Replies to post #997 on Biotech Values

[DewDiligence]

U.S. Medicare decides to reimburse for Visudyne treatment in occult and minimally-classic AMD when lesions are small and disease is rapidly progressing

[This decision substantially increases Medicare coverage for Visudyne, although it refrains from covering all forms of wet AMD by excluding occult/minimally-classic patients with large lesions or stable disease. My estimate is that the proportion of wet AMD cases now covered is 60-65% vs. 25% before the new ruling. In the discussion below, Visudyne treatment is referred to as “ocular photodynamic therapy with verteporfin.” –Dew]

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

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Decision Memo for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R3)

Decision Summary

CMS has determined that the evidence is adequate to conclude that ocular photodynamic therapy (OPT) with verteporfin is reasonable and necessary for treating (1) subfoveal occult with no classic choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD) and (2) subfoveal minimally classic choroidal neovascularization associated with age-related macular degeneration. These indications for ocular photodynamic therapy with verteporfin are reasonable and necessary for both (1) and (2) only when:
• The lesions are small (4 disk areas or less in size) at the time of initial treatment or within the three months prior to initial treatment; and
• The lesions have shown evidence of progression within the three months prior to initial treatment. Evidence of progression must be documented by deterioration of visual acuity (at least five letters on a standard examination), lesion growth (an increase in one disk area), or the new appearance of blood in the lesion.
Therefore we intend to issue a national coverage determination (NCD) expanding coverage of OPT with verteporfin for subfoveal occult with no classic CNV associated with AMD and for subfoveal minimally classic CNV associated with AMD for the stated indications.

This decision memorandum does not alter our national coverage policy for OPT with verteporfin for subfoveal predominantly classic CNV associated with AMD.

Other uses of OPT with verteporfin to treat AMD not already addressed by CMS will continue to be non-covered. These include but are not limited to the following AMD indications:
• Patients with juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea)
• Patients who are unable to obtain a fluorescein angiogram
• Patients with atrophic or "dry" AMD.
OPT with verteporfin for other ocular indications, such as pathologic myopia or the presumed ocular histoplasmosis syndrome, is not addressed in this decision memorandum nor in our national coverage policy, and continues to be eligible for coverage through individual contractor discretion.

[More details in full write-up]
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[DewDiligence]

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

It’s great news for QLTI, but it has no effect on GENR. When the time comes (near the time of FDA approval), GENR’s Squalamine should have no difficulty obtaining Medicare coverage in AMD.

What might have an effect on GENR –in terms of the clinical trial design for Squalamine— is eventual FDA approval of Visudyne in the occult or minimally-classic subgroups. Depending on the timing of FDA decisions, such approvals might cause GENR and partner to test Squalamine+Visudyne combination treatment in these subgroups.