Ocular/Otic

acyclovir 3% ophthalmic ointment (Avaclyr™) Approval Criteria:  

• An FDA approved diagnosis of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex virus (HSV); AND
• A patient-specific, clinically significant reason why the member cannot use trifluridine 1% ophthalmic solution must be provided; AND
• A patient-specific, clinically significant reason why the member cannot use oral acyclovir, famciclovir, or valacyclovir must be provided.   

Cystadrops^® (Cysteamine 0.37% Ophthalmic Solution) and Cystaran™ (Cysteamine 0.44% Ophthalmic Solution) Approval Criteria:

• An FDA approved indication for the treatment of corneal cystine crystal accumulation in members with cystinosis; and
• The requested medication must be prescribed by, or in consultation with, an ophthalmologist; and
• Prescriber must verify that the member has been counseled on the proper storage of the requested medication; and
• For Cystadrops^®, a patient-specific, clinically significant reason (beyond convenience) why the member cannot use Cystaran™ must be provided; and
• A quantity limit of 4 bottles per month will apply. 

Dextenza® (Dexamethasone Ophthalmic Insert) Approval Criteria:

• An FDA approved indication of the treatment of ocular inflammation and pain following ophthalmic surgery; AND
• Prescriber must verify that Dextenza® will be placed by a physician immediately following ophthalmic surgery; AND
• Date of ophthalmic surgery must be provided; AND
• A patient-specific, clinically significant reason why corticosteroid ophthalmic preparations, such as solution or suspension, typically used following ophthalmic surgery are not appropriate for the member must be provided; AND
• A quantity limit of 1 insert per eye every 30 days will apply.

Eysuvis^® (Loteprednol 0.25% Ophthalmic Suspension) Approval Criteria:

• An FDA approved indication for the short-term (up to 2 weeks) treatment of the signs and symptoms of dry eye disease (DED); and
• A documented trial of intermittent or regular artificial tear use within the past 3 months; and
• A patient-specific, clinically significant reason why the member cannot use Restasis^® (cyclosporine 0.05% ophthalmic emulsion), which is available without a prior authorization, must be provided; and
• A patient-specific, clinically significant reason why the member cannot use Tier-1 ophthalmic corticosteroids including Lotemax^® (loteprednol 0.5% suspension) must be provided; and
• Member must not have any contraindications to Eysuvis^®; and
• A quantity limit of 8.3mL per 15 days will apply (Eysuvis^® for the treatment of DED is not indicated for use beyond 15 days).

Iluvien® (Fluocinolone Intravitreal Implant) Approval Criteria: 

• An FDA approved diagnosis of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure; AND
• Iluvien® must be administered by an ophthalmologist; AND
• Prescriber must verify that the member will be monitored for increased intraocular pressure, endophthalmitis, and cataract development; AND  
• A patient-specific, clinically significant reason why the member requires Iluvien® in place of corticosteroid ophthalmic preparations, such as solution or suspension, must be provided; AND
• A quantity limit of 1 implant per eye every 36 months will apply.   

Tier 1 products are covered with no authorization necessary

Tier 2 authorization criteria

• FDA approved diagnosis; AND
• A trial of one Tier-1 medication for a minimum of two weeks in the last 30 days that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
• A contraindication to all lower tiered medications

Tier 3 authorization criteria

• An FDA approved diagnosis; AND
• Recent trials of one Tier-1 medication and all available Tier-2 medications for a minimum of two weeks that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
• A contraindication to all lower tiered medications 

Tier 1 products are covered with no authorization necessary.

Criteria for a Tier 2 medication:

• Approved indication/suspected infection by organism not know to be covered by tier 1 products,or failure of a tier 1 products
• Known contraindication to all indicated tier 1 medication.
• Prescription written by optometrists/ophthalmologists, or
• When used for pre/post-operative prophylaxis.

Criteria for a Tier 3 medication:

• Approved indication/suspected infection by organism not know to be covered by tier 2 products, or failure of a tier 2 product.
• Known contraindication to all indicated tier 2 medication.
• Prescription written by optometrists/ophthalmologists, or
• When used for pre/post-operative prophylaxis.

Tier 1 products are covered with no authorization necessary

Tier 2 authorization criteria

• Documented trials of all Tier-1 ophthalmic corticosteroids (from different product lines) in the last 30 days that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
• Contraindication to all lower tiered medications; OR
• A unique indication for which the Tier-1 anti-inflammatories lack. 

emu = emulsion; oint = ointment; sol = solution; sus = suspension

Tier 1 products are covered with no authorization necessary

Tier 2 authorization requires:

• Comprehensive dilated eye exam within the last 365 day period, AND
• FDA-approved indication, AND
• Member must attempt at least three tier 1 products for a minimum of 4 weeks in duration each within the last 120 days. Tier 1 trails may be from any pharma logic class, OR
• Documented adverse effect, drug interaction, or contraindication to Tier 1 products, OR
• Unique FDA-approved indication for which Tier 1 medications are not indicated.

Special Prior Authorization (PA) Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why a special formulation is needed over a Tier-1 or Tier-2 product; OR
• Approvals may be granted if there is a documented adverse effect, drug interaction, or contraindication to all Tier-1 and Tier-2 medications; OR
• Approvals may be granted if there is a unique FDA approved indication not covered by all Tier-1 and Tier-2 medications; AND
• The member must have had a comprehensive, dilated eye exam within the last 365-day period as recommended by the National Institute of Health; AND
• Approvals will be for the duration of one year.

• An FDA approved indication to reduce intraocular pressure (IOP) in members with open-angle glaucoma (OAG) or ocular hypertension (OHT); and
• Member must be 18 years of age or older; and
• Durysta™ must be prescribed by, or in consultation with, an ophthalmologist; and
• A patient-specific, clinically significant reason why the member requires Durysta™ and cannot utilize ophthalmic preparations, such as solution or suspension, to treat OAG or OHT must be provided; and
• The affected eye(s) has not received prior treatment with Durysta™; and
• The member has no contraindications to Durysta™; and
• A quantity limit of (1) Durysta™ 10mcg implant per eye per lifetime will apply.  

Tier 1 products are covered with no authorization necessary

Tier 2 authorization criteria

•  Documented trials of all Tier-1 ophthalmic NSAIDs (from different product lines) in the last 30 days that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR  
• Contraindication to all lower tiered medications; OR 
• A unique indication for which the Tier-1 anti-inflammatories lack.     

sol = solution; sus = suspension

^ΔNot a required Tier-1 trial; does not have to be attempted for approval of a Tier-2 medication. 

Tier 1 products are covered with no authorization necessary

Tier 2 authorization criteria:

• Members must have adequate 14 day trial of at least two tier 1 medications, or
• Approval may be granted if there is a unique FDA approved indication not covered by tier 1 products or infection by organism not known to be covered by any of the tier 1 agents.

Special PA Criteria:

Otiprio® (Ciprofloxacin 6% Otic Suspension) Approval Criteria:

• An FDA approved indication of one of the following:
  • For the treatment of bilateral otitis media with effusion in members undergoing tympanostomy tube placement; OR  
  • For the treatment of acute otitis externa due to Pseudomonas aeruginosa (P. aeruginosa) or Staphylococcus aureus (S. aureus); AND 
• Member must be 6 months of age or older; AND
• Otiprio® must be administered by a health care professional; AND
• A patient-specific, clinically significant reason why appropriate lower tiered otic anti-infective medications cannot be used; AND
• A quantity limit of 1 vial per treatment course will apply.

cenegermin-bkbj (Oxervate™) Approval Criteria:   

• An FDA approved diagnosis of neurotrophic keratitis; AND
• Oxervate™ must be prescribed by, or in consultation with, an ophthalmologist; AND
• Prescriber must verify that the member has persistent epithelial defect (PED) (stage 2 disease) or corneal ulceration (stage 3 disease) of at least 2 weeks duration that is refractory to 1 or more conventional non-surgical treatments for neurotrophic keratitis; AND  
  • Specific non-surgical treatments and dates of trials must be listed on the prior authorization request; AND 
• Prescriber must verify that the member has evidence of decreased corneal sensitivity within the area of the PED or corneal ulcer and outside of the area of the defect in at least 1 corneal quadrant; AND
• Prescriber must verify the member has been counseled on the proper administration and storage of Oxervate™; AND
• Approvals will be for a maximum duration of 8 weeks of total therapy per eye; AND
• A quantity limit of 2 weekly kits per 14 days will apply. A quantity limit override will be approved for 4 weekly kits per 14 days with prescriber documentation of treatment in both eyes. 

Ozurdex® (Dexamethasone Intravitreal Implant) Approval Criteria: 

• An FDA approved indication of 1 of the following:
  • The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO); OR  
  • The treatment of non-infectious uveitis affecting the posterior segment of the eye; OR
  • The treatment of diabetic macular edema; AND
• Ozurdex® must be administered by an ophthalmologist; AND
• Prescriber must verify that the member will be monitored for increased intraocular pressure, endophthalmitis, and cataract development; AND
• Prescriber must agree to periodically monitor the integrity of the implant by visual inspection; AND
• A patient-specific, clinically significant reason why the member requires Ozurdex® in place of corticosteroid ophthalmic preparations, such as solution or suspension, must be provided; AND
• A quantity limit of 1 implant per eye every 3 months will apply.    

Retisert® (Fluocinolone Intravitreal Implant) Approval Criteria:

• An FDA approved diagnosis of chronic, non-infectious posterior uveitis; AND
• Retisert® must be administered by an ophthalmologist; AND
• Prescriber must verify that the member will be monitored for increased intraocular pressure, endophthalmitis, and cataract development; AND  
• Prescriber must agree to periodically monitor the integrity of the implant by visual inspection; AND
• A patient-specific, clinically significant reason why the member requires Retisert® in place of corticosteroid ophthalmic preparations, such as solution or suspension, must be provided; AND
• A patient-specific, clinically significant reason why the member requires Retisert® in place of Ozurdex® or Yutiq™ must be provided; AND  
• A quantity limit of 1 implant per eye every 30 months will apply.    

teprotumumab-trbw (Tepezza™) Approval Criteria:  

• An FDA approved indication for the treatment of thyroid eye disease in adult members 18 years of age and older; AND
  • Member must be experiencing eye symptoms related to thyroid eye disease; AND  
  • Member must have thyroid blood levels in the normal range or must be undergoing active treatment working toward normal range; AND 
• Female members must not be pregnant and must have a negative pregnancy test prior to initiation of therapy; AND
• Female members of reproductive potential must be willing to use effective contraception prior to initiation, during treatment with Tepezza™, and for at least 6 months after the last dose of Tepezza™; AND
• Member must not have had prior surgical treatment for thyroid eye disease; OR
  • A prior authorization request with patient-specific information may be submitted for consideration of Tepezza™ for members who have had prior surgical treatment for thyroid eye disease, including but not limited to patient-specific, clinically significant information regarding the member’s prior surgery and the need for Tepezza™; AND  
• Medical supervision by an ophthalmologist in conjunction with an endocrinologist for the treatment of thyroid eye disease; AND
  • The name of the ophthalmologist and endocrinologist recommending treatment with Tepezza™ must be provided on the prior authorization request; AND  
• Tepezza™ must be administered as an intravenous (IV) infusion at the recommended infusion rate per package labeling, with appropriate pre-medication(s) based on the member’s risk of infusion reactions; AND
• Tepezza™ must be administered by a health care professional. Prior authorization requests must indicate how Tepezza™ will be administered; AND
  • Tepezza™ must be shipped via cold chain supply to the facility where the member is scheduled to receive treatment; OR  
  • Tepezza™ must be shipped via cold chain supply to the member’s home and administered by a home health care provider and the member (or the member’s caregiver) must be trained on the proper storage of Tepezza™; AND  
• The member’s current weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND
• Approvals will be for a maximum of 8 total infusions.     

Xiidra® (Lifitegrast) Approval Criteria:

• Member must be 17 years of age or older and have an FDA approved diagnosis of dry eye disease (DED); AND
• Prescriber must verify that environmental factors (e.g. humidity, fans) have been addressed; AND
• Member must have trials with at least 3 over-the-counter (OTC) products for 3 days in the last 30 days that failed to relieve signs and symptoms of dry eyes; AND
• A patient-specific, clinically significant reason why the member cannot use Restasis® (cyclosporine ophthalmic emulsion), which is available without a prior authorization; AND
• A quantity limit of 2 vials per day will apply.

fluocinolone acetonide intravitreal implant (Yutiq™) Approval Criteria: 

• An FDA approved diagnosis of chronic, non-infectious uveitis affecting the posterior segment of the eye; AND  
• Yutiq™ must be administered by an ophthalmologist; AND  
• Prescriber must verify that the member will be monitored for increased intraocular pressure and cataract development; AND 
• A patient-specific, clinically significant reason why the member requires Yutiq™ in place of Ozurdex® must be provided; AND  
• A quantity limit of 1 implant per eye every 36 months will apply.