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National Coverage Analysis (NCA) Tracking Sheet

Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration

CAG-00066N

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Issue

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. Verteporfin was approved by the Food and Drug Administration (FDA) on April 13, 2000 and approved for inclusion in the United States Pharmacopoeia (USP) on July 18, 2000. The laser devices for use in OPT have also received FDA approval.

National Coverage Determinations

Benefit Category

Drugs and Biologicals
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
HCFA internally generated request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/26/2000
Expected NCA Completion Date
11/09/2000
Public Comment Period
08/25/2000 - 09/25/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
11/08/2000

Contacts

Lead Analysts
Poppy Kendall
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

July 26, 2000

HCFA internally generated a national coverage review for OPT and verteporfin.

August 25, 2000

HCFA has learned of a press release issued on August 14, 2000 by QLT PhotoTherapeutics Inc. discussing plans to expand the FDA-approved indication for verteporfin for eye conditions beyond AMD. If there is scientific evidence which speaks to verteporfin’s use for indications beyond AMD which might be helpful in HCFA’s current review of OPT with verteporfin in AMD, the agency is interested in reviewing such information. If interested in submitting materials, please contact the lead analysts on this topic.

September 6, 2000

HCFA held a meeting with interested parties from the ophthalmologic industry on the topic of AMD and this coverage review.

September 7, 2000

HCFA received background material on AMD from Dr. Neil Bressler of Johns Hopkins University, principal investigator for the Treatment of AMD with Photodynamic Therapy (TAP) trial.

September 13, 2000

HCFA held a meeting with representatives from Johns Hopkins University to discuss the agency’s interest in sponsoring a research project to determine whether this technology is being appropriately disseminated.

September 15, 2000

HCFA received materials from QLT PhotoTherapeutics, Inc. (the makers of verteporfin) regarding this coverage review.

September 27, 2000

HCFA held a meeting with representatives from Covance Health Economics and Outcomes Services, Inc. and QLT PhotoTherapeutics, Inc. as well as leading clinicians and researchers on the topic of AMD.

October 26, 2000

Due to the complexity of the issue, HCFA will need two extra weeks to complete our review. We are extending the due date to no later then November 9, 2000.

November 6, 2000

Decision was made to issue a national coverage policy for OPT with verteporfin for AMD patients with predominately classic subfoveal CNV lesions (where the area of classic CNV occupies 50% of the area of the entire lesion) as determined by a fluorescein angiogram. Other uses of OPT with verteporfin will not be covered. See Decision Memorandum dated November 6, 2000.
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