CurrentCignaPolicy N/A

Growth Disorders - Increlex Prior Authorization Policy

Defines prior authorization requirements and coverage criteria for Increlex (mecasermin) for pediatric growth disorders under Cigna-administered health benefit plans, including FDA‑approved indications and not-covered uses. Applies to providers prescribing Increlex and to coverage reviewers.

Policy Summary

PayerCigna

PolicyGrowth Disorders - Increlex Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document baseline growth measures and labs; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA‑approved indications covered

1 yrApproval duration

≥2Minimum age

≤ -3.0Height SDS threshold

≤ -3.0Basal IGF‑1 SDS

Coverage Criteria for Increlex (mecasermin)

Policy Summary

PayerCigna

PolicyGrowth Disorders - Increlex Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document baseline growth measures and labs; approvals are provided for 1 year when criteria are met.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial and continuation therapy for Severe Primary IGF‑1 Deficiency

Covered when the following criteria are met for either initial therapy (<1 year) or continuation (≥1 year):

Therapy timing: A) Initial therapy or patient on Increlex < 1 year OR B) Patient has been receiving Increlex ≥ 1 year

Initial therapy (A) requirements: Patient is ≥ 2 years; the epiphyses are open; height standard deviation score (height SDS) is ≤ -3.0 at baseline; basal IGF-1 standard deviation score (basal IGF-1 SDS) is ≤ -3.0 at baseline; growth hormone concentration is normal or increased at baseline; patient will not be receiving concurrent treatment with growth hormone; medication is prescribed by or in consultation with a pediatric endocrinologist.

Baseline = prior to initiation of treatment with Increlex.

Continuation therapy (B) requirements: Patient's height has increased by ≥ 2 cm/year in the most recent year; the epiphyses are open; patient will not be receiving concurrent treatment with growth hormone.

Applies to patients on Increlex ≥ 1 year.

Initial and continuation therapy for Growth Hormone Gene Deletion with neutralizing antibodies

Covered when the following criteria are met for either initial therapy (<1 year) or continuation (≥1 year):

Initial therapy requirements: Patient is ≥ 2 years; the epiphyses are open; patient has developed neutralizing antibodies to growth hormone; patient will not be receiving concurrent treatment with growth hormone; medication is prescribed by or in consultation with a pediatric endocrinologist.

Continuation therapy requirements: Patient's height has increased by ≥ 2 cm/year in the most recent year; the epiphyses are open; patient has developed neutralizing antibodies to growth hormone; patient will not be receiving concurrent treatment with growth hormone.

Increlex is not indicated for secondary forms of IGF‑1 deficiency. Examples of secondary states include growth hormone deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti‑inflammatory corticosteroids. Increlex is also not a substitute for somatropin (growth hormone) when growth hormone therapy is indicated.

Use of Increlex for idiopathic short stature or for any other indications not specifically listed as covered in this policy is considered not medically necessary and may be denied.

Clinical Thresholds and Key Coding Criteria

inv-05: Height increase requirement for continued therapy — ≥ 2 cm/year in the most recent year

Height increase for continuationPatient's height has increased by ≥ 2 cm/year in the most recent year

Applies toPatients receiving Increlex ≥ 1 year as a continuation criterion

Measurement periodIncrease assessed over the most recent 12‑month period

inv-06: Minimum age — Patient is ≥ 2 years of age

Minimum agePatient is ≥ 2 years of age

Applies toBoth initial therapy and continuation therapy criteria

DocumentationAge must be documented in the medical record prior to initiation

inv-07: Baseline height SDS — ≤ -3.0

Baseline height SDS thresholdHeight standard deviation score (SDS) ≤ -3.0 at baseline

Baseline definitionBaseline = prior to initiation of treatment with Increlex

Use contextRequired for initial therapy eligibility for severe primary IGF‑1 deficiency

inv-08: Baseline basal IGF‑1 SDS — ≤ -3.0

Baseline basal IGF‑1 SDS thresholdBasal IGF‑1 standard deviation score (SDS) ≤ -3.0 at baseline

Reference rangesIGF‑1 reference ranges vary by age, sex, and pubertal status—use lab‑specific references

Use contextRequired for initial therapy eligibility for severe primary IGF‑1 deficiency

Provider Requirements and Authorization Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Increlex. Approvals are provided for 1 year when the specified clinical criteria for the FDA‑approved indications are met. Initial approval requires that Increlex be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., pediatric endocrinologist).

Approvals are provided for 1 year when criteria for FDA‑approved indications are met.
Initial approval requires prescription by or in consultation with a specialist (e.g., pediatric endocrinologist).

Denial Risk

No Concurrent Growth Hormone

Increlex is not a substitute for growth hormone (somatropin). Do not use Increlex concurrently with growth hormone when growth hormone therapy is indicated.

Increlex is not a substitute for growth hormone for approved GH indications.
Do not administer Increlex concurrently with growth hormone when GH therapy is indicated.

Documentation Required

Provider Actions — Specialist Involvement Required

Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Increlex, the medication must be prescribed by or in consultation with a specialist (e.g., pediatric endocrinologist) as specified in the clinical criteria.

Prescribing must be by or in consultation with a specialist (e.g., pediatric endocrinologist).
Specialist involvement is required for initial approval and is noted in the FDA‑approved indication criteria.

Denial Risk

Provider Actions — Non‑FDA‑Approved Indications Not Covered

Requests for Increlex for non‑FDA‑approved indications (for example, idiopathic short stature or growth hormone deficiency) are considered not medically necessary per policy and are typically not covered.

Idiopathic short stature: Increlex has not been fully evaluated and is not routinely covered; somatropin is indicated for this condition.
Growth hormone deficiency: Increlex is not indicated and is not a substitute for somatropin.

Background on Increlex (mecasermin)

Increlex (mecasermin) is recombinant insulin‑like growth factor‑1 (IGF‑1) approved for pediatric growth failure in two FDA‑listed situations: severe primary IGF‑1 deficiency (defined by baseline height SDS ≤ -3.0, basal IGF‑1 SDS ≤ -3.0, and normal or elevated growth hormone level) and in patients with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone. It is administered by subcutaneous injection twice daily and therapy is continued until epiphyseal fusion. The product is not indicated for secondary IGF‑1 deficiency states such as growth hormone deficiency.

Definitions

inv-14: Severe primary IGF‑1 deficiency — defined as height SDS ≤ -3.0, basal IGF‑1 SDS ≤ -3.0, and normal or elevated GH level

DefinitionSevere primary IGF‑1 deficiency is defined as: height SDS ≤ -3.0; AND basal IGF‑1 SDS ≤ -3.0; AND normal or elevated growth hormone level.

Treatment contextIndication for Increlex when criteria met and epiphyses are open

Not a substitute for GHIncrelex is not a substitute for growth hormone for approved GH indications and is not indicated for secondary IGF‑1 deficiency

inv-15: Growth hormone gene deletion with neutralizing antibodies — definition and concurrency/therapy notes

DefinitionGrowth hormone gene deletion with neutralizing antibodies: patients with GH gene deletion who have developed neutralizing antibodies to growth hormone.

Concurrent GH therapyPatient will not be receiving concurrent treatment with growth hormone to meet eligibility

PrescriberMedication must be prescribed by or in consultation with a pediatric endocrinologist for initial therapy