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INDEX:

Effective Date: 07/29/2004

Title: Human Growth Hormone

Revision Date: 05/01/2017

Document: BI084:00

CPT Code(s): J2941, S9558

Public Statement

Effective Date:

a) This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

Human growth hormone is medically appropriate therapy in naturally occurring deficiencies and certain conditions where a genetic abnormality causes slow growth.

The administration of growth hormone requires pre-authorization.

Norditropin® products are the exclusive covered growth hormone products. All other products (Genotropin®, Nutropin®, Humatrope®, Omnitrope®, Saizen®, Serostim®, Tev-Tropin®, and Zorbtive®) are not covered.

Medical Statement

Human growth hormone is available through recombinant DNA technology.

1. QualChoice considers Growth Hormone replacement medically necessary for children and adolescents (prior to epiphyseal fusion) after an evaluation by a pediatric endocrinologist (or pediatric nephrologist, in the case of chronic renal failure), when prescribed for one of the following indications:

Idiopathic Growth Hormone Deficiency (E23.0) (All of the following):
1. Has failed to respond to at least two standard GH stimulation tests, defined as a serum GH level (peak level) of less than 10 nanograms per milliliter (ng/ml), after stimulation with insulin, levodopa, arginine, propranolol, clonidine, or glucagon. (However, one abnormal GH test is sufficient for children with defined CNS pathology, history of irradiation, multiple pituitary hormone deficiency (MPHD) or a genetic defect affecting the GH axis); and
2. Appropriate imaging (magnetic resonance imaging (MRI) or computed tomography (CT)) of the brain with particular attention to the hypothalamic-pituitary region has been carried out to exclude the possibility of a tumor; and
3. At least one of the following criteria is met:

· Child has severe growth retardation with height at least 3 standard deviations below the mean for chronological age and sex; or

· Child has moderate growth retardation with height between 2 and 3 standard deviations below the mean for chronological age and sex and decreased growth rate (growth velocity (GV) measured over one year below 25th percentile for age and sex); or

· Child exhibits severe deceleration in growth rate ((GV)measured over 1 year 2 standard deviations below the mean for age and sex); or

· Child has decreasing growth rate combined with a predisposing condition such as previous cranial irradiation or tumor; or

· Child exhibits evidence of other pituitary hormone deficiencies or signs of congenital GHD (hypoglycemia, microphallus); and

Evaluation of bone age demonstrates open epiphyses.
For persons with thyroid deficiency, QualChoice only accepts results of GH secretion tests that are performed after thyroid deficiency is adequately treated because GH secretion may be subnormal merely as a result of hypothyroidism.

Chronic Renal Insufficiency (N18.1 – N18.9): Prior to renal transplantation GH Replacement is considered medically necessary for children with chronic renal insufficiency and growth retardation who meet all of the following criteria:
1. Child`s nutritional status has been optimized, metabolic abnormalities have been corrected, and steroid usage has been reduced to a minimum; and
2. At least one of the following criteria is met:
  - Child has severe growth retardation with height below 3 standard deviations below the mean for chronological age and sex; or
  - Child has moderate growth retardation with height between 2 and 3 standard deviations below the mean for chronological age and sex and decreased growth rate (GV measured over one year below 25th percentile for age and sex); or
  - Child exhibits severe deceleration in growth rate (GV measured over one year at least 2 standard deviations below the mean for age and sex); and
3. Evaluation of bone age demonstrates open epiphyses.
4. Note: Consistent with established guidelines for children with chronic renal insufficiency after renal transplantation, QualChoice does not consider resumption of growth hormone therapy medically necessary until at least 1 year after the transplant to allow time to ascertain whether catch-up growth will occur.
Turner`s Syndrome (Q96.0-Q96.9): QualChoice considers GH replacement medically necessary for children with Turner`s syndrome and growth retardation who meet all of the following criteria:
1. The diagnosis of Turner`s syndrome is confirmed by chromosome analysis; and
2. At least one of the following criteria is met:
  - Child has severe growth retardation with height at least 3 standard deviations below the mean for chronological age and sex; or
  - Child has moderate growth retardation with height between 2 and 3 standard deviations below the mean for chronological age and sex and decreased growth rate (GV measured over one year below 25th percentile for age and sex); or
  - Child exhibits severe deceleration in growth rate (GV measured over one year is at least 2 standard deviations below the mean for age and sex).
Prader Willi Syndrome (Q87.1): QualChoice considers GH replacement medically necessary for children with Prader Willi syndrome and growth retardation who meet all of the following criteria:
1. The diagnosis of Prader Willi syndrome is confirmed by appropriate genetic testing; and
2. Child has GH deficiency; and
3. At least one of the following criteria is met:
  - Child has severe growth retardation with height at least 3 standard deviations below the mean for chronological age and sex; or
  - Child has moderate growth retardation with height between 2 and 3 standard deviations below the mean for chronological age and sex and decreased growth rate (GV measured over one year below 25th percentile for age and sex); or
  - Child exhibits severe deceleration in growth rate (GV measured over one year is at least 2 standard deviations below the mean for age and sex).
Small for Gestational Age (SGA) Children (P05.00 – P05.18):

QualChoice considers growth hormone supplementation medically necessary for children born small for gestational age, and who meet both these criteria:

Child was born small for gestational age, defined as birth weight or length 2 or more standard deviations below the mean for gestational age; and
Child fails to manifest catch up growth by age 3 years, defined as height 2 or more standard deviations below the mean for age and sex.

2. Discontinuation of GH therapy: Re-evaluation at least annually by the prescribing specialist will be required for continuation of therapy. In children and adolescents, GH therapy will be considered not medically necessary if any of the following discontinuation criteria is met:

a. Increase in height velocity is less than 2 cm total growth in one year of therapy; or

b. Expected final adult height has been reached; or

c. Epiphyses are closed on re-evaluation; or

d. If there is a poor response to treatment, generally defined as an increase in growth velocity of less than 50% from baseline, in the first year of therapy. In children with Prader-Willi Syndrome, evaluation of response to therapy should also take into account whether body composition (i.e., ratio of lean to fat mass) has significantly improved; or

e. There are persistent and uncorrectable problems with adherence to treatment.

f. Treatment goals have been met.

3. Growth Hormone Deficiency in Adults: GH replacement is considered medically necessary for adults who meet the following criteria:

a. Destructive lesions of the pituitary (D44.3): GH treatment of adults with laboratory documented GHD is considered medically necessary when all of the following criteria are met:

i. Member has GH deficiency as a result of hypothalamic or pituitary disease (e.g., panhypopituitarism, pituitary adenoma, trauma, cranial irradiation, pituitary surgery) and at least one other hormone deficiency diagnosed (except for prolactin deficiency); and

ii. Member is already receiving adequate replacement therapy for any other pituitary hormone deficiencies; and

iii. Member has a severe GH deficiency, defined as a peak GH response of less than 9 mU/liter (3 ng/ml) during an insulin tolerance test or a cross-validated GH threshold in an equivalent test (growth hormone releasing hormone, arginine, or glucagon); and

iv. Member has a perceived impairment of quality of life (QoL), as demonstrated by a reported score of at least 11 in the disease-specific `Quality of life assessment of growth hormone deficiency in adults` (QoL-AGHDA) questionnaire see figure 1 below.

This treatment is considered medically necessary for an initial 9 months, allowing for an initial 3-month period of GH dose titration, followed by a 6-month therapeutic trial period. Subsequent GH treatment is considered medically necessary only if, upon subsequent testing of the effect of this treatment, the member demonstrates a QoL improvement of 7 or more points in QoL-AGHDA score (see Figure 1 below).

b. Adults who were growth hormone deficient as children or adolescents (E23.0):

i. For adolescents and adults younger than age 25 years with childhood-onset growth hormone deficiency (including idiopathic isolated growth hormone deficiency (IIGHD) or multiple pituitary hormone deficiencies, including growth hormone (MPHD)) who have completed linear growth (growth rate less than 2 cm per year), GH treatment at adult doses is considered medically necessary only :

· In those who have failed to respond to at least two standard GH stimulation tests, defined as a peak GH response of less than 9 mU/liter (3 ng/ml) during an insulin tolerance test and one other cross-validated GH test (growth hormone releasing hormone, arginine, or glucagon).

· For adults having a low IGF-1 (a marker of insulin response) concentration (standard deviation score less than -2), failure to respond to only one standard GH stimulation test is required. In these members, GH supplementation at adult doses is considered medically necessary until adult peak bone mass is achieved (between 25 and 30 years of age).

Note: Continued authorization of GH therapy at adult doses, will be approved provided that GH therapy be stopped for at least 3 months after completion of linear growth (that is, growth rate less than 2 cm/year), and that GH status is reassessed. As a condition of continued authorization, QualChoice requires reassessment of GH status after GH treatment is stopped for at least 3 months before initiating GH supplementation at adult doses. QualChoice will reevaluate the member three or more months after discontinuation of GH therapy to determine if the member fulfills medical necessity criteria for GH treatment at adult doses.

ii. For adults over age 25 years with childhood onset growth hormone deficiency (IIGHD or MPHD), GH treatment at adult doses is considered medically necessary if they meet all of the following criteria:

· Member has failed to respond to at least two standard GH stimulation tests, defined as a peak GH response of less than 9 mU/liter (3 ng/ml) during an insulin tolerance test and one other cross-validated GH test (growth hormone releasing hormone, arginine, or glucagon). For members having a low IGF-1 (a marker of insulin response) concentrations (SDS less than -2), failure to respond to only one standard GH stimulation test is required; and

· Member has a perceived impairment of quality of life (QoL), as demonstrated by a reported score of at least 11 in the disease-specific `Quality of life assessment of growth hormone deficiency in adults` (QoL-AGHDA) questionnaire (see Figure 4 below).

iii. Adults who develop growth hormone deficiency in early adulthood (E23.0): GH treatment at adult doses is considered medically necessary for selected members who develop isolated GH deficiency (IIGHD or MPHD) in adolescence or early adulthood, after linear growth is completed but before the age of 25 years. GH treatment at adult doses is considered medically necessary only in those who have failed to respond to at least two standard GH stimulation tests, defined as a peak GH response of less than 9 mU/liter (3 ng/ml) during an insulin tolerance test and one other cross-validated GH test (growth hormone releasing hormone, arginine, or glucagon). For adults having a low IGF-1 (a marker of insulin response) concentration (SDS less than -2), failure to respond to only one standard GH stimulation test is required. In these members, GH supplementation at adult doses is considered medically necessary until adult peak bone mass is achieved (between 25 and 30 years of age).

iv. Following achievement of peak bone mass between 25 and 30 years of age, continued GH treatment is considered medically necessary for adults who meet both of the following criteria:

· Member has a severe GH deficiency: GH treatment at adult doses is considered medically necessary only in those who have failed to respond to at least two standard GH stimulation tests, defined as a peak GH response of less than 9 mU/liter (3 ng/ml) during an insulin tolerance test and one other cross-validated GH test (growth hormone releasing hormone, arginine, or glucagon). (For adults having a low IGF-1 (a marker of insulin response) concentration (SDS less than -2), failure to respond to only one standard GH stimulation test is required); and

c. AIDS-related Wasting (B20 w/also R64): QualChoice considers GH supplementation to be medically necessary for HIV-infected persons with involuntary weight loss of greater than 10% of pre-illness baseline body weight or body mass index (BMI) less than 20 kg/m2, in the absence of a concurrent illness or medical condition other than HIV infection that would explain these findings, and who have failed to adequately respond or are intolerant to anabolic steroids (e.g., Megace).

d. Dosage: According to available guidelines, for the first 2-3 months dosage adjustments should be made after monthly assessments of serum levels of IGF-1, and in response to the presence of adverse effects, until a maintenance dose is achieved. As a condition of continued authorization, QualChoice requires at least annual reassessment of serum levels of IGF-1 in adults and appropriate dosage adjustments, as GH requirements in adults may decrease with age.

e. Continued Authorization: The continued medical necessity of growth hormone therapy is reviewed at least annually to determine whether growth hormone therapy continues to be medically necessary. The annual medical necessity review focuses on response to therapy, whether discontinuation criteria are met, whether there are any major changes in clinical status affecting the medical necessity of growth hormone supplementation, and verification that the person continues to follow up with the provider and receive appropriate reevaluations and care.

f. Growth Hormone for Short Bowel Syndrome: QualChoice considers GH supplementation to be medically necessary for persons with short bowel syndrome who depend on intravenous parenteral nutrition for nutritional support. Growth hormone treatment of short bowel syndrome for more than four weeks duration is considered experimental and investigational as administration of growth hormone for more than four weeks duration has not been adequately studied for this indication. There is insufficient evidence of the effectiveness of repeat courses of growth hormone for short bowel syndrome.

g. Contraindications: Growth hormone therapy is considered experimental and investigational in persons with any of the following contraindications for which the safety of growth hormone therapy has not been established:

i. Persons with evidence of tumor activity. In persons with tumors, anti-tumor therapy must be completed before initiating growth hormone therapy; or

ii. Critically ill persons (e.g.,, after complications following open heart or abdominal surgery, multiple trauma, acute respiratory failure or similar conditions); or

iii. Persons with known hypersensitivity to growth hormone or to any of its excipients; or

iv. Benign intracranial hypertension (BIH); or

v. Diabetic retinopathy; or

vi. Women who are pregnant or lactating.

Codes Used In This BI:

J2941

Somatropin Injection, 1 mg

S9558

Home injectable therapy; growth hormone, including admin services, prof RX services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

Limits

Experimental and Investigational Indications

QualChoice considers GH therapy to be experimental and investigational for the following indications:

· Constitutional delay of growth and development

· To promote growth of infants with intrauterine growth retardation or Russell-Silver syndrome

· Skeletal dysplasia’s (e.g., achondroplasia, kyphomelic dysplasia)

· Osteogenesis imperfecta

· Down syndrome and other syndromes associated with short stature and increased susceptibility to neoplasms (e.g., Bloom syndrome, Fanconi syndrome)

· “Somatopause” in older adults

· Infertility

· Chronic catabolic states, including respiratory failure, pharmacologic glucocorticoid administration, and inflammatory bowel disease

· Burn injuries

· Obesity

· Hypophosphatemic rickets

· Muscular dystrophy

· Cystic fibrosis

· Noonan syndrome

· Spina bifida

· Juvenile rheumatoid arthritis

· Osteoporosis

· Post-traumatic stress disorder

· Depression

· Hypertension

· Corticosteroid-induced pituitary ablation

· Precocious puberty

· Chronic fatigue syndrome

Background

Growth Hormone QOL Assessment Instrument:

Figure 1: Adult Growth Hormone Deficiency Assessment (QoL - AGHDA)

Instructions: Indicate whether each of the following statements below applies to you:


	Yes	No

I have to struggle to finish jobs	∅	∅

I feel a strong need to sleep during the day	∅	∅

I often feel lonely even when I am with other people	∅	∅

I have to read things several times before they sink in	∅	∅

It is difficult for me to make friends	∅	∅

It takes a lot of effort for me to do simple tasks	∅	∅

I have difficulty controlling my emotions	∅	∅

I often lose track of what I want to say	∅	∅

I lack confidence	∅	∅

I have to push myself to do things	∅	∅

I often feel very tense	∅	∅

I feel as if I let people down	∅	∅

I find it hard to mix with people	∅	∅

I feel worn out even when I`ve not done anything	∅	∅

There are times when I feel very low	∅	∅

I avoid responsibility if possible	∅	∅

I avoid mixing with people I don`t know well	∅	∅

I feel as if I am a burden to people	∅	∅

I often forget what people have said to me	∅	∅

I find it difficult to plan ahead	∅	∅

I am easily irritated by other people	∅	∅

I often feel too tired to do the things I ought to do	∅	∅

I have to force myself to do all the things that need doing	∅	∅

I often have to force myself to stay awake	∅	∅

My memory lets me down	∅	∅

Scoring: 1 point for each “Yes” answer.

Source: McKenna, et al., 1999. A copy of the QoL-AGHDA is available at the following website: www.nice.org.uk.

GH Therapy in Children:

1. An assessment conducted for the National Institute of Clinical Excellence (2001) suggests the following criteria be used to define subnormal growth in children with growth hormone deficiency:

Severe growth retardation with height standard deviation score (SDS) for sex and chronological age less than 3 SDS below the mean; or
Moderate growth retardation with height SDS for sex and chronological age between -2 and -3 SDS below the mean and decreased growth rate (growth velocity (GV) below 25th percentile for age and sex); or
Severe deceleration in growth rate (GV below 3rd percentile for age and sex); or
Decreasing growth rate combined with a predisposing condition such as previous cranial irradiation; or
Evidence of other pituitary hormone deficiencies or signs of congenital GHD (hypoglycemia, microphallus).

2. In addition, retardation of bone maturation is found in most cases of subnormal growth.
Diagnosis of GHD in children is confirmed by measurements of GH secretion, commonly in several samples following stimulation by a provocative agent such as insulin or clonidine (NICE, 2001). The literature states that the standard method of assessing growth hormone secretion in children is to measure the serum growth hormone response to insulin and other stimuli.

3. Because of its pronounced anabolic effects, GH is contraindicated in children with an active malignant condition. There is controversy over whether it is safe to administer growth hormone to children in the year or two following treatment for leukemia, medulloblastomas, ependymomas, or other tumors.

GH treatment in children with childhood-onset GHD is generally begun with a dosage of GH of 0.15 to 0.3 mg/kg per week given six or seven times weekly. A maintenance dosage of up to 0.30 mg/kg of body weight is frequently recommended. Treatment is continued until the handicap of short stature is ameliorated, until epiphyseal closure has been recorded, or until the patient is otherwise no longer responding to GH treatment.

GH Therapy in Adults:

Studies have shown that over 90 percent of adults diagnosed with growth hormone deficiency have overt pituitary disease, which is usually caused by a pituitary adenoma or by surgery or radiation therapy for a pituitary adenoma.
The syndrome of GHD characteristically manifests with deficiencies in bone density, reduction in muscle strength and exercise tolerance, decreases in vitality and energy, emotional liability, feelings of social isolation, and increases in body fat and higher serum lipid concentrations.
The usefulness of GH treatment in adults with pituitary disease who have completed their statural growth is based on the role of GH in increasing bone density and in improving mood and motivation.
The NICE Committee concluded that a trial of GH treatment could be recommended for adults with GH deficiency who have a severe perceived impairment of QoL as demonstrated by a reported score of at least 11 in QoL-AGHDA (NICE, 2003).
NICE recommended that adults with childhood GHD must be retested as adults before long-term GH replacement is instituted, because some GH-deficient children are found to be GH sufficient in adulthood (NICE, 2003).
According to NICE, the diagnosis of GHD in adult patients requires provocative testing of GH secretion (NICE, 2003). Random samples of GH are usually meaningless. In most academic medical centers, the insulin tolerance test (ITT) has been the validated study of choice. However, the literature indicates the test has an inherent risk of profound hypoglycemia, and is contraindicated in patients with abnormal electrocardiographic findings, with a history of ischemic heart disease or cerebrovascular disease, or with seizure disorders. According to available guidelines, the ITT is not generally recommended for patients older than 65 years of age.

Reference

1. Illinois BlueCross BlueShield, Coverage Policy Manual; Growth Hormone, Human at: https://www.bcbsil.com/provider/pdf/hormone.pdf 2. Aetna, Clinical Policy Bulletins; Growth Hormone (GH), Growth Hormone Releasing Hormone (GHRH), and Growth Hormone Antagonists at: http://www.aetna.com/cpb/medical/data/100_199/0170.html 3. National Health Service, National Institute for Clinical Excellence (NICE). Guidance on use of human growth hormone (somatropin) in children with growth failure. Technology Appraisal Guidance No. 188. London, UK: NICE; May 2010. Available at: https://www.nice.org.uk/guidance/TA188 4. National Institute for Clinical Excellence (NICE). Appraisal consultation document: Human growth hormone (somatropin) in adults with growth hormone deficiency. London, UK: NICE; May 2003. Available at: https://www.nice.org.uk/guidance/ta64 5. Bryant J, Cavel C, Mihaylova B, et al. Clinical effectiveness and cost-effectiveness of growth hormone in children: A systematic review and economic evaluation. Health Technol Assess. 2002; 6(18):1-168. 6. Bryant J, Loveman E, Chase D, et al. Clinical effectiveness and cost-effectiveness of growth hormone in adults in relation to impact on quality of life: A systematic review and economic evaluation. Health Technol Assess. 2002; 6(19):1-106. 7. Finkelstein BS, Imperiale TF, Speroff T, et al.Effect of growth hormone therapy on height in children with idiopathic short stature: A meta-analysis. Arch Ped Adoles Med.2002; 156(3):230-240. 8. Isley WL. Growth hormone therapy for adults: Not ready for prime time? Ann Intern Med. 2002; 137(3):190-196. 9. Moore D, Meads C, Roberts L, Song F. The effectiveness and cost-effectiveness of somatostatin analogues in the treatment of acromegaly. Birmingham, UK: West Midlands Health Technology Assessment Collaboration, Department of Public Health and Epidemiology, University of Birmingham; 2002. 10. Wu GH, Wu ZH, Wu ZG. Effects of bowel rehabilitation and combined trophic therapy on intestinal adaptation in short bowel patients. World J Gastroenterol. 2003; 9(11):2601-2604. 11. Seguy D, Vahedi K, Kapel N, et al. Low-dose growth hormone in adult home parenteral nutrition-dependent short bowel syndrome patients: A positive study. Gastroenterology. 2003; 124(2):293-302. 12. Jeppesen PB, Szkudlarek J, Hoy CE, Mortensen PB. Effect of high-dose growth hormone and glutamine on body composition, urine creatinine excretion, fatty acid absorption, and essential fatty acids status in short bowel patients: A randomized, double-blind, crossover, placebo-controlled study. Scand J Gastroenterol. 2001; 36(1):48-54. 13. Szkudlarek J, Jeppesen PB, Mortensen PB. Effect of high dose growth hormone with glutamine and no change in diet on intestinal absorption in short bowel patients: A randomized, double blind, crossover, and placebo controlled study. Gut. 2000; 47(2):199-205. 14. Walvoord EC, Pescovitz OH. Combined use of growth hormone and gonadotropin-releasing hormone analogues in precocious puberty: Theoretic and practical considerations. Pediatrics. 1999; 104(4 Pt 2):1010-1014. 15. Kohn B, Julius JR, Blethen SL. Combined use of growth hormone and gonadotropin-releasing hormone analogues: The national cooperative growth study experience. Pediatrics. 1999; 104(4 Pt 2):1014-1018. 16. Pucarelli I, Segni M, Ortore M, et al. Effects of combined gonadotropin-releasing hormone agonist and growth hormone therapy on adult height in precocious puberty: A further contribution. J Pediatr Endocrinol Metab. 2003; 16(7):1005-1010. 17. Wheeler P, Balk E, Cole C. Criteria for determining disability in infants and children: Short stature. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); 2003. 18. Maison P, Chanson P. Cardiac effects of growth hormone in adults with growth hormone deficiency: A meta-analysis. Circulation. 2003; 108(21):2648-2652. 19. Shadid S, Jensen MD. Effects of growth hormone administration in human obesity. Obesity Res. 2003; 11(2):170-175. 20. Antoniazzi F, Zamboni G. Central precocious puberty: Current treatment options. Paediatr Drugs. 2004; 6(4):211-231. 21. Wit JM, Balen HV, Kamp GA, Oostdijk W. Benefit of postponing normal puberty for improving final height. Eur J Endocrinol. 2004; 151 Suppl 1:S41-S45. 22. Huiming Y, Chaomin W. Recombinant growth hormone therapy for X-linked hypophosphatemia in children. Cochrane Database Syst Rev. 2005 ;( 1).CD004447. Addendum: 1. Effective: 05/01/2017: Clarification of specialist requirement.

Application to Products

This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.

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