Endocrine

*SoonerCare members with Medicare DO NOT need a Prior Authorization*

• darbepoetin (Aranesp®)
• epoetin (Epogen®)
• epoetin (Procrit®)
• peginesatide (Omontys®)

PA Criteria:

FDA approved indication for specific products.

• Treatment of Anemia of Chronic Renal Failure Patients
• Treatment of Anemia of Zidovudine-treated HIV-infected Patients
• Treatment of Anemia of Cancer Patients on Chemotherapy

• Myelosuppressive Chemotherapy-induced Anemia (Hb 8-10 g/dl) Non-Curative

• Reduction of Allogeneic Blood Transfusion in Surgery Patients

Most recent Hb levels (and date obtained) should be included on petition.  Each approval will be for 16 weeks in duration.  Authorization can be granted for up to 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.  Authorization for surgery patients will be for a maximum of 4 weeks.

Continuation Criteria:

• Continue dose if Hb is ≤11.0 g/dL.
• If Hb is increasing and approaching 11.0 g/dL then reduce dose.
• If more than 1 g/dL increase (but Hb not greater than upper limits listed below) has occurred in a 2 week period reduce dose by 25 to 50%.

Discontinuation Criteria

• Discontinue treatment if Hb is at or above 11.0 g/dL.
• If a minimum increase of 1 g/dL has not been achieved after initial 8 weeks of therapy for anemia associated with chemotherapy and 12 weeks of therapy for ESRD.

Reinitiation Criteria:

• If Hb decreases to ≤10 g/dL then therapy may be reinitiated at 25 to 50% of the prior dose.

• Prior Authorization forms
  • Pharmacy  
  • Physician/Outpatient Administered 
   

Approved Indications:

• Classic Human Growth Hormone hGH Deficiency or,
• Short Stature (including Prader-Willi Syndrome) or,
• Short Stature associated with chronic renal insufficiency or,
• Small for Gestational Age (SGA) or,
• Turner’s Syndrome or 45 X, 46 XY mosiacism in males or,
• Hypoglycemia associated with hGH insufficiency or,
• AIDS wasting (Serostim only)
• SHOX (short stature homeobox-containing gene) deficiency
• Prior Authorization forms
  • Pharmacy    
   

Preferred 

• Genotropin® 

• Humatrope® 
• Norditropin® 
• Norditropin Nordiflex® 
• Nutropin® 
• Nutropin AQ® 
• Omnitrope® 
• Saizen® 
• Serostim® 
• Tev-Tropin® 
• Zorbtive® 

PA Criteria:

• To qualify for a tier 2 medication, the member must have a trial of a tier 1 medication (must include a trial of metformin titrated up to maximum dose), or a clinical reason why a tier 1 medication is not appropriate.
• For initiation with dual or triple therapy, additional tier 2 medications can be approved based on current AACE or ADA guidelines.
• To qualify for a tier 3 medication, the member must have tried a tier 2 medication in the same category and have a documented clinical reason why the tier 2 medication is not appropriate.
• To qualify for a Special Prior Authorization medication, the member must be currently stabilized on the requested product or have attempted at least 3 other categories of tier 2 or tier 3 medications, or have a documented clinical reason why the requested product is necessary for the member.

*Brand products are subject to the Brand Name Override where generics are available

 Testosterone replacement products Prior Authorization Criteria

Consideration will be based on both of the following criteria:

• An FDA approved diagnosis of:
  • Testicular failure due to cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome, orchidectomy/orchiectomy; OR
  • Idiopathic gonadotropin or luteinizing-hormone-releasing hormone (LHRH) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation; OR
  • Delayed puberty; OR
  • Advanced inoperable metastatic mammary cancer in females 1 to 5 years postmenopausal, or premenopausal women with breast cancer benefitting from oophorectomy and have been determined to have a hormone-responsive tumor; AND
   
• Must include two labs showing pre-medication morning testosterone levels below 300ng/dL and one lab showing abnormal gonadotropins and/or other information necessary to demonstrate diagnosis.

Testosterone replacement products Tier-2 Prior Authorization Criteria

Consideration will be based on all of the following criteria:

• A trial of at least two tier-1 products (must include at least one injectable and one topical formulation) at least 12 weeks in duration, OR
• A patient-specific, clinically significant reason why member cannot use all available tier-1 medications, OR
• Prior stabilization on a tier-2 medication (within the past 180 days)

*Please note that approval will be for one year.

Testosterone replacement products Special Prior Authorization Criteria

 Consideration will be based on the following criteria:

•  Must provide a patient-specific, clinically significant reason why member cannot use all other available formulations of testosterone.

*Please note that approval will be for one year.

• romiplostim (Nplate®) 
• plerixafor (Mozobil®) 

PA Criteria:

• Documented history of previous singleton spontaneous preterm delivery (SPTD) prior to 37 weeks gestation; and
• Current singleton pregnancy; and
• Gestational age between 16 weeks, 0 days and 20 weeks, 6 days of gestation.
• Authorizations will be for once a week administration in an office setting through 36 weeks, 6 days of gestation.
• Prior Authorization form
  • Pharmacy