Registered Charity No. 1093675

Macular Interest Group

Minutes of the meeting of Wednesday 12 June 2013 At the Royal College of Ophthalmologists

Present: Winfried Amoaku (RCOphth, Chair), Helen Jackman (Macular Society), Matt Broome (V2020 UK) Clara Eaglen (RNIB), Sara Porter (ABDO), John Lawrenson (College of Optometry), Geoff Roberson (AOP) Cathy Yelf (Macular Society, Secretary)

1. Apologies: Jon Gibson (RCOphth), Colin Whitbourn (Action), Sue Leighter (AOP), Lorna Marques Brocksopp (Guide Dogs)

2. Minutes: One correction to a misspelling of Ocuvite on page 3

3. Matters Arising: No matters arising

4. Updates a. WA reported that Eylea has been recommended by NICE. Most stakeholders have accepted it apart from a few factual errors which need correcting eg; it is not true that patients are treated with Lucentis every month. They should be monitored every month and treated if necessary. Today is the final date for appeal submissions. General feeling is that we have to wait and see what the clinical experience is of Eylea so will develop as we go along. Two-monthly treatment may ease capacity issues temporarily but it’s not known yet if everyone will respond well to two-monthly injections. There is concern that some commissioners may not allow clinicians to see patients monthly if necessary as the NICE guidance specifically says ‘two monthly intervals’. There is now a price war which GR and others said was maybe a good thing. Several areas have reported delays in getting NICE guidance implemented. Some trusts are using the excuse that they don't have capacity. MB said this was not an acceptable excuse it was just denial of care. CY said Simon Kelly in Bolton had presented a poster at the RCOphth Congress (May 2013) showing the effect on patients’ sight of delays to treatment caused by the need to apply for individual funding. Similar problems expected with RVO NICE Guidance implementation. AGREED to write a follow up letter to CCGs. RNIB do a routine FOI request to CCGs 90 days after a NICE TAG to find out how many have implemented the TAG. DMO FOI request has already been done. The Macular Interest Group will also send FOI requests to CCGs to reinforce the messages. CY to liaise with Kathy Evans and WA to re-do the retinal specialist survey. b. WA NICE has asked for nominations of experts for the appraisal of ranibizumab in myopic CNV. The EMA has given a positive opinion on Lucentis for this condition. It is therefore expected that Novartis would have a licence within 90 days. This group of patients won’t have a major impact on capacity as there are only a small number of patients and some are being treated already. c. Ocriplasmin: NICE ACD is out recommending treatment for symptomatic vitreomacular traction and early macular hole with no epiretinal membrane. The company has done a deal with the DH on the cost which is officially £2,500 pounds per injection. d. Fluocinolone implant now has an ACD recommending it for third line treatment for chronic DMO. Again, this is at a discounted price to the NHS. e. Oraya is to be trialled in a DH funded phase 3 trial. HJ said this was the STAR trial which, surprisingly, was using Avastin rather than Lucentis as the combination therapy. CE and others said they had heard views from both commissioners and providers that the NHS will ‘have to move to Avastin in the end’. WA reported that there is doubt that the NHS can provide a reliable supply of Avastin. f. AREDS 2 - all familiar so no further discussion. 5. HJ introduced Michele Acton, Chief Executive Fight For Sight (FFS). FFS has been working with the James Lind Alliance looking at research priorities across all sight loss conditions. One area is on AMD where the Macular Society has been involved. MA explained the reasons for the work. FFS has found it difficult to decide which research they should fund; there are lots of good quality applications and can’t fund them all so there is a need to prioritise. There is not much in the Vision Strategy on research and the research group of V2020 UK felt there was a need for a strategy for research and a debate about how priorities are set and by whom. Came to the view that it was necessary to get the views of people who would benefit from research (patients, carers and their families) and the people who treat patients. Fortunately the James Lind Alliance had already done this with other health sectors eg diabetes and cancer. The JLA is now under the umbrella of NIHR and they had already developed a methodology for engaging patients, carers, families and professionals. The College of Optometry, the NIHR, the RCOphth and RNIB have funded the work which became a large project. Stage 1 was a survey which asked one question: What questions about the prevention, diagnosis and treatment of sight loss and eye disease would you like to see answered by research? An overwhelming 2200 responses generation 4461 questions. Stage 2 was data assessment. 12 categories were identified - AMD is one of the categories. Stage 3 was a further consultation on 42 specific questions to identify a top 10 list for patients/carers and one for professionals which showed a lot of overlap. Stage 4 was a series of one day workshops involving patients, professionals and, in the case of AMD, HJ as the main patient support organisation. The task was to reduce 29 questions to a list of 10. The result is that for each of the 12 categories we have a top 10 list of priority questions which research should answer. The top priority for AMD is: “Can a treatment to stop dry AMD progressing and/or developing into wet AMD be devised?” All priorities can be seen on the website www.sightlosspsp.org.uk HJ said the workshops were really hard work. The top 10 areas are not research questions but they do help decide what the important topics are. MA said a full report will be produced which will set out the specific questions behind the broad topics. Taking it forward, existing research funders will be encouraged to use these priorities. Organisations such as the College of Optometry are looking at how the work will get woven into their research policy. MA wants to talk to NIHR about doing specific calls to address these questions. Fundraising charities can also use them when applying for funds as it helps answer the question: “How do you know this is important?” Industry will also benefit from addressing these questions. MA also wants to encourage others to fund research. A Parliamentary answer on 13 March stated that 0.9% or 1.3% of NIHR spend goes on eye research. There are three enormous charities in the eye care sector but none funds large scale medical research. RNIB, Guide Dogs, Sight Savers probably get £160m of public income p.a. but only a small part of this is going into research to stop the sight loss conditions. (This is an observation not a criticism and it is recognised that these charities were not set up to fund research.) Some research costs millions but some of the priorities eg. glaucoma and compliance with eye drops are about simple things, ie in this case better bottles. HJ agreed a lot of good is done by funding early stage, proof of concept research. MA said a byproduct of the JLA work was to raise the profile of eye research. NIHR have a new consultation process to include patient voices. FFS is represented on this committee. GR asked how future-proof the priorities are. MA agreed they would not last forever and said there was a need to track all new research and see how it fits with these priorities. All agreed this was important work which needed to be disseminated widely. HJ said the Macular Society research call will ask applicants to identify which area their research is addressing. MB said social research questions are also being put together from this exercise.

6. Capacity Action Plan a. Olivia Sibley joined the meeting. She explained that the RCOphth statement on non-HCP administering IVT came from the Professional Standards Committee and will be incorporated into the new AMD guidelines being drawn up by Usha Chakravarthy. WA said some nurses have been giving injections in the SW region for a while as it was thought that it made the system more efficient. As there are not enough doctors and it may be a way to expand capacity. His view now was that it was acceptable with safeguards. It is not a quick fix as staff have to be trained and supervised. Injections have to be given in a hospital type clinic. Under AQP they could possibly be given outside hospitals but facilities must meet hospital standards - treatment centre or GP clinic, but must be a clean room. No official RCN view is published as yet. All agreed safeguards through implementation were important b. Letters have gone to CCGs and the meeting had earlier agreed to a follow up. ACTION: CY to circulate the letter again. c. Review of service models: HJ had drafted tender specifications but after discussion with the Chair of RCOphth Scientific Cttee (Prof Tony Moore) advises that there is insufficient funding to do this work properly. The Group and others should approach NIHR to fund a proper cost effectiveness study of different models. WA said based on that and taking into account MA’s work it might be a good idea to ask FFS to provide supporting funds for this project or ask them to support an approach to DH and NIHR for funding. JL agreed more funding is needed for such a piece of work. AGREED: HJ will co-ordinate an approach to NIHR. The Macular Society is also supporting Rob Johnston’s audit using the national ophthalmology database looking at different treatment intervals and outcome on VA. d. New structure of NHS. HJ said there was confusion on how to engage with the new bodies and where the points of accountability are. MB and other agreed that the new structure is complex and difficult to engage. ACTION: CE will provide a summary of the new structure for the Group. MB is encouraging Visionary to get their local charities to share the information they get. GR said another problem is that the dust is still settling and the new bodies don't know themselves what they are doing. All agreed that JSNAs will be set at such a high level that eye health will never feature. There will be a need to tie it to something else eg; smoking. CE said RNIB has a parliamentary launch on capacity in general on eye health. They will call for a clinical lead on ophthalmology. They probably won’t call for more resources but will point out that each time something new comes out in ophthalmology it has a knock on elsewhere eg; concern that cataract is getting pushed out by retina. CY said pharma have also called for clinical director for eyes.

7. Clinical Guidance. CE and CY reported this has been delayed. The quality standard is postponed to 2018 and NICE said all glaucoma, AMD and cataract might be combined into one quality standard so they will need only one committee. RNIB is opposing this. GR agrees that the areas are too different to combine. WA said NICE has no experts in the field on the appraisal committees and have extrapolated this approach for the quality standard. We need to tell them that this is the wrong approach. AGREED: The group will write to NICE as a Group and individual organisations will do the same. ACTION: MB to inform Anita Lightstone. JL pointed out that the commissioning guidance for glaucoma came from quality standards. CE said the proposed process would create an update on glaucoma so their quality standard won't be as affected. GR said IGA might want to keep it separate as well.

8. AOB: HJ asked people to feedback on these meetings to their organisations as the group has moved into a different gear in terms of actions. MB said V2020 trying to get groups to talk to each other more. If actions being implemented under V2020 UK the board and comms need to know about them. MB will produce an organisational chart. The new V2020 UK Board now elected.

Dates for future meetings. Venues TBC.

11 September 2013 11 December 2013 12 March 2014 11 June 2014 10 Sept 2014 10 December 2014.