CurrentmhnPolicy CP.PHAR.486

Bimatoprost intracameral implant (Durysta)

Defines medical necessity criteria, contraindications, dosing limits, re-authorization policy, and coding implications for Durysta (bimatoprost intracameral implant) for commercial, ICHRA, and Medicaid lines of business administered by Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyBimatoprost intracameral implant (Durysta)

Policy CodePolicy CP.PHAR.486

Change TypeAdministrative updates; step therapy bypass (IL HIM); added ICHRA LOB

Effective Date06.01.20

Next Review Date

Key ActionProvider must submit documentation demonstrating member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

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

Added ICHRA line of business.

Annual reviews through 2Q 2026: no significant changes; references reviewed and updated.

1Implants allowed per eye (lifetime)

≥18Minimum patient age

10 mcgMaximum dose per eye

J7351Key HCPCS code

Coverage Summary

Policy subject: Durysta (bimatoprost intracameral implant). This policy defines medical necessity criteria, contraindications, dosing limits, re-authorization rules, and coding implications for Durysta when used to reduce intraocular pressure for open angle glaucoma or ocular hypertension. Durysta is covered with criteria for the listed lines of business: Commercial, ICHRA, and Medicaid (Centene-affiliated plans), with specific criteria required for approval including diagnosis, prescriber, age, contraindication exclusions, dose limits and prior Durysta status.

Key limits and codes

Minimum patient age≥ 18 years

Maximum dose per eye10 mcg per eye

Implants allowed per eye (lifetime)One implant per eye (lifetime)

Key HCPCS codeJ7351

Initial Therapy Criteria — Open Angle Glaucoma / Ocular Hypertension

Initial Approval Criteria - Open Angle Glaucoma and Ocular Hypertension

Durysta is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
Prescribed by or in consultation with an ophthalmologist.
Age ≥ 18 years.
Medical justification supports inability to manage regular glaucoma eye drop use (e.g., due to age or comorbidities including visual impairment).
Illinois HIM requests: step therapy requirements do not apply as of 2026-01-01 per IL HB 5395.
The affected eye has not received prior treatment with Durysta.

Initial Therapy — Other Diagnoses / Off-Label Pathways

Initial Approval Criteria - Other diagnoses/indications

If request does not meet primary criteria, follow one of the pathways:

ANY of the following

If drug label changed within last 6 months and policy not yet updated, refer to no coverage or non-formulary policies as appropriate (CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary).
If requested use is not listed under section III and no recent label change applies, refer to off-label use policy for relevant line of business (CP.CPA.09; HIM.PA.154; CP.PMN.53).

Re-authorization / Continuation

Re-authorization rules for approved indication:

ALL of the following

Re-authorization is not permitted; members must meet initial approval criteria.
Approval duration: one implant per eye (lifetime total).

Not Authorized / Exclusions

Diagnoses/Indications Not Authorized

Coverage is NOT authorized when:

Indication is a non-FDA approved use not addressed in this policy, unless there is sufficient documentation per off-label use policies or evidence of coverage.

Provider Actions

Prior Authorization

Prior authorization required

Durysta is subject to medical necessity review and requires prior authorization demonstrating the listed initial approval criteria are met.

J7351

Documentation Required

Submit supporting documentation

Provider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating member meets all approval criteria.

Applicable Codes

HCPCS codes referencedHCPCS

J7351

Injection, bimatoprost, intracameral implant, 1 microgram

Codes referenced in this policy are informational and do not guarantee coverage; bill according to payer and current professional coding guidance. Prior authorization is required and providers must submit documentation demonstrating that the listed initial approval criteria are met.

Clinical Evidence & References

Evidence sources cited in the policy include the FDA Durysta Prescribing Information (AbbVie, October 2024) and the Phase 3 ARTEMIS 2 trial (20-month study, 2021).

Trials referenced

ARTEMIS 2Phase 3, 20-month study (2021)

Durysta PIDurysta Prescribing Information, AbbVie, October 2024

Background

Durysta is a single-use intracameral biodegradable implant containing 10 mcg bimatoprost indicated to reduce intraocular pressure in patients with open angle glaucoma or ocular hypertension. The implant is a single-use applicator and should not be re-administered to an eye that previously received Durysta. Administration must be performed under magnification and using standard aseptic intracameral technique.

Definitions

DSAEKDescemet's Stripping Automated Endothelial Keratoplasty

OAGOpen angle glaucoma

OHTOcular hypertension

IOPIntraocular pressure

Revision History

06.27.25material_added

Added step therapy bypass for IL HIM per IL HB 5395; applies to Illinois HIM line of business; noted that IL HIM requests are exempt as of 2026-01-01.

03.31.26 / P&T Approval 05.26addedLatest

Added ICHRA line of business (2Q 2026 annual review); no significant clinical policy statement changes.

2022-2026 (annual reviews)revised

Multiple annual reviews (2Q 2022, 2Q 2023, 2Q 2024, 2Q 2025, 2Q 2026) with no significant clinical policy statement changes; references reviewed and updated.