Medical Policy
Effective Date:01/01/2024 Title:Izervay
Revision Date: Document:BI732:00
CPT Code(s):
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Izervay (avacincaptad pegol) requires prior authorization.

2)    Izervay is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

3)    Izervay is covered under the medical benefit.
Medical Statement

Initial Approval Criteria

A.   Geographic Atrophy (must meet all):

1.    Diagnosis of GA with all of the following characteristics:

a)    GA is secondary to AMD;

b)    Total GA area > 2.5 and < 17.5 mm2 (1 and 7 disk areas [DA] respectively

c)    If GA is multifocal, at least one focal lesion > 1.25mm2 (0.5 DA)

d)    Presence of hyperautofluorescence in the junctional zone of GA;

e)    GA is not centered in the fovea;

2.    Prescribed by or in consultation with an ophthalmologist;

3.    Age > 50 years;

4.    Best corrected visual acuity (BCVA) between 20/25 and 20/320;

5.    Member does not have either of the following:

a)    Signs of diabetic retinopathy in either eye;

b)    Evidence of choroidal neovascularization in the eye(s) affected by GA;

c)    Dose does not exceed 2mg (0.1ml of 20mg/ml solution) in each eye every 21 days.
Limits
Intentially left empty
Reference

1.    Izervay Prescribing Information. Parsippany, NJ: IVERIC bio; August 2023. Available at: https://ivericbio.com/wp-content/uploads/IZERVAY-avacincaptad-pegol-intravitreal-solution-PI_Final_8.4.23.pdf. Accessed August 21, 2023.

2.    Jaffe GJ, Westby K, Csaky KG, et al. C5 inhibitor avacincaptad pegol for geographic atrophy due to age-related macular degeneration: a randomized pivotal phase 2/3 trial. Ophthalmology. 2021;128(4):576-586.

3.    ClinicalTrials.gov. A phase 3 safety and efficacy study of intravitreal administration of Zimura (complement C5 inhibitor). Available at: https://clinicaltrials.gov/study/NCT04435366. Accessed August 21, 2023.

4.    American Academy of Ophthalmology Retina/Vitreous Committee. Preferred Practice Pattern® Guidelines. Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/education/preferred-practice-pattern/age-related-macular-degeneration-ppp. Accessed August 21, 2023.

 
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.