ANTI-VEGF INJECTIONS

Just how qualified are general ophthalmologists in making the decisions to give patients ranibizumab (Lucentis, Genentech) injections?

In Canada, this is an issue because many patients live in rural communities and don’t have access to centres where specialists are located. The topic was discussed at the recent 51st Walter Wright Annual Ophthalmology and Vision Sciences Symposium in Toronto.

According to David Lane MD, a general ophthalmologist in the rural community of Lindsay, Ontario, the key issue is access to care. Retinal specialists tend to be located in urban centres, and are usually the ones who do Lucentis injections there. But in small, outlying communities, general ophthalmologists take on much of the load.

Alan R Berger BSc, MDCM, FRCSC, Dip ABO, a vitreoretinal specialist and ophthalmologist-in-chief at St Michael’s Hospital, a university of Toronto teaching hospital, argues that while general ophthalmologists are capable of giving the injections, they are not as well trained to make the needed clinical decisions, especially in confusing or complex cases.

Lucentis is approved for coverage for the treatment of AMD under Canada’s public healthcare system in most of the country’s 10 provinces. Bevacizumab (Avastin, Genentech) is not reimbursed in most provinces and must still be paid for out-of-pocket by patients.

A large part of Canada’s population resides in small communities where it takes at least a couple of hours to drive to urban centres. Many Canadians live in even more remote communities where access to even a general ophthalmologist is not easy, and may even require flying to regional hospitals for visits. For many patients, especially older, sicker patients, regular visits to a specialist centre is difficult, stressful, and often impossible.

“Access to care is inextricably linked to quality of care. You can’t separate the two. If you don’t have access to the care, your quality of care will be poor,†Dr Lane said.

He notes general ophthalmologists are not only capable of performing intravitreal injections, but should be able to read an OCT, and can recognise macular degeneration.

The question of clinical judgement could be an issue. If a general ophthalmologist who’s been in practice for 10 or more years has only a small amount of experience with retinal pathology, and has limited experience with OCT, that could be a concern. “If you don’t feel comfortable with intravitreal injections, don’t do them,†he said.

Dr Lane argues that ophthalmologists working in rural communities are preventing more vision loss than doing potential harm. “I see at least one patient every day who would lose vision if I didn’t inject,†he said. In four years, this means about 1,200 people would permanently lose vision due to poor access to care.

To illustrate his point, he offered a hypothetical situation: Assume a generalist gives 50 patients injections each week. Assume too that their clinical judgement is so poor that 10 per cent of the time they perform injections that never should been done. This would equal five inappropriate injections per week. This equals 250 injections per year. If the rate of complications is one in 1,000, it would take four years for one patient to potentially lose vision because of the injections.

“This means 1,200 people would lose vision in four years due to poor access to care versus potentially one patient due to poor clinical judgment. It is clear where the risks lie, poor access to care,†he said.

However, general ophthalmologists who want to start doing Lucentis injections shouldn’t go into it cold. He suggests teaming up with a retinal specialist and working some sort of a co-management model as a way to learn more about AMD. He looks at this as a learning model.

The other side

The concept of co-management is something Dr Berger strongly supports, but considers it more of a standard of practice rather than simply a learning model.

He described several difficult and complex cases where the incorrect diagnosis of macular degeneration was made by the general ophthalmologist and Lucentis injection treatment was started. In one case, the patient went on to develop endophthalmitis after 11 months of Lucentis injections. While OCT studies had initially been performed, no fluorescein angiogram was done initially and the incorrect diagnosis made.

“The patient didn’t need Lucentis treatment. She had adult vitelliform macular degeneration which is most commonly a stable disease that doesn’t progress,†Dr Berger said.

In another case, a general ophthalmologist diagnosed wet AMD in both eyes and suggested Lucentis injections. However, it turned out the patient didn’t have AMD, but rather idiopathic juxtafoveal retinal telangiectasia. This is an uncommon retinal vascular condition rarely associated with choroidal neovascularisation.

“Most retinal specialists undergo 12 to 24 months of intense retinal fellowship treatment training, and most see over 250 patients per week, specifically with retinal diseases,†he said.

The field of retinal disease, diagnostics and therapeutics has exponentially expanded. It’s difficult for even a full-time retinal specialist to keep up, he noted.

“Can the general ophthalmologist, who sees retina patients maybe 20 per cent of the time, possibly keep current and still do a good job? It’s not to say they can’t do Lucentis injections, but the diagnosis and follow-up decision process can be tricky,†Dr Berger said.

The number of Lucentis injections increased from 60,000 to 120,000 between 2008 and 2010 in Ontario alone. In two Canadian provinces, intravitreal injections are paid for by the provincial health service only if retinal specialists do the injections. If general ophthalmologists do the injections, patients have to pay for the injections out-of-pocket.

Dr Lane argues the situation in those provinces is “a disasterâ€. Special clinics were supposed to be set up where specialists would visit periodically, but never materialised. If specialists do fly in to do injections, they aren’t there for follow-up or to deal with complications. Rural patients are now paying to have the injections by their local general ophthalmologist, which is unfair.

Is there a compromise? For people in rural communities, Dr Berger supports the idea of close, continuous co-management. “My ideal scenario is that the retinal specialist either makes or confirms the proper diagnosis and discusses the treatment options and initiates treatment,†he said. Periodic consultation with the retinal specialist is a good idea.

“I think it’s optimal for the patient in terms of accuracy of diagnosis, accuracy of knowing whether they need further treatment. It’s also good support for the general ophthalmologist,†he said. And if the patient lives in a remote area, then the retinal specialist can still help co-manage via telemedicine.