Blue Cross Blue Shield Iowa Growth Hormone Coverage

Coverage Criteria for Growth Hormone Therapy

Initial therapy — Pediatric growth hormone deficiency

Covered when ONE of the following groups is met:

Neonatal diagnosis: Patient is a neonate diagnosed with growth hormone (GH) deficiency with medical records supporting the diagnosis (e.g., hypoglycemia with random GH level, evidence of multiple pituitary hormone deficiency, chart notes, or MRI)neonate

Ngenla, Skytrofa and Sogroya exclusions and age restrictions apply per policy

Pediatric GHD criteria for non-neonates: Patient meets ALL: (i) Either two pretreatment pharmacologic provocative GH tests with both results demonstrating a GH peak < 10 ng/mL, OR for patients ≥2.5 years at initiation a documented pituitary or CNS disorder and a pretreatment IGF-1 level > 2 SD below the mean; (ii) Pretreatment height > 2 SD below the mean and growth velocity is slow for age <2.5 years, OR for patients ≥2.5 years pretreatment height > 2 SD below the mean and 1-year height velocity > 1 SD below the mean OR pretreatment 1-year height velocity > 2 SD below the mean; (iii) Epiphyses are openGH peaks, IGF-1, height/velocity, open epiphyses

Specific age cutpoints and testing details per policy (see cited sections)

Initial therapy — Turner Syndrome

Covered when ALL of the following are met:

Turner Syndrome: Diagnosis of Turner syndrome confirmed by karyotyping; pretreatment height is less than the 5th percentile for age; epiphyses are openkaryotype, <5th percentile height

Approval duration: 12 months

Initial therapy — Noonan Syndrome

Covered when ALL of the following are met:

Noonan Syndrome: Epiphyses are open; pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean OR pretreatment 1-year height velocity is > 2 SD below the meanheight and velocity

Approval duration: 12 months

Initial therapy — Chronic kidney disease

Covered when ALL of the following are met:

Chronic kidney disease: Pretreatment height is > 2 SD below the mean and growth velocity is slow; age-specific height/velocity criteria apply (different criteria for <2.5 years and ≥2.5 years at initiation); epiphyses are openheight/velocity, open epiphyses

Nutropin may be used for CKD as exception to preferred agent requirement; approval duration: 12 months

Initial therapy — Small for gestational age

Covered when ALL of the following are met:

Small for gestational age: Birth weight < 2500 g at gestational age > 37 weeks AND at least one of: birth weight or length < 3rd percentile for gestational age OR birth weight or length ≥ 2 SD below the mean for gestational age; pretreatment age is ≥ 2 years; failed catch-up growth by age 2 (pretreatment height > 2 SD below the mean); epiphyses are openbirth weight/length, age ≥2 yrs, height >2 SD

Approval duration: 12 months

Initial therapy — Prader-Willi Syndrome

Covered when ALL of the following are met:

Prader-Willi Syndrome: Diagnosis of Prader-Willi syndrome confirmed by genetic testing demonstrating one of: deletion in chromosome 15q11.2-q13, maternal uniparental disomy of chromosome 15, or imprinting defects/translocations/inversions involving chromosome 15genetic confirmation

Continuation requires improvement or stabilization of body composition and psychomotor function; approval duration: 12 months

Initial therapy — SHOX deficiency

Covered when ALL of the following are met:

SHOX deficiency: Diagnosis of SHOX deficiency confirmed by molecular or genetic analyses; pretreatment height is > 2 SD below the mean and 1-year height velocity is > 1 SD below the mean OR pretreatment 1-year height velocity is > 2 SD below the mean; epiphyses are opengenetic confirmation, height/velocity

Approval duration: 12 months

Initial therapy — Adult growth hormone deficiency

Covered when ANY of the following are met:

Two provocative GH tests abnormal: Patient has two pretreatment pharmacologic provocative GH tests with both results demonstrating deficient GH responses, for example ITT peak < 5 ng/mL, Macrilen peak < 2.8 ng/mL, or glucagon stimulation test peak thresholds that vary by BMI and pretest probabilitytest-specific peak levels

Numeric cutoffs and BMI-based distinctions are specified in the policy

One test with low IGF-1 and supportive features: Patient has one pretreatment provocative GH test demonstrating a deficient response AND the patient has a low pre-treatment IGF-1 (between 0 to 2 SD below the mean) or a pretreatment IGF-1 > 2 SD below the mean with documented genetic/structural hypothalamic-pituitary defects or organic diseaseIGF-1 thresholds and test-specific peaks

Approval duration: 12 months

Initial therapy — HIV-associated wasting/cachexia

Covered when ALL of the following are met:

HIV wasting/cachexia: Diagnosis of HIV-associated wasting/cachexia; patient is currently on antiretroviral therapy; patient has tried and had a suboptimal response to alternative therapies (e.g., cyproheptadine, dronabinol, megestrol acetate, or testosterone if hypogonadal) unless contraindicated or intolerant; pretreatment BMI is less than 18.5 kg/m2BMI <18.5 kg/m2

Approval duration: 12 weeks

Initial therapy — Short Bowel Syndrome

Covered when ALL of the following are met:

Short Bowel Syndrome: Patient is dependent on intravenous parenteral nutrition; growth hormone will be used in conjunction with optimal management of short bowel syndrome unless Zorbtive is requested; patient has not previously received GH therapy for more than 8 weeks (4 weeks for Zorbtive)parenteral nutrition dependence, prior GH exposure limits

Approval duration: 12 weeks (8 weeks for Zorbtive)

Continuation of therapy

Covered when ALL of the following are met for continuation:

Pediatric continuation: Patient's growth rate is > 2 cm/year unless there is a documented clinical reason for lack of growth (e.g., nearing final height or late puberty); epiphyses are open (confirmed by X-ray or X-ray not available)>2 cm/year, open epiphyses

Approval duration: 12 months

Prader-Willi continuation: Body composition and psychomotor function have improved or stabilized on growth hormone therapyclinical improvement/stabilization

Approval duration: 12 months

Adult continuation: Continuation criteria for adult GHD mirror initial adult testing and IGF-1/structural disease confirmations; current IGF-1 must not be elevated for age and genderIGF-1 not elevated

Initial and Continuation Criteria (adult GHD and congenital/structural causes)

Covered when criteria specific to the clinical scenario are met

Adult GHD or related indications – GH testing and IGF-1 criteria

Low pre-treatment IGF-1 pathway: Patient has low pre-treatment IGF-1 (between 0 to 2 SD below the mean) and current IGF-1 is not elevated for age/gender; one provocative GH test demonstrating deficiency per test-specific cutoffs is requiredIGF-1 between 0 and -2 SD
Provocative test numeric cutoffs vary by test and BMI; see policy
Very low IGF-1 pathway: Pretreatment IGF-1 > 2 SD below the mean AND organic hypothalamic-pituitary disease (e.g., suprasellar mass with prior surgery or cranial irradiation) with > 3 documented pituitary hormone deficienciesIGF-1 >2 SD below mean; >3 pituitary hormone deficiencies
Refer to Appendix B for pituitary hormone list

HIV-Associated Wasting/Cachexia — Continuation Therapy

Continuation of growth hormone therapy for HIV-Associated Wasting/Cachexia may be considered medically necessary when ALL of the following are met

HIV-associated wasting continuation: Patient is diagnosed with HIV-associated wasting/cachexia; patient is currently on antiretroviral therapy; current BMI is less than 27 kg/m2BMI <27 kg/m2

Ngenla, Skytrofa, and Sogroya are restricted to their labeled pediatric growth hormone deficiency (GHD) age ranges and will not be covered for any other indication. Specifically, Ngenla is covered only for pediatric GHD in patients 3 years of age and older, Skytrofa only for pediatric GHD in patients 1 year and older who weigh at least 11.5 kg (and adult GHD), and Sogroya only for pediatric GHD in patients 2.5 years of age and older (and adult GHD).

Serostim and Zorbtive are excluded from the health plan's preferred growth hormone requirement and are handled as product-specific exceptions rather than as preferred agents; they are not subject to the preferred-agent step unless otherwise specified.

Growth hormone therapy is considered not medically necessary for patients who do not meet the criteria set forth in this policy. Requests that fail to satisfy the applicable diagnostic, testing, or continuation requirements described in the criteria sections will be denied as not medically necessary.

If a patient's presentation does not meet the explicit policy criteria for initiation or continuation of growth hormone therapy (for example, missing required provocative test results, insufficient IGF‑1 reduction, or absence of required clinical or genetic documentation), the therapy is not medically necessary and coverage will not be authorized.

Growth hormone therapy is not medically necessary when the specified diagnostic or continuation criteria are not satisfied. This includes situations where required pretreatment testing (e.g., provocative GH testing or IGF‑1 measurement), documentation of congenital/structural hypothalamic‑pituitary disease, or the continuation benchmarks (such as growth response in children or BMI thresholds in HIV‑associated wasting) are not provided or not met.

Procedures, Tests and Thresholds

Procedures and billing codesmixed

No codes listed

Biochemical and anthropometric thresholds — key numeric cutoffs

Pediatric provocative GH test requirementTwo pretreatment pharmacologic provocative GH tests with both results demonstrating a GH level < 10 ng/mL

Adult ITT thresholdInsulin tolerance test (ITT) peak GH < 5 ng/mL defines deficiency

Adult Macrilen thresholdMacrilen (macimorelin) peak GH < 2.8 ng/mL defines deficiency

Glucagon stimulation test thresholdsGlucagon peak GH cutoffs vary by BMI and pretest probability: e.g., <3 ng/mL for BMI ≤30 kg/m2 with high pretest probability; lower cutoffs for BMI >25 kg/m2 or low pretest probability as specified in policy

Pretreatment IGF-1 cutoffsLow pre-treatment IGF-1 defined as between 0 to 2 SD below mean; very low defined as >2 SD below mean for age and gender

BMI thresholds for HIV wasting criteria

Provider Requirements, Prior Authorization, and Limits

Prior Authorization

Prior Authorization and Preferred Agent Requirement

Prior authorization is required for all growth hormone agents. The plan’s preferred agents (Norditropin and Humatrope) must be tried and documented as inadequate, intolerable, or contraindicated before non-preferred growth hormones are approved, except when Nutropin/Nutropin AQ is requested for chronic kidney disease (CKD). Serostim and Zorbtive are excluded from the preferred agent requirement. Members receiving medication samples or via a manufacturer patient assistance program must meet the same prior authorization criteria as other members.

PA required for all growth hormone agents
Preferred agents required first: Norditropin, Humatrope (exceptions: Nutropin/Nutropin AQ for CKD; Serostim and Zorbtive excluded from preferred requirement)

Documentation Required

Required Documentation for Prior Authorization

Provide the following documentation with the prior authorization request. Requests without required documentation may be delayed or denied.

Background and Scope

Growth hormone (somatropin and related analogs) is an FDA‑approved therapy for multiple pediatric and adult indications, including pediatric and adult growth hormone deficiency, Turner syndrome, Noonan syndrome, Prader‑Willi syndrome, small for gestational age (SGA), chronic kidney disease (CKD), idiopathic short stature (ISS), SHOX deficiency, HIV‑associated wasting/cachexia, and short bowel syndrome (SBS). Prescribing generally requires specialist input and appropriate diagnostic evaluation; some products have age‑ or indication‑specific approvals that the policy enforces (see product restrictions and preferred‑agent requirements).

Definitions and Preferred Products

Preferred growth hormones and exceptions

Preferred agentsNorditropin and Humatrope are the health plan's preferred growth hormones and must be used prior to non-preferred agents

Exception — Nutropin for CKDNutropin/Nutropin AQ may be requested for chronic kidney disease as an exception to the preferred agent requirement

Exclusions from preferred requirementSerostim and Zorbtive are excluded from the preferred growth hormone requirement (product-specific coverage limits apply)

FDA-approved indications across GH products

Pediatric labeled indicationsTurner syndrome; growth hormone (GH) deficiency; Noonan syndrome; Prader-Willi syndrome; small for gestational age (SGA); chronic kidney disease (CKD); idiopathic short stature (ISS); SHOX deficiency

Adult labeled indications

OpenPayer

Growth Hormone Therapy (Somatropin and Analogs) — Medical Necessity and Prior Authorization

Coverage Criteria for Growth Hormone Therapy

Procedures, Tests and Thresholds

Provider Requirements, Prior Authorization, and Limits

Background and Scope

Definitions and Preferred Products