CurrentMass General Brigham Health PlanPolicy N/A

Complement Inhibitors and Miscellaneous Immunosuppressive Agents Izervay (avacincaptad pegol)

Pharmacy benefit prior authorization and quantity-limit policy governing coverage and continuation criteria for Izervay (avacincaptad pegol) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for members of Mass General Brigham Health Plan / MassHealth UPPL.

Policy Summary

PayerMass General Brigham Health Plan

PolicyComplement Inhibitors and Miscellaneous Immunosuppressive Agents Izervay (avacincaptad pegol)

Policy CodePolicy N/A

Change TypeFormatting and criteria adoption

Effective DateFeb 18, 2025

Next Review Date

Key ActionPrior authorization required under the pharmacy benefit for Izervay (avacincaptad pegol); contact phone/fax numbers provided on policy.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and updated for P&T in January 2025 with formatting updates to header; effective 02/18/2025.

6 monthsInitial approval duration

1 yearMaximum recertified approval duration

>50Minimum patient age

2 mg Q28dRequested dosing

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Coverage Summary

Policy places prior authorization and quantity limits for Izervay (avacincaptad pegol) under the pharmacy benefit for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Coverage stance: covered with criteria.

Key Thresholds and Stats

Age> 50 years

BCVA (normal luminance best corrected visual acuity)≤ 224 letters (20/320 Snellen equivalence)

Total GA lesion area≥ 2.5 and < 17.5 mm2, with at least 1 lesion ≥ 1.25 mm2 if multifocal

Dose and interval2 mg (0.1 mL) every 28 days

Maximum supported duration by data≤ 1 year (no data supporting dosing > 1 year)

Initial Therapy Criteria

Initial Authorization (Authorization may be granted when ALL of the following are met)

Authorization may be granted for members when all the following criteria are met:

Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
Prescriber specialty: Prescriber is an ophthalmologist
Age: Member is > 50 years of age
Absence of neovascular AMD: Absence of choroidal neovascularization (CNV or Wet-AMD) in the treatment eye
BCVA:

Continuation Therapy Criteria

Continuation of Therapy

Prescriber must provide documentation of ALL of the following:

Positive response to therapy
Prescriber must document clinically meaningful benefit
No nAMD development: Member has not developed nAMD (wet AMD)
Treatment duration: Total treatment duration < 1 year< 1 year
Continuation documentation required while treatment duration is less than 1 year

Authorization for Members New to the Plan

Authorization for members new to plan currently receiving treatment

Authorization may be reviewed on a case by case basis for members who are new to the plan currently receiving treatment with requested medication

Authorization for members new to plan currently receiving treatment: Member is new to the plan and currently receiving the requested medication

Excludes medication obtained as samples or via manufacturer's patient assistance programs

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required

Prior authorization required under the pharmacy benefit for Izervay (avacincaptad pegol); contact phone/fax numbers provided on policy.

Documentation Required

Document baseline diagnostic and clinical measures

Prescriber must document the following baseline diagnostic and clinical measures in the medical record before authorization:

Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
Prescriber specialty: ophthalmologist
Member age > 50 years
Best corrected visual acuity (BCVA) (normal luminance) ≤ 224 letters (20/320 Snellen equivalence)
Absence of choroidal neovascularization (CNV / wet AMD) in the treatment eye

Applicable Codes & Benefit Classification

Medical benefit / pharmacy benefit classificationmixed

No codes listed

Clinical Evidence & Background

Izervay (avacincaptad pegol) is indicated for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The policy aligns with MassHealth criteria and places prior authorization and quantity limits under the pharmacy benefit. Review history notes adoption of MassHealth criteria and formatting updates effective 02/18/2025.

Izervay [package insert], Iveric Bio, Inc; 2023 Aug

Definitions & Key Thresholds

GA: Geographic atrophy secondary to age-related macular degeneration.

CNV: Choroidal neovascularization (wet AMD).

BCVA: Normal luminance best corrected visual acuity (documented in letters or Snellen equivalence).

Numeric Thresholds (for criteria)

Age>50 years

BCVA≤ 224 letters (20/320)

Total GA lesion area≥ 2.5 and < 17.5 mm2; if multifocal, at least 1 lesion ≥ 1.25 mm2

Dose2 mg (0.1 mL) every 28 days (Q28d)

Maximum supported duration≤ 1 year

Revision History

2025-02-18policy_updateLatest

Policy reviewed and updated for P&T in January 2025 with formatting updates to header; effective 02/18/2025.

2024-05-06policy_effective

Policy adopted MassHealth criteria; Izervay required prior authorization under the medical benefit and was made effective 05/06/2024.

2024-04-10policy_created

Policy Summary

PayerMass General Brigham Health Plan

PolicyComplement Inhibitors and Miscellaneous Immunosuppressive Agents Izervay (avacincaptad pegol)

Policy CodePolicy N/A

Change TypeFormatting and criteria adoption

Effective DateFeb 18, 2025

Next Review Date

Key ActionPrior authorization required under the pharmacy benefit for Izervay (avacincaptad pegol); contact phone/fax numbers provided on policy.

SourceLink

On This Page

Normal luminance best corrected visual acuity (BCVA) ≤ 224 letters (20/320 Snellen equivalence)

≤ 224 letters (20/320)

Document BCVA in clinical record

Total GA lesion area ≥ 2.5 and < 17.5 mm2, with at least 1 lesion ≥ 1.25 mm2 if GA is multifocal≥ 2.5 and < 17.5 mm2; ≥ 1.25 mm2 if multifocal

Policy text appears to have formatting issues; interpreted numeric thresholds from provided text

Pattern of hyperautofluorescence: Presence of pattern of hyperautofluorescence in the junctional zone of GA

Any pattern

Requested dosing is 2 mg (0.1 mL) every 28 days2 mg every 28 days

Total GA lesion area ≥ 2.5 and < 17.5 mm2, with at least 1 lesion ≥ 1.25 mm2 if multifocal

Presence of pattern of hyperautofluorescence in the junctional zone of the GA

Requested dosing: 2 mg (0.1 mL) every 28 days

Documentation Required

Continuation documentation

For continuation of therapy, the prescriber must document all of the following:

Positive response to therapy (clinically meaningful benefit)
Member has not developed neovascular AMD (nAMD / wet AMD)
Total treatment duration is less than 1 year

Billing Rule

Initial approval duration

Initial approval duration will be granted for 6 months. Recertification may be granted such that total approval duration does not exceed 1 year (no data supporting dosing > 1 year).

Initial approval: 6 months
Maximum recertified approval duration: 1 year

Policy created for P&T on 04/10/2024.