Bimatoprost Intracameral Implant (Durysta™)

• Bimatoprost intracameral implant (Durysta™) for ophthalmic intracameral administration by a healthcare professional 

• For reduction of intraocular pressure in patients with open angle glaucoma or ocular hypertension 

The restricted product(s) may be considered medically necessary when the following criteria are met: 

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT); AND 
3. ONE of the following:
   1. The patient has tried[D] and had an inadequate response to BOTH of the following [medical record documentation required]: 
      1. At least two intraocular pressure (IOP) lowering topical ophthalmic agents with different mechanisms of action, one of which must include a topical ophthalmic prostaglandin analog, after at least a one-month trial of each agent; AND
      2. Combination therapy with IOP lowering topical ophthalmic agents (either as two single agents or as a combination product) after at least a one-month trial; OR
   2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL IOP lowering topical ophthalmic agents that is NOT expected to occur with the requested agent [medical record documentation required]; OR 
   3. The prescriber has provided documentation indicating the patient is unable to manage instilling ophthalmic drops (e.g., due to age, visual impairment, comorbidities) [medical record documentation required]; AND 
4. The patient has NOT been previously treated with the requested agent in the affected eye(s); AND
5. 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.

Duration of Approval: 365 days (one implant per eye per lifetime)

All information referenced is from FDA package insert unless otherwise noted below. 

1. Medeiros FA, Walters TR, Kolko M, et al. Phase 3, randomized, 20-month study of bimatoprost implant in open-angle glaucoma and ocular hypertension (ARTEMIS 1). Ophthalmology. June 2020;1-15.
2. Prum BE, Rosenberg LF, Gedde SJ, et al. American Academy of Ophthalmology. Primary openangle glaucoma preferred practice pattern guidelines. Ophthalmology. 2015;123(1):P41-P111.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.