Reviewing the evidence for photodynamic therapy (PDT) as a vital tool in the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), Neil M. Bressler, MD, suggested that it was the best currently available treatment despite limitations, while Jack O. Sipperley, MD, questioned whether PDT was cost-effective.
Dr. Bressler is the James P. Gills Professor of Ophthalmology, the Johns Hopkins University School of Medicine, Baltimore. Dr. Sipperley is in private practice with Retinal Consultants of Arizona, Phoenix. The two debated the merits of PDT.
"Why bother to debate? The advanced stage of macular degeneration is a major, growing public health problem throughout the world," Dr. Bressler explained. "So until more effective treatments are available, PDT with verteporfin (Visudyne, Novartis Ophthalmics and QLT Inc.)-at least for this next year-while pal-liative and expensive, is a vital tool for pa-tients in whom the therapy reduces the risk of vision loss."
"The issue really isn't whether PDT produces a better result than placebo," he said. "The question really is in a time of Medicare being excised to the bare bones and new drug bills being placed on the menu at the expense of the physician's reimbursement fees, is it really worth the enormous cost?"
Benefits of PDT Dr. Bressler cited data demonstrating a benefit to PDT. Studies have shown that in predominantly classic lesions PDT can reduce the risk of at least a 3-line loss at 24 months from 69% without PDT to 41% with PDT, and it reduces the risk of at least a 6-line loss by 24 months from 36% without PDT to 15% with PDT.
"Avoiding a 3- and 6-line loss really does have an impact on the quality of life," Dr. Bressler said.
He explained that data reported in 2003 from the Submacular Surgery Trials showed that a 3-line change in visual acuity was equivalent to about a 7-point change in the overall NEI visual function score, while a 6-line change was equivalent to about a 14-point change. Most vision function experts believe that a 5-point change in visual function represents a significant worsening of function.
Evidence agreeing with the conclusion that PDT should be considered as standard care is widespread, Dr. Bressler said. PDT is the American Academy of Ophthalmology's preferred practice pattern for management of selected cases of neovascular AMD. In addition, regulatory agencies in the United States, the European Union, Australia, and Japan have approved verteporfin for use in PDT for CNV.
Coverage by third-party payers such as the Centers for Medicare and Medicaid also indicates acceptance of the evidence.
"Improvement, which I think anyone could accept as being worthwhile, and which to be definitive would need to be at least 3 lines of vision, only occurs with PDT 9% of the time by a 24-month examination. Without PDT, it is only 4%," he explained.
"It doesn't take away your chance of improving, but very few people have improvement," Dr. Bressler added. "We reduce the risk of vision loss, but without any marked improvement; that's very difficult for a patient to accept. That means PDT is indeed palliative."
Expense of PDT The expense of PDT, whether borne by patients or their third-party payers, is also fueling debate over the procedure, Dr. Bressler and Dr. Sipperley agreed. According to Dr. Bressler, the cost of the drug and physician fees for a single treatment is nearly $2,000, and a series of five treatments over 2 years could reach $10,000.