Bimatoprost Implant (Durysta)
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
Glaucoma is a progressive disease of the eye that can lead to irreversible vision loss and blindness. It is marked by increased levels of pressure in the eye, or ocular hypertension. Primary open-angle glaucoma (POAG) is the most common form of glaucoma. It is a form of glaucoma in which intra-ocular pressure (IOP) elevation is caused by increased resistance to aqueous outflow through 2 pathways—the trabecular meshwork and uveoscleral outflow pathways. POAG is a progressive, often asymptomatic, and chronic disease of unknown etiology characterized by elevated IOP as determined by a patient’s physician that, when uncontrolled, causes optic nerve damage and loss of vision.
The most common treatment is prostaglandin eye drops, with other treatments including laser trabeculoplasty, minimally invasive surgery and incisional surgery. A number of medications are currently in use to treat glaucoma. Typically medications are intended to reduce elevated intraocular pressure and prevent damage to the optic nerve. Eye drops used in managing glaucoma decrease eye pressure by helping the eye’s fluid to drain better and/or decreasing the amount of fluid made by the eye. Drugs to treat glaucoma are classified by their active ingredient. These include: prostaglandin analogs, beta blockers, alpha agonists, carbonic anhydrase inhibitors, and rho kinase inhibitors. Combination drugs are available for patients who require more than one type of medication.
On March 4, 2020, the U.S. Food and Drug Administration (FDA) approved Allergan’s Durysta (bimatoprost implant) 10 mcg for intracameral administration to treat open-angle glaucoma (OAG) or ocular hypertension (OHT). The approval is built on data from two multicenter, randomized, parallel-group, controlled 20-month (including 8-month extended follow-up) Phase III ARTEMIS trials that evaluated 1,122 patients with Durysta (bimatoprost implant) compared to twice-daily topical timolol 0.05% drops. In the trials, Durysta (bimatoprost implant) decreased IOP by about 30% over baseline over the 12-week primary efficacy period. Durysta (bimatoprost implant) demonstrated an IOP reduction of approximately 5 to 8 mm Hg in patients with a mean baseline IOP of 24.5 mm Hg. The most common ocular adverse reaction observed in the two randomized, active-controlled clinical trials with Durysta (bimatoprost implant) in patients with OAG or OHT was conjunctival hyperemia, which was reported in 27% of patients. Other common ocular adverse reactions reported in 5% to 10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular pressure increased, corneal endothelial cell loss, vision blurred, and iritis. The most common nonocular adverse reaction was headache (5% of patients).
As per the FDA labeled package insert, Durysta (bimatoprost implant) is a biodegradable implant intended for a single administration and should not be re-administered to an eye that received a prior Durysta (bimatoprost implant).
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. ophthalmologist) or has consulted with a specialist in the area of the patient’s diagnosis.
II. Durysta (bimatoprost implant) is considered medically necessary when ALL of the following are met:
III. When Durysta (bimatoprost implant) is considered medically necessary, therapy will be approved as a one-time implant in each affected eye at the following FDA approved recommended dose:
a. Member is at 18 years of age or older
b. Member has a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
c. Member has tried and had an inadequate response to a topical eye drop used for the diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
d. Member does not have any of the following:
i. History of narrow-angle or closed-angle glaucoma
ii. Intraocular surgery within the 3 months prior to treatment
iii. Contraindication to therapy (e.g. ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal transplantation, absent or ruptured posterior lens capsule, hypersensitivity)
[INFORMATIONAL NOTE: As per the Glaucoma Research Foundation, examples of current glaucoma eye drops include:
- Iopidine (Apraclonidine HCL 0.5%, 1%)
- Alphagan P (Brimonidine tartrate 0.1%, 0.15%)
Carbonic Anhydrase Inhibitors
- Timolol Maleate USP (Timolol Maleate 0.5%)
- Betoptic S (Betaxolol HCL 0.25%, 0.5%)
- Metipranolol 0.3%
- Istalol (Timolol Maleate Ophthalmic Solution 0.5%)
- Timoptic-XE (Timolol Maleate Ophthalmic gel forming solution 0.25%, 0.5%)
- Betimol (Timolol hemiydrate 0.25%, 0.5%)
- Azopt (Brinzolamide ophthalmic solution, 1%)
- Trusopt (Dorzolamide HCL 2%)
- Isopto Carpine (Pilocarpine 1%, 2%, 4%)
- Isopto Carbachol 1.5%, 3%
- Pilocarpine HCl Ophthalmic Solution USP (Pilocarpine 1%, 2%, 4%)
- Combigan (Brimonidine Tartrate & Timolol Maleate)
- Cosopt (Dorzolamide HCl & Timolol Maleate)
- Simbrinza Suspension (Brinzolamide/Brimonidine tartrate ophthalmic suspension 1%/0.2%)
Rho Kinase Inhibitors
- Travatan Z (Travaprost 0.004%)
- Lumigan (Bimatoprost 0.01%, 0.03%)
- Vyzulta (Latanoprostene bunod 0.024%)
- Zioptan (Tafluprost opthalmic solution 0.0015%)
- Xalatan (Latanoprost 0.005%)
- Rhopressa (Netarsudil 0.02%)]
IV. Other uses of Durysta (bimatoprost implant) are considered investigational, including but not limited to, repeat administration of Durysta (bimatoprost).
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
Bimatoprost Implant (Durysta)
Durysta (Bimatoprost Implant)
1. Durysta [package insert]. Madison, NJ: Allergan USA, Inc. March 2020.
2. Lewis RA, Christie WC, Day DG, et al. Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial. Am J Ophthalmol 2017;175:137–147.
3. Craven, E.R., Walters, T., Christie, W.C. et al. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs 80, 167–179 (2020).
4. Formulary Submission Dossier: Durysta for open-angle glaucoma or ocular hypertension. Version 1. April 30, 2020. Allergan.
5. Glaucoma Research Foundation. Care and Treatment - Medication Guide. Available at: https://www.glaucoma.org/treatment/medication-guide.php#alpha_agonist. Accessed June 3, 2020.
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy