CurrentCareSourcePolicy N/A

Durysta (bimatoprost intracameral implant) utilization

Defines prior authorization, coverage criteria, dosing limits, and situations not recommended for approval for Durysta (bimatoprost intracameral implant) for treatment of open-angle glaucoma or ocular hypertension; applicable to providers requesting medical benefit coverage in North Carolina.

Policy Summary

PayerCareSource

PolicyDurysta (bimatoprost intracameral implant) utilization

Policy CodePolicy N/A

Change TypeAdded contraindicationclarified specialty administrationupdated example medications

Effective Date

Next Review DateFeb 12, 2025

Key ActionSubmit prior authorization with documentation that patient is ≥18, the treated eye has not been previously treated with Durysta, and that the implant will be administered by or under the supervision of an ophthalmologist.

SourceLink

POLICY UPDATE CHANGES

A prohibition on concurrent use of Durysta with iDose TR (travoprost intracameral implant) was added to conditions not recommended for approval.

Specialty requirement language was changed to require the medication be administered by or under the supervision of an ophthalmologist.

The note listing example ophthalmic prostaglandins was revised to include Iyuzeh (latanoprost 0.005% ophthalmic solution) and Omlonti (omidenepag isopropyl 0.002% ophthalmic solution).

onemaximum approved implants per eye (one-time use)

twomaximum total implants per patient

≥18

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Coverage Criteria for Durysta (bimatoprost intracameral implant)

FDA-Approved Indications (Ocular Hypertension and Open-Angle Glaucoma)

Covered when ALL of the following are met for the treated eye:

Eligibility: A) Patient is ≥ 18 years of age; B) Patient is not receiving re-treatment of eye(s) previously treated with Durysta; C) Patient meets BOTH of the following (i and ii):

Prior medication trials (both required): i) Patient has tried at least two ophthalmic prostaglandins (either as monotherapy or concomitant therapy) for the treatment of open-angle glaucoma or ocular hypertension; ii) Patient has tried at least two other ophthalmic products (either as monotherapy or concomitant therapy) from two different pharmacological classes for the treatment of open-angle glaucoma or ocular hypertension;

Examples of ophthalmic prostaglandins include bimatoprost 0.03% and 0.01% (Lumigan), latanoprost 0.005% (including Iyuzeh), travoprost 0.004%, Vyzulta (latanoprostene bunod 0.024%), Xelpros (latanoprost 0.005% emulsion), tafluprost 0.0015%, and Omlonti (omidenepag isopropyl 0.002%). Examples of pharmacological classes include beta-blockers, alpha-agonists (brimonidine), carbonic anhydrase inhibitors, and rho kinase inhibitors (netarsudil).

Exceptions for prior medication trials: For each ophthalmic medication that was tried, the prescriber may document EITHER: i) the medication was tried and failed, OR ii) the patient experienced adverse event(s) severe enough to warrant discontinuation of the previously tried ophthalmic product; documentation must be provided by the prescriber.

Administration and dosing: E) The medication is administered by or under the supervision of an ophthalmologist; Approve up to one Durysta implant per treated eye (one-time use per treated eye), with a maximum of two implants per patient.

Approvals are for a one-time intracameral administration per treated eye.

Coverage of Durysta is not recommended in the following situations. Re-treatment of previously treated eye(s): Durysta is approved for a one-time use in each treated eye; repeat administration to an eye previously treated with Durysta is not approvable. Concurrent intracameral implants: the concurrent use of Durysta with iDose TR (travoprost intracameral implant) is not recommended. Coverage is also not recommended for circumstances not listed in the Recommended Authorization Criteria; the criteria will be updated as new published data become available.

Repeat administration to an eye previously treated with Durysta is considered not approvable because Durysta is authorized as a single intracameral administration per treated eye. Requests for re-treatment of a previously treated eye therefore do not meet the authorization criteria and will be denied as not medically necessary for re-treatment.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required — limits on implants

Prior authorization is required for medical benefit coverage of Durysta. Approvals are for one implant per treated eye (one-time use) with a maximum of two implants per patient; approvals are issued to allow treatment of one or both eyes and are contingent on meeting the listed criteria including age, prior medication trials, and ophthalmology supervision.

Approvals provided for one implant per treated eye (one-time use).
Maximum of two implants per patient.

Step Therapy

Prior medication trials required

Before approval, the prescriber must document that the patient tried at least two ophthalmic prostaglandins and at least two other ophthalmic products from two different pharmacologic classes (these may be monotherapy or concomitant therapy). For each medication tried, the prescriber may document treatment failure or discontinuation for adverse events.

At least two ophthalmic prostaglandins tried (examples provided in policy).

Definitions

inv-09: Durysta

ProductDurysta (bimatoprost intracameral implant)

Formulation & DoseBiodegradable intracameral implant containing 10 mcg bimatoprost per implant

IndicationIndicated to reduce intraocular pressure (IOP) in open‑angle glaucoma or ocular hypertension

AdministrationSingle intracameral administration; given as a single‑use implant

Re‑administration restrictionShould not be re‑administered to an eye previously treated with Durysta

Background

Durysta (bimatoprost intracameral implant) is a biodegradable, single-use intracameral implant containing 10 mcg of bimatoprost intended to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It is administered as a one-time intracameral implant per treated eye to lower IOP and reduce the risk of glaucoma progression; because the implant is intended for single administration, re-administration to the same eye is not supported.