Diabetic Macular Edema: Cheaper Therapies May Be Fine

Yael Waknine

December 13, 2012

Many ophthalmologists have made efforts to trim patient expenses but some may not be aware of therapeutically equivalent, cheaper alternatives for treating diabetic macular edema (DME).

Using results from various multicenter, prospective trials, William E. Smiddy, MD, professor of ophthalmology at the Bascom Palmer Eye Institute in Miami, Florida, concluded that some DME eyes could be effectively treated with less expensive options, yielding cost savings ranging from 40% to 88%.

His findings, published in the December issue of Ophthalmology, suggest that pseudophakic patients and those with visual acuity (VA) worse than 20/200 experience similar outcomes when treated with intravitreal corticosteroids or the more expensive anti-VEGF agents. In contrast, patients with better vision (VA > 20/32) have only been included in laser trials and thus should receive that treatment.

In addition, certain treatment regimens may be equally effective whether administered with "treat and extend" or "as-needed" dosing, and alternate anti-VEGF therapies might be equivalent to the more expensive ones.

"Utilizing less expensive, but similarly efficacious, treatment options for the very common condition of diabetic macular edema could yield substantial cost savings [that] can be realized without significant outcome differences in such subgroups," Dr. Smiddy emphasized in an interview with Medscape Medical News.

Cost a Growing Concern

"Physicians care for patients and offer modalities that may help or harm the patient. It is standard good medicine for the physician to be aware of the various treatments in terms of efficacy as well as potential complications or practical abilities to carry out the treatment," Frank J. Weinstock, MD, told Medscape Medical News in an interview. He noted that cost, which is always an issue, is a growing concern as the price of medications continues to increase.

"Speak to any pharmacist and you will find that too many patients refuse to get their prescriptions refilled due to the cost — they have to make a choice between eating and using the medication," explained Dr. Weinstock, who is a professor of ophthalmology at Northeast Ohio Medical University in Rootstown; affiliate clinical professor in the Charles E. Schmidt College of Biomedical Science at Florida Atlantic University, Boca Raton; and volunteer professor of ophthalmology at the University of Miami Leonard M. Miller School of Medicine in Florida. Dr. Weinstock was not involved with the study.

That said, attempts by clinicians to make connections between efficacy and cost savings may be obscured by an ever-increasing number of new medications and treatable medical conditions. Pharmaceutical companies are constantly looking for new medications to offer patients, and although the ultimate solution may be a low-cost generic, providing one is often not practical. Many lower-cost medications and treatments might be efficacious, but evaluating them in studies may be extremely difficult in terms of time and cost, Dr. Weinstock added.

"We owe it to our patients to be aware of cost, efficacy, and their ability to use medications and treatments. And we also have an obligation to be aware of costs to the insurance companies and the system and keep them as low as possible without harming the patient," he emphasized.

Equal Benefit, Lower Costs

For the study, Dr. Smiddy identified studies that evaluated treatments for DME causing losses of visual acuity below 20/200, DME yielding visual acuity of 20/32 or greater, and pseudophakic DME.

Although overall data from the Diabetic Retinopathy Clinical Research Network study showed that standard focal laser grid treatment yielded better VA than intravitreal triamcinolone (IVTA) beyond 16 months (a 5-letter advantage), stratification of the 2-year results by baseline VA showed a slight advantage for 4 mg IVTA among a small subgroup of patients with VA 20/200 to 20/320.

As a result, the benefit of IVTA in this subgroup was calculated to yield a 62% lower cost/line and cost/line-year figure, despite the similarity in annual treatment costs (laser, $2330 vs IVTA, $1907).

With respect to the treatment of DME in patients with VA of 20/32 or better, the only modality with published study results was focal laser. According to Dr. Smiddy, using laser rather than the more expensive VEGF inhibitors is expected to save up to 92% of costs per year.

Dr. Smiddy used data for pseudophakic eyes from the Diabetic Retinopathy Clinical Research study, which compared the intravitreal VEGF inhibitor ranibizumab with IVTA plus laser and laser alone. Although the overall findings suggested a 6-letter benefit for ranibizumab over the laser treatments at 2 years, data available in the online-only supplemental materials' "expanded analysis" revealed that the differences were minimal in a subset of eyes that were pseudophakic at baseline.

Meanwhile, Dr. Smiddy calculated the treatment costs for IVTA plus laser and laser alone as 85% and 88% lower, respectively, than those of ranibizumab. Moreover, with the benefit of IVTA treatment similar to that of ranibizumab, and approximately 50% lower for laser-only treatment, the costs/line saved and costs/line-year saved were still less than for ranibizumab alone.

In a trial comparing aflibercept dosing regimens, researchers saw similar results with monthly and every-other-month dosing after patients had received 3 loading doses (1.9 lines saved vs 1.4 lines saved). Assuming a stable result from 6 months to 1 year and reasonable extrapolations of use, the estimated annual costs for each regimen were $25,913 and $15,785, respectively, representing a 39% lower cost for the every-other-month dosing group.

In the largest randomized controlled trial of intravitreal bevacizumab for DME (Bevacizumab or Laser Therapy in the Management of Diabetic Macular Edema Study [BOLT]), the mean number of letters gained (8.0) compared favorably with the mean gained with aflibercept (8.5 - 11.4) and ranibizumab (9.4) in a multicenter, nonrandomized trial known as Pan-American Collaborative Retina Study Group 13. However, bevacizumab required fewer injections during the study year (5.8 vs 9), and therefore could yield 85% savings in costs ($2684 vs $4718) without substantial VA differences.

The author and Dr. Weinstock have disclosed no relevant financial relationships.

Ophthalmology. 2012;119:2558-2562. Abstract