Visudyne users sue U.S. government
Leonard Zehr
A coalition of American consumer groups and Medicare beneficiaries is suing the United States government after insurance regulators rejected coverage for expanded use of QLT Inc.'s blindness drug Visudyne.
The American Council of the Blind, the Gray Panthers and the American Association of People with Disabilities, along with three individuals, claim that an appeals process enacted by Congress in 2000 and signed by former president Bill Clinton that allows individuals to challenge decisions for national insurance coverage of drugs has not been implemented.
"It's nothing short of an outrage when the agency set up to provide for health care won't even hear the simple request for reconsideration of a decision that puts the eyesight of the Medicare-eligible elderly on the chopping block of administrative arrogance," Charles Crawford, executive director of the American Council of the Blind, said in a statement yesterday.
The lawsuit against the U.S. Department of Health and Human Services and Centers for Medicare and Medicaid Services (CMS) follows a ruling in March by CMS to reject insurance coverage for Visudyne to treat "occult lesions" in patients with age-related macular degeneration (AMD).
Visudyne, which is used around the world to treat the classic version of AMD, has been approved by regulators in Australia, New Zealand and Europe to treat occult lesions. AMD is the result of abnormal blood vessels that leak in the back of the eye. When leaky blood vessels are easily diagnosed, they are called classic, compared with harder-to-detect occult lesions.
Paul Hastings, president and chief executive officer of Vancouver-based QLT, said the company is conducting clinical trials with occult AMD patients and hopes to file for regulatory approval in the United States in 2005.
He said QLT is prohibited from appealing the CMS insurance decision but is supporting consumer groups. |
