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National Coverage Analysis (NCA) Tracking Sheet for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R2)

Ocular Photodynamic Therapy (OPT) is a new treatment for age-related macular degeneration (AMD), a common eye disease among the elderly. AMD is the leading cause of blindness in adults over the age of 50. OPT involves the infusion of an intravenous (IV) photosensitizing drug called verteporfin followed by exposure to a laser. The laser activates verteporfin, which selectively targets and treats the pathologic ocular tissue.

On October 17, 2001 The Centers for Medicare and Medicaid Management (CMS) announced its intent to cover OPT with verteporfin for AMD patients with occult but no classic subfoveal choroidal neovascularization (CNV) lesions. After posting this Decision Memorandum, CMS discovered new issues concerning the data from the clinical trial upon which it based its analysis. In order to further examine the clinical trial data, CMS has internally generated a request for reconsideration of this indication.

Drugs and Biologicals
Physicians' Services
Requestor Name(s)Centers for Medicare and Medicaid Services
Formal Request Accepted and Review Initiated10/30/2001
Expected NCA Completion Date03/29/2002
Public Comment Period11/29/2001 - 12/29/2001
Decision Memo Released03/28/2002
Lead Analyst(s)
  • Poppy S. Kendall
  • Samantha Richardson
Lead Medical Officer(s)
  • Ronald Dei Cas, MD

October 29, 2001

CMS internally generated a request for reconsideration. CMS believes that further review is needed to fully understand the new concerns raised regarding the clinical trial data and decide if this will impact our coverage determination. CMS will not implement the October 17, 2001 Decision Memorandum until this reconsideration is completed.

January 28, 2002

CMS is continuing to review new information submitted at its request by the requestor. To allow sufficient time to receive and review all the material requested by CMS, we will extend the due date and seek to issue a decision memorandum on or by February 28, 2002.

February 22, 2002

CMS met with representatives from the Vitreous Society and Novartis Pharmaceuticals at their request. More time is needed to evaluate comments made in the meeting. The due date will therefore be extended to March 15, 2002.

March 7, 2002

The due date has been postponed until March 29, 2002 to accommodate a meeting between Novartis Pharmaceuticals and CMS. The meeting was requested by Novartis Pharmaceuticals.

March 28, 2002

Decision Memorandum  posted announcing intent to reaffirm the current national noncoverage policy

August 2002

NCD updated

November 2002

NCD updated