Izervay™
Drug - Izervay™ (avacincaptad pegol intravitreal solution) [Astellas Pharma Inc.]
January 2025
Therapeutic area - Macular Degeneration Agents
Initial approval criteria
- Patient is ≥ 18 years of age; AND
- Patient has a diagnosis of geographic atrophy (GA) as defined by a phenotype of central GA having ≥ 1 zones of well-demarcated retinal pigment epithelium (RPE) and/or choriocapillaris atrophy; AND
- Patient’s disease is secondary to age-related macular degeneration (AMD); AND
- Conditions other than AMD have been ruled out (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies); AND
- Patient has a baseline assessment for all the following: best corrected visual acuity (BCVA), fundus autofluorescence (FAF) imaging, and optical coherence tomography (OCT); AND
- Patient is free of ocular and/or peri-ocular infections; AND
- Patient does NOT have active intraocular inflammation; AND
- Will NOT be used in combination with other intravitreal complement inhibitor therapies; AND
- Patient does NOT have category 6 or higher visual impairment or blindness (e.g., no light perception-total blindness).
- Initial approval is for 6 months
Renewal criteria
- Patient must continue to meet the above criteria; AND
- Patient has had disease stabilization or slowing of the rate of disease progression while on therapy compared to pre-treatment baseline as measured by any of the following: BCVA, FAF, OCT; AND
- Continued administration is necessary for the maintenance treatment of the condition and patient and provider have discussed potential decrease in frequency of administrations; AND
- Patient has NOT received a total of 12 months (e.g., 12 doses per each eye) of therapy; AND
- Patient has NOT experienced any treatment-restricting adverse effects (e.g., endophthalmitis, retinal detachment, neovascular [wet] AMD or choroidal neovascularization, increased intraocular pressure) that cannot be adequately treated.
- Renewal approval is for 6 months
Quantity limits
- 1 vial (2 mg/0.1 mL solution) per eye every 28 days
- Maximum 4 mg every 28 days up to 12 months (based on administration to both eyes)
Questions?
Provider Call Center 844-575-7887