Endocrine 2019

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

Procrit® (Epoetin Alfa), Epogen® (Epoetin Alfa), and Retacrit™ (Epoetin Alfa-epbx) Approval Criteria:   

• An FDA approved diagnosis of 1 of the following:
  • Anemia due to chemotherapy in patients with non-myeloid malignancies; OR
  • Anemia in zidovudine-treated Human Immunodeficiency Virus (HIV)-infected patients; OR
  • The reduction of allogeneic blood transfusion(s) in surgery patients; OR
  • An FDA approved diagnosis of anemia associated with chronic renal failure; AND  
    • For the diagnosis of anemia associated with chronic renal failure: member must not be receiving dialysis [erythropoietin stimulating agents (ESAs) are included in the bundled dialysis payment if member is on any form of dialysis and cannot be billed separately]; AND   
• Recent hemoglobin levels must be provided; AND
• Approvals will be for the duration of 16 weeks of therapy. Recent hemoglobin levels must be provided with continuation requests, and further approval may be granted if the member’s recent hemoglobin level is <11g/dL.  

Prior Authorization forms

• Pharmacy  
• Physician/Outpatient Administered  

Supprelin® LA (Histrelin) and Synarel® (Nafarelin) Approval Criteria:

• An FDA approved diagnosis of central precocious puberty confirmed by submitting the following:
• Documentation of onset of symptoms <8 years of age in females and 9 years of age in males; AND
• Documentation that bone age is advanced 1 year beyond the chronological age; AND
• Lab assessment:
• Documentation of abnormal basal gonadotropin levels; OR
• Documentation of pubertal response to a gonadotropin-releasing hormone analog stimulation test; AND
• Approvals may be granted with documentation of failed trials of lower tiered products or an FDA approved indication not covered by a lower tiered product.  

elagolix (Orilissa™) Approval Criteria:

• An FDA approved diagnosis of moderate-to-severe pain associated with endometriosis; AND
• Member must be 18 years of age or older; AND  
• Member must not have known osteoporosis; AND
• Female members must not be pregnant and must have a negative pregnancy test prior to initiation of therapy; AND
• Female members of reproductive potential must be willing to use effective non-hormonal contraception during treatment with Orilissa™ and for at least one week after discontinuing treatment; AND
• Member must not have severe hepatic impairment (Child-Pugh C); AND
• Member must not be taking a strong organic anion transporting polypeptide (OATP) 1B1 inhibitor (e.g., cyclosporine, gemfibrozil); AND
• Orilissa™ must be prescribed by, or in consultation with, an obstetrician/gynecologist or a specialist with expertise in the treatment of endometriosis; AND
• A failed trial at least one month in duration with nonsteroidal anti-inflammatory drugs (NSAIDs) or a patient-specific, clinically significant reason why the member cannot use NSAIDs; AND
• A failed trial at least three months in duration of hormonal contraceptives or a patient-specific, clinically significant reason why the member cannot use hormonal contraceptives; AND
• A patient-specific, clinically significant reason why the member cannot use leuprolide depot formulations which are available without prior authorization; AND
• Dosing and lifetime approval duration will be limited based on the following:  
• Coexisting condition of moderate hepatic impairment (Child-Pugh B):
• 150mg once daily for a maximum of 6 months; AND 
• Normal liver function or mild hepatic impairment (Child-Pugh A):  
• 150mg once daily for a maximum of 24 months; OR
• 200mg twice daily for a maximum of 6 months. 

leuprolide acetate for Depot Suspension and Norethindrone Acetate Tablets (Lupaneta Pack™) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use the individual components.
  

• leuprolide (Lupron® Depot) 
• leuprolide  (Lupron Depot-Ped®)
• triptorelin (Triptodur®)

• histrelin (Supprelin® LA)

• nafarelin (Synarel®)

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) or,
• SHOX (short stature homeobox-containing gene) deficiency or,
• Noonan Syndrome,
• Idiopathic Short Stature (ISS)
• Secondary panhypopituitarism due to tumor, trauma, or surgery 12 months post trauma or surgery if no evidence of tumor recurrence and growth has not restarted.

Prior Authorization forms 

• Pharmacy  

Preferred

• Genotropin®

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

PA Criteria:

• An FDA approved diagnosis as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism; AND
• Natpara® is not FDA approved for hypoparathyroidism caused by calcium-sensing receptor mutations.
• Natpara® is not FDA approved for hypoparathyroidism due to acute post-surgery. 
• Magnesium deficiency must be ruled out; AND  
• Member must have pretreatment serum calcium above 7.5mg/dL before starting Natpara®; AND
• Prescriber must verify the member has sufficient 25-hydroxyvitamin D level per standard of care; AND
• Member must be unable to be adequately well-controlled on calcium supplements and active forms of vitamin D alone; AND  
• Health care provider and dispensing pharmacy must be certified through the Natpara® Risk Evaluation and Mitigation Strategies (REMS) Program; AND
• A quantity limit of two cartridges (each package contains two 14-day cartridges) per 28 days will apply.  The maximum covered dose will be 100mcg per day.

 PA Criteria for oral diabetic medications:

• 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. 
• A clinical exception will apply for medications with the FDA approved diagnosis to reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes mellitus (DM) and established CV disease. Tier structure rules for this indication will apply.

Diabetes Medications Special Prior Authorization (PA) Approval Criteria:  

• Member must be currently stabilized on the requested product or have attempted at least three other categories of Tier-2 or Tier-3 medications, or have a documented clinical reason why the requested product is necessary for the member; AND
  
• Use of Invokamet® XR [canagliflozin/metformin extended-release (ER)] or Jentadueto® XR (linagliptin/metformin ER) will require a patient-specific, clinically significant reason why the member cannot take the immediate-release formulation(s); OR
  
• Use of Bydureon® BCise™ (exenatide ER autoinjector pen) will require tier trials be met, and a patient-specific, clinically significant reason why the member cannot use other available formulations of exenatide must be provided. 

Soliqua® 100/33 (Insulin Glargine/Lixisenatide) Approval Criteria:  

• An FDA approved diagnosis of type 2 diabetes mellitus; AND  
• A patient-specific, clinically significant reason why the member cannot use Lantus® (insulin glargine) with an alternative glucagon-like peptide-1 (GLP-1) receptor agonist must be provided.
• Current Tier-3 criteria will apply.

Xultophy® 100/3.6 (Insulin Degludec/Liraglutide) Approval Criteria:  

• An FDA approved diagnosis of type 2 diabetes mellitus; AND
• A patient-specific, clinically significant reason why the member cannot use Lantus® (insulin glargine) with Victoza® (liraglutide) must be provided. Please note: Victoza® (liraglutide) may require prior authorization.
• Current Tier-3 criteria will apply.

Tier 1

Tier 2

Tier 3

Special PA

Biaguanides 

• metformin (Glucophage®)
• metformin SR (Glucophage XR®)
• metformin-glyburide (Glucovance®)
• metformin-glipizide (Metaglip®)

Sulfonylureas

• chlorpropamide
• glimepiride (Amaryl®)
• glyburide (Diabeta®)
• glyburide micronized (Micronase®)
• glipizide (Glucotrol®)
• glipizide SR (Glucotrol XL®)
• tolbutamide

Alpha-Glucosidase Inhibitors

• acarbose (Precose®)

 Glinides

• repaglinide (Prandin®)

Thiazolidinediones 

• pioglitazone (Actos®)

DDP-4 Inhibitors 

• linagliptin (Tradjenta®)
• linagliptin-metformin (Jentadueto^TM) 
• sitagliptin (Januvia®)
• sitagliptin-metformin (Janumet®)
• sitagliptin-metformin ER (Janumet XR®)

SGLT2 inhibitor

• dapagliflozin (Farxiga ®)
• dapagliflozin-metformin (Xigduo™ XR)
• empagliflozin (Jardiance®
• empagliflozin/metformin (Synjardy®)
• empagliflozin/metformin ER (Synjardy® XR)

Glinides

• nateglinide (Starlix®) 
• repaglinide-metformin (Prandimet®)

GLP-1 Agonists

• liraglutide (Victoza®)
• exenatide (Byetta®)
• exenatide (Bydureon®) 
  

 DDP-4 Inhibitors 

• alogliptin-metformin (Kazano®)
• alogliptin (Nesina®)
• alogliptin-pioglitazone (Oseni®)
• saxagliptin (Onglyza®)
• saxagliptin-metformin (Kombiglyze®, Kombiglyze®XR) 

 Thiazolidinediones  

• rosiglitazone (Avandia®) 
• pioglitazone-metformin (Actoplus Met®, Actoplus Met XR®)
• pioglitazone-glimepiride (Duetact®)
• rosiglitazone-metformin (Avandamet®)
• rosiglitazone-glimepiride (Avandaryl®) 

Alpha-Glucosidase Inhibitors

• miglitol (Glyset®)

SGLT2 inhibitor

• canagliflozin (Invokana®)
• canagliflozin/metformin (Invokamet^TM )
• ertugliglozin (Steglatro™)
• ertugliflozin/metformin (Segluromet™) 
  

Dopamine Agonist

• bromocriptine (Cycloset®)

SGLT-2/DPP-4 Inhibitor

• dapagliflozin/saxagliptin (Qtern®)
• empagliflozin/linagliptin (Glyxambi®)
• ertugliflozin/sitagliptin (Steglujan™)

GLP-1 Agonists

• albiglutide (Tanzeum™)
• dulaglutide (Trulicity®)
• lixisenatide (Adlyxin™)
• semaglutide (Ozempic®)

GLP-1 Agonists/Insulin

• insulin degludec/ liraglutide (Xultophy® 100/3.6) 
• insulin glargine/ lixisenatide (Soliqua™ 100/33) 

• metformin solution (Riomet®)
• metformin long acting (Fortamet®, Glumetza®)

Amylinomimetic

• pramlintide (Symlin®)
    

DDP-4 Inhibitors 

• linagliptin-metformin (Jentadueto® XR)*

SGLT2 inhibitor

•  canagliflozin/metformin (Invokamet^TM XR)

GLP-1 Agonists  

•  exenatide ER (Bydureon® BCise™)
  

Admelog® and Insulin Lispro(Insulin Lispro) Approval Criteria: 

• An FDA approved diagnosis of diabetes mellitus; AND  
• A patient-specific, clinically significant reason why the member cannot use Humalog® (insulin lispro) must be provided. 

Afrezza® (Insulin Human) Inhalation Powder Approval Criteria:

• An FDA approved diagnosis of diabetes mellitus; AND
• Member must be 18 years of age or older; AND
• A patient-specific, clinically significant reason why other rapid-acting injectable insulins are not appropriate; AND
• For the indication of type 1 diabetes, the member must use Afrezza® with a long-acting insulin; AND
• The member must not smoke or have chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD).

• An FDA approved diagnosis of diabetes mellitus; AND
• A patient-specific, clinically significant reason why the member cannot use Lantus® (insulin glargine) or Levemir® (insulin detemir).

Fiasp® (Insulin Aspart) Approval Criteria:  

• An FDA approved diagnosis of diabetes mellitus; AND
• A patient-specific, clinically significant reason why the member cannot use NovoLog® (insulin aspart) must be provided.

Humulin® R U-500 Vials (Insulin Human 500 Units/mL) Approval Criteria:  

• An FDA approved diagnosis of diabetes mellitus; AND
• A patient-specific, clinically significant reason why the member cannot use the Humulin® R U-500 KwikPen® (insulin human 500units/mL), which is available without prior authorization, must be provided.

Humalog® KwikPen® U-200 (Insulin Lispro 200 Units/mL) Approval Criteria:

• A patient-specific, clinically significant reason the member cannot use the 100 unit/mL strength is required for authorization of the 200 unit/mL strength.

Toujeo® (Insulin Glargine) Approval Criteria:

• An FDA approved diagnosis of diabetes mellitus; AND
• A patient-specific, clinically significant reason why member cannot use Lantus® (insulin glargine), and member must be using a minimum of 100 units of Lantus® (insulin glargine) per day. 

Tresiba® (Insulin Degludec) Approval Criteria:

• An FDA approved diagnosis of diabetes mellitus; AND
• A patient-specific, clinically significant reason why the member cannot use Lantus® (insulin glargine) or Levemir® (insulin detemir). 

pregabalin (Lyrica®) Approval Criteria (Diabetic Neuropathy Diagnosis):

• For the diagnosis of diabetic neuropathy, a trial of duloxetine and a trial of gabapentin or a patient-specific, clinically significant reason why duloxetine or gabapentin cannot be used must be provided
• Other criteria for Lyrica® (pregabalin) will continue to apply.
• Clinical exceptions for Lyrica® (pregabalin) include:
• Diagnosis of seizures or postherpetic neuralgia

• An FDA approved diagnosis of one of the following:
• Members with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option; OR
• Members with Cushing’s disease from a pituitary tumor for whom pituitary surgery is not an option or has not been curative; AND 
• For a diagnosis of acromegaly, the member must have a documented trial with octreotide long-acting or lanreotide depot with an inadequate response or have a patient-specific, clinically significant reason why the other long-acting somatostatin analogs (SSAs) are not appropriate for the member; AND
• Pasireotide LAR must be prescribed by an endocrinologist or in consultation with an endocrinologist; AND 
• Pasireotide LAR must be administered by a health care professional; AND
• Prescriber must document that the member has had an inadequate response to surgery or is not a candidate for surgery; AND
   Prescriber must verify liver function tests (LFTs) (e.g., ALT, AST, bilirubin) will be monitored when starting treatment and periodically thereafter; AND
• Authorizations will be for the duration of 12 months; AND  
• Reauthorization may be granted if the prescriber documents the member is responding well to treatment. 

*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(total testosterone) levels below 300ng/dL; AND  
• Must include one lab showing abnormal gonadotropins and/or other information necessary to demonstrate diagnosis; OR
• Testosterone and gonadotropin labs are not required for authorization of testosterone therapy if documentation is provided for established hypothalamic pituitary or gonadal disease or if the pituitary gland or testes has/have been removed.

Testosterone replacement products Tier-2 Prior Authorization Criteria:

• All diagnoses and laboratory requirements listed above must be met; AND
• 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).
• Approvals will be for the duration of one year; AND
• For Xyosted™ [testosterone enanthate subcutaneous (sub-Q) auto-injector]:
  
  • Member must be trained by a health care professional on sub-Q administration and storage of Xyosted™ sub-Q auto-injector. 

Testosterone replacement products Special Prior Authorization Criteria

 Consideration will be based on the following criteria:

• All diagnoses and laboratory requirements listed above must be met; AND
• A patient-specific, clinically significant reason why member cannot use all other available formulations of testosterone.
• Approvals will be for the duration of one year.
  

*Please note that approval will be for one year.

Tier 1

Tier 2

Special PA

• methyltestosterone powder
• testosterone cypionate injection (Depo-Testosterone®)
• testosterone enanthate injection
• testosterone topical gel (Androgel®)

• testosterone enanthate sub-Q auto-injector (Xyosted™)
• testosterone patch (Androderm®)
• testosterone topical gel (Fortesta®)
• testosterone topical solution (Axiron®)
• testosterone nasal gel (Natesto™)
• testosterone undecanoate injection (Aveed®)
• testosterone topical gel (Testim®, Vogelxo™)

• fluoxymesterone oral tablet (Androxy®)
• methyltestosterone oral tablet/capsule (Android®, Methitest®, Testred®)
• testosterone buccal tablet (Striant®)
• testosterone (Testopel Pellets®)

plerixafor (Mozobil®)   

estradiol gel 0.06% (Elestrin®) Approval Criteria:

• An FDA approved diagnosis of moderate-to-severe vasomotor symptoms due to menopause; AND
• Member must not have any contraindications for use of Elestrin®; AND
• A patient-specific, clinically significant reason why other topical estradiol formulations (e.g., Divigel®) are not appropriate for the member; AND
• Members greater than 65 years of age will generally not be approved without supporting information; AND
• Approvals will be for the duration of six months to ensure the need for continued therapy is reassessed periodically and the medication is being used for the shortest duration possible; AND
• A quantity limit of 52 grams per 30 days will apply. 

progesterone vaginal gel (Crinone®) Approval Criteria:  

• Current singleton pregnancy; AND
• Member must not have history of previous singleton spontaneous preterm delivery (SPTD); AND
• Cervical length of ≤ 20mm; AND
• Gestational age between 20 weeks, 0 days and 26 weeks, 6 days of gestation; AND
• A patient-specific, clinically significant reason why the member cannot use Endometrin® (progesterone vaginal insert). 
• Authorizations will be given for treatment through 36 weeks, 6 days of gestation.  
• Crinone® will not be covered for use with assisted reproductive technology (ART) for female infertility. 

progesterone vaginal insert (Endometrin®) Approval Criteria:  

• Current singleton pregnancy; AND
• Member must not have history of previous singleton spontaneous preterm delivery (SPTD); AND
• Cervical length of ≤ 20mm; AND
• Gestational age between 20 weeks, 0 days and 26 weeks, 6 days of gestation;  
• Authorizations will be given for treatment through 36 weeks, 6 days of gestation.  
• Endometrin® will not be covered for use with assisted reproductive technology (ART) for female infertility.

 Prior Authorization form

•  Pharm-23   

estradiol/progesterone capsule (Bijuva™) Approval Criteria:

• An FDA approved indication for the treatment of moderate-to-severe vasomotor symptoms due to menopause in women with an intact uterus; AND
• A patient-specific, clinically significant reason why the member cannot use all other available estrogen/progestin products indicated for vasomotor symptoms of menopause must be provided; AND
• A quantity limit of 30 capsules (1 pack) per 30 days will apply. 

PA Criteria:

• An FDA approved indication of one of the following in non-pregnant women:
  
  • For the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); OR
  • For the management of amenorrhea (primary and secondary) or abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; OR
  • As a test for endogenous estrogen production or for the production of secretory endometrium and desquamation; AND
• The quantity approved will be patient-specific depending on patient diagnosis, maximum recommended dosage, and manufacturer packaging.  
• Requests for the prevention of preterm birth in pregnant women with a history of previous singleton spontaneous preterm delivery (SPTD) prior to 37 weeks gestation will not be approved for generic Delalutin® and should be resubmitted for authorization of Makena® (hydroxyprogesterone caproate).   

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 26 weeks, 6 days of gestation.
• Authorizations will be for once a week administration by a healthcare professional through 36 weeks, 6 days of gestation; AND
• For Makena® SubQ autoinjector:
• Initial dose must be administered by a healthcare professional; AND
• Member and caregiver must be trained by a healthcare professional on SubQ administration and storage of Makena® SubQ autoinjector. 

Prior Authorization form - Makena

calcifediol er capsules (Rayaldee®) Approval Criteria:

• An FDA approved indication for treatment of secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD) stage 3 or 4; AND
• Member must not have CKD stage 5 or end-stage renal disease on dialysis; AND
• Member should have a serum total 25-hydroxyvitamin D level less than 30ng/mL before starting treatment; AND  
• Member should have a serum calcium level below 9.8mg/dL before initiating treatment; AND
• Rayaldee® must be prescribed by a nephrologist, endocrinologist, or provider who specializes in the treatment of SHPT; AND
• Member must have a documented failure or clinically-significant reason why the member cannot use available generic vitamin D analogs including calcitriol; AND
• Initial approval will be for 30mcg daily for three months; AND
• After three months, approval for 60mcg daily for 12 months can be considered if intact parathyroid hormone (iPTH) is above the treatment goal and serum calcium is below 9.8mg/dL, phosphorus is below 5.5mg/dL, and 25-hydroxyvitamin D is below 100ng/mL. 
• Additional approvals will not be granted if iPTH is persistently abnormally low, serum calcium is consistently above the normal range, or serum 25-hydroxyvitamin D is consistently above 100ng/mL. 
• A quantity limit of 60 capsules per 30 days will apply.  

etelcalcetide injection (Parsabiv™) Approval Criteria:

• An FDA approved indication for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis; AND
• Parsabiv™ will not be approved for parathyroid carcinoma, primary hyperparathyroidism, or in patients with CKD who are not on hemodialysis and is not recommended for use in these populations; AND
• Member’s corrected serum calcium should be at or above the lower limit of normal (≥ 8.3mg/dL) prior to initiation, dose increase, or re-initiation of Parsabiv™; AND
   Parsabiv™ must be prescribed by a nephrologist, endocrinologist, or provider who specializes in the treatment of SHPT; AND
• Member must have a documented failure or a clinically-significant reason why the member cannot use available generic vitamin D analogs including calcitriol; AND
• Member must have a documented failure or a clinically-significant reason why the member cannot use Sensipar® (cinacalcet); AND
• A quantity limit of 12 vials per month will apply.

paricalcitol capsules (Zemplar®) Approval Criteria:

• Member must be 10 years of age or older; AND
• An FDA approved indication for the prevention and treatment of secondary hyperparathyroidism (SHPT) associated with one of the following:
• Chronic kidney disease (CKD) stage 3 or 4; OR
• CKD stage 5 in patients on hemodialysis or peritoneal dialysis; AND
• Members with CKD stage 5 should have a corrected total serum calcium equal to or less than 9.5mg/dL before initiating treatment; AND 
• Zemplar® must be prescribed by a nephrologist, endocrinologist, or provider who specializes in the treatment of SHPT; AND
• Member must have a documented failure or a clinically-significant reason why the member cannot use other generic vitamin D analogs available without prior authorization including calcitriol and Zemplar® injection; AND
• A quantity limit of 30 capsules per 30 days will apply.

doxercalciferol capsules (Hectorol®) Approval Criteria:

• An FDA approved diagnosis; AND
• Member must have a documented failure or a clinically-significant reason why the member cannot use calcitriol.