Special Formulations

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.

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.

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 quantity limit of 60 single-use vials (1 box) per 30 days will apply. 

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. 

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.  

PA criteria:

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

• Authorization of Veripred™ 20 or Millipred™ requires a patient-specific, clinically significant reason why the member cannot use a tablet or an alternative strength liquid formulations.

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.

Approval Criteria:

• An FDA approved indication of nasal polyps in adults 18 years of age and older who have had ethmoid sinus surgery; AND
• Date of ethmoid sinus surgery must be provided; AND
• Sinuva™ must be prescribed and implanted by a physician specializing in otolaryngology; AND
• Failure of intranasal corticosteroids after at least a three month trial at the maximum recommended dose in combination with a 14-day trial of oral corticosteroids within the last six months (if not contraindicated); AND
• Prescriber must confirm the member has recurrent nasal obstruction/congestion symptoms and recurrent bilateral sinusitis or chronic sinusitis due to nasal polyps; AND
• A quantity limit of 2 implants per member will apply. 

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.

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.

dexamethasone tablet (TaperDex™) 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.  

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. 

Thyquidity™ (Levothyroxine Oral Solution), Tirosint^® (Levothyroxine Capsule), and Tirosint^®-SOL (Levothyroxine Oral Solution) 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.  

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.