Special Formulations

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.

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. 

• 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.     

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.  

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. 

• 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 maximum dose for at least 8 weeks; AND
• Prescriber must verify that member has not been able to achieve normal thyroid lab levels despite maximum dosing and compliance with levothyroxine tablets.  

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. 

• 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.  

riluzole film or suspension (Exservan™ and Tiglutik™) Approval Criteria:

• An FDA approved indication for the treatment of amyotrophic lateral sclerosis (ALS); AND
• A patient-specific, clinically significant reason why the member cannot use riluzole tablets, even when tablets are crushed, must be provided; AND
• A quantity limit of 20mL per day or 600mL per 30 days will apply for Tiglutik®; AND
• A quantity limit of 2 films per day or 60 films per 30 days will apply for Exservan™.

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. 

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 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.