CurrentAnthemPolicy CC-0163

Medical Drug Clinical Criteria - Durysta (bimatoprost implant)

Clinical criteria for medical-benefit coverage and prior authorization of Durysta (bimatoprost intracameral implant) to reduce elevated intraocular pressure in individuals with open-angle glaucoma or ocular hypertension, including contraindications, quantity limits, and applicable codes.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria - Durysta (bimatoprost implant)

Policy CodePolicy CC-0163

Change TypeReviewed (06/09/2025); prior clinical revisions in 2021 and initial creation in 2020

Effective Date

Next Review Date

Key ActionDocument trials and insufficient response or intolerance to two IOP eye-drop agents used as combination therapy, specifying that one agent was a prostaglandin analog, when submitting requests for Durysta.

SourceLink

POLICY UPDATE CHANGES

06/09/2025 - Annual Review: No changes. Coding Reviewed: Updated description for HCPCS J7351. Administrative update to remove erroneous ICD-10 codes.

05/21/2021 - Annual Review: Update criteria to require only trial of combination use of topical eye drops prior to Durysta.

05/15/2020 - Add new clinical criteria document for Durysta (bimatoprost implant).

2Required prior topical agents (as combination)

2Lifetime applicator limit (10 mcg)

1Implants allowed per eye (single administration only)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Clinical criteria for medical-benefit coverage and prior authorization of Durysta (bimatoprost intracameral implant) to reduce elevated intraocular pressure in individuals with open-angle glaucoma or ocular hypertension, including contraindications, quantity limits, and applicable codes. Indication: Durysta is indicated to reduce elevated intraocular pressure (IOP) in open-angle glaucoma or ocular hypertension. Limits: one implant per eye (single administration only) and a lifetime applicator limit of 2 (Durysta 10 mcg single-use applicator, limit = 2 per lifetime).

Quick facts — Durysta (bimatoprost implant)

Required prior topical agents (as combination)Trial and insufficient response or intolerance to two (2) IOP eye-drop agents used as combination therapy (either 2 single-agent products or 1 combined-agent product), with one agent being a prostaglandin analog

Lifetime applicator limit (10 mcg)Durysta 10 mcg single-use applicator limited to 2 applicators (10 mcg) per lifetime

Implants allowed per eyeOnly one implant per eye; repeat administration in the same eye is not approved due to increased risk of corneal endothelial cell loss

Initial Therapy / Approval Criteria

Approval Criteria (Durysta) "} ,{"ref":"b2_0","title":"Not Approved / Contraindications","intro":"Durysta (bimatoprost implant) may not be approved for the following:","citations":["4"],"nodes":["{\"operator\":\"any\",\"n\":0,\"label\":\"Not approved if ANY of the following apply\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"all\",\"n\":0,\"label\":\"\",\"text\":\"Repeat administration in the same eye\",\"threshold\":\"\",\"note\":\"\"},{\"operator\":\"all\",\"n\":0,\"label\":\"\",\"text\":\"Active or suspected ocular or periocular infections\",\"threshold\":\"\",\"note\":\"\"},{\"operator\":\"all\",\"n\":0,\"label\":\"\",\"text\":\"Corneal endothelial cell dystrophy (for example, Fuchs' Dystrophy)\",\"threshold\":\"\",\"note\":\"\"},{\"operator\":\"all\",\"n\":0,\"label\":\"\",\"text\":\"Prior corneal transplantation, or endothelial cell transplants (for example, Descemet's Stripping Automated Endothelial Keratoplasty [DSAEK])\",\"threshold\":\"\",\"note\":\"\"},{\"operator\":\"all\",\"n\":0,\"label\":\"\",\"text\":\"Absent or ruptured posterior lens capsule\",\"threshold\":\"\",\"note\":\"\"},{\"operator\":\"all\",\"n\":0,\"label\":\"\",\"text\":\"When the above criteria are not met and for all other indications\",\"threshold\":\"\",\"note\":\"\"}]}"]}]}

Requests for Durysta (bimatoprost implant) may be approved if the following criteria are met:

ALL of the following

Individual has a diagnosis of open angle glaucoma or ocular hypertension with elevated intraocular pressure
Individual has had a trial and insufficient response or intolerance to two (2) IOP eye-drop agents as combination therapy (either as 2 single agent products or 1 combined agent product), where one agent is a prostaglandin analog (for example, bimatoprost, latanoprost, travoprost, or tafluprost)

Definitions: IOP — Intraocular pressure; measurement of the fluid pressure inside the eye. Operational note: Durysta is an intracameral, biodegradable sustained-release bimatoprost implant delivered via a disposable single-use applicator inserted into the anterior chamber. Because of an increased risk of corneal endothelial cell loss, administration is limited to one implant per eye (no retreatment).

Not Approved / Contraindications

Denial Risk

Contraindication denial risk

Claims may be denied for repeat administration to the same eye or when listed contraindications are present.

Repeat administration in the same eye
Active or suspected ocular or periocular infections
Corneal endothelial cell dystrophy (for example, Fuchs' Dystrophy)
Prior corneal transplantation or endothelial cell transplants (for example, DSAEK)
Absent or ruptured posterior lens capsule

Provider Actions & Billing Rules

Prior Authorization

Prior authorization requirement

Requests for Durysta are subject to clinical review (prior authorization) and will be approved only when the specified clinical criteria are met, including diagnosis of open-angle glaucoma or ocular hypertension with elevated IOP and trial/intolerance to two IOP eye-drop agents used as combination therapy including a prostaglandin analog.

J7351

Documentation Required

Document prior topical therapy

Provider must document trials and insufficient response or intolerance to two IOP eye-drop agents used as combination therapy (either two single-agent products or one combined-agent product), and document that one agent was a prostaglandin analog (for example, bimatoprost, latanoprost, travoprost, or tafluprost).

Billing Rule

Lifetime quantity limit

Durysta 10 mcg single-use applicator is limited to 2 applicators (10 mcg) per lifetime.

J7351: Lifetime limit = 2 applicators

Clinical Evidence & Guidance

Evidence: Guideline cited — American Academy of Ophthalmology Primary Open-Angle Glaucoma 2020 preferred practice pattern. Background evidence summary: Durysta is an FDA-approved intracameral, biodegradable sustained-release bimatoprost implant to reduce IOP in individuals with open-angle glaucoma or ocular hypertension. It is delivered via a disposable single-use applicator inserted into the anterior chamber. Due to an increased risk of corneal endothelial cell loss, patients should receive only one implant per eye and no retreatment. Quantity limits in the policy specify a Durysta 10 mcg single-use applicator limit of 2 applicators per lifetime.

Revision History

05/15/2020added

Initial policy creation: Add new clinical criteria document for Durysta (bimatoprost implant) and initial coding additions (HCPCS J3490, C9399; ICD-10 H40.10X0-H40.1194, H40.051-H40.059).

05/21/2021revised

Clinical criteria revised to require trial of combination use of topical eye drops prior to Durysta (specifying two IOP eye-drop agents as combination therapy with one agent a prostaglandin analog).

06/09/2025clarifiedLatest

Administrative/coding update only: Annual review noted no clinical changes; updated description for HCPCS J7351 and removal of erroneous ICD-10 codes.