Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A brochure for 'HYLO-Tear' eye drops, which was directed toward medical professionals, the front cover of which stated "At £5.10* per month to the NHS, HYLO-Tear is a simple, safe and cost effective option". The back cover featured a graph comparing HYLO-Tear and HYLO-Forte to three competitor products, stating that the cost per patient per month was £15.84, £14.98 and £9.04 for the competitors, and £7.65 and £7.13 for HYLO-Tear and HYLO-Forte respectively. The page also contained a table noting the manufacturer, key ingredient, strength, unit of measure, NHS price, average pack use per patient per month, and cost per patient per month. An inside page contained the same graph as the back page and a truncated version of the comparison table with only the NHS price, packs per month, and monthly cost per patient featured. Both pages stated "FACT In November 2013 The Isle of Wight (IOW) conducted an audit of the preparations used in the treatment of Dry Eye based on a population of 140,000 patients" and included a footnote stating "Audit of Dry Eye treatment conducted by Dr.D. Turner for Isle of Wight CCG, November 2013."
Issue
Allergan Ltd, who had two products included in the comparison and considered that the comparator products were not representative of those tested, challenged whether:
1. the comparison figures were presented in a misleading manner; and
2. the statement "cost effective option" was misleading and could be substantiated.
Response
1 & 2. Scope Ophthalmics stated that they had used the claim "cost effective" because they believed that this was supported by the Isle of Wight Audit that looked into how many packs of dry eye products a patient would need to use per month. They said that the results of this audit were such that the Isle of Wight clinicians took the decision to add HYLO products to the formulary, a decision made independently of Scope and one that would not have been made if the product had not been cost effective. They stated that they had chosen to select some of the competing products from the audit because listing all of them in their marketing would have made it more difficult to read and understand. They stated that they did not cherry pick the products with the best results for themselves, as their intention was to highlight the independent audit to health care practitioners reading the ad. They stated that they discussed their marketing materials with the author of the audits and that he was comfortable with their approach and agreed that it was a fair representation of what he had found.
Scope provided two Isle of Wight audits, conducted on the population of the island. The first compared several different products, including those listed in the ad. For both the Isle of Wight and the country in general the audit stated proportion of usage of these products by the number of packs prescribed and also by the cost to the care trust/NHS. The audit also stated how many patients used each treatment, how many packs were used by the average patient each month, and how much this cost per patient per month. The second audit examined the usage and relative cost of HYLO products following their inclusion in the Isle of Wight formulary. The audit stated the proportion of usage for dry eye products (this time including HYLO products), again by packs prescribed and cost. The audit stated that HYLO-Tear and -Forte had a per-patient monthly cost of £7.65 and £7.13 respectively.
Assessment
1. Upheld
The ASA noted that the tables compared HYLO products with three other, more expensive, options and considered that, in conjunction with the claim "cost effective", readers would understand from the ad that HYLO products were cheaper per patient per month than all other products with comparable efficacy and that the products against which the comparison was made were representative of the market. We noted that the phrase "Eye Drops Usage Audit" appeared above the comparison information and considered that the ad therefore implied that the selection of products reflected all those that were included in the audit. We acknowledged Scope's statement that the intention of the comparison was to draw attention to the independent audit, but considered that readers would expect the comparison as shown in the ad to be supported by the data from the audit. We noted their statement that they had only selected a few comparators to include on the ad for ease of reading and considered that it was reasonable to highlight only a few competitors as long as the selection was representative of the market and did not mislead. However, Scope did not provide a rationale for including the three particular comparator products in their ad. We noted that there were several products included in the audit that had a significantly lower cost per patient per month than HYLO, some of which had a large representation in the market breakdowns and three of which were the most commonly prescribed in the NHS at rates approximately twice that of the closest comparator in the ad and nearly twenty times that of one of the others. In the absence of evidence to demonstrate that the selected products constituted a representative selection from comparable treatments, we therefore concluded that the cost comparison between the products was misleading.
The ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
3.33
3.33
Marketing communications that include a comparison with an identifiable competitor must not mislead, or be likely to mislead, the consumer about either the advertised product or the competing product.
and
3.35
3.35
They must objectively compare one or more material, relevant, verifiable and representative feature of those products, which may include price.
(Comparisons with identifiable competitors) and
3.39
3.39
Marketing communications that include a price comparison must make the basis of the comparison clear.
CAP has published a Help Note on Retailers' Price Comparisons and a Help Note on Lowest Price Claims and Price Promises.
(Price comparisons).
2. Upheld
The ASA understood that 'cost effectiveness' of treatments had a particular meaning in the field of healthcare, and that analysis of a product's cost effectiveness needed to balance the cost of the treatment against the health effects (both positive and negative) produced. In this context we considered that, because the ad was targeted at healthcare professionals, readers would understand the statement "cost effective" as a claim that HYLO products had a comparable or superior cost-effectiveness to other dry eye treatments. We noted Scope's assertion that HYLO products had been added to the Isle of Wight formulary, but did not consider that this in itself was a demonstration of cost effectiveness. The audits studied the total monthly costs of a range of treatments, taking into account average pack use per patient, but did not analyse the effectiveness of these treatments to determine whether HYLO had comparable efficacy. We considered that, regardless of which intervention had the lowest per patient per month cost, the lack of comparison between the outcomes of these treatments meant that the audits were insufficient to support the claim "cost effective" in the context of an ad for a medicine. We therefore concluded that the ad was misleading.
The ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
3.33
3.33
Marketing communications that include a comparison with an identifiable competitor must not mislead, or be likely to mislead, the consumer about either the advertised product or the competing product.
and
3.35
3.35
They must objectively compare one or more material, relevant, verifiable and representative feature of those products, which may include price.
(Comparisons with identifiable competitors) and
3.39
3.39
Marketing communications that include a price comparison must make the basis of the comparison clear.
CAP has published a Help Note on Retailers' Price Comparisons and a Help Note on Lowest Price Claims and Price Promises.
(Price comparisons).
Action
The ad must not appear again in its current form. We told Scope Ophthalmics Ltd to ensure that future comparisons were made against a representative selection of comparable treatments and that claims about cost effectiveness were based on an analysis of efficacy as well as cost.
