Description
Blimatoprost (Durysta™) is an intracameral implant, sustained-release drug delivery system that is a prostaglandin analogue with ocular hypotensive activity. It involves the use of a biodegradable, solid polymer drug delivery system for slow, sustained drug release designed to lower intraocular pressure (IOP) over a 4 – 6 month period. It is administered via a single-use applicator that is inserted into the anterior chamber of the affected eye. Prior to this approval, pharmacologic therapy consisted of topical eye drops with varying mechanisms of action. Due to an increased risk of corneal endothelial cell loss, patients should only receive one implant per eye and no retreatment.

Regulatory Status
On March 4, 2020, the FDA approved Bimatoprost (Durysta) 10 mcg for the intracameral administration for open-angle glaucoma (OAG) or ocular hypertension (OHT).

Policy
Coverage of Durysta is available when the following criteria have been met:

1. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), AND
2. Member is 18 years of age or older, AND
3. Member is not receiving re-treatment of eye(s) previously treated with Durysta, AND
4. Medication is prescribed by, or in consultation with, an ophthalmologist, AND
5. Member has tried and failed, or had intolerance to 1 (one) prostaglandin analog (e.g., latanoprost, travoprost, or bimatoprost), AND
6. Member has tried and failed, or had intolerance to 1 (one) additional IOP reducing eye drop agents from a different medication class such as beta-blockers, alpha-agonist (brimonidine), carbonic anhydrase inhibitors, and rho kinase inhibitor (netarsudil), AND
7. Member does not have any of the following contraindication to therapy: 
   1. Active or suspected ocular or periocular infection
   2. Diagnosis of corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy)
   3. Prior corneal transplantation or endothelial cell transplant
   4. Absent or ruptured posterior lens capsule 
   5. Hypersensitivity to bimatoprost or to any other component of Durysta

Coverage duration: One implant per eye per lifetime, approval duration will be for 6 months

Rationale
Open-angle glaucoma is an optic neuropathy characterized by progressive peripheral visual loss. The peripheral vision loss is often followed by central field loss. Open-angle glaucoma is typically accompanied by intraocular pressure increases caused by increased aqueous production and/or decreased aqueous outflow. Elevated intraocular pressure presents a major risk factor for glaucomatous field loss. The higher the level of intraocular pressure, the greater the likelihood of optic nerve damage and visual field loss. Ocular hypertension is distinguished from glaucoma in that there are no detectable changes in vision, no evidence of visual field loss, and no damage to the optic nerve. Patients diagnosed with ocular hypertension are at an increased risk of developing glaucoma.

Typical treatments for open-angle glaucoma and ocular hypertension include drug classes such as ophthalmic prostaglandins (e.g., latanoprost) and ophthalmic beta 
blockers (e.g. timolol), both of which have generic products available in their respective classes.

The efficacy of Durysta was evaluated in two identically designed pivotal clinical trials: 192024 – 091 and 192024 – 092. Retreatment were performed at 16-week intervals (a total of 3 administrations) to maintain. All Hour 0 IOP examinations were scheduled at 0800 ± 1 hour; and Hour 2 IOP examinations occurred 2 hours after the Hour 0 IOP exam. The protocol-defined success criteria for non-inferiority of each dose of Bimatoprost SR to timolol was that the upper limit of the 95% Cls around the difference in mean IOP values (Bimatoprost SR - timolol) was less than 1.5 mmHg at all six time points for Weeks 2, 6 and 12.

The two studies demonstrated that both doses of Bimatoprost SR (15 µg and 10 µ.g) were efficacious in reducing elevated intraocular pressure. As the lower dose group may have less safety concerns, the statistical reviewer recommended the approval of Bimatoprost SRl O µg for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

References

1. American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Hospkins.Center for Quality Eye Care(2020) Primary Open-Angle Glaucoma 2020.https://www.aao.org/preferred practice-pattern/primary-open-angle-glaucoma-ppp.
2. 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).
3. Durysta [package insert]. Madison, NJ: Allergan USA, Inc. March 2020.
4. 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.
5. U.S. Food and Drug Administration (FDA).(2020) Durysta. Prescribing Information.https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211911s000lbl.pdf Accessed on December 06, 2021

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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