Avacincaptad Pegol (Izervay)

Number: 1041

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Brand Selection for Medically Necessary Indications for Commercial Medical Plans

As defined in Aetna commercial policies, health care services are not medically necessary when they are more costly than alternative services that are at least as likely to produce equivalent therapeutic or diagnostic results. Izervay is more costly to Aetna than other medications for the treatment of geographic atrophy secondary to age-related macular degeneration. There is a lack of reliable evidence that Izervay is superior to the lower cost for the treatment of geographic atrophy secondary to age-related macular degeneration: Syfovre. Therefore, Aetna considers Izervay to be medically necessary only for members who have a contraindication, intolerance or ineffective response to the available equivalent alternative for the treatment of geographic atrophy secondary to age-related macular degeneration: Syfovre.

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Policy

Note: Requires Precertification: 

Precertification of avacincaptad pegol (Izervay) is required of all Aetna participating providers and members in applicable plan designs. For precertification of avacincaptad pegol (Izervay), call (866) 752-7021 (commercial) or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification. 

1. Exclusions 

   Aetna will not provide coverage for members for the following:

   1. Coverage will not be provided beyond 12 months of therapy;
   2. Coverage will not be provided for the treatment of geographic atrophy (GA) secondary to a condition other than AMD (such as Stargardt disease, cone rod dystrophy, toxic maculopathies).

2. Prescriber Specialties

   This medication must be prescribed by or in consultation with an ophthalmologist.

3. Criteria for Initial Approval

   Geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

   Aetna considers avacincaptad pegol (Izervay) medically necessary for treatment of geographic atrophy when both of the following criteria are met:

   1. Member has a diagnosis of geographic atrophy secondary to age-related macular degeneration; and
   2. Member will receive 2mg injection into each affected eye once monthly for up to 12 months.

   Aetna considers all other indications as experimental, investigational, or unproven.

4. Continuation of Therapy

   See Dosage and Administration information.

Dosage and Administration

Avacincaptad pegol is supplied as Izervay intravitreal solution 20 mg/mL in a single-dose vial for intravitreal injection.

Izervay must be administered by a qualified physician.

The recommended dose for Izervay is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately every 28 ± 7 days) for up to 12 months.

Source: Iveric bio, 2023

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
67028	Intravitreal injection of a pharmacologic agent (separate procedure)
HCPCS codes covered if selection criteria are met:
J2782	Injection, avacincaptad pegol, 0.1 mg
ICD-10 codes covered if selection criteria are met:
H35.30	Unspecified macular degeneration [Geographic atrophy]
H35.3110 - H35.3194	Nonexudative age-related macular degeneration [Geographic atrophy]
H35.3210 – H35.3293	Exudative age-related macular degeneration [Geographic atrophy]
ICD-10 codes not covered for indications listed in the CPB:
H35.381 – H35.389	Toxic maculopathy
H35.52	Pigmentary retinal dystrophy [cone rod dystrophy]
H35.53	Other dystrophies primarily involving the sensory retina [Stargardt's disease]

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Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

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

Avacincaptad pegol is available as Izervay (Iveric bio, Inc.) and is a ribonucleic acid (RNA) aptamer, a PEGylated oligonucleotide that binds to and inhibits complement protein C5.Through C5 inhibition, Izervay may prevent its cleavage to C5a and C5b thus decreasing membrane attack complex (MAC) formation (Iveric bio, 2023).

According to the prescribing information, Izervay carries the following contraindications:

• Ocular or periocular infections
• Active intraocular inflammation

Per the prescribing information, Izervay carries the following warnings and precautions:

• Endophthalmitis and retinal detachments
• Neovascular AMD
• Increase in intraocular pressure (IOP)

Per the prescribing information for Izervay, the most common adverse reactions include: conjunctival hemorrhage (13%), increased IOP (9%), blurred vision (8%) and neovascular age-related macular degeneration (7%).

On August 4, 2023, the U.S. Food and Drug Administration (FDA) approved avacincaptad pegol (Izervay), a C5 complement inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The FDA approval was based on supporting data from the GATHER1 and GATHER2 phase 3 clinical trials (Astellas Pharma, 2023).

The GATHER1 and GATHER2 trials were two randomized, multi-center, double-masked, sham-controlled, 18- and 12-month studies, respectively. In both studies, investigators evaluated the safety and efficacy of Izervay in patients with GA due to AMD. In all, 292 patients received treatment with intravitreal Izervay 2 mg and 332 patients received sham. The mean rate of GA (slope) from baseline to month 12 was measured by Fundus Autofluorescence (FAF) and evaluated at baseline, month 6, and month 12 in GATHER1 and GATHER2. Data was available through month 18 for GATHER1 and month 12 for GATHER2. The primary efficacy endpoint for each study was the observed GA rate of growth. In each study, the primary analysis over a 12-month period showed a statistically significant reduction in the rate of GA growth in patients receiving Izervay versus sham. Furthermore, the slowing of disease progression was noted as early as 6 months with up to a 35% reduction in the first year of treatment (Astellas Pharma, 2023; Iveric bio, 2023).

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References