Human Growth Hormone and Insulin-like Growth Factor-1

POLICY NUMBER

L.5.01.490

Egrifta SV (tesamorelin)

Genotropin (somatropin)

Humatrope (somatropin)

Increlex (mecasermin)

Ngenla (somatrogon-ghla)

Norditropin (somatropin)

Nutropin AQ (somatropin)

Omnitrope (somatropin)

Serostim (somatropin)

Skytrofa (lonapegsomatropin-tcgd)

Sogroya (somapacitan-beco)

Zomacton (somatropin)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Growth hormone (GH) is produced by the pituitary somatroph cells and is the most abundant anterior pituitary hormone. GH production begins early in fetal life and continues throughout life, although at a progressively lower rate. Daily GH secretory rates peak during puberty and decline over time. This decline parallels the age-related decline in body mass index. The predominant action of GH is to stimulate hepatic synthesis and secretion of the hormone insulin-like growth factor (IGF-1). IGF-1 is a critical protein induced by GH and likely responsible for most of the growth-promoting activities of GH.  

GH stimulates linear growth in children by acting directly and indirectly (via the synthesis of IGF-1) on the epiphyseal plates of long bones. GH also has specific metabolic actions in adults including increased lipolysis and lipid oxidation, stimulation of protein synthesis, antagonism of insulin action, and phosphate, water, and sodium retention.

Recombinant human GH (rhGH) contains the identical sequence of amino acids found in human GH. It is administered in an attempt to mimic normal GH secretion or action when the pituitary gland fails to produce enough hormone (GH deficiency) or GH secretion or response is impaired due other conditions (i.e., genetic disorders, chronic kidney disease, etc.). Recombinant DNA technology has also produced an insulin-like growth factor-1 (rhGF-1) product for severe primary IGF-1 deficiency.

POLICY

Priorauthorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

The requested agent may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The request is for Norditropin (somatropin) and ONE of the following:

      1. The individual is less than 18 years of age and ONE of the following:

         1. The individual has a documented diagnosis of neonatal GH deficiency with medical records to support diagnosis (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or magnetic resonance imaging [MRI] results);

         2. The individual has a documented diagnosis of pediatric GH deficiency and ONE of the following:

            1. The individual has extreme short stature (e.g., height less than or equal to -3 SD), normal nutrition, significantly reduced IGF-1 and IGFBP-3 (e.g., less than -2 SD), and delayed bone age (e.g., less than -2 SD); OR

            2. ALL of the following:

               1. Baseline pretreatment serum IGF-1 or IGFBP-3 is low (i.e., z-score less than 0) for age and gender as established per the laboratory’s reference range (laboratory documentation must be provided);

               2. The individual has ONE of the following:

                  1. Height greater than 2 SD below the mean for age and sex;

                  2. Height velocity (HV) greater than 2 SD below the mean over one year or greater than 1.5 SD sustained over two years;

                  3. Height-for-age curve has deviated downward across two major height percentile curves (e.g., from above the 25th percentile to below the 10th percentile);

                  4. The individual is 2 to 4 years of age with a HV less than 5.5 cm/year (less than 2.2 inches/year);

                  5. The individual is 4 to 6 years of age with a HV less than 5 cm/year (less than 2 inches/year); OR

                  6. The individual is 6 years of age to puberty and ONE of the following:

                     1. The individual is male with a HV less than 4 cm/year (less than 1.6 inches/year); OR

                     2. The individual is female with a HV less than 4.5 cm/year (less than 1.8 inches/year); AND

               3. ONE of the following:

                  1. The individual has failed at least 2 GH stimulation tests (e.g., peak GH values of less than 10 mcg/L after stimulation or otherwise considered abnormal as determined by testing lab);

                  2. The individual has failed at least 1 GH stimulation tests (e.g., peak GH values of less than 10 mcg/L after stimulation or otherwise considered abnormal as determined by testing lab) and ONE of the following:

                     1. Pathology of the central nervous system;

                     2. History of irradiation;

                     3. Other pituitary hormone defects (e.g., multiple pituitary hormone deficiency [MHPD]); OR

                     4. A genetic defect; OR

                  3. The individual has a pituitary abnormality and a known deficit of at least one other pituitary hormone;

         3. The individual has a documented diagnosis of Noonan Syndrome;

         4. The individual has a documented diagnosis of Turner Syndrome;

         5. The individual has a documented diagnosis of Prader-Willi Syndrome;

         6. The individual has a documented diagnosis of short stature homeobox-containing gene (SHOX) deficiency; OR

         7. The individual has a documented diagnosis of panhypopituitarism (at least 3 pituitary hormone deficiencies (ACTH, TSH, FSH, LH, prolactin) AND serum IGF-I levels below the age- and sex-appropriate reference range when off GH therapy; OR

      2. The individual 18 years of age or older and ALL of the following:

         1. The individual has a documented diagnosis of GH deficiency; AND

         2. ONE of the following:

            1. The individual has a diagnosis of childhood-onset growth hormone deficiency and has failed at least one growth hormone (GH) stimulation test as an adult;

            2. The individual has a low insulin-like growth factor-1 (IGF-1) level and ONE of the following:

               1. Organic hypothalamic-pituitary disease (e.g., suprasellar mass with previous surgery and cranial irradiation);

               2. Pituitary structural lesion or trauma; OR

               3. Panhypopituitarism or at least 3 pituitary hormone deficiencies (ACTH, TSH, FSH, LH, prolactin);

            3. The individual has an established causal genetic mutation OR hypothalamic-pituitary structural defect other than ectopic posterior pituitary; OR

            4. The individual has failed at least one GH stimulation test as an adult AND has an organic pituitary disease;

   2. The request is for Nutropin AQ (somatropin) and ALL of the following:

      1. The individual is less than 18 years of age;

      2. The individual has documented diagnosis of growth failure due to chronic kidney disease (i.e. stage 3-5 [GFR<60] chronic kidney disease or dialysis-dependent);

      3. ONE of the following:

         1. HV for age is less than -1.88 SD; OR

         2. HV for age is less than the 3rd percentile;

      4. Short stature as a result of a different etiology (e.g., malnutrition, fluid and electrolyte abnormalities, anemia, etc.) has been ruled out; AND

      5. The individual has not received a functioning renal transplant;

   3. The request is for Serostim (somatropin) and ALL of the following:

      1. The individual has a documented diagnosis of HIV wasting syndrome;

      2. Weight loss as a result of an underlying condition or different etiology (e.g., malnutrition, mental illness, endocrine disease, etc.) has been ruled out;

      3. ONE of the following:

         1. The individual has weight loss of at least 10% from baseline weight in the last 12 months; OR

         2. The individual has a BMI <20;

      4. The individual is currently treated with and will continue appropriate antiretroviral therapy with the requested agent; AND

      5. The individual has tried and had an inadequate response (see definition of Medication Failure in Policy Guidelines section) to dronabinol; OR

   4. The request is for Increlex (mecasermin) and ALL of the following:

      1. The individual is 2 years to less than 18 years of age with open epiphyses;

      2. The individual has a documented diagnosis of ONE of the following:

         1. Severe primary IGF-1 deficiency defined by ALL of the following:

            1. Height standard deviation score less than -3.0;

            2. Basal IGF-1 standard deviation score less than -3.0; AND

            3. Normal or elevated growth hormone (GH); OR

         2. Growth hormone gene deletion in individuals who have developed neutralizing antibodies to GH; AND

      3. The requested agent will not be used in combination with human growth hormone therapy;

2. The prescriber is a specialist or has consulted with a specialist in an area of the individual’s diagnosis (i.e., endocrinologist, geneticist, nephrologist);

3. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval:  HIV wasting: 12 weeks                                 All other indications: 12 months

  Renewal Criteria

The requested agent may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for therapy with the requested agent through the BCBSMS PA process;

2. ONE of the following:

   1. The individual is less than 18 years of age and ONE of the following:

      1. The individual has a documented diagnosis of GH deficiency, growth failure due to Noonan’s syndrome, SHOX deficiency, Turner syndrome, renal function impairment with growth failure, or severe primary IGF-1 deficiency and BOTH of the following:

         1. The individual’s height has increased at least 2 cm over the previous year with GH therapy; AND

         2. The individual does NOT have closed epiphyses (radiographic testing to determine if epiphyses are closed may be required at age 14 in girls and at age 16 in boys, and annually thereafter, if still open); OR

      2. The individual has a diagnosis of Prader-Willi syndrome and has had clinical benefit with the requested agent (e.g., linear growth, body composition/obesity, bone density, physical function, motor development); OR

   2. The individual is 18 years of age or older and ONE of the following:

      1. The individual has a diagnosis of growth hormone deficiency and BOTH of the following:

         1. The individual’s IGF-1 level has been evaluated to confirm the appropriateness of the current dose; AND

         2. The individual has had clinical benefit with the requested agent (i.e., body composition, hip-to-waist ratio, cardiovascular health, bone mineral density, serum cholesterol, physical strength, or quality of life); OR

      2. The individual has a diagnosis of HIV wasting and ALL of the following:

         1. The individual is currently treated with and will continue antiretroviral therapy; AND

         2. The individual has had clinical benefit with the requested agent (i.e., increase in weight or weight stabilization); OR

3. The individual will not be receiving concurrent treatment with growth hormone and Increlex (mecasermin);

4. The individual is being monitored for adverse effects of therapy (i.e., monitoring serum IGF-1 levels);

5. The prescriber is a specialist or has consulted with a specialist in an area of the member’s diagnosis (i.e., endocrinologist, geneticist, nephrologist);

6. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

7. The prescribed dosage is within the program quantity limits based on FDA-approved labeled dosage.

Length of Approval: 12 months

Recombinant human growth hormone is considered not medically necessary for treatment of short children who are not GH deficiency (this includes Small for Gestational Age [SGA]), except for Turner’s syndrome.

Recombinant human growth hormone is considered investigational for all other off-label applications including, but not limited to the following:

• Treatment of altered body habitus (e.g., buffalo hump) associated with antiviral therapy in HIV-infected individuals

• Constitutional delay (lower than expected height percentiles compared with target height percentiles and delayed skeletal maturation when growth velocities and rates of bone age advancement are normal)

• Treatment of children with “genetic potential” (i.e., lower than expected height percentiles based on parents’ height)

• In conjunction with gonadotropin-releasing hormone analogs as a treatment of precocious puberty

• Growth hormone therapy in older adults without proven deficiency

• Treatment of cystic fibrosis

• Anabolic therapy (except for AIDS) provided to counteract acute or chronic catabolic illness (e.g., surgery outcomes, trauma, cancer, chronic hemodialysis, chronic infectious disease) producing catabolic (protein wasting) changes in both adult and pediatric individuals

• Anabolic therapy to enhance body mass or strength for professional, recreational, or social reasons

• Glucocorticoid-induced growth failure

• Short stature due to Down syndrome

• Treatment of obesity

• Treatment of idiopathic dilated cardiomyopathy

• Treatment of juvenile idiopathic or juvenile chronic arthritis

• Infertility

• Use as an antiaging agent

• Chronic fatigue syndrome

• Fibromyalgia

• Crohn’s Disease

• Osteoporosis

• Familial short stature

• Intrauterine growth retardation

The following diagnostic tests for growth hormone deficiency are considered not medically necessary:

• 24-hour continuous monitoring of GH levels.

Increlex (mecasermin) is considered investigational for all other off-label applications including, but not limited to the following:

• Secondary forms of IGF-1 deficiency (GH deficiency, malnutrition, hypothyroidism, or chronic corticosteroid therapy);

• Growth failure due to other identifiable causes (e.g., Prader-Willi syndrome, Turner syndrome, Noonan syndrome)

• Diabetes

• AIDS-associated wasting

• Anorexia nervosa

• Obesity

• Advanced chronic renal failure

• Cystic fibrosis

• Amyotrophic lateral sclerosis (ALS)

• Severe head injury

• Use in combination with GH

Genotropin, Humatrope, Ngenla, Omnitrope, Skytrofa, Sogroya, and Zomacton are considered not medically necessary as other formulary alternatives are covered by the Plan.

Egrifta (tesamorelin) is considered not medically necessary as the reduction of excess abdominal fat is considered cosmetic.

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for >3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

8/1995: Approved by Medical Policy Advisory Committee (MPAC).

2/1998: Comprehensive revision approved by MPAC.

2/2000: Comprehensive revision approved by Pharmacy & Therapeutics (P & T) Committee.

10/4/2000: Prader-Willi syndrome moved from investigational to medically necessary. Estrogen therapy should be delayed until the patient is 15 years of age or when the height deficit is no longer substantial added to Turner's Syndrome. Sources updated.

5/8/2001: Serostim ® for HIV wasting added.

5/14/2001: BMI calculation formula added.

7/27/2001: Panhypopituitarism from pituitary surgery or radiation surgery added to medically necessary.

8/2001: Policy revisions.

1/30/2002: Flow of the paragraph revised under "Patients <18 years of age"; "up to the time of renal transplant" added to Chronic Renal Insufficiency; ITT is the gold standard added to "GH therapy is covered for adult patients with documented"; prior authorization added.

2/13/2002: Investigational definition added.

3/12/2002: New 2002 codes added.

5/1/2002: Type of Service and Place of Service deleted.

9/27/2002: Contraindications added to Adult Growth Hormone Deficiency.

11/6/2002: Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted.

11/27/2002: Indication for Turner's Syndrome added, Sources updated.

1/17/2003: Policy section updated.

7/2003: Reviewed by MPAC, no changes, Sources updated.

9/17/2003: Contraindications added to Prader-Willi syndrome.

9/29/2003: Code Reference section updated, ICD-9 diagnosis codes 941.30-941.39, 942.30-942.39, 943.30-943.39, 944.30-944.38, 945.30-945.9 (should have been 945.59), 946.3, 949.3 moved to non-covered, ICD-9 diagnosis 270.0, 402.01, 402.11, 402.91, 404.01, 404.11, 404.91, 428.0, 606.0, 606.1, 606.8, 606.9, 628.0, 628.1, 628.2, 628.3, 628.4, 628.8, 628.9, 656.50, 656.51, 656.53, 757.39, 758.0, 759.89, 764.90, 764.91, 764.92, 764.93, 764.94, 764.95, 764.96, 764.97, 764.98, 764.99, 783.43, 940.0, 940.1, 940.2, 940.3, 940.4, 940.5, 940.9, 941.00, 941.01, 941.02, 941.03, 941.04, 941.05, 941.06, 941.07, 941.08, 941.09, 941.10, 941.11, 941.12, 941.13, 941.14, 941.15, 941.16, 941.17, 941.18, 941.19, 941.20, 941.21, 941.22, 941.23, 941.24, 941.25, 941.26, 941.27, 941.28, 941.29, 941.40, 941.41, 941.42, 941.43, 941.44, 941.45, 941.46, 941.47, 941.48, 941.49, 941.50, 941.51, 941.52, 941.53, 941.54, 941.55, 941.56, 941.57, 941.58, 941.59, 942.00, 942.01, 942.02, 942.03, 942.04, 942.05, 942.09, 942.10, 942.11, 942.12, 942.13, 942.14, 942.15, 942.19, 942.21, 942.22, 942.23, 942.24, 942.25, 942.29, 942.40, 942.41, 942.42, 942.43, 942.44, 942.45, 942.49, 942.50, 942.51, 942.52, 942.53, 942.54, 942.55, 942.59, 943.00, 943.01, 943.02, 943.03, 943.04, 943.05, 943.06, 943.09, 943.10, 943.11, 943.12, 943.13, 943.14, 943.15, 943.16, 943.19, 943.20, 943.21, 943.22, 943.23, 943.24, 943.25, 943.26, 943.29, 943.40, 943.41, 943.42, 943.43, 943.44, 943.45, 943.46, 943.49, 943.50, 943.51, 943.52, 943.53, 943.54, 943.55, 943.56, 943.59, 944.00, 944.01, 944.02, 944.03, 944.04, 944.05, 944.06, 944.07, 944.08, 944.10, 944.11, 944.12, 944.13, 944.14, 944.15, 944.16, 944.17, 944.18, 944.20, 944.21, 944.22, 944.23, 944.24, 944.25, 944.26, 944.27, 944.28, 944.40, 944.41, 944.42, 944.43, 944.44, 944.45, 944.46, 944.47, 944.48, 944.50, 944.51, 944.52, 944.53, 944.54, 944.55, 944.56, 944.57, 944.58, 945.00, 945.01, 945.02, 945.03, 945.04, 945.05, 945.06, 945.09, 945.10, 945.11, 945.12, 945.13, 945.14, 945.15, 945.16, 945.19, 945.20, 945.21, 945.22, 945.23, 945.24, 945.25, 945.26, 945.29, 946.0, 946.1, 946.2, 946.4, 946.5, 947.0, 947.1, 947.2, 947.3, 947.4, 947.8, 947.9, 948.00, 948.10, 948.11, 948.20, 948.21, 948.22, 948.30, 948.31, 948.32, 948.33, 948.40, 948.41, 948.42, 948.43, 948.44, 948.50, 948.51, 948.52, 948.53, 948.54, 948.55, 948.60, 948.61, 948.62, 948.63, 948.64, 948.65, 948.66, 948.70, 948.71, 948.72, 948.73, 948.74, 948.75, 948.76, 948.77, 948.80, 948.81, 948.82, 948.83, 948.84, 948.85, 948.86, 948.87, 948.88, 948.90, 948.91, 948.92, 948.93, 948.94, 948.95, 948.96, 948.97, 948.98, 948.99, 949.0, 949.1, 949.2, 949.4, 949.5 added to non-covered, HCPCS J3490 description revised “Somatotropin®, Somatrem® deleted”

12/2/2003: New labeling changes added for Prader-Willi syndrome

9/24/2004: Code Reference section updated, ICD-9 procedure code 99.24 description revised, HCPCS J2940, J2941, Q2014 description revised, HCPCS S9558 note added “BCBSMS considers the services included in code S9558 an integral component of the nursing visit or the HCPCS code for the injection. A separate allowance will not be made for this code.” non-covered table deleted, non-covered ICD-9 diagnosis code 270.0, 402.01, 402.11, 402.91, 404.01, 404.11, 404.91, 428.0, 606.0, 606.1, 606.8, 606.9, 628.0, 628.1, 628.2, 628.3, 628.4, 628.8, 628.9, 656.50, 656.51, 656.53, 757.39, 758.0, 759.89, 764.90, 764.91, 764.92, 764.93, 764.94, 764.95, 764.96, 764.97, 764.98, 764.99, 783.43, 940.0, 940.1, 940.2, 940.3, 940.4, 940.5, 940.9, 941.00, 941.01, 941.02, 941.03, 941.04, 941.05, 941.06, 941.07, 941.08, 941.09, 941.10, 941.11, 941.12, 941.13, 941.14, 941.15, 941.16, 941.17, 941.18, 941.19, 941.20, 941.21, 941.22, 941.23, 941.24, 941.25, 941.26, 941.27, 941.28, 941.29, 941.30, 941.31, 941.32, 941.33, 941.34, 941.35, 941.36, 941.37, 941.38, 941.39, 941.40, 941.41, 941.42, 941.43, 941.44, 941.45, 941.46, 941.47, 941.48, 941.49, 941.50, 941.51, 941.52, 941.53, 941.54, 941.55, 941.56, 941.57, 941.58, 941.59, 942.00, 942.01, 942.02, 942.03, 942.04, 942.05, 942.09, 942.10, 942.11, 942.12, 942.13, 942.14, 942.15, 942.19, 942.21, 942.22, 942.23, 942.24, 942.25, 942.29, 942.30, 942.31, 942.32, 942.33, 942.34, 942.35, 942.39, 942.40, 942.41, 942.42, 942.43, 942.44, 942.45, 942.49, 942.50, 942.51, 942.52, 942.53, 942.54, 942.55, 942.59, 943.00, 943.01, 943.02, 943.03, 943.04, 943.05, 943.06, 943.09, 943.10, 943.11, 943.12, 943.13, 943.14, 943.15, 943.16, 943.19, 943.20, 943.21, 943.22, 943.23, 943.24, 943.25, 943.26, 943.29, 943.30, 943.31, 943.32, 943.33, 943.34, 943.35, 943.36, 943.39, 943.40, 943.41, 943.42, 943.43, 943.44, 943.45, 943.46, 943.49, 943.50, 943.51, 943.52, 943.53, 943.54, 943.55, 943.56, 943.59, 944.00, 944.01, 944.02, 944.03, 944.04, 944.05, 944.06, 944.07, 944.08, 944.10, 944.11, 944.12, 944.13, 944.14, 944.15, 944.16, 944.17, 944.18, 944.20, 944.21, 944.22, 944.23, 944.24, 944.25, 944.26, 944.27, 944.28, 944.30, 944.31, 944.32, 944.33, 944.34, 944.35, 944.36, 944.37, 944.38, 944.40, 944.41, 944.42, 944.43, 944.44, 944.45, 944.46, 944.47, 944.48, 944.50, 944.51, 944.52, 944.53, 944.54, 944.55, 944.56, 944.57, 944.58, 945.00, 945.01, 945.02, 945.03, 945.04, 945.05, 945.06, 945.09, 945.10, 945.11, 945.12, 945.13, 945.14, 945.15, 945.16, 945.19, 945.20, 945.21, 945.22, 945.23, 945.24, 945.25, 945.26, 945.29, 945.30, 945.31, 945.32, 945.33, 945.34, 945.35, 945.36, 945.39, 945.40, 945.41, 945.42, 945.43, 945.44, 945.45, 945.46, 945.49, 945.50, 945.51, 945.52, 945.53, 945.54, 945.55, 945.56, 945.59, 946.0, 946.1, 946.2, 946.3, 946.4, 946.5, 947.0, 947.1, 947.2, 947.3, 947.4, 947.8, 947.9, 948.00, 948.10, 948.11, 948.20, 948.21, 948.22, 948.30, 948.31, 948.32, 948.33, 948.40, 948.41, 948.42, 948.43, 948.44, 948.50, 948.51, 948.52, 948.53, 948.54, 948.55, 948.60, 948.61, 948.62, 948.63, 948.64, 948.65, 948.66, 948.70, 948.71, 948.72, 948.73, 948.74, 948.75, 948.76, 948.77, 948.80, 948.81, 948.82, 948.83, 948.84, 948.85, 948.86, 948.87, 948.88, 948.90, 948.91, 948.92, 948.93, 948.94, 948.95, 948.96, 948.97, 948.98, 948.99, 949.0, 949.1, 949.2, 949.3, 949.4, 949.5 deleted.

11/02/2005: Description section updated. Somatram® and Somatropin® deleted. Policy section updated: changed preferred provider to Accredo, changed telephone # from 1-866-591-9075 to 1-866-240-3373, changed fax # from 1-866-591-9094 to 1-888-355-6682.

11/4/2005: Code Reference section update, ICD9 diagnosis code 253.5 deleted, 585.1, 585.2, 585.3, 585.4, 585.5, 585.6, 585.9 added, 253.2, 253.3 description revised, the drugs Tev-tropin and Zorbtive added to the description of code J2941.

11/2005: Approved by Pharmacy & Therapeutics (P&T) Committee.

2/6/2006: Code Reference table updated: ICD9 diagnosis code 250.40 deleted, codes 250.41, 586, V15.3 added, description updated on code 250.43; HCPCS code Q0515 added, deletion date added to code Q2014, Biotropin added to the description of code J2941, description revised on code S9558

03/09/2006: Coding updated. HCPCS 2006 revisions added to policy.

09/12/2006: Coding updated. ICD9 2006 revisions added to policy.

09/21/2006: IGF-1 description and policy information added.

12/28/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions.

1/29/2007: Trade name Omnitrope® added to policy.

2/16/2007: Short Bowel Syndrome indication for Zorbtive® added.

01/01/2009: Accredo preferred provider information removed. BCBSMS information added.

08/27/2015: Code Reference section updated for ICD-10. Added HCPCS code J2170.

05/31/2016: Policy number L.5.01.490 added. Policy Guidelines updated to add medically necessary and investigative definitions.

07/22/2016: Policy statements updated regarding documentation of growth hormone deficiency for patients less than 18 years of age and for adults.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

03/29/2018: Medically necessary criteria for patients younger than 18 years of age updated to add levodopa for provocative stimuli of GH release testing.

11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to add a 12 month length of approval for initial therapy. Policy statement regarding GH therapy in girls with Turner's Syndrome moved from the continuation guidelines section to the section for patients with Turner's Syndrome.

02/12/2019: Policy description updated to add tradenames for growth hormone.

09/24/2019: Code Reference section updated to add new ICD-10 diagnosis codes Q87.11 and Q87.19, effective 10/01/2019.

12/23/2019: Policy statement updated to state that effective 01/01/2020, coverage may only be provided for the growth hormones Norditropin, Serostim, and Zorbtive. Omnitrope is not covered effective 01/01/2020.

09/30/2020: Code Reference section updated to add new ICD-10 diagnosis codes N18.30, N18.31, and N18.32, effective 10/01/2020. Removed deleted ICD-10 diagnosis code Q87.1.

12/29/2020: Corrected typo for the drug, Zorbtive, listed at the top of the policy.

09/30/2022: Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to add new ICD-10 diagnosis code E34.321, effective 10/01/2022.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

03/07/2023: Policy section updated to add guidelines for neonatal GH deficiency.

04/01/2024: Policy updated to state that Ngenla (somatrogon-ghla) and Sogroya (somapacitan-beco) are considered not medically necessary as there are other formulary alternatives which share the same place in therapy covered by the Plan. Sources updated.

06/03/2025: Policy reviewed by Pharmacy & Therapeutics (P&T) Committee; no changes.

08/01/2025: Effective 10/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to add Egrifta SV (tesamorelin), Genotropin (somatropin), Humatrope (somatropin), Increlex (mecasermin), Nutropin AQ (somatropin), Omnitrope (somatropin), Skytrofa (lonapegsomatropin-tcgd), and Zomacton (somatropin). Removed Zorbtive (somatropin) from the list of drugs. Policy description revised. Policy section updated to add that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy criteria extensively revised. Policy Guidelines updated regarding medication failure and medical records requests. Sources updated. Policy update effective 10/01/2025.

SOURCE(S)

1. American Academy of Pediatrics. Considerations related to the use of recombinant human growth hormone in children. Ped 1997; 99:122-129.

2. American Association of Clinical Endocrinologists. Clinical practice guidelines for growth hormone use in adults and children. May-June 1998.

3. Blue Cross Blue Shield Association policy #5.01.06

4. Claus Hojbjerg Gravholt, MD, PhD et al. Short-Term Growth Hormone Treatment in Girls With Turner Syndrome Decreases Fat Mass and Insulin Sensitivity: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study. PEDIATRICS Vol. 110 No. 5 November 2002; 889-896.

5. Egrifta SV prescribing information. Theratechnologies Inc. December 2024. Last accessed March 2025.

6. Genotropin prescribing information. Pfizer Laboratories Div Pfizer Inc. February 2025. Last accessed March 2025.

7. Humatrope prescribing information.  Eli Lilly and Company. November 2024. Last accessed March 2025.

8. Increlex prescribing information. Ipsen Biopharmaceuticals, Inc. March 2024. Last accessed March 2025.

9. Melmed S. Physiology of growth hormone. In: UpToDate, Connor RF (Ed), Wolters Kluwer.  https://www.uptodate.com/contents/physiology-of-growth-hormone (Last accessed March 21, 2025)

10. Ngenla prescribing information. Pfizer Laboratories Div Pfizer Inc. December 2024. Last accessed March 2025.

11. Norditropin prescribing information. Novo Nordisk. March 2020. Last accessed March 2025.

12. Nutropin AQ prescribing information. Genentech, Inc. November 2024. Last accessed March 2025.

13. Omnitrope prescribing information. Sandoz Inc. November 2024. Last accessed March 2025.

14. Rogol AD. Treatment of growth hormone deficiency in children. In: UpToDate, Connor RF (Ed), Wolters Kluwer.  https://www.uptodate.com/contents/treatment-of-growth-hormone-deficiency-in-children (Last accessed March 21, 2025)

15. Serostim prescribing information. EMD Serono, Inc. February 2022. Last accessed March 2025.

16. Skytrofa prescribing information. Ascendis Pharma Endocrinology, Inc. May 2024. Last accessed March 2025.

17. Sogroya prescribing information. Novo Nordisk. February 2025. Last accessed March 2025.

18. Sundberg DE, Brook AE, Campos SP. Short stature: A psychosocial burden requiring growth hormone therapy? Ped 1994; 94:832-40.

19. Tonshoff B. Growth failure in children with chronic kidney disease: Treatment with growth hormone. In: UpToDate, Connor RF (Ed), Wolters Kluwer. https://www.uptodate.com/contents/growth-failure-in-children-with-chronic-kidney-disease-treatment-with-growth-hormone (Last accessed March 21, 2025)

20. Wyatt DT, Mark D. Slyper A. Survey of growth hormone treatment practices by 251 pediatric endocrinologists. J Clin Endo Metab 1995; 80:3292-97.

21. Zomacton prescribing information. Ferring Pharmaceuticals Inc. May 2024. Last accessed March 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.