Ocular/Otic

Enzeevu™ (Aflibercept-abzv), Opuviz™ (Aflibercept-yszy), and Yesafili™ (Aflibercept-jbvf) Approval Criteria:

• An FDA approved diagnosis; and
• A patient-specific, clinically significant reason why the member cannot use Eylea^®/Eylea^® HD (aflibercept) or Pavblu™ (aflibercept-ayyh) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products. 

Izervay™ (Avacincaptad Pegol) Approval Criteria:

• An FDA approved indication for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD); and
• Member must not have ocular or periocular infections or active intraocular inflammation; and
• Izervay™ must be prescribed and administered by an ophthalmologist, or a physician experienced in intravitreal injections; and
• Prescribers must verify the member will be monitored for endophthalmitis, retinal detachment, increase in intraocular pressure, and neovascular (wet) AMD; and
• A quantity limit of (1) 0.1mL single-dose vial per eye once monthly will apply.

Susvimo™ (Ranibizumab Intravitreal Implant) Approval Criteria:

• An FDA approved diagnosis of 1 of the following in adults:
  • Neovascular (wet) age-related macular degeneration (AMD); or
  • Diabetic macular edema (DME); or
  • Diabetic retinopathy (DR); and
• Member must have previously responded to ≥2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor; and
• Member must not have ocular or periocular infections or active intraocular inflammation; and
• Susvimo™ must be prescribed and administered by an ophthalmologist or a physician experienced in vitreoretinal surgery; and
• Prescriber must verify the member will be monitored for endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, and conjunctival blebs; and
• A patient-specific, clinically significant reason why the member cannot use ranibizumab intravitreal injection or other VEGF inhibitor injection products (appropriate to disease state) available without prior authorization [i.e., Beovu^® (brolucizumab-dbll), Byooviz™ (ranibizumab-nuna), Cimerli^® (ranibizumab-eqrn), Eylea^®/Eylea^® HD (aflibercept), Lucentis^® (ranibizumab), Pavblu™ (aflibercept-ayyh)] ] must be provided; and
• The following quantity limits will apply per eye: 
  • AMD or DME: (1) 0.1mL single-dose vial (SDV) per 6 months; or
  • DR: (1) 0.1mL SDV per 9 months.

Syfovre™ (Pegcetacoplan) Approval Criteria:

• An FDA approved indication for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD); AND
• Member must not have ocular or periocular infections or active intraocular inflammation; AND
• Syfovre™ must be prescribed and administered by an ophthalmologist, or a physician experienced in intravitreal injections; AND
• Prescriber must verify the member will be monitored for endophthalmitis, retinal detachment, increase in intraocular pressure, intraocular inflammation, and neovascular (wet) AMD; AND
• A quantity limit of (1) 0.1mL single-dose vial per eye every 25 to 60 days will apply.

Vabysmo^® (Faricimab-svoa Intravitreal Injection) Approval Criteria:

• An FDA approved diagnosis of 1 of the following:
  • Neovascular (wet) age-related macular degeneration (AMD); or
  • Diabetic macular edema (DME); or
  • Macular edema following retinal vein occlusion (RVO); and
• Member must be 18 years of age or older; and
• Member must not have ocular or periocular infections or active intraocular inflammation; and
• Vabysmo^® must be prescribed and administered by an ophthalmologist or a physician experienced in vitreoretinal injections; and
• Prescriber must verify the member will be monitored for endophthalmitis, retinal detachment, increase in intraocular pressure, and arterial thromboembolic events, and
• Female members of reproductive potential must have a negative pregnancy test prior to initiation of therapy and must agree to use effective contraception during treatment and for 3 months after the final dose of Vabysmo^®; and
• Member must have previously tried and failed 1 VEGF inhibitor injection product (appropriate to the disease state) available without prior authorization [i.e., Beovu^® (brolucizumab-dbll), Byooviz™ (ranibizumab-nuna), Cimerli^® (ranibizumab-eqrn), Eylea^®/Eylea^® HD (aflibercept), Lucentis^® (ranibizumab), Pavblu™ (aflibercept-ayyh)] or a patient-specific, clinically significant reason why a preferred VEGF inhibitor injection product is not appropriate for the member must be provided; and 
• A quantity limit of 0.05mL per 28 days will apply. 

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.    

Prior Authorization form   

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.

Prior Authorization form

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.   

Prior Authorization form   

Miebo™ (Perfluorohexyloctane) Approval Criteria:

• An FDA approved diagnosis of dry eye disease (DED); and
• Member must be 18 years of age or older; 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) single-use vials, which are available without a prior authorization, and Xiidra^® (lifitegrast ophthalmic solution) must be provided; and
• A quantity limit of 12mL per 30 days 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 

Prior Authorization form   

**no products available for coverage by SoonerCare currently

Verkazia^® (Cyclosporine 0.1% Ophthalmic Emulsion) Approval Criteria:

• An FDA approved indication of vernal keratoconjunctivitis (VKC); and
• Member has had 1 recurrence of VKC in the last year; and
• Verkazia^® must be prescribed by, or in consultation with, an allergist, optometrist, or ophthalmologist (or an advanced care practitioner with a supervising physician who is an allergist, optometrist, or ophthalmologist); and
• Prescriber must verify that environmental factors (e.g., sun, wind, salt water) have been addressed; and
• Member must have a trial of a topical mast cell stabilizer, antihistamine, or combination product or a patient-specific, clinically significant reason why those products are not appropriate must be provided; and
• A patient-specific, clinically significant reason why the member cannot use cyclosporine 0.05% ophthalmic emulsion single-use vials, which are available without a prior authorization, must be provided; and
• A quantity limit of 120 single-use vials per 30 days will apply. 

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition
Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).
HC= hydrocortisone; oint= ointment; susp= suspension

Ophthalmic Antibiotic Medications Tier-2 Approval Criteria:

• An FDA approved indication/suspected infection by an organism not known to be covered by Tier-1 products, or failure of a Tier-1 product; or
• Known contraindication to all indicated Tier-1 medications; or
• Prescription written by an optometrist or ophthalmologist; or
• When requested medication is being used for pre/post-operative prophylaxis.

Ophthalmic Antibiotic Medications Tier-3 Approval Criteria:

• An FDA approved indication/suspected infection by an organism not known to be covered by Tier-2 products, or failure of a Tier-2 product; or
• Known contraindication to all indicated Tier-2 medications; or
• Prescription written by an optometrist or ophthalmologist; or
• When requested medication is being used for pre/post-operative prophylaxis.

Ophthalmic Antibiotic/Steroid Combination Products Tier-2 Approval Criteria:

• Prescription written by an optometrist or ophthalmologist; or
• When requested medication is being 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. 

 Prior Authorization form

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.  

iDose^® TR (Travoprost Intracameral Implant) Approval Criteria:

• 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
• iDose^® TR must be prescribed by, or in consultation with, an ophthalmologist; and
• A patient-specific, clinically significant reason why the member requires iDose^® TR and cannot utilize ophthalmic preparations, such as solution or suspension, to treat OAG or OHT must be provided; and
• A patient-specific, clinically significant reason why the member cannot use Durysta^® (bimatoprost intracameral implant) must be provided; and
• The affected eye has not received prior treatment with iDose^® TR; and
• Member has no contraindications to iDose^® TR; and
• A quantity limit of (1) iDose^® TR 75mcg implant per eye per lifetime will apply.  

Prior Authorization form

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.  

 Prior Authorization form     

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:

Acetasol HC and VoSol HC (Acetic Acid/Hydrocortisone) Approval Criteria:

• Diagnosis of acute otitis externa; and
• Recent trials (within the last six months) with all other commonly used topical otic anti-infectives that have failed to resolve infection; or
• Allergy to all available products and failure of acetic acid alone.

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.

Prior Authorization form  

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. 

Prior Authorization form

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.    

Prior Authorization form   

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.    

Prior Authorization form   

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 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.     

Prior Authorization form

Vevye^® (Cyclosporine 0.1% Solution) Approval Criteria:

• An FDA approved diagnosis of dry eye disease (DED); and
• Member must be 18 years of age or older; 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) single-use vials, which are available without prior authorization, and Xiidra^® (lifitegrast ophthalmic solution) must be provided; and
• A quantity limit of 2mL per 50 days will apply. 

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.     

Prior Authorization form