Monday, April 24, 2006

AVASTIN UPDATE ll: AAO supports Medicare coverage for off-label Avastin use

April 24, 2006, As reported by the OSN Supersite:

AAO supports Medicare coverage for off-label Avastin use

SAN FRANCISCO — A drug being used off-label for the treatment of age-related macular degeneration should be considered for Medicare coverage, said the American Academy of Ophthalmology. According to an AAO press release, the organization sent a letter to U.S. regulators supporting Medicare reimbursement for the drug.

AAO said in its letter to the Centers for Medicare and Medicaid Services 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.”

Avastin (bevacizumab, Genentech) is approved in the United States for the systemic treatment of colorectal cancer. The intravitreal dosage is being used by “a large number” of retinal specialists who believe it is “reasonable and medically necessary for treatment of some patients with neovascular AMD,” AAO said.

“The scientific studies related to the use of intravitreal injections of bevacizumab for the treatment of neovascular AMD are supportive,” AAO said in the letter, “but they are not conclusive of its safety and efficacy.”

H. Dunbar Hoskins, MD, said the letter is not to be interpreted as an endorsement by the AAO of the off-label use, but that physicians who choose to use intravitreal Avastin “be reimbursed as they are with other off-label therapies.”

The AAO said it supports physician reimbursement, but limits the support to “patients who are deemed by their treating physician to have failed Food and Drug Administration-approved therapies” or for whom the physician believes would benefit from the use of the intravitreal version.

“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, AAO executive vice president, said in the release. “Most patients continue to lose vision after 1 year of therapy.”

According to the release, AAO issued its letter in response to member requests for clarification on the coverage issue. Further, the AAO said more than 6,800 injections in 5,055 patients from 68 centers in 12 countries have been documented with a low rate of ocular or systemic adverse events.

The American Society of Retinal Specialists survey found 4% of 289 respondents had noted any thromboembolic complications thought to be related to the intravitreal treatment, and 92% of respondents said they believed intravitreal bevacizumab was “somewhat better” or “much better” than other approved or covered therapies, the release said.

Author’s Note on Avastin

Since the original posting on January 31st, I have now added four updates on this important drug for treating age-related macular degeneration. In addition to the posting you are reading, here is a listing (with links) to the others:

Avastin: A New Hope for Treating AMD

Avastin Update: Medicare not Likely to Cover its Use

ARVO 2006: A Further Update on Both Avastin and Lucentis for Treating AMD

Avastin/Lucentis Update 4: FDA Approves Lucentis for Treating Wet AMD


At 7:57 PM, Blogger Billy said...

Welcome to the blogmos

At 9:26 AM, Anonymous Anonymous said...

Very nice article.


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