ModifiedNorth Carolina MedicaidPolicy N/A

Outpatient Pharmacy Prior Approval Criteria: Growth Hormones

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This policy governs North Carolina Medicaid and NC Health Choice prior approval and coverage criteria for outpatient growth hormone therapies, including somatropin, mecasermin, and tesamorelin.

Policy Summary

PayerNorth Carolina Medicaid

PolicyOutpatient Pharmacy Prior Approval Criteria: Growth Hormones

Policy CodePolicy N/A

Change TypeModified

Effective DateMarch 4, 2002

Next Review DateN/A

Key ActionSubmit growth hormone prior authorization requests through the physician’s office, with pharmacist handling of the therapeutic-class request.

SourceLink

POLICY UPDATE CHANGES

Coverage was added for children with craniopharyngiomas, panhypopituitarism, and unexplained short stature, along with continuation criteria.

Criteria were added for Zomacton.

Old Nutropin GCNs were removed.

GCNs, Norditropin NordiFlex, and Tev-Tropin were removed from the criteria.

Skytrofa was added to the policy criteria.

North Carolina Medicaid and NC Health Choice criteria were combined into one policy without substantive changes.

11Growth hormone products listed

5Pediatric coverage pathways

2Separate product criteria or exclusions

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ModifiedNorth Carolina MedicaidPolicy N/A

Outpatient Pharmacy Prior Approval Criteria: Growth Hormones

Customize your policy alerts

Sign up for all North Carolina Medicaid policy alerts

Know when North Carolina Medicaid releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs North Carolina Medicaid and NC Health Choice prior approval and coverage criteria for outpatient growth hormone therapies, including somatropin, mecasermin, and tesamorelin.

Policy Summary

PayerNorth Carolina Medicaid

PolicyOutpatient Pharmacy Prior Approval Criteria: Growth Hormones

Policy CodePolicy N/A

Change TypeModified

Effective DateMarch 4, 2002

Next Review DateN/A

Key ActionSubmit growth hormone prior authorization requests through the physician’s office, with pharmacist handling of the therapeutic-class request.

SourceLink

POLICY UPDATE CHANGES

Coverage was added for children with craniopharyngiomas, panhypopituitarism, and unexplained short stature, along with continuation criteria.

Criteria were added for Zomacton.

Old Nutropin GCNs were removed.

GCNs, Norditropin NordiFlex, and Tev-Tropin were removed from the criteria.

Skytrofa was added to the policy criteria.

North Carolina Medicaid and NC Health Choice criteria were combined into one policy without substantive changes.

11Growth hormone products listed

5Pediatric coverage pathways

2Separate product criteria or exclusions

1 yearMaximum approval length

Coverage Criteria

Adults with growth hormone deficiency

Coverage is provided when ALL of the following are met.

Required adult findings

Biochemical diagnosis of somatotropin deficiency by a negative response to a standard growth hormone stimulation testNegative response
Underlying cause: The deficiency, alone or with multiple hormone deficiencies, results from pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma
Childhood-onset deficiency: If diagnosed with GH deficiency in childhood, the adult has a low IGF-1 level after being off GH therapy for at least 1 monthLow IGF-1; off GH for at least 1 month

Children with growth hormone deficiency

Coverage is provided when ALL of the following are met.

Required pediatric findings

Provocative testing: GH dysfunction or lack of adequate endogenous GH is documented by any two provocative testsLess than 10 mg/mL
Height: Beneficiary's height is below the third percentile for age- and gender-related heightBelow 3rd percentile
Epiphysis: For beneficiaries older than 9 years, the epiphysis is confirmed as openOpen epiphysis; age >9 years

Children with specified conditions

Coverage is provided when ANY of the following conditions are met. Growth hormone stimulation testing is not required for these pathways.

ONE qualifying condition

Craniopharyngioma: Child has a craniopharyngioma
Panhypopituitarism: Child has multiple pituitary hormone deficiencies, abnormal height velocity, and low serum IGF-1 and IGFBP-3Height velocity <25th percentile for bone age
Anatomic hypopituitarism: Child has abnormal height velocity, low IGF-1/IGFBP-3 levels, and MRI evidence of hypopituitarism, including an ectopic posterior pituitary bright spot, small or hypoplastic pituitary gland or stalk, or empty sellaHeight velocity <25th percentile for bone age

Trial of therapy for unexplained short stature

Coverage for a trial of GH therapy is provided when ALL of the following are met.

Trial criteria

Unexplained short stature: Child has otherwise unexplained short stature and may pass GH stimulation tests
Height is more than 2.25 standard deviations below the mean for age>2.25 SD below mean
Height velocity is below the 25th percentile for bone age<25th percentile for bone age
Bone age is more than 2 standard deviations below the mean for age>2 SD below mean

Coverage without documented GH deficiency

Coverage is provided in the absence of documented GH deficiency, stimulation tests, or IGF-1 levels when ANY of the following applies.

ONE qualifying pathway

Turner syndrome: Beneficiary has Turner's syndrome
Chronic renal insufficiency: Child has chronic renal insufficiency and height less than the third percentile for chronological ageHeight <3rd percentile
Prader-Willi syndrome: Beneficiary has Prader-Willi syndrome
SGA/IUGR without catch-up growth: Child was born small for gestational age or with intrauterine growth retardation, with birth weight and/or length more than 2 standard deviations below the mean for gestational age, and failed to show catch-up growth by age 2

Increlex

Increlex is covered only when ALL of the following are met.

Increlex eligibility

Population and treatment response: Child has growth failure that will not respond to GH therapy
ONE underlying indication
- GH resistance caused by a mutation in the GH receptor or post-GH receptor signaling pathway
- IGF-I gene defect
- GH gene deletion with neutralizing antibodies to GH
- Severe short stature after failure of a trial of GH therapy

Zorbtive

Coverage is limited to the stated indication.

Qualifying indication: Beneficiary has short bowel syndrome

Continuation therapy in children

Coverage is provided when ALL of the following continuation criteria are met, unless the stated exemption applies.

Pediatric continuation

Required growth response
- Growth response is greater than 4.5 cm/year during the prepubertal growth phase>4.5 cm/year
- Growth response is greater than 2.5 cm/year during the postpubertal growth phase>2.5 cm/year
Biochemical monitoring: Minimum yearly IGF-I and/or IGFBP-3 monitoring is performed, with results within age-appropriate rangesAt least yearly; within age-appropriate ranges

Serostim for AIDS wasting syndrome is exempt from this policy and does not require prior approval.

EPSDT does not apply to NC Health Choice beneficiaries. Health Choice beneficiaries must meet the applicable outpatient pharmacy prior approval clinical coverage criteria; otherwise, services are denied, subject to coverage under the Health Choice State Plan and applicable clinical coverage policies, service definitions, or billing codes.

Zorbtive is reserved for beneficiaries with short bowel syndrome.

EPSDT does not require coverage of services, products, or procedures that are unsafe, ineffective, experimental, or investigational, are not medical in nature, or are not generally recognized as an accepted method of medical practice or treatment.

Clinical Coding and Thresholds

Therapeutic Class Codesmixed

P1A	Growth Hormones
P7A	Growth Hormones

Pediatric provocative GH tests

PopulationChildren with growth hormone deficiency

Testing requirementAny two provocative tests

Test thresholdLess than 10mg/ml

Height percentile or velocity

Height thresholdBelow the third percentile for age and gender-related height

Height velocity thresholdBelow the 25th percentile for bone age

ApplicationHeight or height velocity applies as applicable to the coverage pathway

Prior Approval and Provider Requirements

Prior Authorization

Prior Approval Required

Prior approval is required for the listed growth hormone products. Serostim for AIDS wasting syndrome is exempt from this policy and does not require prior approval.

Genotropin and Genotropin Miniquick
Humatrope; Norditropin; Nutropin AQ and Nuspin; Omnitrope; Saizen; Skytrofa; Zomacton; Zorbtive; Increlex

Prior Authorization

EPSDT Does Not Waive Prior Approval

Being under 21 does not eliminate prior approval when the requested service, product, or procedure requires it.

Apply prior approval requirements even when EPSDT may otherwise apply.

Prior Authorization

Policy Scope

This policy addresses outpatient coverage and prior approval for growth hormone replacement and selected growth-related therapies in adults and children. Covered pathways include documented growth hormone deficiency, specified endocrine or genetic conditions, selected pediatric short-stature indications, mecasermin for growth failure associated with growth hormone resistance or severe short stature after failed growth hormone therapy, and tesamorelin for short bowel syndrome.

Clinical Definitions

SGA/IUGR

TermSmall for gestational age (SGA) or intrauterine growth retardation (IUGR)

Birth weightMore than 2 standard deviations below the mean for gestational age

Birth lengthMore than 2 standard deviations below the mean for gestational age

Catch-up growth failure

DefinitionFailure to show catch-up growth by age 2

Height velocityBelow 1 standard deviation score

AdjustmentAdjusted for age

Initial Therapy

Somatropin initial therapy

Initial therapy with listed growth hormone products requires an applicable adult or pediatric coverage pathway.

ONE applicable coverage pathway

Adult growth hormone deficiency criteria are met
Pediatric growth hormone deficiency criteria are met
A specified pediatric condition pathway is met; growth hormone stimulation testing is not required for those conditions
Trial-of-GH criteria for otherwise unexplained short stature are met
A qualifying pathway without documented GH deficiency is met, including Turner syndrome, chronic renal insufficiency with height below the third percentile, Prader-Willi syndrome, or SGA/IUGR without catch-up growth

Continuation Therapy

Continuation therapy in adults

Continuation therapy exception.

Adult exemption: Adult beneficiary has a genetic cause of GH deficiency or hypopituitarism and multiple pituitary hormone deficiencies

These beneficiaries are exempt from continuation therapy criteria requirements.

Continuation of therapy in children

Coverage is provided when ALL of the following continuation criteria are met, unless the stated exemption applies.

Required pediatric continuation criteria

Growth response
- Growth response is greater than 4.5 cm/year during the prepubertal growth phase>4.5 cm/year

Step Therapy Requirements

Step	Requirement	Applies to	Coverage label
1	Failure of a trial of GH therapy is required before Increlex may be considered.	Children with severe short stature	Covered with criteria

Policy Summary

PayerNorth Carolina Medicaid

PolicyOutpatient Pharmacy Prior Approval Criteria: Growth Hormones

Policy CodePolicy N/A

Change TypeModified

Effective DateMarch 4, 2002

Next Review DateN/A

Key ActionSubmit growth hormone prior authorization requests through the physician’s office, with pharmacist handling of the therapeutic-class request.

SourceLink

On This Page

Hypoglycemia with hypopituitarism: Adequately nourished infant or child has hypoglycemia, a low GH response to hypoglycemia, and other signs of hypopituitarism

Post-cranial-irradiation hypopituitarism: Child received cranial irradiation, has decreased height velocity, and has other evidence of hypopituitarismHeight velocity <25th percentile for bone age; at least one additional pituitary hormone deficiency

Growth factors: Serum IGF-1 and/or IGFBP-3 levels are lowLow

Birth weight/length >2 SD below mean; height velocity below 1 SD score adjusted for age

Severity and laboratory findings: Child has severe short stature with height less than 3 standard deviations below the mean, IGF-I less than 3 standard deviations below the mean, and normal or elevated GH levelsHeight <3 SD; IGF-I <3 SD; normal or elevated GH

Trial of GH therapy short stature criteria

HeightMore than 2.25 standard deviations below the mean for age

Bone ageMore than 2 standard deviations below the mean for age

Growth factorsLow serum IGF-1/IGFBP-3

SGA/IUGR criteria

Birth sizeBirth weight and/or length more than 2 standard deviations below the mean for gestational age

Catch-up growthFailure to show catch-up growth by age 2

Height velocityBelow 1 standard deviation score, adjusted for age

Increlex severity criteria

HeightLess than 3 standard deviations below the mean

IGF-ILess than 3 standard deviations below the mean

Growth hormone levelNormal or elevated GH levels

Prepubertal growth response

Continuation phasePrepubertal growth phase

Required responseGreater than 4.5 cm/year

Coverage conditionThe growth response must occur for continuation of coverage

Postpubertal growth response

Continuation phasePostpubertal growth phase

Required responseGreater than 2.5 cm/year

Coverage conditionThe growth response must occur for continuation of coverage

IGF-I and/or IGFBP-3 monitoring

Monitoring testsIGF-I and/or IGFBP-3

Minimum frequencyYearly

Required resultsWithin age-appropriate ranges

Submit Growth Hormone Prior Authorization Through the Physician’s Office

Prior authorization requests for this therapeutic class are handled by a pharmacist and must be submitted by the physician’s office. Approval may be granted for up to one year.

Pharmacist handles growth hormone prior authorization requests.
Request must come from the physician’s office.
Approval length: up to one year.

Unsupported block type: documentation

Documentation Required

Pediatric Growth Documentation

For pediatric growth hormone requests, submit the applicable growth, laboratory, skeletal maturity, and clinical documentation. Some qualifying conditions do not require stimulation testing but require the specified alternative findings.

Document two provocative tests showing GH dysfunction or inadequate endogenous GH, each less than 10 mg/ml, when required.
Document height below the third percentile for age and gender and open epiphyses for beneficiaries older than 9 years, when applicable.
For specified conditions without stimulation testing, document the relevant diagnosis and findings, including abnormal height velocity below the 25th percentile for bone age, low IGF-1/IGFBP-3, hypopituitarism, hypoglycemia with low GH response, or cranial irradiation with additional pituitary hormone deficiency.
For unexplained short stature trial therapy, document height more than 2.25 standard deviations below the mean, height velocity below the 25th percentile for bone age, bone age more than 2 standard deviations below the mean, and low IGF-1/IGFBP-3.
For qualifying Turner syndrome, chronic renal insufficiency, Prader-Willi syndrome, or SGA/IUGR cases, submit the applicable diagnosis and growth documentation, including failure of catch-up growth by age 2 when required.

Documentation Required

Increlex Documentation

Reserve Increlex for children whose growth failure is not expected to respond to GH therapy, or for severe short stature after a failed GH trial. Document the underlying cause or failed trial and the required severity findings.

Document GH resistance from a GH-receptor or post-GH-receptor signaling mutation, IGF-I gene defect, or GH gene deletion with neutralizing antibodies.
For severe short stature after failed GH therapy, document height less than 3 standard deviations below the mean, IGF-I less than 3 standard deviations below the mean, and normal or elevated GH levels.

Documentation Required

Document EPSDT Medical Necessity

When requesting services under EPSDT, provide documentation showing that the requested service, product, or procedure is medically necessary to correct or ameliorate the identified defect, illness, or condition and to improve, maintain, or protect the beneficiary’s health.

Explain how the request corrects or improves or maintains the beneficiary’s health, compensates for a health problem, prevents worsening, or prevents additional health problems.
The most economic similarly efficacious treatment must be used, without delaying needed care or limiting free choice of providers.
Document how the request meets all applicable EPSDT criteria when policy limitations on scope, amount, duration, frequency, location, or other criteria are exceeded or may not apply.

Documentation Required

Pediatric Continuation Documentation

For pediatric continuation of coverage, document the required growth response and complete minimum yearly IGF-I and/or IGFBP-3 monitoring, with results in age-appropriate ranges.

Pre-pubertal growth response must be greater than 4.5 cm/year.
Post-pubertal growth response must be greater than 2.5 cm/year.
Genetic causes of GH deficiency or hypopituitarism and multiple pituitary hormone deficiencies are exempt from the continuation criteria requirements.

Denial Risk

NC Health Choice Criteria Must Be Met

NC Health Choice beneficiaries do not receive EPSDT exceptions. If a request does not meet the applicable clinical coverage criteria, the request is denied.

Only services included under the Health Choice State Plan and applicable DMA clinical coverage policies, service definitions, or billing codes are covered.

Denial Risk

Unsafe or Experimental Treatment Is Not Required

EPSDT does not require coverage of services, products, or procedures that are unsafe, ineffective, experimental, investigational, nonmedical, or not generally recognized as accepted medical practice or treatment.

Do not rely on EPSDT to require coverage for unsafe, ineffective, experimental, investigational, or nonmedical treatment.

Denial Risk

Clinical Criteria Must Be Met

Coverage may be denied when the applicable clinical criteria are not met. Submit documentation supporting the relevant adult, pediatric, Increlex, or continuation requirements.

Adult requests must meet the applicable deficiency testing and underlying-disorder requirements.
Pediatric requests must meet the applicable growth, laboratory, skeletal maturity, diagnosis, or trial-therapy requirements.
Increlex requests must meet the cause, prior GH response or failed-trial, and severity requirements.
Zorbtive requests must be for short bowel syndrome.

Denial Risk

Zorbtive Indication Restriction

Zorbtive therapy is restricted to beneficiaries with short bowel syndrome. Requests for other indications may be denied.

Document short bowel syndrome as the indication for Zorbtive.

Denial Risk

Continuation Criteria Must Be Met

Pediatric continuation coverage may be denied when the required growth response or annual laboratory monitoring is not documented or does not meet the policy requirements.

Growth response must exceed 4.5 cm/year in the pre-pubertal phase or 2.5 cm/year in the post-pubertal phase.
Annual IGF-I and/or IGFBP-3 results must be within age-appropriate ranges.
Genetic causes of GH deficiency or hypopituitarism and multiple pituitary hormone deficiencies are exempt from the continuation criteria requirements.

Abnormal height velocity

DefinitionHeight velocity below the 25th percentile for bone age

MeasureHeight velocity

ReferenceBone age

Increlex initial therapy

Initial Increlex therapy is reserved for children with growth failure that will not respond to GH therapy.

Required Increlex criteria

ONE qualifying indication
- GH resistance caused by a mutation in the GH receptor or post-GH receptor signaling pathway
- IGF-I gene defect
- GH gene deletion with neutralizing antibodies to GH
- Severe short stature after failure of a trial of GH therapy
Severity and laboratory findings: Child has height less than 3 standard deviations below the mean, IGF-I less than 3 standard deviations below the mean, and normal or elevated GH levelsHeight <3 SD; IGF-I <3 SD; normal or elevated GH

Zorbtive initial therapy

Zorbtive initial therapy is limited to beneficiaries with short bowel syndrome.

Qualifying indication: Beneficiary has short bowel syndrome

Growth response is greater than 2.5 cm/year during the postpubertal growth phase>2.5 cm/year

IGF-I and/or IGFBP-3 monitoring: Minimum yearly IGF-I and/or IGFBP-3 monitoring is performed, and results are within age-appropriate rangesAt least yearly; within age-appropriate ranges