Ophthalmic Corticosteroids Form

The following are ophthalmic corticosteroids requiring prior authorization: dexamethasone (Maxidex®), difluprednate (Durezol®), fluorometholone (FML®, FML® Forte), loteprednol (Alrex®, Lotemax®), and prednisolone (Pred Mild®). FDA Approved Indication(s) Alrex is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
Durezol is indicated for the treatment of: • • Endogenous anterior uveitis Inflammation and pain associated with ocular surgery FML and FML Forte are indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Lotemax suspension is indicated for the treatment of: • Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. • Post-operative inflammation following ocular surgery Lotemax gel and ointment are indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Maxidex is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. Pred Mild is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Page 1 of 8

CLINICAL POLICY Ophthalmic Corticosteroids 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 Alrex, Durezol, FML, FML Forte, Lotemax, Maxidex, and Pred Mild are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. All FDA-Approved Indications (must meet all):

1. Request is for one of the following uses (a – d): a. Durezol, Lotemax: following ocular surgery; b. FML, FML Forte, Lotemax suspension, Maxidex, Pred Mild: inflammation of the eye; c. Alrex: seasonal allergic conjunctivitis; d. Durezol: uveitis;
   2. If request is for FML or FML Forte: Age ≥ 2 years;
2. If request is for Alrex or Lotemax: Age ≥ 18 years;

3. Failure of at least two preferred generic ophthalmic corticosteroids (e.g., dexamethasone, fluorometholone, prednisolone) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;

   5. If request is for the brand name drug with the same active ingredient as previously trialed, medical justification why the requested brand name drug will work despite inadequate response to the generic (e.g., contraindications to excipients);
   6. Request does not exceed one of the following (a, b, c, d, or e): a. Alrex, FML, FML Forte, Lotemax suspension, Pred Mild: 1 bottle per 30 days; b. Durezol: 2 bottles per 30 days; c. Lotemax ointment: 2 tubes per 30 days; d. Lotemax gel: 3 bottles per 30 days; e. Maxidex: 4 bottles per 30 days. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
   7. 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: HIM.PA.33 for health insurance marketplace; 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: HIM.PA.103 for health insurance marketplace; or
   8. 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 Page 2 of 8

   CLINICAL POLICY Ophthalmic Corticosteroids criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. All FDA-Approved Indications (must meet all):

4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
5. Member is responding positively to therapy;

6. If request is for a dose increase, request does not exceed one of the following (a, b, c, d, or e): a. Alrex, FML, FML Forte, Lotemax suspension, Pred Mild: 1 bottle per 30 days; b. Durezol: 2 bottles per 30 days; c. Lotemax ointment: 2 tubes per 30 days; d. Lotemax gel: 3 bottles per 30 days; e. Maxidex: 4 bottles per 30 days. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

   1. 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: HIM.PA.33 for health insurance marketplace; 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: HIM.PA.103 for health insurance marketplace; or
   2. 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: HIM.PA.154 for health insurance marketplace.
      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 – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Page 3 of 8

   CLINICAL POLICY Ophthalmic Corticosteroids Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose 12 drops/day in affected eye 4 drops/day in affected eye 1 to 2 drops in affected eye four to six times per day. 1 drop in affected eye BID to QID. dexamethasone 0.1% solution fluorometholone 0.1% suspension (FML Liquifilm) prednisolone 1% solution/suspension (Omnipred®, Pred Forte®, Pred Mild) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 1 drop in affected eye BID to QID. 4 drops/day in affected eye Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o Viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures o Pred Mild: acute untreated purulent ocular infections o Alrex, FML, FML Forte, Lotemax, Maxidex, and Pred Mild: hypersensitivity o Maxidex: acute, untreated bacterial infections • Boxed warning(s): none reported V. Dosage and Administration
   Drug Name dexamethasone (Maxidex) Indication Steroid responsive inflammatory conditions difluprednate (Durezol) Ocular surgery
   Maximum Dose 12 drops/day in affected eye; 4 bottles/30 days 4 drops/day in affected eye; 2 bottles/30 days Dosing Regimen 1 to 2 drops in affected eye. In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily. 1 drop in affected eye QID beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by BID dosing for 1 week and then tapered based on response. Page 4 of 8

   CLINICAL POLICY Ophthalmic Corticosteroids Drug Name Indication Endogenous anterior uveitis fluorometholone suspension (FML, FML Forte) Steroid responsive inflammatory conditions loteprednol (Alrex) loteprednol (Lotemax) Seasonal allergic conjunctivitis Steroid responsive disease Ocular surgery
   Dosing Regimen 1 drop in affected eye QID for 14 days followed by tapering as clinically indicated. 1 drop in affected eye BID to QID. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. 1 drop in the affected eye QID Suspension: 1 to 2 drops in the affected eye QID. During the initial treatment within the first week, dosing may be increased up to 1 drop every hour if necessary. Begin treatment 24 hours after surgery for 2 weeks
   Suspension/0.5% gel: 1 to 2 drops in the affected eye QID. Ointment: Approximately ½ inch ribbon of ointment in affected eye QID.
   prednisolone (Pred Mild) Steroid responsive inflammatory conditions 1 drop in affected eye BID to QID. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. VI. Product Availability
   Maximum Dose 4 drops/day in affected eye; 2 bottles/30 days 4 drops/day in affected eye; 1 bottle/30 days 4 drops/day in affected eye; 1 bottle/30 days Suspension: 8 drops/day in affected eye; 1 bottle (suspension)
   Suspension/0.5% gel: 8 drops/day in affected eye; 1 bottle (suspension) or 3 bottles (gel)/30 days Ointment: 2 inch ribbon/day in affected eye; 2 tubes/30 days 4 drops/day in affected eye; 1 bottle/30 days Drug Name Availability dexamethasone (Maxidex) Multidose bottle with 0.1% suspension: 5 mL Multidose bottle with 0.05% suspension: 5 mL difluprednate (Durezol) Multidose bottle with 0.25% suspension: 5 mL, 10 mL fluorometholone suspension (FML, FML Forte) loteprednol (Alrex) Multidose bottle with 0.2% suspension: 5 mL in 7.5 mL bottle, 10 mL in 10 mL bottle Multidose bottle with 0.5% suspension: 5 mL, 10 mL, 15 mL loteprednol (Lotemax) Page 5 of 8

   CLINICAL POLICY Ophthalmic Corticosteroids Drug Name prednisolone (Pred Mild) Availability Multidose bottle with 0.5% gel: 5 g in 10 mL bottle Tube with 0.5% ointment: 3.5 g Multidose bottle with 0.12% suspension: 5 mL, 10 mL VII.