Endocrine/Diabetics

Anti-Diabetic Medications Tier-2 Approval Criteria:  

• A trial at least 3 months in duration (unless intolerable adverse effects) of metformin titrated up to maximum dose, or a patient-specific, clinically significant reason why a 3-month trial of metformin titrated up to maximum tolerated dose is not appropriate must be provided. 
• For initiation with dual or triple therapy, additional Tier-2 medications may be approved based on current American Association of Clinical Endocrinologists (AACE) or American Diabetes Association (ADA) guidelines. 
• A clinical exception will apply for medications with a unique FDA approved indication not covered by all Tier-1 medications. Tier structure rules for unique FDA approved indications will apply.

Anti-Diabetic Medications Tier-3 Approval Criteria:

• Member must have failed a trial at least 3 months in duration and at recommended dosing (and member must be adherent to therapy) with 1 Tier-2 medication in the same category and have a documented clinical reason why the member cannot continue treatment with the Tier-2 medication.  
  • For members who did not complete a 3 month trial (i.e., due to intolerable adverse effects), the member must have a documented clinical reason why they cannot utilize a different Tier-2 medication in the same category, a Tier-2 medication in a different category, or provide detailed information regarding adverse effects occurring with the Tier-2 medication(s) that are not expected to occur with the requested Tier-3 medication that is in the same category. 
  • For Tier-3 medications that do not have a similar category in Tier-2, a medication from any category in Tier-2 may be used. 
• A clinical exception will apply for medications with a unique FDA approved indication not covered by all Tier-1 and Tier-2 medications. Tier structure rules for unique FDA approved indications will apply.

Anti-Diabetic Medications Special Prior Authorization (PA) Approval Criteria:

• 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; AND  
• Use of Adlyxin^® (lixisenatide) or Mounjaro^® (tirzepatide) will require a patient-specific, clinically significant reason the member cannot use the vial or pen formulation.  
• Use of generic dapagliflozin or dapagliflozin/metformin ER will require a patient-specific, clinically significant reason why they member cannot use brand name Farxiga^® (dapagliflozin) or Xigduo^® XR (dapagliflozin/metformin ER) and all available lower-tiered sodium-glucose cotransporter-2 (SGLT-2) inhibitors; and
• Use of glipizide 2.5mg immediate-release tablet will require a patient-specific, clinically significant reason why the member cannot use other appropriate Tier-1 products including splitting a glipizide 5mg tablet to achieve a 2.5mg dose; and
• Use of generic liraglutide will require a patient-specific, clinically significant reason why they member cannot use brand name Victoza® (liraglutide); and
• Use of Zituvio™ (sitagliptin) and Zituvimet™ (sitagliptin/metformin) will require a patient-specific, clinically significant reason (other than convenience) why the member cannot use all available lower-tiered glucagon-like peptide 1 receptor agonists (GLP-1 agonists).  

Inpefa^® (Sotagliflozin) Approval Criteria:

• An FDA approved indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors; and
• Member must be 18 years of age or older; and
• A patient-specific, clinically significant reason why the member cannot use all other lower tiered SGLT-2 inhibitors that have a similar indication must be provided.

Kerendia^® (Finerenone) Approval Criteria:

• An FDA approved indication to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult members with chronic kidney disease (CKD) associated with type 2 diabetes mellitus (T2DM); and
• Member must be receiving a maximum tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or have a contraindication to use; and
• A patient specific, clinically significant reason why the member cannot use a sodium-glucose cotransporter-2 (SGLT-2) inhibitor must be provided; and
• Member must not be receiving concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir); and
• Member must not have adrenal insufficiency; and
• Member must not have severe hepatic impairment (Child Pugh C); and
• Prescriber must measure serum potassium and eGFR prior to initiation of Kerendia^®; and
• Prescriber must verify serum potassium is not >5.0mEq/L prior to treatment initiation with Kerendia^®; and
• Prescriber must agree to monitor serum potassium levels 4 weeks after a dose adjustment and throughout treatment and adjust the dose accordingly per package labeling; and
• Initial authorization will be for 4 weeks, after which time serum potassium levels will be required for continued approval; and
• A quantity limit of 30 tablets per 30 days will apply. The member’s eGFR should be provided for initiation of treatment to ensure the correct recommended dose per package labeling. The following initial dose will be approved based on eGFR:
  • Kerendia^® 10mg once daily in members with eGFR 25 to <60mL/min/1.73m²; or
  • Kerendia^® 20mg once daily in members with eGFR ≥60mL/min/1.73m².

Lantidra™ (Donislecel-jujn) Approval Criteria:

• An FDA approved diagnosis of type 1 diabetes mellitus (T1DM); and
• Member must be 18 years of age or older; and
• Must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
• Member must have had T1DM for ≥5 years and has been receiving intensive insulin management defined as:
  • Self-monitoring of blood glucose levels at least 3 times per day on average; and
  • Using insulin pump therapy or using at least 3 insulin injections per day; and
  • Under the care of a diabetes specialist with at least 3 evaluations in the past 12 months; and
• Member is exhibiting 1 of the following despite intensive insulin management efforts:
  • Hypoglycemic unawareness; or
  • Two or more episodes of severe hypoglycemia, defined as an event with symptoms consistent with hypoglycemia in which the patient requires the assistance of another person and which is associated with a blood glucose level <54mg/dL; or
  • Two or more hospital visits (inpatient and/or emergency department) for diabetic ketoacidosis over the last year; or
  • Progressive secondary complications of diabetes as defined by retinopathy, nephropathy, or neuropathy despite efforts at optimal glucose control; and
• Member must receive concomitant immunosuppression. Lantidra™ is contraindicated in adults who have a contraindication to immunosuppression; and
• Member is T- and B-cell crossmatch assay negative; and
• Member must not have any of the following:
  • Severe cardiac disease defined by 1 of the following:
    • Recent, within the past 6 months, myocardial infarction; or
    • Angiographic evidence of non-correctable coronary artery disease; or
    • Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for members with a history of ischemic disease); or
    • Heart failure > New York Heart Association (NYHA) II; or
    • History of stroke within the past 6 months; and
  • No active infections, including hepatitis C, hepatitis B, human immunodeficiency virus (HIV), or tuberculosis; and
  • No history of malignancy except squamous or basal skin cancer; and
  • No concomitant disease or condition that contradicts the procedure or immunosuppression; and
  • No history of liver disease or renal failure and has not been the recipient of a renal transplant; an
  • No history of a prior portal vein thrombosis excluding thrombosis limited to second- or third-order portal vein branches; and
  • C-peptide ≥0.3ng/mL following a 5g arginine intravenous (IV) infusion challenge; and
  • Insulin requirements >0.7 IU/kg/day; and
  • Recent hemoglobin A1C (HbA1c) >12%; and
• Female members of reproductive potential must not be pregnant or breastfeeding and must agree to use effective contraception prior to initiation of immunosuppression and thereafter; and
• Initial approvals will be for 12 months. Reauthorization may be granted if the prescriber documents the member has not achieved independence from exogenous insulin within 1 year of infusion or may be granted within 1 year after losing independence from exogenous insulin after a previous infusion; and
  • Prescriber must verify the member is still receiving concomitant immunosuppression; and
• Lantidra™ must be administered at a manufacturer approved transplant center; and
• Approvals will be for a maximum of 3 infusions per member per lifetime.

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) or insulin glargine-yfgn (generic Semglee^®) with an alternative glucagon-like peptide-1 (GLP-1) receptor agonist must be provided.
• Current Tier-3 criteria will apply. 

Tzield^® (Teplizumab-mzwv) Approval Criteria:

• An FDA approved diagnosis of stage 2 Type 1 diabetes mellitus (DM). Diagnosis must be confirmed by the following:
  • Laboratory testing confirming the presence of ≥2 pancreatic islet autoantibodies; AND
    • Documentation must be submitted with results of autoantibody testing; AND
  • Documented evidence of dysglycemia without overt hyperglycemia as demonstrated by an abnormal oral glucose tolerance test (OGTT) meeting 1 of the following:
    • Fasting plasma glucose ≥100mg/dL and <126mg/dL; OR
    • 2-hour plasma glucose ≥140 mg/dL and <200mg/dL; OR
    • 30-, 60-, or 90-minute value on OGTT ≥200mg/dL; AND
• Member must be 8 years of age or older; AND
• Prescriber must confirm that member’s clinical history does not suggest a diagnosis of Type 2 DM; AND
• Tzield^® must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); AND
• All of the following will be required for initiation of treatment:
  • Verification that female members of reproductive potential are not pregnant and are currently using reliable contraception; AND
  • Verification that the member has no active infection(s); AND
  • Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; AND
  • Liver function tests and verification that levels are acceptable to the prescriber; AND
  • Verification that all age-appropriate vaccinations have been administered prior to treatment; AND
  • Prescriber must agree to premedicate the member for the first 5 days of dosing and as needed with a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, an antihistamine, and/or an antiemetic; AND
• Tzield^® must be administered by a health care professional. Approvals will not be granted for self-administration. Prior authorization requests must indicate how Tzield^® will be administered; AND
  • Tzield^® must be shipped via cold chain supply to the facility where the member is scheduled to receive treatment; OR
  • Tzield^® must be shipped via cold chain supply to the member’s home and administered by a home health care provider and the member or member’s caregiver must be trained on the proper storage of Tzield^®; AND
• The member’s recent body surface area (BSA) must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND
• A quantity limit of 28mL per 14 days will apply; AND
• Approvals will be for (1) 14-day cycle per member per lifetime.
  
  Tzield PA Form

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) or insulin glargine-yfgn (generic Semglee^®) with Victoza® (liraglutide) must be provided. Please note: Victoza® (liraglutide) may require prior authorization.
• Current Tier-3 criteria will apply.  

*Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

**no products available for coverage by SoonerCare currently

⁺Unique criteria applies.

DPP-4 = dipeptidyl peptidase-4; ER = extended-release; GLP-1 = glucagon-like peptide-1; PA = prior authorization; SGLT-2 = sodium-glucose cotransporter-2; soln = solution; SR = sustained-release; 

susp = suspension

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
• 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. 

Myfembree® (Relugolix/Estradiol/Norethindrone) Approval Criteria:

• An FDA approved diagnosis of 1 of the following: 
  • Heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women; OR
  • Moderate-to-severe pain associated with endometriosis in premenopausal women; AND
• Member must be 18 years of age or older; AND
• Member must not have any contraindications to therapy including:
  • Osteoporosis; AND
  • Pregnancy; 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 and for at least 1 week after discontinuing treatment; AND
  • Hepatic impairment or disease; AND
  • Undiagnosed abnormal uterine bleeding; AND
  • High risk of arterial, venous thrombotic, or thromboembolic disease, including uncontrolled hypertension; AND
  • Current or history of breast cancer or other hormonally-sensitive malignancies; AND
  • Known hypersensitivity to ingredients in Myfembree®; AND
• Must be prescribed by, or in consultation with, an obstetrician/gynecologist or a specialist with expertise in the treatment of uterine leiomyomas (fibroids) or endometriosis; AND
• A failed trial at least 1 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 3 months in duration of hormonal contraceptives or a patient-specific, clinically significant reason why the member cannot use hormonal contraceptives; AND
• A quantity limit of 28 tablets per 28 days will apply; AND
• Lifetime approval duration will be limited to a maximum of 24 months. For members previously approved for Oriahnn® or Orilissa^®, a combined cumulative maximum treatment duration of 24 months will apply.

Oriahnn (elagolix/estradiol/norethindrone and elagolix) Approval Criteria:

• An FDA approved diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women; AND
• Member must be 18 years of age or older; AND
• Member must not have any contraindications to therapy including:
  • Osteoporosis; AND
  • Pregnancy; 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 and for at least 1 week after discontinuing treatment; AND
  • Hepatic impairment or disease; AND
  • Undiagnosed abnormal uterine bleeding; AND
  • High risk of arterial, venous thrombotic, or thromboembolic disease, including uncontrolled hypertension; AND
  • Current or history of breast cancer or other hormonally-sensitive malignicies; AND
  • Known hypersensitivity to ingredients in Oriahnn; AND
  • Prescriber must verify the member will not use Oriahnn® concomitantly with an organic anion transporting polypeptide (OATP) 1B1 inhibitor (e.g., cyclosporine, gemfibrozil); AND
• Must be prescribed by, or in consultation with, an obstetrician/gynecologist or a specialist with expertise in the treatment of uterine leiomyomas (fibroids); AND
• A failed trial at least 1 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 3 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 available without prior authorization must be provided; AND 
• A patient-specific, clinically significant reason why the member cannot use Myfembree® (relugolix/estradiol/norethindrone) must be provided; AND
• A quantity limit of 56 tablets per 28 days will apply; AND
• Lifetime approval duration will be limited to a maximum of 24 months. For members previously approved for Myfembree, a combined cumulative maximum treatment duration of 24 months will apply.

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. 

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), or Wholesale Acquisition Costs (WAC) if NADAC unavailable

Growth Hormone Covered Indications (prior to epiphyseal closure)*:

• Growth hormone deficiency (GHD) of 1 of the following types:
  • Classic GHD as determined by childhood GH stimulation tests; or
  • Panhypopituitarism; or
  • Hypoglycemia with evidence for GHD; or
  • Neurosecretory dysfunction; or
  • Other evidence for GHD submitted for panel review and decision; or
• Short stature associated with Prader-Willi Syndrome; or
• Short stature associated with Noonan Syndrome; or
• Short stature associated with chronic renal insufficiency (pre-transplantation); or
• Growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by 2 years of age; or
• Idiopathic short stature (ISS) in children with height ≥2.25 SD below the mean for age and gender and who are unlikely to catch up in height; or
• Turner syndrome or 45X, 46XY mosaicism; or
• Short-stature homeobox-containing gene (SHOX) deficiency with genetic evidence for SHOX deficiency.

*Please refer to the complete prior authorization criteria for each indication, listed below.

Growth Hormone Tier-2 Approval Criteria:

• Documented allergic reaction to non-active components of all available Tier-1 products; or
• A clinical exception applies to members with a diagnosis of acquired immunodeficiency syndrome (AIDS) wasting syndrome, in which case Serostim^® can be used regardless of its current Tier status; or
• A clinical exception applies to members with a diagnosis of short bowel syndrome (SBS), in which case Zorbtive^® can be used regardless of its current Tier status. 

Discontinuation of Therapy or Transition to Adult Therapy Criteria:

• Failure to show improvement in height percentile on growth chart after 1 year of treatment; or
• Growth velocity <2.5cm/year unless associated with another growth-limiting and treatable medical condition (i.e., hypothyroidism); or
• Epiphyseal closure; or
• Covered height has been reached:
  • 152.4cm (60 inches) for girls; or
  • 165.1cm (65 inches) for boys; or
  • The covered height does not apply for members with a diagnosis of growth hormone deficiency (GHD) or panhypopituitarism; or
• Inadequate compliance; or
• Significant adverse effects.

Growth Hormone Dosing (doses must be individualized and titrated):

• Children: 22 to 100mcg/kg/day according to current pediatric guidelines; or
• Adults:
  • Initial Dosing: 0.1 to 0.5mg per day – Doses should be evaluated and titrated at 1 to 2 month intervals targeting an insulin-like growth factor 1 (IGF-1) level within the age-adjusted reference range provided by the laboratory utilized [IGF-1 standard deviation score (SDS) between -2 and +2]. In general, younger patients may require higher doses than older patients. The following initial doses are suggested by the current American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) guidelines, but these doses should be titrated based on IGF-1 levels:
    • Age <30 years: 0.4 to 0.5mg per day (may be higher for patients transitioning from pediatric treatment); or
    • Age 30-60 years: 0.2 to 0.3mg per day; or
    • Age >60 years: 0.1 to 0.2mg per day; and
  • Transition Dosing: In patients transitioning from pediatric to adult dosing, resuming GH doses at 50% of the dose last used in childhood is suggested, as they tend to be more tolerant of higher doses.

Growth Hormone Deficiency (GHD) Approval Criteria:

• Initial Approval:
  • Member must be 2 years of age or older (unless hypoglycemia is present); and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
  • Member must meet at least 1 of the following:
    • Member’s growth velocity (GV) must be <10% on a GV curve for gender and age; or
    • Member must have evidence of delayed bone age (undefined delay); and
  • Member must have open epiphyses; and
  • Member’s height must be ≥2.25 standard deviations (SD) below the mean for age and gender; and
  • Member’s growth chart and parental heights must be provided; and
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and
  • There must be no contributing medical conditions (e.g., cystic fibrosis, malnutrition, psychosocial deprivation); and
  • Member must have suboptimal response of ≤10ng/mL on 2 of the following provocative growth hormone stimulation tests, using the highest level per date of testing. (Stimulation tests are always required for approval unless hypoglycemia is observed, in which case a random low glucose level and low growth hormone level would be acceptable):
    • Propranolol with exercise; or
    • Levodopa; or
    • Insulin hypoglycemia test; or
    • Arginine HCl infusion; or
    • Clonidine; or
    • Glucagon (not approved for use in children); or
  • If hypoglycemia is present and member is growth hormone deficient: request may be approved for 6 months (other criteria above is not applicable). If the member has hypoglycemia, a low glucose level must be submitted along with additional evidence of GHD such as:
    • Low insulin-like growth factor 1 (IGF-1), random growth hormone level, or suboptimal growth hormone stimulation tests; or
    • MRI evidence of congenital anomaly which includes pituitary damage or absence; or
    • Other pituitary hormones also being replaced (e.g., thyroid, cortisol, etc.).
• Approval Length: 6 months if criteria met, compliant, and not needing to transition to adult dosing.
• Dosing:
  • Pediatric Dosing: FDA approved dosing varies by product. See the “Growth Hormone Dosing” section above for current guideline-based dosing considerations; OR
  • Adult Dosing: Members with this diagnosis may transition to adult dosing (see “Growth Hormone Dosing” section above for recommendations for adult and transition dosing) after 1 or both of the following:
    • Epiphyseal closure; or
    • GV <2.5cm/year; and
    • If either of the above have occurred and the member has not yet transitioned to adult dosing, may be approved short term (3 months) to allow time for transition to adult dosing.
  • Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • GV should not be <2.5cm/year if not on adult dosing; and
  • For members on adult dosing, recent IGF-1 level and standard deviation score (SDS) should be submitted and SDS should be between -2 and +2. 

Panhypopituitarism Approval Criteria:

• Initial Approval:
  • Member must be 2 years of age or older (unless hypoglycemia is present); and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
  • Member must meet at least 1 of the following:
    • Member’s growth velocity (GV) must be <10% on a GV curve for gender and age; or
    • Member must have evidence of delayed bone age (undefined delay); and
  • Member must have open epiphyses; and
  • Member’s height must be ≥2.25 standard deviations (SD) below the mean for age and gender; and
    • For members with secondary panhypopituitarism due to tumor, trauma, or surgery 12 months post trauma or surgery, approval may be granted if no evidence of tumor recurrence and growth has not restarted. The member must still meet all the other criteria; however, authorization would not require height ≥2.25 SD below the mean in these circumstances; and
  • Member’s growth chart and parental heights must be provided; and
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and
  • Member must have a history of pituitary or hypothalamic injury due to tumor, trauma, surgery, documented whole brain radiation, irradiation, hemorrhage or infarction, or a congenital anomaly; and
    • Deficiency in ≥3 pituitary hormones and insulin-like growth factor 1 (IGF-1) ≥2.5 SD below the mean for member’s age; or
    • No deficiency, or deficiency in <3 pituitary hormones, and IGF-1 <50th percentile and subnormal response of 10ng/mL or less on at least 2 provocative growth hormone stimulation tests, using the highest level per date of testing. (Stimulation tests are always required for approval unless hypoglycemia is observed, in which case a random low glucose level and low growth hormone level would be acceptable); or
  • If member has MRI evidence of pituitary stalk agenesis, empty sella, or ectopic posterior pituitary “bright spot”, member is exempt from height requirement (criteria letter e listed above); and
    • If they lack the hormones testosterone, luteinizing hormone (LH), or follicle-stimulating hormone (FSH) then an MRI is not required; or
  • If hypoglycemia is present and member is growth hormone deficient: request may be approved for 6 months (other criteria above is not applicable). If the member has hypoglycemia, a low glucose level must be submitted along with additional evidence of GHD such as:
    • Low IGF-1, random growth hormone level, or suboptimal growth hormone stimulation tests; or
    • MRI evidence of congenital anomaly which includes pituitary damage or absence; or
    • Other pituitary hormones also being replaced (e.g., thyroid, cortisol); and
• Approval Length: 6 months if criteria met, compliant, and not needing to transition to adult dosing.
• Dosing:
  • Pediatric Dosing: FDA approved dosing varies by product. See the “Growth Hormone Dosing” section above for current guideline-based dosing considerations; OR
  • Adult Dosing: Members with this diagnosis may transition to adult dosing (see “Growth Hormone Dosing” section above for recommendations for adult and transition dosing) after 1 or both of the following:
    • Epiphyseal closure; or
    • GV <2.5cm/year; and
    • If either of the above have occurred and the member has not yet transitioned to adult dosing, may be approved short term (3 months) to allow time for transition to adult dosing.    
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • GV should not be <2.5cm/year if not on adult dosing; and
  • For members on adult dosing, recent IGF-1 level and standard deviation score (SDS) should be submitted and SDS should be between -2 and +2.

Neurosecretory Dysfunction Approval Criteria:

• Initial Approval:
  • Member must be 2 years of age or older; and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
  • Member’s growth velocity (GV) must be <10% on a GV curve for gender and age; and
  • Member’s height must be ≥2.25 standard deviations (SD) below the mean for age and gender; and
  • Member must have evidence of delayed bone age and open epiphyses; and
  • Member’s growth chart and parental heights must be provided; and
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and
  • Member’s serum insulin-like growth factor 1 (IGF-1) must be below the mean for member’s age; and
    • Note: Children with profoundly low GV, who are at risk for growth hormone deficiency due to CNS radiation or other organic causes, termed neurosecretory dysfunction, may demonstrate “normal” responses to provocative tests, often for several years, but often benefit from growth hormone therapy.
  • Growth hormone stimulation testing is required; however, growth hormone levels may be normal; and
• Approval Length: 6 months if criteria met, compliant, and not needing to transition to adult dosing.
• Dosing:
  • Pediatric Dosing: FDA approved dosing varies by product. See the “Growth Hormone Dosing” section above for current guideline-based dosing considerations; OR
  • Adult Dosing: Members with this diagnosis may transition to adult dosing (see “Growth Hormone Dosing” section above for recommendations for adult and transition dosing) after 1 of the following:
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year; and
    • If any of the above have occurred and the member has not yet transitioned to adult dosing, may be approved short term (3 months) to allow time for transition to adult dosing.
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • GV should not be <2.5cm/year if not on adult dosing; and
  • For members on adult dosing, recent IGF-1 level and standard deviation score (SDS) should be submitted and SDS should be between -2 and +2. 

Idiopathic Short Stature Approval Criteria:

• Initial Approval:
  • Member must be 8 years of age or older; and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
  • Member’s growth velocity (GV) must be <10% on a GV curve for gender and age; and
  • Member’s height must be ≥2.25 standard deviations (SD) below the mean for age and gender; and
  • Member must have evidence of delayed bone age (undefined delay) and open epiphyses; and
  • Member’s growth chart and parental heights must be provided
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and
• Approval Length: 6 months if criteria met and compliant. No adult dosing will be approved for this indication. Once epiphyses are closed, covered height has been met, or GV is <2.5cm/year, therapy should be discontinued.
• Dosing:
  • Pediatric Dosing: FDA approved dosing varies by product. See the “Growth Hormone Dosing” section above for current guideline-based dosing considerations. Treatment may continue until 1 of the following:
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year; and
  • Adult Dosing: No proven benefit to continuing growth hormone treatment in adulthood.
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Epiphyses are open; and
  • GV should not be <2.5cm/year.

Short Stature Associated with Chronic Renal Insufficiency (Pre-Transplantation) Approval Criteria:

• Initial Approval:
  • Member must be 2 years of age or older; and
  • Member’s estimated creatinine clearance (CrCl) must be <50mL/min; and
  • Member must not be post-kidney transplant; and
  • Growth hormone therapy must be prescribed by an endocrinologist or pediatric nephrologist (or an advanced care practitioner with a supervising physician who is an endocrinologist or pediatric nephrologist); and
  • Member’s growth chart and parental heights must be provided; and
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and   
  • Members meeting the above criteria are exempt from height requirements.
• Approval Length: 6 months if criteria met and compliant. No adult dosing will be approved for this indication. Once epiphyses are closed, covered height has been met, growth velocity (GV) is <2.5cm/year, or member has received renal transplant, therapy should be discontinued.
• Dosing:
  • Pediatric Dosing: Standard dosing applies for members receiving pediatric dosing (0.05mg/kg/day). Treatment may continue until 1 of the following:
    • Renal transplantation; or
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year; and
  • Adult Dosing: No proven benefit to continuing growth hormone treatment in adulthood.
• Continuation Approval:
  • Member is still pre-transplant; and
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights; and
  • Member should be compliant; and
  • Epiphyses are open; and
  • GV should not be <2.5cm/year.

Short Stature Associated with Prader-Willi Syndrome (PWS) Approval Criteria:

•  Initial Approval:
  • Member must have a chromosome analysis confirming the diagnosis of PWS; and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
  • Member’s growth chart and parental heights must be provided; and
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and
• Approval Length: 6 months if criteria met, compliant, and not needing to transition to adult dosing.
• Dosing: 
  • Pediatric Dosing: 0.5-1mg/m²/day or 0.24mg/kg/week. Treatment should continue until 1 of the following:
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year; and
  • Adult Dosing: After attainment of adult height, adults with PWS may be considered for adult dosing if evidence is submitted documenting adult growth hormone deficiency [e.g., low insulin-like growth factor 1 (IGF-1) level and GH stimulation testing]. 
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • GV should not be <2.5cm/year; and
  • For members on adult dosing, recent IGF-1 level and standard deviation score (SDS) should be submitted and SDS should be between -2 and +2.

Short Stature Associated with Turner Syndrome or 45X, 46XY Mosaicism Approval Criteria:

• Initial Approval:
  • Member must be 2 years of age or older; and
  • Member must have a chromosome analysis confirming the diagnosis of Turner Syndrome in females or 45X 46XY mosaicism in males; and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
• Approval Length: 6 months if criteria met and compliant. No adult dosing will be approved for this indication. Once epiphyses are closed, covered height has been met, or growth velocity (GV) is <2.5cm/year, therapy should be discontinued.
• Dosing:
  • Pediatric Dosing: FDA approved dosing varies by product. See the “Growth Hormone Dosing” section above for current guideline-based dosing considerations. Treatment should continue until 1 of the following:
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year; and
  • Adult Dosing: No proven benefit to continuing growth hormone treatment in adulthood.
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Epiphyses should be open; and
  • GV should not be <2.5cm/year.

Short Stature Associated with Noonan Syndrome Approval Criteria:

• Initial Approval:
  • Member must be 2 years or older; and
  • Member must have a chromosome analysis confirming the diagnosis of Noonan Syndrome; and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
• Approval Length: 6 months if criteria met and compliant. No adult dosing will be approved for this indication. Once epiphyses are closed, covered height has been met, or growth velocity (GV) is <2.5cm/year, therapy should be discontinued.
• Dosing: 
  • Pediatric Dosing: Standard dosing applies for members receiving pediatric dosing (up to 0.066mg/kg/day). Treatment should continue until 1 of the following:
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year.
  • Adult Dosing: No proven benefit to continuing growth hormone treatment in adulthood.
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Epiphyses should be open; and
  • GV should not be <2.5cm/year.

Short Stature Associated with Short Stature Homeobox-Containing Gene (SHOX) Deficiency Approval Criteria:

• Initial Approval:
  • Member must be 2 years or older; and
  • Member must have a chromosome analysis confirming the diagnosis of SHOX deficiency; and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
  • Member’s growth velocity (GV) must be <10% on a GV curve for gender and age; and
  • Member’s height must be ≥2.25 standard deviations (SD) below the mean for age and gender; and
  • Member must have evidence of delayed bone age (undefined delay) and open epiphyses; and
  • Member’s growth chart and parental heights must be provided; and
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and
  • Member must have a normal endocrine screen; and
  • Member must have no evidence of growth hormone deficiency or insensitivity, tumor activity, diabetes mellitus, history of impaired glucose tolerance, or other serious illness known to interfere with growth; and
• Approval Length: 6 months if criteria met and compliant. No adult dosing will be approved for this indication. Once epiphyses are closed, covered height has been met, or GV is <2.5cm/year, therapy should be discontinued.
• Dosing:  
  • Pediatric Dosing: Standard dosing applies for members receiving pediatric dosing (up to 0.05mg/kg/day). Treatment should continue until 1 of the following:
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year; and
  • Adult Dosing: No proven benefit to continuing growth hormone treatment in adulthood.
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Epiphyses should be open; and
  • GV should not be <2.5cm/year.

Small for Gestational Age (SGA) Approval Criteria:

• Initial Approval:
  • Member must be 2 years or age or older; and
  • Documentation of birth weight <2,500 grams at gestational age of more than 37 weeks or birth weight or length below the 3rd percentile for gestational age; and
  • Growth hormone therapy must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
  • Member’s growth velocity (GV) must be <10% on a GV curve for gender and age; and
  • Member’s height must be ≥2.25 standard deviations (SD) below the mean for age and gender; and
  • Member must have evidence of delayed bone age (undefined delay) and open epiphyses; and
  • Member’s growth chart and parental heights must be provided; and
    • If the form is completed, a growth chart is not required; and
    • Parental heights are not always available; and
• Approval Length: 6 months if criteria met and compliant. No adult dosing will be approved for this indication. Once epiphyses are closed, covered height has been met, or GV is <2.5cm/year, therapy should be discontinued.
• Dosing: 
  • Pediatric Dosing: FDA approved dosing varies by product. See the “Growth Hormone Dosing” section above for current guideline-based dosing considerations. Treatment should continue until 1 of the following:
    • Epiphyseal closure; or
    • Covered height [Boys: 165.1cm (65 inches); Girls: 152.4cm (60 inches)]; or
    • GV <2.5cm/year; and
  • Adult Dosing: No proven benefit to continuing growth hormone treatment in adulthood.
• Continuation Approval:
  • Medications and dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Epiphyses should be open; and
  • GV should not be <2.5cm/year. 

Prior Authorization forms 

• Growth Hormone PA form

*Supplementally rebated product(s); tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

⁺Additional approval criteria applies.

All products, other than Sogroya^®, contain the identical 191 amino acid sequence found in pituitary-derived human growth hormone (hGH). For Sogroya^®, 1 amino acid has been substituted and linked to an albumin-binding side chain.

Ngenla^® (Somatrogon-ghla) Approval Criteria:

• Member must have a confirmed diagnosis of growth hormone deficiency (GHD) or panhypopituitarism meeting the initial growth hormone approval criteria (listed under “Initial Approval”) for the member’s specific diagnosis; and
• Member must be 3 years of age or older; and
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use all Tier-1 product(s) must be provided; and
• Prescriber must verify the member has been counseled on proper administration and storage of Ngenla^®; and
• Initial approvals will be for the 0.66mg/kg dose recommended in package labeling; and
• Initial approvals will be for the duration of 6 months. For additional approval consideration:
  • Dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Growth velocity should not be <2.5cm/year; and
  • Prescriber must verify member still has open epiphyses; and
• Ngenla^® will not be approved following epiphyseal closure. Ngenla^® is contraindicated in children with closed epiphyses.

Sogroya^® (Somapacitan-beco) Approval Criteria:

• Member must have a confirmed diagnosis of 1 of the following:
  • Pediatric growth hormone deficiency (GHD) or panhypopituitarism meeting all the “Initial Approval” criteria for the member’s specific diagnosis; or
  • Adult GHD confirmed by 1 of the following:
    • Insulin tolerance test (ITT) or glucagon test with a peak growth hormone (GH) response <3ng/mL; or
    • ≥3 pituitary hormone deficiencies and insulin like growth factor-1 (IGF-1) standard deviation score (SDS) <-2.0; and
• Member must be 2.5 years of age or older; and
• Sogroya^® must be prescribed by an endocrinologist (or an advanced care practitioner with a supervising physician who is an endocrinologist); and
• Member’s baseline IGF-1 level and SDS must be provided; and
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use all Tier-1 product(s) must be provided; and
• Prescriber must verify the member does not have active malignancy or active proliferative or severe non-proliferative diabetic retinopathy; and
• Prescriber must verify the member has been counseled on proper administration and storage of Sogroya^®; and
• Approval quantity will be based on the FDA approved dosing in accordance with the package labeling; and
• Initial approvals will be for the duration of 6 months. For additional approval consideration:
  • Dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Growth velocity should not be <2.5cm/year if not on adult dosing; and
  • For members on adult dosing, recent IGF-1 level and SDS should be submitted and SDS should be between -2 and +2; and
  • For members initially approved as adults, the prescriber must verify the member is responding well to treatment as demonstrated by a reduction in truncal fat percentage or normalization of IGF-1 level (IGF-1 SDS of -0.5 to 1.75); and
• A maximum approved dose of 8mg per week will apply for members with adult GHD.

Skytrofa^® (Lonapegsomatropin-tcgd) Approval Criteria:

• Member must have a confirmed diagnosis of growth hormone deficiency (GHD) or panhypopituitarism meeting the initial growth hormone approval criteria (listed under “Initial Approval”) for the member’s specific diagnosis; and
• Member’s weight must be ≥11.5kg; and
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use all Tier-1 product(s) must be provided; and
• Prescriber must verify the member has been counseled on proper administration and storage of Skytrofa^®; and
• Initial approvals will be for the 0.24mg/kg weekly dose, using the specific dose recommended in the Skytrofa^® Prescribing Information; and
• Initial approvals will be for the duration of 6 months. For additional approval consideration:
  • Dosing should be appropriate; and
  • Member should have had a recent office visit with new information regarding heights provided; and
  • Member should be compliant; and
  • Growth velocity should not be <2.5cm/year; and
  • Prescriber must verify member still has open epiphyses; and
• Skytrofa^® will not be approved following epiphyseal closure. Skytrofa^® is contraindicated in children with closed epiphyses.

Voxzogo™ (Vosoritide) Approval Criteria:

• Member must have an FDA approved diagnosis of achondroplasia; and
  • Diagnosis must be confirmed by genetic testing identifying a pathogenic mutation in the FGFR3 gene; and
• Prescriber must verify member has open epiphyses; and
• The member’s baseline height and growth velocity (GV) must be provided; and
• Voxzogo™ must be prescribed by a geneticist, endocrinologist, or other specialist with expertise in the treatment of achondroplasia (or an advanced care practitioner with a supervising physician who is a geneticist, endocrinologist, or other specialist with expertise in the treatment of achondroplasia); and
• Member’s recent weight (taken within the past 3 weeks) must be provided in order to ensure appropriate dosing in accordance with the Voxzogo™ Prescribing Information; and
• Prescriber must verify the member or member’s caregiver has been counseled on proper administration and storage of Voxzogo™, including the need for adequate food and fluid intake prior to each dose; and
• A quantity limit of 30 vials per 30 days will apply; and
• Initial and subsequent approvals will be for the duration of 6 months. For additional approval consideration:
  • Member’s current height must be provided and must demonstrate an improvement in GV from baseline; and
  • Member’s recent weight must be provided and dosing must be appropriate; and
  • Member should be compliant; and
  • Prescriber must verify member still has open epiphyses; and
• Voxzogo™ will not be approved following epiphyseal closure. 

*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  
• The prescriber must verify the member has been evaluated for the presence of a pituitary tumor as the potential cause of low testosterone and the member will receive appropriate follow-up and/or treatment as necessary; 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.

Prior Authorization Form