Biotech Values

[10nisman]

http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=101

QLTI information. I didn't read it just saw this link from QLT Yahoo message board. QLT should be up huge on this news, and I believe it should help us as well. It would definitely be the week of AMD companies, if we announced a partnership tomorrow or Friday.

GENR is mentioned below 5th paragraph.

DEW - what does this ruling mean for QLT and GENR?



4. Medicare Coverage Advisory Committee

The Medicare Coverage Advisory Committee (MCAC) met on September 9, 2003, to discuss and make recommendations concerning the quality of the evidence and related issues for the use of OPT with verteporfin in routine clinical use in the population of Medicare beneficiaries who have AMD and occult with no classic CNV.

CMS staff presented the panel with information on AMD in the Medicare population, a history of Medicare coverage of verteporfin, and a review of MCAC voting questions and discussion questions. In addition, Dr. Charles P. Wilkinson presented the perspective of a practicing ophthalmologist, followed by a CMS review of evidence and data analysis.

Representatives from Novartis and QLT presented the panel with an overview of what macular degeneration is, how it can lead to decrease in vision, and ultimately to blindness. They explained various test and trial procedures and results from the TAP and VIP trials, and responded to the points raised in the CMS presentation. They presented new exploratory analyses that combined data from the TAP and VIP studies that suggested that response to OPT with verteporfin in patients with minimally classic or occult but no classic lesions was inversely proportional to lesion size. Some of the panel members suggested that this new evidence could alter their responses and requested a reconvening of the panel at a latter date to allow time to review this evidence. However, the majority of the panel voted to review only the evidence submitted prior to the meeting.

Representatives from the American Society of Retinal Specialists, the American Academy of Ophthalmology, and the American Council for the Blind addressed the panel, supporting national coverage for the requested treatment. Medicare recipients also related personal experiences with macular degeneration to the panel.

Thirteen scheduled public speakers addressed the panel. Representatives from Genaera and Genentech informed the panel of studies currently underway addressing possible treatment of macular degeneration being sponsored by their companies. Representatives of the Gray Panthers, the Seniors Coalition, the Baltimore Office of the NAACP, the American Association of People with Disabilities, the League of United Latin American Citizens, Lighthouse International, and Prevent Blindness America addressed the panel. Three Medicare beneficiaries and one other individual patient, all of who had received or were receiving verteporfin therapy related their personal experiences to the panel.

Five additional speakers addressed the panel during a period of open public comment, including the daughter of a Medicare beneficiary who had been treated with verteporfin, a representative from “Advancing Independence” and “Modernizing Medicare and Medicaid,” the spouse of a Medicare beneficiary who had been treated with verteporfin, an attorney representing Novartis and QLT, and a retired physician who had received verteporfin therapy.