much monitoring, several treatment cycles and had an array of adverse events; it was difficult to understand how a patient could appreciate life with all these factors. The complainant stated that women of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 9 months after the last dose. This should have been made clear on the page in view of the image presented which included a young woman.
The detailed response from Roche is given below.
The Panel noted Roche’s submission that the Roche Resources website was designed primarily for desktop or laptop computer use and as such was certified on a desktop or laptop computer, with additional checks being performed to ensure all mandatory information, including prescribing information, was prominent on other devices such as an iPad. The Panel further noted Roche’s submission that the technology sitting behind the website optimised the statement in question ‘Welcome to Roche Resources - access information, news and resources about our medicines and the therapy areas in which they are used’ to appear differently on certain mobile devices, however, the context of the text and nature of the material was the same regardless of the make or model of device, size or orientation on screen.
The Panel noted Roche’s submission that on certain mobile devices, the prescribing information link would automatically move to sit in a hamburger menu. The Panel considered that the presentation of a prescribing information link within a hamburger menu did not meet the Code’s requirement for a clear prominent statement as to where the prescribing information could be found and a breach of the Code was ruled as acknowledged by Roche in relation to the homepage and medicines page.
Whilst the Panel noted Roche’s submission that the website was certified on a computer, with additional checks being performed on other devices such as an iPad, Roche made no submission with regard to checks being performed on any specific smartphones. The Panel noted that the certificates of the job bags for the homepage and medicines webpages (M-GB-00001886 and -GB-00003975) made no mention of the devices that the signatory had reviewed the website on and which devices he/she had performed additional checks to ensure that the requirements of the Code were met; there did not appear to be mention of any device, such as a smartphone or iPad in the metadata. In its response, Roche had only provided a screenshot of how the website was visible on an iPhone 11; the Panel noted that the prescribing information link was not immediately visible and sat within the hamburger menu when viewed in the most likely orientation, portrait. The Panel further noted that, whilst Roche submitted that the website was primarily intended to be viewed from a desktop or laptop computer, there did not appear to be a statement to this effect on the website.
The Panel, on the evidence before it, considered that it appeared that Roche had not adequately reviewed the website on various, commonly used devices to ensure that it met the requirements of the Code when displayed on such devices and considered that if the website was designed primarily for desktop view, that this should have been made clear to readers. The Panel thus ruled a breaches of the Code including that high standards had not been maintained.
The Panel noted Roche’s submission that the prescribing information remained available, albeit from a hamburger menu icon. The Panel considered that a robust certification procedure underpinned self-regulation and although noting its comments and ruling above, it did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2, which was a sign of particular censure and was reserved for such use; no breach was ruled.
The Panel noted Roche’s submission that a link to adverse event reporting was at the top of all pages when viewed on the majority of devices including desktop computers; the adverse event reporting link, however, was automatically moved into the hamburger menu when viewed on certain mobile devices. Whilst the Panel noted that in its view, a link to adverse event reporting, regardless of its prominence, did not meet the requirements of the Code that all promotional material must include the prominent statement 'Adverse events should be reported. Reporting forms and information can be found at [website address which links directly to the MHRA Yellow Card site]. Adverse events should also be reported to [relevant pharmaceutical company]', it noted Roche’s further submission that an adverse event reporting statement was available on all Roche Resources pages and could be viewed regardless of make or model of device, size or orientation of screen; it was located at the bottom of the page on a banner of darker colour to the background of the rest of the webpage. The Panel noted that the text was in the footer of the webpage, in smaller font size than the text in the main body of the webpage, and, in the Panel’s view, was not sufficiently prominent regardless of device and a breach of the Code was ruled in relation to the homepage and medicines page.
The Panel noted Roche’s submission that the claim ‘time to appreciate life’ implied that patients prescribed polatuzumab vedotin had the potential to see a longer progression free period, complete response and/or higher chance of overall survival and therefore more time to appreciate life. The Panel noted Roche’s submission that the pivotal randomised data that supported the grant of a conditional marketing authorisation demonstrated a significant improvement in overall survival, progression free survival and complete response in those patients administered polatuzumab vedotin, rituximab and bendamustine vs those administered rituximab plus bendamustine. Beneath the Efficacy rectangular tab below the image and claim in question the material stated ‘Find out how POLIVY + R-Benda could offer patients more time to appreciate life vs R-Benda alone’.
The Panel did not consider based on the evidence provided that the claim ‘time to appreciate life’, implied that the patient’s life would be free of monitoring, treatment cycles, or risk of adverse events as alleged and based on the narrow allegation ruled no breaches of the Code including no breach of Clause 2.
With regard to allegation that the image was not of a high standard, as it included a woman of childbearing potential and it should have been made clear on the page that such women be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 9 months after the last dose, the Panel noted Roche’s submission that the image depicted a scene of a woman (approximately 60 to 70 years of age) appearing to be calmly reflecting and appreciating life whilst an active family were enjoying themselves in the background. The Panel nonetheless considered that DLBLC could occur at any age and therefore the presence of other individuals within the image, including the young adult woman, was not irrelevant.
The Panel noted that Polivy was not contraindicated in women of childbearing potential. However, the SPC included that women of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 9 months after the last dose and that male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 6 months after the last dose.
Section 4.4 of the Polivy SPC (special warnings and precautions for use) included a number of warnings and precautions, which covered a number of different clinical issues across a wide demographic.
The Panel considered that whether a special warning or precaution needed to be highlighted within a particular section of promotional material, in addition to its requirement to be included within the prescribing information depended on all of the circumstances including the nature of the warning/precaution and the content, layout, audience and intended use of the material.
The Panel noted that Polivy was a specialist product only to be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients. The Panel considered that such health professionals would take particular care when prescribing oncology medicines to women of childbearing potential. Nonetheless, the Panel considered that material must not be misleading in this regard.
The Panel, on balance, did not consider that the image misleadingly implied that Polivy could be used in women of childbearing potential without any concerns or considerations. The Panel did not consider that the complainant had established that high standards had not been maintained nor that the special nature of medicines or the professional nature of the audience had not been respected or that it had caused offence and based on the very narrow allegation no breaches of the Code were ruled.
In relation to the allegation that the claim ‘Recommended by NICE and SMC’ on the Polivy webpage was a false endorsement, the Panel noted that the claim was immediately above the statement ‘POLIVY + R-Benda [rituximab and bendamustine] is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for haematopoietic stem cell transplant’.
The Panel noted that the NICE recommendation stated ‘Polatuzumab vedotin with rituximab and bendamustine is recommended, within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults who cannot have a haematopoietic stem cell transplant. It is recommended only if the company provides polatuzumab vedotin according to the commercial arrangement’.
Similarly, the SMC stated that this advice applied only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that was equivalent or lower. The Panel noted Roche’s submission that both recommendations for Polivy by NICE and the SMC were provided on the basis of a simple discount patient access scheme between Roche and the NHS and that the commercial arrangements for Polivy were automatically in place whenever the product was supplied to the NHS.
The Panel considered that whilst it would have been helpful to include the information that Polivy was only recommended if provided according to the commercial arrangement, on the evidence before it, the Panel did not consider that the claim ‘Recommended by NICE and SMC’ was misleading, incapable of substantiation or did not encourage the rationale use of the medicine as alleged and no breaches of the Code were ruled.