At Issue: PDT and general ophthalmologists

At Issue posed the following question to a panel of experts: “Are general ophthalmologists performing photodynamic therapy themselves in their AMD patients?”

Substantial resources needed

Abdhish R. Bhavsar, MD: Photodynamic therapy (PDT) for age-related macular degeneration (AMD) involves a substantial commitment of time and staff resources.

The only agent approved for ocular PDT at this time is Visudyne (verteporfin for injection, Novartis Ophthalmics/QLT). The first step involves a thorough clinical ocular and retinal examination of the patient. Fluorescein angiography is necessary to determine whether there is a choroidal neovascular membrane (CNVM) and to determine whether the CNVM is predominantly classic (more than 50%). At this time, predominantly classic CNVM is the only pattern of CNVM that is approved by the Food and Drug Administration for treatment with PDT.

Patients then must be educated about other treatment options, which may include observation, standard macular photocoagulation, limited retinal translocation surgery or possibly submacular surgery or other clinical trials for AMD. These procedures are typically not performed by general ophthalmologists, which would make it difficult for a general ophthalmologist to discuss these options thoroughly with a patient. At the Retina Center, we as physicians discuss the treatment options with the patients and their families first. Then, our trained PDT staff discuss the treatment with patients and show them a PDT patient education videotape. Particular attention is given to discussion of protection from exposure to sunlight after the treatment for 5 days.

If the patient opts for PDT, he or she is scheduled for PDT within 1 to 2 weeks in our office. The treatment session involves measuring body surface area, preparing the verteporfin and dilating the eye to be treated. The diameter of the CNVM must be measured, based on the fluorescein angiogram, to allow calculation of the treatment spot size. The intravenous infusion of verteporfin takes 10 minutes, and 5 minutes later, laser at 689 nm is applied for 83 seconds with a fundus contact lens. The entire treatment session often takes about 45 to 60 minutes.

Abdhish R. Bhavsar, MD, is an attending retina surgeon at Phillips Eye Institute and a clinical assistant professor at the University of Minnesota. He can be reached at 710 East 24th St., Suite 304, Minneapolis, MN 55403; (612) 871-2292; fax: (612) 871-0195; e-mail: bhavs001@tc.umn.edu. Dr. Bhavsar is a member of the Speakers Bureau for Novartis and a stockholder in QLT Inc.

Location is key

Herve M. Byron, MD: A key point in answering this question is the location of the general ophthalmologist. For example, here in Bergen County, N.J., very close to midtown Manhattan, the density of general ophthalmologists per square mile is probably the highest anywhere in the United States, if not the world. I called 20 randomly selected general ophthalmologists in New Jersey and New York to ask if they have used or plan to use PDT for their AMD patients. Only one of the 20 was even thinking about using it, but has not yet done so. I believe the availability of excellent retinal specialists in this area allows general ophthalmologists to provide higher quality care for their AMD patients by referring them to these experts. On the other hand, general ophthalmologists located in the areas where such retinal experts are inaccessible might very well take the time and effort to learn how to use PDT for their AMD patients.

Herve M. Byron, MD, is a clinical professor of ophthalmology in the department of ophthalmology at George Washington University, Washington, D.C. He can be reached at 114 Roberts Road, Englewood Cliffs, NJ 07632; (201) 567-9479; fax: (201) 568-7765; e-mail: byronmd@rcn.com.

Referring to other subspecialists

I. Howard Fine, MD: There are nine ophthalmologists in the Oregon Eye Associates’ Building in Eugene, Ore., and none of them is using PDT at this time. One of the ophthalmologists is a fellowship-trained vitreoretinal specialist whose practice is limited to his subspecialty; he is referring patients who may be candidates to other ophthalmologists who are using this treatment modality. I believe that some of the issues involve questions of efficacy as well as reimbursement.

I. Howard Fine, MD, is an associate clinical professor of ophthalmology at the Oregon Health Sciences University. He can be reached at 1550 Oak St., Ste. 5, Eugene, OR 97401; (541) 687-2110; fax: (541) 484-3883. Dr. Fine has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Substantial investment required

Gregory M. Fox, MD: It is uncommon for general ophthalmologists in our area to provide PDT for their patients with exudative macular degeneration. The investment required to provide PDT — including qualified staff to administer the drug, the laser and the need to accurately identify which patients will benefit from treatment — discourage treatment with PDT by other than retinal specialists. This impression was confirmed by questioning our local drug and laser sales representatives. In our area, only one general ophthalmologist, without retinal subspecialty training, has chosen to provide PDT because of the distance of his practice from retinal subspecialty care.

Gregory M. Fox, MD, can be reached at the Hunkeler Eye Center, 4321 Washington, Suite 6000, Kansas City, MO 64111; (816) 931-4733; fax: (816) 931-9498; e-mail: gfox@novamed.com; Web site: www.hunkeler.com.

Trained subspecialist is best

Bert M. Glaser, MD: To determine whether general ophthalmologists will use the current form of PDT for exudative AMD, it is important to first look at the criteria for PDT. The treating physician must understand, too, the presentation and course of exudative AMD in all its complexity.

A decision to use PDT requires the ability to analyze clinical and angiographic findings to assess the percentages of classic and occult choroidal neovascularization (CNV). This is because scientific evidence and Health Care Financing Administration guidelines require that PDT be reserved for eyes with greater than 50% of the classic form of CNV.

Once it has been determined that a patient is eligible for PDT, the doctor must decide whether PDT is, in fact, the best option. The relative efficacy and risk of PDT must be compared to other treatments such as direct laser photocoagulation (which is still the best treatment in some cases), macular translocation, feeder vessel treatment and transpupillary thermotherapy.

When a decision to treat with PDT is made, the full extent of the CNV (all components including classic and occult) must be accurately mapped to determine the correct laser settings. Accurate mapping of the lesion requires a full understanding of the classification and characterization of CNV in AMD.

Multiple treatments with PDT are currently necessary and require that the treating physician be thoroughly familiar with the normal progression of the disease and its response to PDT. At each follow-up time point, these considerations must be weighed to determine whether additional treatment with PDT or another modality is necessary.

All of these requirements are important for a successful outcome with PDT. The question of which ophthalmologists have the training and experience to properly use PDT must be answered on an individual basis. However, it is likely that a trained retinal specialist, more so than a general ophthalmologist, will have the required skills to properly use PDT.

Bert M. Glaser, MD, is a professor of ophthalmology at George Washington University. He is the chairman of Glaser Murphy Retina Treatment Centers and can be reached at 901 Dunlanet Valley Road, Suite 200, Towson, MD 21204-0603; (410) 337-4500; fax: (410) 339-7326.

In academia, only subspecialists

Randall J. Olson, MD: We in our practice, being in an academic institution, are protected, and therefore I know unequivocally that the only ones here using PDT are our retinal subspecialists. I am not aware of any general ophthalmologists in the area who are using PDT.

Randall J. Olson, MD, can be reached at the John Moran Eye Center, 50 N. Medical Dr., Salt Lake City, UT 84132; (801) 585-6622; fax: (801) 581-8703; e-mail: randall.olson@hsc.utah.edu.

Not a promising ROI for generalists

John Pinto: Since the approval of PDT, I have yet to see a general ophthalmologist get involved with this new therapy. Although I work with some of the most entrepreneurial surgeons in the country, my fellowship-trained retinal clients are the only surgeons I see offering this directly to their patients. The general/cataract/refractive ophthalmologists are either referring this care out, or it is not yet on their professional radar screens. (This represents an opportunity for retinologists to do a better job of peer education.)

Unless there are significant economic dislocations in the typical general practice (for instance, a sharp drop in cataract or LASIK fees), I would expect PDT to remain rather far down the list of potential new service offerings for the typical general practice. At the lower procedure volumes available in the average practice, the net profit per provider hour falls short of other opportunities.

I see no changes in the near or intermediate term. However, I think that in the event of a return to an era of provider consolidation, when more ophthalmologists work in vertically integrated multi-subspecialty groups, independent retinologists may find an erosion of not only their referred PDT practice but of the balance of their subspecialty care.

John Pinto can be reached at J. Pinto & Associates Inc., 376 San Antonio Ave., Suite C4, San Diego, CA 92106; (619) 223-2233; fax: (619) 223-2253; e-mail: pintoinc@aol.com; Web site: www.pintoinc.com.

Self-referral, informed consent

William A. Sarraille, JD: We have seen very little activity by general ophthalmologists whom we represent in the provision of PDT services. A very small number of general ophthalmologists have discussed the provision of PDT services within their own practices through independent contractor or part-time employee agreements with retinal subspecialists. These relationships must be carefully and appropriately designed in compliance with the federal anti-kickback statute and the Stark self-referral law.

In the context of these representations and in our representation of retinal practices, some interesting informed consent issues have developed, which may account for at least part of the reason why seemingly so few general ophthalmologists have pursued PDT services. Despite practices’ efforts to inform patients that PDT is only likely to arrest macular degeneration and not to reverse the effects of the disease, patients appear to have expectations that their underlying condition will, in fact, improve.

Unfortunately, this has led to a not-insignificant rate of patient dissatisfaction with the therapy and conflicts with providers. The development of specific and carefully drafted informed consent forms that are signed by PDT candidates can be a mechanism to address these sorts of situations. In addition, informed consents should deal with the issue of possible continued regression despite the completion of the therapy, as this is becoming a fairly common informed consent issue as well.

William A. Sarraille, JD, can be reached at Arent Fox Kintner Plotkin & Kahn, PLLC, 1050 Connecticut Ave. NW, Washington, DC 20036; (202) 857-6359; fax: (202) 857-6395; e-mail: sarrailw@arentfox.com.

Barriers to non- subspecialist use

Scott Steidl, MD: PDT is now a proven safe and statistically effective treatment for classic and occult CNV due to AMD and CNV with myopia. Many, if not most, retina practices in this country have considered or are currently using PDT. This does not appear to be the case with general ophthalmology practices.

There are barriers to the use of PDT in the non-subspecialty practice. These barriers include the cost of purchasing the laser or the availability, cost and logistics of using a rental unit. Offering PDT to patients requires high-quality fluorescein angiograms and the expertise to appropriately determine the location and size of the membrane as well as its proper categorization as occult or classic. Also, an ability to distinguish the underlying disease process, whether myopia, angioid streaks, macular degeneration or some other retinal process, is crucial.

In addition, there are impediments to incorporating this treatment in a busy practice. One needs associated nursing staff, correct drug preparation, successful placement of an intravenous line and appropriate billing protocols. The break-even point on reimbursement relative to the laser costs and medication costs can be small unless many PDT treatments are done.

With these issues in mind, it is no wonder that few general ophthalmology practices are employing this technique, a technique that appears largely confined to retina specialty practices and academic centers. A local Visudyne representative recently communicated to me that he was unaware of even one case of a general ophthalmologist doing PDT.

Scott Steidl, MD, can be reached at University of Maryland Eye Associates, 419 W. Redwood St., 4th Floor, Baltimore, MD 21201; (410) 328-5934; fax: (410) 328-1178.

Skilled practitioners needed

George A. Williams, MD: In Michigan, I am unaware of any general ophthalmologist using PDT for AMD patients. However, I believe that any ophthalmologist experienced in the interpretation of fluorescein angiography for CNV is capable of performing PDT. This assumes that such an individual is comfortable with macular photocoagulation techniques, such as the use of wide-field lenses for macular biomicroscopy. The interpretation of fluorescein angiography in AMD is not an absolute science. Even in the TAP Study, approximately 10% of enrolled patients were technically ineligible based on retrospective review of the fluorescein angiograms. This demonstrates that even among experienced clinicians, there is not complete agreement on the interpretation of fluorescein angiography.

Individuals wishing to perform PDT must also be willing to make the commitment to provide adequate intravenous access. Typically, this requires a nurse skilled in intravenous access. Alternatively, the physician can provide the intravenous access, but then must be present during the infusion to watch for any signs of extravasation of the drug. Patients must be closely monitored through the entire infusion process.

PDT has been demonstrated to retard visual loss in patients with subfoveal CNV that is either predominantly classic or purely occult. Patients with CNV due to pathologic myopia also benefit. The more ophthalmologists there are who are skilled in PDT, the more patients can gain access to this beneficial treatment.

George A. Williams, MD, is chairman of the department of ophthalmology at William Beaumont Hospital in Royal Oak, Mich.; director of the Beaumont Eye Institute and clinical professor of biomedical sciences at Oakland University, Rochester, Mich. He can be reached at Associated Retinal Consultants PC, 3535 West Thirteen Mile Road, Suite 632, Royal Oak, Mich. 48073; (248) 288-2280; fax: (734) 464-2300; e-mail: gawarc@netscape.net.

Not in the mission statement

Steven B. Siepser, MD: Our practice mission statement directs us toward the care of patients whose vision we can improve without the use of external prostheses. Because we are dealing essentially with laser vision correction, cataract surgery and anterior segment reconstruction, getting involved in macular disease does not seem consistent with our mission, nor is it of great interest to me personally. For this reason, along with concerns about patient mix and dealing with the poorly sighted in a high-tech, advanced eye care setting, the use of PDT would probably not be consistent with our goals.

Because our practice is a true general ophthalmology setting but devoted to anterior segment surgery, this particular treatment regimen is not consistent with the care we give and, therefore, is not offered in our practice.

Steven B. Siepser, MD, can be reached at 91 Chestnut Road, Paoli, PA 19301; (610) 296-3333; fax: (610) 296-3030; e-mail: ssiepser@clear-sight.com.