Special Formulations

Absorica LD™ (Isotretinoin Capsule) Approval Criteria:

•  An FDA approved diagnosis of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5mm or greater; AND
• Absorica LD™ is not covered for members older than 20 years of age; AND
• Prescriber must verify member is enrolled in the iPLEDGE REMS program; AND
• Prescriber must verify lipid profile and liver function tests will be monitored prior to initiation of Absorica LD™ and at regular intervals during treatment in accordance with the prescribing information; AND
• A patient-specific, clinically significant reason why the member cannot use other isotretinoin capsules available without prior authorization must be provided; AND
• A recent patient weight must be provided on the prior authorization request in order to authorize the appropriate amount of medication according to drug labeling.

Aspruzyo Sprinkle™ [Ranolazine Extended-Release (ER) Granules] Approval Criteria:

• An FDA approved diagnosis of chronic angina; and
• A patient-specific, clinically significant reason why the member cannot use ranolazine ER tablets must be provided. 

Approval Criteria:

• An FDA approved indication to increase tear production in patients with keratoconjunctivitis sicca (dry eye); 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 Xiidra^® (lifitegrast 5% ophthalmic solution) must be provided; AND
• A quantity limit of 60 single-use vials (1 box) per 30 days will apply. 

Prior Authorization form

Clindacin^® ETZ Kit (Clindamycin 1% Swabs and Cleanser) Approval Criteria:

• An FDA approved diagnosis; and
• A patient specific, clinically significant reason the member cannot use the preferred topical clindamycin products including lotion, solution, swabs, or the preferred generic clindamycin gel (generic Cleocin T^®) must be provided; and
• Clindacin^® ETZ kit will not be covered for members older than 20 years of age.

Alkindi® Sprinkle (Hydrocortisone Oral Granule) Approval Criteria:

• An FDA approved indication of replacement therapy in pediatric members with adrenocortical insufficiency; and
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use hydrocortisone tablets, even when tablets are crushed, must be provided.

Eohilia™ (Budesonide Oral Suspension) Approval Criteria:

• An established diagnosis of eosinophilic esophagitis (EoE) defined as:
  • The presence of clinical symptoms of EoE ≥2 times per week (i.e., dysphagia, emesis, epigastric pain); and
  • Intraepithelial eosinophilia [≥15 eosinophils per high-power field (eos/hpf)] in the esophagus; and
• Member must be 11 years of age or older; and
• Must be prescribed by a gastroenterologist, allergist, or immunologist, or the member must have been evaluated by a gastroenterologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a gastroenterologist, allergist, or immunologist); and
• Member must have a documented trial for a minimum of 8 weeks that resulted in failure with 1 high-dose proton pump inhibitor (i.e., omeprazole 20-40mg twice daily or equivalent in adults or 1-2mg/kg of omeprazole daily or equivalent in children) or have a contraindication or documented intolerance; and
• A patient specific, clinically significant reason why the member cannot use a swallowed respiratory corticosteroid (e.g., budesonide, fluticasone) must be provided; and
• Approvals will be for (1) 3-month treatment course; and
• A quantity limit of 600mL per 30 days will apply; and
• Eohilia™ will not be approved for maintenance treatment. Reauthorization for additional 3-month treatment course(s) may be considered if the prescriber documents the following;
  • The member had a positive initial response to Eohilia™; and
  • Is now experiencing recurrent worsening symptoms of EoE after completing the treatment course with Eohilia™; and
  • A patient specific, clinically significant reason why the member still cannot use a swallowed respiratory corticosteroid (e.g., budesonide, fluticasone) must be provided.

Millipred™ (Prednisolone 5mg Tablet) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use prednisone 5mg tablets, methylprednisolone 4mg tablets, or alternative oral corticosteroids that are available without a prior authorization must be provided.

Millipred™ (Prednisolone Sodium Phosphate 10mg/5mL Oral Solution) and Veripred™ 20 (Prednisolone Sodium Phosphate 20mg/5mL Oral Solution) Approval Criteria:

• Approval of Millipred™ or Veripred™ 20 requires a patient-specific, clinically significant reason why the member cannot use an alternative strength liquid formulation of generic prednisolone oral solution including the 5mg/5mL, 15mg/5mL, and 25mg/5mL strengths which are available without a prior authorization. 

Orapred ODT® [Prednisolone Sodium Phosphate Orally Disintegrating Tablet (ODT)] Approval Criteria:

• Approval requires a patient-specific, clinically significant reason why the member cannot use an alternative oral corticosteroid tablet or generic prednisolone oral solutions (5mg/5mL, 15mg/5mL, and 25mg/5mL strengths) that are available without a prior authorization; and
• A quantity of 10 ODTs will be available without prior authorization for members 10 years of age or younger.

TaperDex™ dexamethasone tablet Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use dexamethasone 1.5mg individual tablets, which are available without a prior authorization, must be provided.  

Tarpeyo™ [Budesonide Delayed Release (DR) Capsule] Approval Criteria:

• An FDA approved indication to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression; and
• The diagnosis of primary IgAN must be confirmed by the following:
  • Kidney biopsy; and
  • Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
• Member must be 18 years of age or older; and
• Must be prescribed by a nephrologist (or advanced care practitioner with a supervising physician who is a nephrologist); and
• Member must be at risk of rapid disease progression as demonstrated by ≥1 of the following, despite maximal supportive care:
  • Urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g; or
  • Proteinuria >0.75g/day; and
• Member must be on a stable dose of a maximally-tolerated angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB), unless contraindicated or intolerant; and
• A patient-specific, clinically significant reason why a 6-month trial of an alternative formulation of budesonide DR oral capsules (e.g., Entocort® EC) or alternative oral corticosteroids is not appropriate for the member must be provided; and
• Approval duration will be for 9 months; and
• A quantity limit of 120 capsules per 30 days will apply.

Zilretta™ Approval Criteria:

• An FDA approved diagnosis of osteoarthritis (OA) pain of the knee; AND
• Zilretta™ will only be approvable for use in the knee(s) for OA pain; AND
• A patient-specific, clinically significant reason why the member cannot use Kenalog-40® (triamcinolone acetonide 40mg injection) and Depo-Medrol® (methylprednisolone injection) must be provided.
• A quantity limit of 1 injection per knee per 12 weeks will apply. 

Ermeza™ (Levothyroxine Oral Solution), Thyquidity™ (Levothyroxine Oral Solution), and Levothyroxine Capsule (Generic Tirosint^®) Approval Criteria:

• An FDA approved diagnosis of one of the following: 
  • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism; OR
  • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer; AND
• A patient-specific, clinically significant reason why the member cannot use all other formulations of levothyroxine sodium must be provided. For the oral solution, a reason why the member cannot use the levothyroxine tablet formulation, even when the tablets are crushed, must be provided; AND
• Prescriber must verify member has been compliant with levothyroxine tablets at a greatly increased dose for at least 8 weeks; AND
• Prescriber must verify that member has not been able to achieve normal thyroid lab levels despite a greatly increased dose and compliance with levothyroxine tablets.  

Prior Authorization form

Erythromycin 2% Swabs and 2% Topical Gel Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use erythromycin 2% topical solution must be provided

Gimoti™ (Metoclopramide Nasal Spray) Approval Criteria:

• An FDA approved indication of acute or recurrent diabetic gastroparesis in adult members; and
• A patient-specific, clinically significant reason why the member cannot use metoclopramide oral tablets and metoclopramide oral solution  must be provided; and
• For members 65 years of age or older, approvals will not be granted for initiation of metoclopramide therapy; and
• For members 65 years of age or older requesting to switch from an alternative metoclopramide product to Gimoti™:
• a.     Member must be taking a stable dose of metoclopramide 10mg 4 times daily for at least 10 days; and
• b.     Duration of current metoclopramide treatment must be provided; and
• A maximum approval duration of 8 weeks total from all sources will apply; and
• A quantity limit of 9.8mL per 28 days will apply.

nitroglycerin sublingual powder (GoNitro™) Approval Criteria:

• An FDA approved indication of acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease; AND  
• A patient-specific, clinically significant reason why the member cannot use nitroglycerin sublingual tablets or nitroglycerin lingual spray. 

Prior Authorization form

Horizant® [Gabapentin Enacarbil Extended-Release (ER) Tablet] Approval Criteria:

• For the FDA approved indication of restless leg syndrome:
  
  • Member must be 18 years of age or older; and
    
  • Documented treatment attempts at recommended dosing with at least 2 of the following medications that did not yield adequate relief:
    
    • Carbidopa/levodopa; or
      
    • Pramipexole; or
      
    • Ropinirole; and
      
  • A patient-specific, clinically significant reason why the member cannot take the immediate-release formulation of gabapentin must be provided.
    
• For the FDA approved indication of postherpetic neuralgia (PHN):
  
  • Member must be 18 years of age or older; and
    
  • Documented treatment attempts, at recommended dosing, with at least 1 agent from 2 of the following drug classes that did not yield adequate relief:
    
    • Tricyclic antidepressants; or
      
    • Anticonvulsants; or
      
    • Topical or oral analgesics; and
      
• A patient-specific, clinically significant reason why the member cannot take the immediate-release formulation of gabapentin must be provided.
  

Jylamvo^® (Methotrexate Oral Solution) Approval Criteria:

• An FDA approved diagnosis of 1 of the following:
  • Acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen; or
  • Mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen; or
  • Relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen; or
  • Rheumatoid arthritis; or
  • Severe psoriasis; and
• Member must be 18 years of age or older; and
• A patient-specific clinically significant reason why the oral tablets and the generic injectable formulation cannot be used must be provided.

levoleucovorin injection (Khapzory™) Approval Criteria:  

• An FDA approved indication of 1 of the following:
  • Rescue after high-dose methotrexate (MTX) therapy in patients with osteosarcoma; OR  
  • Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired MTX elimination; OR
  • Treatment of patients with metastatic colorectal cancer in combination with fluorouracil; AND  
• A patient-specific, clinically significant reason why the member cannot use generic leucovorin injection or generic levoleucovorin calcium injection must be provided.  

Prior Authorization form

Klor-Con® 20mEq Packet (Potassium Chloride) and PoKonza™ (Potassium Chloride 10mEq Packet Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use the all of the following must be provided.
  
  • Potassium chloride tablet; and
  • Potassium chloride extended-release (ER) dispersible tablet; and
  • Potassium chloride ER sprinkle capsule; and
  • Potassium chloride oral solution.

Phexxi^® (Lactic Acid/Citric Acid/Potassium Bitartrate Vaginal Gel) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use an over-the-counter (OTC) spermicide and all other forms of contraception (e.g., condoms, oral contraceptives) must be provided. Various OTC spermicides containing nonoxynol 9 are covered by SoonerCare without prior authorization. 

Pyridostigmine 30mg Tablet Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use pyridostigmine 60mg tablets, which are available without prior authorization, must be provided.

Reltone™ (Ursodiol Capsule) Approval Criteria:

• An FDA approved indication for the dissolution of radiolucent, noncalcified gallstones <20mm in greatest diameter or the prevention of gallstone formation in obese members experiencing rapid weight loss; and 
• For the indication of dissolution of radiolucent, noncalcified gallstones <20mm in greatest diameter:
• a.     Prescriber must confirm member is not a candidate for elective cholecystectomy due to 1 or more of the following:
•                                            i.      Increased surgical risk due to systemic disease; or
•                                            ii.      Advanced age; or
•                                           iii.     Idiosyncratic reaction to general anesthesia; or
•                                           iv.     Member refuses surgery; and
• b.     Prescriber must confirm the member does not have compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula; and
• For the indication of prevention of gallstone formation in obese members experiencing rapid weight loss:
• a.     Member’s baseline body mass index (BMI) and weight must be provided; and  
• b.     Member’s current weight must be provided supporting rapid weight loss compared to baseline; and
• For both FDA approved indications, a patient-specific, clinically significant reason why the member cannot use other generic formulations of ursodiol must be provided; and
• Initial approvals for the indication of dissolution of gallstones will be for the duration of 6 months, after which time the prescriber must confirm (via ultrasound imaging) partial or complete dissolution of gallstone(s). Subsequent approvals will be for the duration of 12 months; and
• Approvals for prevention of gallstone formation in obese members experiencing rapid weight loss will be for 6 months, after which time the member’s current weight must be provided to justify continued rapid weight loss and need for preventative treatment; and
• Treatment duration will be limited to a maximum of 24 months for all diagnoses.

Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use Restasis® in the individual dosage formulation (single-use vials) must be provided; AND
• A patient-specific, clinically significant reason why the member cannot use Xiidra^® (lifitegrast 5% ophthalmic solution) must be provided.

Prior Authorization form

Nextstellis^® (Drospirenone/Estetrol Tablet) and Slynd™ (Drospirenone Tablet) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use alternative formulations of hormonal contraceptives, which are available without a prior authorization, must be provided.

tamoxifen citrate 10mg/5mL oral solution (Soltamox®) Approval Criteria:

• An FDA approved indication of one of the following: 
  • Treatment of metastatic breast cancer in women and men; OR
  • Adjuvant treatment of node-positive breast cancer in postmenopausal women and for the adjuvant treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation; OR
     The reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS), following breast surgery and radiation; OR
  • To reduce the incidence of breast cancer in women at high risk for breast cancer; AND 
• A patient-specific, clinically significant reason why the member cannot use tamoxifen tablets.

Prior Authorization form

Talicia^® (Omeprazole/Amoxicillin/Rifabutin Capsule) Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why the member cannot use the individual components of other triple-therapy treatments approved for the same diagnosis (e.g., omeprazole, amoxicillin, and clarithromycin), which are available without prior authorization, must be provided; AND
• A quantity limit of 168 capsules per 14 days will apply.

norethindrone acetate/ethinyl estradiol capsules & ferrous fumarate capsules (Taytulla™) Approval Criteria:

• An FDA approved indication to prevent pregnancy in women; AND
• A patient-specific, clinically significant reason why the member cannot use all other generic formulations of norethindrone acetate/ethinyl estradiol tablets with ferrous fumarate tablets. 

Prior Authorization form

Tyrvaya™ (Varenicline Nasal Spray) Approval Criteria:

• An FDA approved indication for the treatment of the signs and symptoms of dry eye disease (DED) in members 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 at least 3 days in duration (per product) in the last 30 days that failed to relieve signs and symptoms of DED; and
• A patient-specific, clinically significant reason why the member cannot use Restasis^® (cyclosporine 0.05% ophthalmic emulsion) single-use vials, which are available without a prior authorization, must be provided; and
• A patient-specific, clinically significant reason why the member cannot use all available ophthalmic preparations for the treatment of DED must be provided; and
• A quantity limit of 8.4mL (2 bottles) per 30 days will apply.

Vuity™ (Pilocarpine 1.25% Ophthalmic Solution) Approval Criteria:

• An FDA approved indication of the treatment of presbyopia in adults; and
• Must be prescribed by an ophthalmologist or optometrist; and
• Prescriber must verify the member does not have iritis; and
• Prescriber must verify the member has been counseled on the risk of retinal detachment with use of Vuity™ and when to seek immediate medical care; and
• Prescriber must verify the member has been advised to use caution with night driving and hazardous occupations in poor illumination as vision may not be clear in these conditions while using Vuity™; and
• A patient-specific, clinically significant reason the member cannot use corrective lenses must be provided; and
• A patient-specific, clinically significant reason the member cannot use generic pilocarpine ophthalmic solution (Isopto^® Carpine) must be provided.

Xipere^® (Triamcinolone Acetonide Injection) Approval Criteria:

• An FDA approved indication for the treatment of macular edema associated with non-infectious uveitis; and
• Member must be 18 years of age or older; and
• Xipere^® must be administered by an ophthalmologist; and
• Prescriber must confirm that the member does not have an active ocular or periocular infection; and
• Prescriber must confirm member does not have untreated ocular hypertension or uncontrolled glaucoma; and
• A patient-specific, clinically significant reason why the member cannot use corticosteroid ophthalmic preparations, such as solution or suspension, must be provided; and
• A patient-specific, clinically significant reason the member cannot use Triesence^® (triamcinolone acetonide injection) must be provided; and
• Initial authorization will be for 12 weeks, with an additional dose approved at or after 12 weeks if the prescriber documents improvement from baseline in visual acuity.