AUTH/2996/12/17 - Pharmacist v Seqirus

Promotion of Fluad

  • Received
    14 December 2017
  • Case number
    AUTH/2996/12/17
  • Applicable Code year
    2016
  • Completed
    10 May 2018
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the August 2018 Review

Case Summary

A clinical commissioning group (CCG) lead prescribing support pharmacist complained about a promotional email for Fluad (influenza vaccine, adjuvanted) headed 'New guidance issued on adult flu vaccines' sent from Seqirus UK.

The complainant alleged that the email implied that the Joint Committee on Vaccination and Immunisation (JCVI) had changed its recommendations for 2018/19 such that Fluad should be used for everyone over 65 years, which was not so. Unless readers delved deeper, they would think this was a national recommendation and change in policy.

The complainant stated that if Fluad was adopted by CCGs for those aged over 65 years, it would have a huge cost implication for prescribing budgets, even though it was claimed to be cost effective. The complainant added that the evidence showed that Fluad was most cost effective in those aged over 75 years. The complainant alleged that the email was misleading.

The detailed response from Seqirus is given below.

The Panel noted that according to its summary of product characteristics (SPC) Fluad was indicated for active immunisation against influenza in the elderly (65 years of age and over) especially for those with an increased risk of complications and its use should be based on offcial recommendations.

The Panel noted that the email in question included a prominent highlighted blue box that read 'Important: Influenza vaccine policy change affecting your order for 2018/19'. Readers were told to make sure that their elderly patients received the suitable flu vaccine for them in 2018/2019. Under a subheading 'Improved influenza vaccines needed for people aged 65 years and over' it stated that according to the draft JCVI October 2017 meeting minutes the 2016/2017 season showed signifcant effectiveness against all laboratory confrmed influenza and specially the A(H3N2) virus in 18-64 year olds but non-signifcant vaccine effectiveness (VE) in the 65 years.

The email also stated that Fluad was a flu vaccine that specifcally protected those aged 65 years and over and quoted the draft JCVI October 2017 meeting minutes referring to 'low influenza vaccine effectiveness seen in the over 65-74 year olds over several A(H3N2) dominated seasons and non signifcant VE for all types of influenza in the over 75s' and 'use of aTIV [adjuvanted trivalent influenza vaccine] in those aged 65 years and over would be more effective than the non-adjuvanted vaccines currently in use, and also cost-effective'.

The Panel considered that the email made it clear from the outset and throughout that its quotations were from a draft JCVI minute. A highlighted prominent box towards the end of the email noted that the JCVI agreed that using Fluad in patients aged 65 years and over would be more effective than non-adjuvanted vaccines currently in use, as well as more cost-effective. The text in the box concluded by stating on the basis of clinical and cost-effective evidence and recent JCVI guidance encourage your GP to act now by ordering Fluad for their patients aged 65 years and over. The draft JCVI minutes were reflected in the NHS Green Book and thus it was not unreasonable to describe the subject matter of the email as a policy change. The source, and draft status of the JCVI minute was prominent and clear from the outset. In the Panel's view, the email in question was not misleading nor incapable of substantiation on this point as alleged. No breaches of the Code were ruled.

The Panel noted that the email at issue quoted the JCVI's draft minutes stating that the committee agreed that the available evidence indicated adjuvanted influenza vaccines were more effective in those over 65 years of age, compared with influenza vaccines currently used in the UK and mathematical modelling indicated that, under quite conservative estimates of effectiveness, the adjuvanted vaccine would be highly cost-effective in both the 65-75 and 75 and over age groups. The Panel did not consider that the complainant had established that the email was misleading with regards to this comparison and ruled no breach of the Code.

The Panel noted the complainant's allegation that it was misleading to state that Fluad was cost effective as there would be a huge cost implication for prescribing budgets and money saved would be elsewhere and not from the prescribing budget. The Panel noted that the email did not state how the cost-effectiveness would be achieved within the NHS but referenced the JCVI's own assessment based on Public Health England's modelling. The Panel did not consider that the email was misleading on the narrow ground alleged. There was no implication that cost effectiveness savings would mean that there was no negative impact on prescribing budgets as inferred by the complainant and no breach of the Code was ruled on this point. The Panel considered that the complainant had not provided evidence to show that the claim for cost effectiveness was not capable of substantiation and no breach of the Code was ruled.

The Panel noted the relevant comments about cost-effectiveness in the draft JCVI minute above. The Panel noted that the email in question did not differentiate as to the cost-effectiveness across different age groups above 65 years and therefore ruled no breach of the Code in relation to the complainant's allegation that the email was misleading because the evidence showed that Fluad was most cost effective in those aged over 75 years.

The Panel noted that each quotation used in the email gave the source as the JCVI meeting draft minutes October 2017 and each quote was faithfully reproduced. The Panel therefore ruled no breach of the Code.

The Panel noted its rulings above and considered that Seqirus had not failed to maintain high standards. The Panel ruled no breach of the Code