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

• 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%.

• 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.

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

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

• 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.  

• Biaguanides
  • metformin SR (Glucophage XR®)
  • metformin-glyburide (Glucovance®)
  • metformin-glipizide (Metaglip®)
    
• Sulfonylureas
  • glyburide (Diabeta®)
  • glyburide micronized (Micronase®)
  • glipizide (Glucotrol®)
  • glipizide SR (Glucotrol XL®)
• Alpha-Glucosidase Inhibitors
  • acarbose (Precose®)

• DDP-4 Inhibitors
  • alogliptin (Nesina®)
  • alogliptin-pioglitazone (Oseni®)
  • linagliptin (Tradjenta®)
  • saxagliptin (Onglyza®)
  • saxagliptin-metformin (Kombiglyze®)
  • linagliptin-metformin (Jentadueto™)
  • sitagliptin (Januvia®)
  • stiagliptin-metformin (Janumet®)
  • sitagliptin-metformin ER (Janumet XR®)
  • sitagliptin-simvastatin (Juvisync®)
  • alogliptin-metformin (Kazano®)
    
• Thiazolidinediones
  • pioglitazone (Actos®)
• Glinides
  • repaglinide-metformin (Prandimet®)
  • repaglinide (Prandin®)
  • nateglinide (starlix®)
• GLP-1 Agonistsliraglutide (Victoza®)
  • exenatide (Byetta®)
  • exenatide (Bydureon®)
    
• Alpha-Glucosidase Inhibitors
  
  • acarbose (Precose®)

• Thiazolidinediones
  • pioglitazone-metformin (Actoplus Met®, Actoplus Met XR®)
  • pioglitazone-glimepiride (Duetact®)
• GLP-1 Agonists
  
  
• Alpha-Glucosidase Inhibitors
  • miglitol (Glyset®)
• SGLT2 inhibitor
  • canagliflozin (Invokana®)

• Biaguanides
  • metformin solution (Riomet®)
  • metformin long acting (Fortamet®, Glumetza®)
• Thiazolidinediones
  • rosiglitazone (Avandia®)
  • rosiglitazone-metformin (Avandamet®)
  • rosiglitazone-glimepiride (Avandaryl®)
• Amylinomimetic
  • pramlintide (Symlin®)

• Methyltestosterone powder
• Testosterone cypionate injection (Depo-Testosterone®)
• Testosterone enanthate injection
• Testosterone topical gel (Androgel® 1%,  Testim®)
  

• Testosterone patch (Androderm®)
• Testosterone topical gel (Androgel 1.62%, Fortesta®)
• Testosterone topical solution (Axiron®)
  

• Fluoxymesterone oral tablet (Androxy®)
• Methyltestosterone oral tablet/capsule (Android®,Methitest®, Testred®)
• Testosterone buccal tablet (Striant®)

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®)
• plerisafor (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.