This article is more than 5 years old. Information may no longer be current.
AAO supports Medicare coverage for intravitreal Avastin
In a letter to U.S. regulators, the AAO supported payment for the off-label use of the cancer drug in patients who have failed other therapies.
Click Here to Manage Email Alerts
SAN FRANCISCO – The American Academy of Ophthalmology has recommended to federal regulators that Medicare should pay for the off-label use of a cancer drug to treat age-related macular degeneration. The ophthalmology organization sent a letter to the Centers for Medicare and Medicaid Services supporting payment for intravitreal injection of bevacizumab when it is medically appropriate.
The AAO said in the letter that it “supports reimbursement for treating AMD with intravitreal injections of bevacizumab, to meet the medical needs of many patients who have not responded to therapy with ocular photodynamic therapy with verteporfin or intravitreal pegaptanib.”
Both of those treatments have been approved by the Food and Drug Administration for treatment of AMD; bevacizumab has not. That drug, marketed by Genentech as Avastin, is FDA-approved for systemic use for treatment of colorectal cancer.
The intravitreal treatment is being used by “a large number of retinal specialists [who] believe that it is reasonable and medically necessary for treatment of some patients with neovascular AMD,” the AAO letter said, according to a press release from the AAO.
“The scientific studies related to the use of intravitreal injections of bevacizumab for the treatment of neovascular AMD are supportive,” the AAO said in the letter, but it cautioned that the studies are “not conclusive of its safety and efficacy.”
Specialty society recommendation
The AAO statement is what retina specialists and Medicare carriers alike have been waiting for during the past year, said George A. Williams, MD, chief of ophthalmology at Beaumont Hospital.
“We have been told by some carriers that they were looking for a statement of support from the Academy,” he told Ocular Surgery News in a telephone interview.
The AAO acknowledged in the press release that the letter was issued in response to requests from members and Medicare carriers for clarification of the coverage issue.
Some local Medicare carriers, such as Cigna Government Services in North Carolina and Montana Medicare, did not wait for the AAO letter. At least those two carriers issued decisions to cover the off-label use of Avastin for AMD before the AAO sent its letter to the CMS, Dr. Williams said.
After the letter was sent, Noridian Administrative Services, a carrier that administers Medicare in 12 mostly western and midwestern states, issued a determination to cover the drug’s use in AMD. The determination, accessed on the Noridian Web site, cites the AAO letter and says that “emerging literature in support of the use of intravitreal injections of bevacizumab ... is now sufficient to allow payment.”
Dr. Williams said subsequent decisions may be made on a carrier-by-carrier basis, but he and his colleagues are interested in whether there will be a policy decision by the central CMS.
“They are under no legal obligation to take our advice, but my experience is that they’re trying to do the right thing and that they want to do what is in the patient’s best interest,” Dr. Williams said.
Not an endorsement
H. Dunbar Hoskins Jr., MD, said in the AAO press release that the letter is not to be interpreted as an endorsement by the AAO of intravitreal Avastin, but rather a recommendation that physicians who choose to use intravitreal Avastin be reimbursed “as they are with other off-label therapies.”
The AAO’s support for physician reimbursement is limited to “patients who are deemed by their treating physician to have failed FDA-approved therapies” or who, in the judgment of the physician, would benefit from the use of the intravitreal treatment.
“The Academy is concerned that in spite of the current treatments available, fewer than 10% of patients have had significant improvement in visual acuity,” Dr. Hoskins, the executive vice president of the AAO, said in the press release. “Most patients continue to lose vision after 1 year of therapy.”
Broad scientific support
The use of Avastin as a treatment for AMD was first brought to the attention of the ophthalmic community by a June 2005 article in Ophthalmology by Michels and coworkers at Bascom Palmer Eye Institute. That paper described intravenous use of the drug, which was well-tolerated over the course of 3 months, with an improvement of visual acuity and angiographic outcomes.
Since that time, almost a dozen papers have been published on intravitreal use of Avastin for choroidal neovascularization secondary to AMD, most recently a study in Retina by Spaide and colleagues discussing results in 266 eyes of 266 patients. That study found a significant decrease in macular thickness and improvement of visual acuity at 3 months. The authors noted that studies with longer follow-up are called for.
The lack of longer published follow-up is a concern for many physicians, noted Robert L. Avery, MD, of California Retina Consultants.
Dr. Avery is among the authors who have published their results with Avastin. He has also been involved in larger studies of other anti-VEGF drugs. He said one factor that must be investigated is the incidence of thromboembolic events with intravitreal use of Avastin.
“That’s the thing that concerns me the most,” he said. “There are patients who are going to have thromboembolic events with or without the treatment in this age-group population, and sorting out whether it’s due to the drug or not is going to be difficult,” he said during an interview with Ocular Surgery News.
The AAO press release said that more than 6,800 injections in 5,055 patients from 68 centers in 12 countries have now been documented, with a low rate of ocular or systemic adverse events.
A survey of members of the American Society of Retinal Specialists found that 4% of 289 respondents had seen thromboembolic complications thought to be related to intravitreal Avastin, and 96% thought the drug was the same or better in overall safety than other FDA-approved or covered therapies for AMD.
In that survey, completed in March, 92% of respondents said they believed intravitreal bevacizumab was “somewhat better” or “much better” than other approved or covered therapies, according to the AAO release.
Awaiting Lucentis
Lucentis (ranibizumab, Genentech/Novartis) is an anti-VEGF drug that Genentech is developing specifically for the treatment of wet AMD. Ranibizumab, an antibody fragment, has been the subject of several ongoing randomized, controlled clinical trials.
Dawn Kalmar, a spokeswoman for Genentech, said that, while the company is aware of the AAO statement of support for the use of Avastin in AMD and the current unmet medical need among patients, Genentech is directing its energy toward approval of Lucentis for wet AMD.
“We are focusing on working with the FDA to get Lucentis to patients quickly and anticipate a response from the FDA by the end of June,” she told Ocular Surgery News in a telephone interview. In February, the FDA granted Lucentis expedited review.
The AAO press release notes that patients can still be enrolled in the SAILOR (Safety assessment of intravitreal Lucentis for AMD) trial, a 1-year phase 3b study to evaluate the safety of Lucentis. The trial is open to eligible patients with all subtypes of new or recurrent active subfoveal wet AMD.
For more information:
- George A. Williams, MD, can be reached at 3535 West 13 Mile Road, Suite 555, Royal Oak, MI 48073; 248-551-2175; fax: 248-551-4362; e-mail: gwilliams@beaumont.edu.
- Robert L. Avery, MD, can be reached at California Retina Consultants, 515 East Micheltorena St., Suite C, Santa Barbara, CA 93103; 805-963-1648; fax: 805-965-5214; e-mail: avery1@jhu.edu.
- The American Academy of Ophthalmology press release describing its letter to the Centers for Medicare and Medicaid Services can be read on its Web site: www.aao.org.
- For more information on the SAILOR trial, or to enroll patients, visit the online clinical trials database: www.clinicaltrials.gov/ct/show/NCT00251459?order=2.
- Genentech Inc., developer of Avastin and Lucentis, can be reached at 1 DNA Way, South San Francisco, CA 94080-4990; 650-225-1000; fax: 650225-6000; Web site: www.gene.com.
References:
- Michels S, Rosenfeld PJ, et al. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: Twelve-week results of an uncotrolled open-label study. Ophthalmology. 2005:112(6):1035-1047.
- Spaide RF, Laud K, et al. Intravitreal bevacizumab treatment of choroidal neovascularization secondary to age-related macular degeneration. Retina. 2006;26(4):383-390.
- Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.
- Michelle Dalton is Managing Editor of OSNSuperSite.com. She writes daily updates on developments in all aspects of ophthalmology.