CurrentmhnPolicy CP.PHAR.486

Bimatoprost Implant (Durysta)

Medical necessity and coverage criteria for the use of the bimatoprost intracameral implant (Durysta) to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension for members of the health plan.

Policy Summary

Payermhn

PolicyBimatoprost Implant (Durysta)

Policy CodePolicy CP.PHAR.486

Change TypeStep therapy bypass added (IL HIM)

Effective Date06.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation that the member meets all initial approval criteria, including diagnosis, ophthalmologist involvement, age ≥18, inability to manage topical drops, absence of contraindications, and dose limits.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

10 mcgmaximum per-eye bimatoprost dose

Oneimplant per eye

≥18minimum age

J7351billing code

Coverage Criteria

Policy Summary

Payermhn

PolicyBimatoprost Implant (Durysta)

Policy CodePolicy CP.PHAR.486

Change TypeStep therapy bypass added (IL HIM)

Effective Date06.01.20

Next Review Date

SourceLink

On This Page

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Initial approval for OAG/OHT: 1. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT); 2. Prescribed by or in consultation with an ophthalmologist; 3. Age ≥ 18 years; 4. Medical justification supports inability to manage regular glaucoma eye drop use (e.g., due to age or comorbidities including visual impairment); 5. The affected eye has not received prior treatment with Durysta; 6. Member has none of the following contraindications: (a) active or suspected ocular or periocular infection; (b) corneal endothelial cell dystrophy (e.g., Fuchs' Dystrophy); (c) history of corneal transplantation or endothelial cell transplant (e.g., DSAEK); (d) absent or ruptured posterior lens capsule; (e) hypersensitivity to bimatoprost or components; 7. Dose does not exceed both: (a) 10 mcg per eye and (b) one implant per eye.

Approval duration: one implant per eye (lifetime total).

Other diagnoses/indications

For uses not covered under the main criteria, one of the following must apply:

Other diagnoses/indications: 1) If the drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the referenced formulary or non-formulary/no-coverage criteria policies for the applicable line of business; OR 2) If the requested use (e.g., diagnosis, age, dosing regimen) is not specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

See cited payer policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Durysta (HCPCS J7351). Providers must request PA before dispensing/implanting the product.

Affected code: J7351 (Durysta)
Approval duration: one implant per eye (lifetime total)

Step Therapy

Step Therapy / Medical Justification Required

If step therapy is applicable, the provider must submit medical justification demonstrating inability to use or inadequate response to regular glaucoma eye drops (for example due to age, visual impairment, or comorbidities). For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395 (effective 01/01/2026).

Operational exception: IL HIM — step therapy bypass applies

Documentation Required

Supporting Documentation Required

Provider must submit clinical documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant ophthalmology consultation notes, diagnostic test results, and any other information demonstrating inability to use topical drops or meeting other stated criteria.

Examples: office notes, labs, imaging, prior medication trials, ophthalmology consults

Denial Risk

Contraindications Trigger Denial

Presence of any listed contraindication will result in denial of the request. Contraindications include active or suspected ocular/periocular infection; corneal endothelial cell dystrophy (e.g., Fuchs' Dystrophy); history of corneal transplantation or endothelial cell transplant (e.g., DSAEK); absent or ruptured posterior lens capsule; or hypersensitivity to bimatoprost or any component of Durysta.

Active or suspected ocular or periocular infection
Corneal endothelial cell dystrophy (e.g., Fuchs' Dystrophy)
History of corneal transplantation or endothelial cell transplant (e.g., DSAEK)
Absent or ruptured posterior lens capsule
Hypersensitivity to bimatoprost or any component of Durysta

Definitions & Dosing

Durysta dosing/administration

Dose and formulationIntracameral implant containing 10 mcg of bimatoprost in a biodegradable drug delivery system; single intracameral administration

Repeat administrationDurysta should not be readministered to an eye that previously received Durysta; maximum one implant per eye

Indication contextIndicated to reduce intraocular pressure in open-angle glaucoma (OAG) or ocular hypertension (OHT)

Administration procedure

Magnification and visualizationAdminister under magnification that allows clear visualization of anterior chamber structures

Aseptic techniquePerform procedure using standard aseptic conditions for intracameral procedures with patient's head stabilized

Pupil managementDo not dilate the eye prior to the procedure

Packaging handlingOpen foil pouch over a sterile field and use applicator promptly; follow package insert for additional instructions

Background

Durysta is a single‑use intracameral biodegradable implant that contains bimatoprost and is indicated to reduce intraocular pressure in patients with open‑angle glaucoma or ocular hypertension. It is administered intracamerally by an ophthalmologist using magnification and aseptic technique and is intended as a one‑time implant per eye; re‑administration to an eye that previously received Durysta is not permitted. The implant delivers 10 mcg of bimatoprost and coverage is limited to one implant per eye in accordance with the policy criteria.

Revision History

2025-06-27policy_revisionLatest

Added step therapy bypass for Illinois Health Insurance Marketplace (HIM) requests per Illinois HB 5395, indicating the step therapy requirements do not apply for IL HIM requests as of 1/1/2026.

2021-01-11annual_review

Coding implications section added and references updated (2Q 2021 annual review).

2022-01-13annual_review

References reviewed and updated (2Q 2022 annual review).

2023-02-02annual_review

References reviewed and updated (2Q 2023 annual review).

2024-01-31annual_review

References reviewed and updated (2Q 2024 annual review).

2025-01-22annual_review

References reviewed and updated (2Q 2025 annual review).