Medical Necessity and Standard of Care Assessment for Vabysmo in AMD
Direct Answer to Medical Necessity
Vabysmo (faricimab) 6 mg intravitreal every 4 weeks is medically necessary and represents standard of care for the eye with neovascular (wet) AMD and active choroidal neovascularization (CNV), but it is NOT indicated for the eye with intermediate dry AMD. 1, 2
Treatment Indication Analysis
For the Eye with Neovascular AMD and Active CNV
This is the appropriate indication and Vabysmo is FDA-approved standard of care:
Vabysmo is FDA-approved for neovascular (wet) age-related macular degeneration, which is precisely what this patient has in one eye with documented active CNV 1, 2
Anti-VEGF therapy must be initiated immediately upon diagnosis of wet AMD, as early treatment within 2 years significantly reduces legal blindness and visual impairment 1
The standard protocol involves administration at 8,12, or 16-week intervals after 4 initial monthly loading doses, but treatment intervals should be adjusted based on clinical response 2
Patients showing evidence of persistent or recurrent disease activity may require shorter treatment intervals, such as every 4 weeks 2
There is no consensus on ideal treatment intervals with anti-VEGF agents, with recognized protocols including monthly/bimonthly injections, treat-and-extend, or PRN (as needed) 2
For the Eye with Intermediate Dry AMD
Vabysmo is NOT indicated and NOT standard of care for this eye:
Dry AMD accounts for approximately 85-90% of AMD cases and is characterized by drusen and retinal pigment epithelial changes, NOT choroidal neovascularization 1
The only proven intervention for intermediate dry AMD is AREDS2 supplementation (vitamin C, vitamin E, zinc, copper, lutein 10mg, zeaxanthin 2mg), which reduces progression risk by up to 36% over 10 years 1
No FDA-approved therapies are currently available to slow geographic atrophy progression in dry AMD 1
Anti-VEGF agents like Vabysmo are specifically indicated for neovascular AMD with active CNV, not for dry AMD 3, 1
Standard of Care Determination
Evidence-Based Treatment Protocol
For the neovascular AMD eye, the treatment plan follows established standard of care:
The American Academy of Ophthalmology recommends intravitreal anti-VEGF therapy as the primary treatment for wet AMD, which should be initiated as soon as diagnosis is made 3, 1
Treatment regimens using anti-VEGF agents (including fixed continuous treatment approximately every 4 weeks, PRN, or treat-and-extend) are all recognized as standard approaches 3, 4
Monthly regimens are probably more effective than PRN regimens using seven or eight injections in the first year, though the difference is small and clinically insignificant 4
Patients with neovascular AMD who demonstrate positive clinical response but experience symptom recurrence before the standard treatment interval may require continuation of treatment every 4 weeks 2
Treatment Frequency Justification
Every 4-week dosing is justified when:
The patient shows evidence of persistent or recurrent disease activity before longer intervals 2
Disease stabilization has not been achieved with extended intervals 2
OCT imaging demonstrates persistent or recurrent subretinal or intraretinal fluid 1, 2
The treating ophthalmologist's clinical judgment determines more frequent dosing is necessary to maintain disease control 2
Experimental vs. Standard Treatment Classification
This treatment is NOT experimental or investigational:
Vabysmo (faricimab) is FDA-approved for neovascular (wet) AMD 1, 2
Anti-VEGF therapy represents the gold standard treatment for wet AMD and has been extensively studied in major clinical trials (MARINA, VIEW, CATT, IVAN, HARBOR) 3
Monthly injection regimens are well-established in the literature and represent one of the standard treatment approaches 3, 4
The American Academy of Ophthalmology Preferred Practice Pattern guidelines explicitly support anti-VEGF therapy for neovascular AMD 3, 1
Critical Clinical Considerations
Monitoring Requirements
OCT imaging must be performed at each visit to assess for persistent or recurrent fluid 1, 2
Patients must be monitored for signs of endophthalmitis, retinal detachment, or decreased vision with any intravitreal therapy 2
The fellow eye with intermediate dry AMD remains at high risk for conversion to wet AMD and requires periodic monitoring every 6-12 months even without symptoms 1
Safety Profile
Endophthalmitis risk with monthly anti-VEGF injections is approximately 8 in every 1000 people per year 4
PRN regimens are associated with reduced risk of endophthalmitis compared to monthly injections (1 in 1000 people per year) 4
All anti-VEGF treatments may carry theoretical risks for systemic arterial thromboembolic events and increased intraocular pressure, though clinical trial results remain inconclusive 3
Recommendation for Authorization
Approve Vabysmo 6 mg intravitreal every 4 weeks ONLY for the eye with neovascular AMD and active CNV. This represents medically necessary, FDA-approved, standard of care treatment supported by American Academy of Ophthalmology guidelines. 3, 1, 2
Deny Vabysmo for the eye with intermediate dry AMD. This represents off-label use without supporting evidence, as the standard of care for intermediate dry AMD is AREDS2 supplementation, not anti-VEGF therapy. 1
The authorization should specify treatment is for the eye with documented neovascular AMD and active CNV only, with continuation of every 4-week dosing justified based on clinical response assessment and the treating ophthalmologist's determination that more frequent dosing is necessary to maintain disease control. 2