Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Durysta (bimatoprost implant) requires prior authorization.

2)    Durysta is used to treat open angle glaucoma and ocular hypertension.

3)    Durysta is billed under the medical benefit.

Durysta is considered medically necessary when the following criteria are met:

Initial Approval Criteria

I.             Open Angle Glaucoma and Ocular Hypertension (must meet all)

a.    Diagnosis of OAG or OHT;

b.    Prescribed by or in consultation with an ophthalmologist;

c.    Age ≥ 18 years;

d.    Medical justification supports inability to manage regular glaucoma eye drop use (e.g., due to age or comorbidities including visual impairment);

e.    The affected eye has not received prior treatment with Durysta;

f.     Member has none of the following contraindications:

                                          i.    Active or suspected ocular or periocular infection

                                        ii.    Diagnosis of corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy);

                                       iii.    History of corneal transplantation or endothelial cell transplant (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]);

                                       iv.    Absent or ruptured posterior lens capsule;

                                        v.    Hypersensitivity to bimatoprost or to any other component of Durysta

g.    Dose does not exceed both of the following

                                          i.    10 mcg per eye;

                                        ii.    One implant per eye.

Approval Duration: one implant per eye (lifetime total)

            Reauthorization Not Applicable

Codes Used In This BI:

1)    Durysta Prescribing Information. Madison, NJ: Allergan USA, Inc.; November 2020. Available at https://media.allergan.com/products/durysta_pi.pdf. Accessed February 2, 2023.

2)    Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed February 2, 2023.

3)    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. Clinicaltrials.gov identifier: NCT01157364.

4)    Craven ER, Walters T, Christie WC, et al. 24‑month phase I/II clinical trial of bimatoprost sustained-release implant (Bimatoprost SR) in glaucoma patients. Drugs 2020; 80:167-179. Clinicaltrials.gov identifier: NCT01157364.

5)    Craven ER, Walters T, Christie W, Bejanian M, Goodkin ML, Guo Q, Zhang J, Robinson MR, Ahmed IK. Phase 3 evaluation of Bimatoprost sustained-release implant in patients with glaucoma or ocular hypertension: results at primary database lock [abstract no. PA054-2019]. Presented at the American Academy of Ophthalmology 2019 meeting, San Francisco, CA, 12–15 October 2019. ClinicalTrials.gov. NCT02250651, NCT02247804.

6)    Gedde SJ, Vinod K, Wright MM, et al. Primary Open-Angle Glaucoma Preferred Practice Pattern® Guidelines. Ophthalmology; November 2020. Available at: https://www.aao.org/preferred-practice-pattern/primary-open-angle-glaucoma-ppp. Accessed February 2, 2023.