Bimatoprost Implant (Durysta) Form

Bimatoprost intracameral implant (Durysta™) is a prostaglandin analog. FDA Approved Indication(s) Durysta is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Durysta is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Open Angle Glaucoma and Ocular Hypertension (must meet all):

1. Diagnosis of OAG or OHT;
   2. Prescribed by or in consultation with an ophthalmologist;
   3. Age ≥ 18 years;
   4. Medical justification supports inability to manage regular glaucoma eye drop use (e.g., due to age or comorbidities including visual impairment);
   5. The affected eye has not received prior treatment with Durysta;
   6. Member has none of the following contraindications: a. Active or suspected ocular or periocular infection; b. Diagnosis of corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy); c. History of corneal transplantation or endothelial cell transplant (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]); d. Absent or ruptured posterior lens capsule; e. Hypersensitivity to bimatoprost or to any other component of Durysta;

2. Dose does not exceed both of the following (a and b): a. 10 mcg per eye; b. One implant per eye.
   Approval duration: one implant per eye (lifetime total) Page 1 of 6

   CLINICAL POLICY Bimatoprost Implant B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Open Angle Glaucoma and Ocular Hypertension
5. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable
   B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   Page 2 of 6

   CLINICAL POLICY Bimatoprost Implant IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key DSAEK: Descemet’s Stripping Automated Endothelial Keratoplasty
   FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable IOP: intraocular pressure OAG: open angle glaucoma OHT: ocular hypertension Appendix C: Contraindications/Boxed Warnings • Contraindication(s): ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal transplantation, absent or ruptured posterior lens capsule, hypersensitivity to bimatoprost or to any other components of the product • Boxed warning(s): none reported V. Dosage and Administration
   Indication Dosing Regimen OAG, IOH Intracameral implant containing 10 mcg of bimatoprost in a drug delivery system Maximum Dose One implant per eye General Information: Durysta is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant. Durysta should not be readministered to an eye that received a prior Durysta. Administration: The intracameral injection procedure must be performed under magnification that allows clear visualization of the anterior chamber structures and should be carried out using standard aseptic conditions for intracameral procedures, with the patient’s head in a stabilized position. The eye should not be dilated prior to the procedure. Remove the foil pouch from the carton and examine for damage. Then, open the foil pouch over a sterile field and gently drop the applicator on a sterile tray. Once the foil pouch is opened, use promptly. See package insert for additional instructions. VI. Product Availability
   Intracameral implant in a single-use applicator that is packaged in a sealed foil pouch containing desiccant: 10 mcg bimatoprost VII.