The recent high court judgment, published 21/09/18 [1], regarding Clinical Commissioning Group (CCG) policies on the use of Avastin (a non-licensed, lower cost-per-use alternative to Lucentis and Eylea), for wet AMD management, has opened a Pandora’s box of unknowns for those now training or specializing in medical retina. Whilst legal history has been made, it is unclear how this ruling will impact ophthalmologists on the front line of service delivery. Worryingly, no data exist on what types of challenges are likely to arise, which leaves the professional body ill-equipped to foresee or meet the demands ahead. To address this, we conducted a survey questionnaire of consultant ophthalmologists across all sub-specialties (n = 13). A five-point scale from “strongly agree” to “strongly disagree” was used to identify key areas of concern regarding Avastin use in wet AMD, and an open comments box was incorporated for qualitative data capture (see Fig. 1).

Fig. 1
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Summary of ophthalmology consultant survey questionnaire results

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We found that all participants either “agreed” (54%) or “strongly agreed” (56%) that drug licensing regulations were a challenge in offering wet AMD patients Avastin. Nobody “disagreed” or “strongly disagreed” that concerns over GMC action (23% neutral, 31% agree, and 46% strongly agree) and drug company marketing (38.5% neutral, 23% agree, and 38.5% strongly agree) were also an issue. A greater range of responses was recorded for patient understanding and misinformation (8% disagreed, 38.5% strongly agreed), Trust/Health board negotiation & policy (15% disagreed, 31% strongly agreed) and management support & leadership (15% disagreed, 31% strongly agreed). The greatest variation in responses was seen for ethical concerns (15% strongly disagreed, 38.5% strongly agreed) and legal implications (8% strongly disagreed, 38.5% strongly agreed).

Of the comments received a reoccurring theme was capacity, and whether current infrastructure can subsume the increased number of intravitreal injections (IVT) per patient required with Avastin compared with Lucentis [2]. Examples of feedback included: ‘need to have a significant increase in clinic capacity’ and ‘capacity in IVT will worsen if Avastin introduced, needs to be addressed first’. Another theme was the lack of support from key players: ‘This is a regulatory matter, to be solved by the regulators (MHRA) [Medicines and Healthcare products Regulatory Agency] and government. Doctors should not be being put in this position,’ and “The college and professional bodies have not been as strong a lobby as they should have been’. Interestingly, some unique change ideas were also suggested by the consultants surveyed. These ranged from: ‘need to change SOP [Standard Operating Process] for nurse injectors’ and ‘public information exercise needed…RNIB [Royal National Institute for the Blind]/ Macular Disease Society could help inform’ to ‘trusts should offer Avastin only as first line’.

What emerges is a unique snapshot of, as yet, unchartered territory. Multi-organizational co-operation from drug licensers, governing bodies, and health care leaders is required to achieve a national-level consensus that can provide clear clinical policy. As such, it remains to be seen if spinning high court ruling into clinical practice will be our new reality or our make-believe. Until an outcome is clear, it is vital that prescribers are aware of current policy from licensors and governing bodies (see Table 1).

Table 1 Statements to be aware of, regarding prescribing Avastin in wet AMD
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