Treat diabetic macular oedema with one eye injection in three years?


It may sound too good to be true but a new injectable steroid product is now on the market in the UK and comes with the claim that only one injection is required which can last three years. This product called Iluvien (drug name fluocinolone) is new slow release implant product licensed to treat diabetic macular oedema.Diabetic macular oedema is a major cause of sight loss in patients with diabetes. Previously treatment options were limited to laser which rarely improved vision but helped stabilized the condition. More recently the introduction of Lucentis and Avastin injection treatments has improved the prognosis for this condition considerably.
In particular for Lucentis there are now a number of large studies confirming its benefit and also showing that the results are superior to laser treatment.
There appears to be only a small additional benefit of laser versus Lucentis treatment alone. Recently NICE has approved this treatment on the National Health Service. This is good news for patients in Manchester where a higher proportion of patients are affected by diabetes compared to the UK average.
Although Lucentis is a great option for diabetic macular oedema it does require a commitment to regular hospital visits and regular monthly treatment and in the first year of treatment on average 7 to 8 injections may be required. In the second year, most people may need less only 3-5 injections and if good control of the diabetes and blood pressure can be maintained then I would expect the number of injections required to maintain vision per year to remain quite low.
Lucentis works by blocking the chemical “vascular endothelial growth factor”. In diabetics this chemical is a factor in causing diabetic retinopathy and macular oedema. However, there are also raised levels of many different chemicals which contribute to inflammation. It therefore makes sense to consider steroid treatment as well. Steroids have been less popular in the past because of potential side effects included raised pressure and cataract. However, pressure in the majority is manageable with eye drops and we have effective treatment for cataract.
The studies of Iluvien have shown that a single implant injection can slowly release a small dose of steroid continuously for a couple of years. In diabetics who have been affected by macular oedema for a number of years and other therapies are failing this looks like an effective option. In the iluvein studies, over 30% of patients had meaningful improvement in vision after three years versus only 13% without. A single implant injection and then periodic monitoring visits to check progress and watch for side effects is an attractive option.
If you know you have diabetic macular oedema and your current treatments do not appear to be working and you want to be considered for such therapy or want a second opinion then arrange a consultation with Mr Mahmood.

Eylea – finally a serious competitor Lucentis?

Eylea (also known as aflibercept and VEGF Trap Eye) has now been approved and licensed in Europe. It’s UK launch is planned for the begninning of december 2012. With great success so far on the American market the manufacturer (Regeneron) and distributor (Bayer) are hopeful that it will make an impact on treatment of wet AMD in the UK. The benefits proposed include longer intervals between treatments, fewer review appointments and lower overrall cost. In the first year after three initial doses the recommendation is that an injection is given at a fixed two month interval. This has shown similar visual results to monthly lucentis. In the second year the dose interval and review interval is at the discretion of the doctor treating the patient. The benefits are gained though at the cost of a higher average number of injections in the first year.
In the second year the number of treatments required for Lucentis or Eylea patients is not dissimilar. Lucentis treatment is now being recommended on an individualised basis and most patients need 6 to 7 injections in their first year rather than a fixed 8 injections.
So what should you do, and is it better to have more injections and attend less or have fewer injections but go to the clinic for more appointments? The approach will very much depend on your individual case. There would appear to be no good reason to change treatment if you are having lucentis and only requiring infrequent injections. If you are requiring injections at most visit this might be due to the severity of disease which warrants more treatment or you may not be a responder to Lucentis so Eylea may help.
If you have been newly diagnosed you may be interested in starting on Eylea from the outset but your treatment options may be constrained by funding. Until there is national guidance through NICE it is unlikely that in most places Eylea will be available on the NHS until some time in 2013. If local health commissioners are convinced of the benefits in terms of cost and convenience for patients they may suggest usage pre-empting NICE guidance. In contrast with the Lucentis and Avastin debate, Eylea has the advantage of being a licensed treatment for the eye. Although in Manchester and Cheshire some commissioners still prefer Avastin because of it’s lower cost it’s usage has been on the decline since the Lucentis price cut agreed later earlier this year.
If you want to have an up-to-date review of your wet AMD and want to be considered for Eylea at the earliest opportunity then please request a consultation using the contact details on this website.

Cataract Surgery. Will the NHS or my insurance company pay?

Recently cataract surgery has been restricted by some primary care trusts in Manchester and Cheshire. The aim is to restrict surgery to patients who really need the operation but the thresholds, sometimes just based on vision chart measurements not quality of life have been set at a level which in some cases is a worse level of vision than would be necessary to be legal for driving.When considering whether to have cataract surgery discuss with your optician what can be managed by optimising your glasses.

If you are struggling with vision related tasks such as reading and driving and adjusting the glasses prescription is not likely to be helpful then you should discuss this at your hospital visit and make clear that the cataract is impairing your quality of life.
If the NHS won’t pay for your cataract operation will your private provider? One of the benefits of private healthcare was the expectation that you could have your consultation and surgery with the consultant of your choice with whom you had developed a relationship and trust. However although most private insurers do not place the same restrictions on cataract surgery some are trying to reduce how much they spend. This may involve a contract with a certain private hospital or individual providers who may have negotiated a lower fee.
The private insurer may therefore ask you to have your cataract surgery done by a hospital and surgeon you have had no previous contact with. This may leave you in the difficult position of losing the choice which you thought you had or face a surcharge from your consultant to cover the shortfall from the payment by your insurance company. Before accepting this type of limitation from your insurer do check the wording of your policy and discuss any concerns about your choice with your insurance company.

Lucentis price cut in the UK

The biggest controversy in relation to treatment with lucentis has been the price. The need for repeated monthly review and repeat treatments soon cause the overall cost to build up. Understandably, the manufacturer needs to recoup the costs of such a ground breaking development and invest in future research. The worldwide sales have been huge and are set to increase as the drug is used for more disease types.
Despite the strong clinical evidence of benefit for patients affected by diabetic macular oedema and retinal vein occlusion, so far NICE have not recommended usage on the NHS on grounds of cost-effectiveness.This could soon be about to change. The department of health has now agreed a price cut with Novartis who sell the drug in the UK.

Instead of the previous arrangement for wet AMD patients whereby the company covered the drug cost after fourteen treatments, Lucentis is now provided at an agreed discount regardless of number of injections.
The actual discount is confidential and not public knowledge. Whatever the level it is a positive development which should mean savings for the NHS and allow NICE to reconsider the cost effectiveness for other diseases. In the UK it may also limit any further attempts to switch to Avastin on grounds of cost. The primary care trusts whose action led Novartis to initiate a judicial review of their policy to commission Avastin have also withdrawn their plans and will continue now with Lucentis usage. Some parts of Manchester and Cheshire may also need to review their policies.
It will also be interesting to see what effect this will have on the uptake of the new drug Eylea (Aflibercept, VEGF Trap Eye) in the UK. This has already had strong sales in the US but the European license is awaited. This should be announced very soon and Bayer should then be able to start promoting the treatment in the UK. The potential for a lower cost drug and fewer hospital visits is attractive but the overall number of injections required is not dissimilar to Lucentis. No doubt competition between Novartis and Bayer will mean price will need to be competitive. Hopefully patients and the NHS will benefit from this increased choice as well as reduction in costs.

Avastin versus Lucentis in court?


The last month has been an eventful one in the continuing debate over Lucentis and Avastin for wet age-related macular degeneration. The UK distributor Novartis has gone as far as to ask for “judicial review” of the policy of some primary care trusts in the South of England who have commissioned local Avastin services.
This news spread through the media and gave the impression that the NHS was being sued by Novartis in an attempt to protect profits and prevent PCTs from saving money by using Avastin. Evan Davis on the Today programme questioned the value of funding Lucentis claiming that the switch to Avastin could save the NHS the equivalent of 3000 extra nurses.Novartis have since

confirmed that they are not seeking to sue the NHS but to clarify the legal position of primary care trusts who choose to offer Avastin and limit access to Lucentis.

The company has not helped its image by taking this action but on the specific issues being questioned they have a potentially strong case.
Based on guidance from the General Medical Council a doctor may choose to prescribe an unlicensed treatment if it serves the patient’s needs better than a licensed alternative. PCTs who commissioned Avastin services have sometimes done so by suggesting potential benefits of Avastin over Lucentis. This has not been confirmed in the comparative studies and the effect of the two drugs appears to be equivalent. A local decision to save money would lead to postcode based prescribing and it is hard to justify a decision to change on this basis of cost when the nationally appointed government body NICE has judged a treatment to be cost-effective.
Any change to Avastin would therefore need to be centrally led and regulated but such a move would be difficult for the NHS without undermining the drug regulatory process and negating the value of NICE in making decisions on what treatments should be funded. The results of this judicial review will certainly be of interest though and will likely shape the direction of future Avastin usage in the UK.