Endocrine 2017 Archive

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

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

PA Criteria:

FDA approved indication for specific products.

• Treatment of Anemia of Chronic Renal Failure Patients (ESAs are included in the dialysis payment if patient is on ANY form of dialysis)
• 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) 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.

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)
• saxagliptin (Onglyza®)
• saxagliptin-metformin (Kombiglyze®, Kombiglyze®XR)
• sitagliptin (Januvia®)
• sitagliptin-metformin (Janumet®)
• sitagliptin-metformin ER (Janumet XR®)

SGLT2 inhibitor

• canagliflozin (Invokana®)
• canagliflozin/metformin (Invokamet^TM )

Glinides

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

GLP-1 Agonists

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

 DDP-4 Inhibitors 

• alogliptin-metformin (Kazano®)
• alogliptin (Nesina®)
• alogliptin-pioglitazone (Oseni®)
  
  

 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

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

Dopamine Agonist

• bromocriptine (Cycloset®)

SGLT-2/DPP-4 Inhibitor

• empagliflozin/linagliptin (Glyxambi®)
• dapagliflozin/saxagliptin (Qtern®)

GLP-1 Agonists

• albiglutide (Tanzeum™)
• dulaglutide (Trulicity®)
• exenatide (Bydureon®) 
• lixisenatide (Adlyxin™)

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)
• empagliflozin/metformin ER (Synjardy® XR)

GLP-1 Agonists  

•  exenatide ER (Bydureon® BCise™)

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).

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

*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.

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

Tier 3

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

• 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®)

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

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 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.

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.
• Prior Authorization form
•  Pharm-23   

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.