CurrentHealth NetPolicy N/A

Clinical Policy: Mecasermin (Increlex) coverage

This policy defines medical necessity criteria, limitations, and approval durations for use of mecasermin (Increlex) for pediatric growth failure due to severe primary IGF-1 deficiency or GH gene deletion with neutralizing GH antibodies, and applies to Health Net lines of business listed.

Policy Summary

PayerHealth Net

PolicyMecasermin (Increlex) coverage — Clinical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date03.01.11

Next Review DateN/A

Key ActionSubmit prior authorization with office chart notes, lab results, growth measurements (SD, height, date, and age in months), and other clinical documentation demonstrating criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Height ≤ -3.0 SDdiagnostic threshold per FDA indication

2–<18 yrsage range

0.12 mg/kg BIDmax dose

Commercial 6 moapproval duration

J2170HCPCS code

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Coverage Criteria for Mecasermin (Increlex)

Initial Therapy - Severe primary IGFD

Covered when ALL of the following are met:

Initial Approval - Severe primary IGFD: 1. Diagnosis of severe primary IGF-1 deficiency (IGFD) defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0; 2. Prescribed by or in consultation with a pediatric endocrinologist; 3. Age ≥ 2 and < 18 years; 4. IGF-1 serum level is ≥ 3 standard deviations (SD) below the mean; 5. Growth hormone (GH) serum level is normal or elevated; 6. Height is ≥ 3 SD below the mean for age and sex with documentation of SD, height, date, and age in months within the last 90 days; 7. Member does not have malignant neoplasia or a history of malignancy (contraindication); 8. Increlex (mecasermin) is not prescribed concurrently with growth hormone products; 9. Dose does not exceed 0.12 mg/kg twice daily.see node text

Approval durations vary by line of business (see Approval duration).

Initial Therapy - GH Insensitivity / GH gene deletion

Covered when ALL of the following are met:

Initial Approval - GH insensitivity: 1. Diagnosis of acquired GH insensitivity or genetic GH deficiency due to GH gene deletion with development of neutralizing GH antibodies; 2. Prescribed by or in consultation with a pediatric endocrinologist; 3. Age ≥ 2 and < 18 years; 4. If age > 10 years, radiographic documentation of open epiphyses on X-ray; 5. Documentation of neutralizing GH antibodies or genetic testing confirming GH gene deletion; 6. Member meets growth criteria (either a. Short stature: height > 2 SD below the mean for age and sex with SD, height, date, and age in months within the last 90 days; or b. Growth failure with required deceleration/velocity criteria documented by serial measurements as specified in policy); 7. Member does not have malignant neoplasia or a history of malignancy (contraindication); 8. Increlex (mecasermin) is not prescribed concurrently with growth hormone products; 9. Dose does not exceed 0.12 mg/kg twice daily.see node text

Serial height documentation requirements (dates, ages in months, intervals) are required per policy.

Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy: 1. Member is currently receiving Increlex via the plan benefit or previously met initial approval criteria (including situations covered by continuity of care); 2. If member has been treated ≥ 1 year, height has increased ≥ 2 cm in the prior year documented by two height measurements taken no more than 1 year apart (dates and height measurements required); 3. Increlex is not prescribed concurrently with growth hormone products; 4. Member does not have malignant neoplasia or a history of malignancy; 5. If request is for a dose increase, the new dose does not exceed 0.12 mg/kg twice daily.see node text

Approval duration for continuation aligns with initial approval periods by line of business.

Requests for mecasermin (Increlex) for patients with secondary forms of IGF-1 deficiency are not authorized under this policy. Examples of secondary causes explicitly excluded include GH deficiency, malnutrition, hypothyroidism, and chronic treatment with pharmacologic doses of anti-inflammatory corticosteroids. These conditions should be addressed and corrected when appropriate prior to consideration of therapy directed at primary IGF-1 deficiency.

Documentation submitted for prior authorization should make clear that the member’s low IGF-1 is not due to one of these secondary causes (for example, normal thyroid function and adequate nutritional status), because requests for treatment of secondary IGF-1 deficiency are denial triggers per policy.

Mecasermin is contraindicated in pediatric patients with active malignant neoplasia or a history of malignancy; known hypersensitivity to mecasermin; in patients with closed epiphyses when therapy is being used for growth promotion; and when administered intravenously. These contraindications align with the policy’s safety exclusions and should be confirmed in the medical record prior to approval.

Prior to initiating therapy, assess for a history of malignancy, document growth plate status (radiograph for epiphyseal closure when indicated by age), and confirm there is no known hypersensitivity to mecasermin. The policy notes that thyroid and nutritional deficiencies should be corrected before initiating Increlex.

As of the 3Q 2024 review the policy language was updated to clarify that Increlex is not prescribed concurrently with growth hormone. This revised verbiage extends the prior restriction (previously specified for somatropin) to all growth hormone products and is a condition included across initial and continuation criteria.

Increlex is indicated for primary IGF-1 deficiency and is not a substitute for growth hormone. Use of mecasermin for secondary IGF-1 deficiency (for example due to GH deficiency, hypothyroidism, malnutrition, or chronic corticosteroid therapy) or as a replacement for approved GH indications is considered not medically necessary under this policy and may be denied.

When requests appear to be seeking mecasermin as an alternative to standard GH therapy, reviewers should verify the clinical diagnosis and prior treatment history; the policy requires that Increlex be used only when exogenous growth hormone is ineffective (for example, GH gene deletion with neutralizing antibodies or primary IGF-1 defects).

Coding, Dosing, and Product Information

No CPT/HCPCS codes listed in this partmixed

No codes listed

HCPCS Codes referencedHCPCS

J2170

Injection, mecasermin, L mg

IGF-1 and height thresholds — diagnostic & alternative thresholds for GH insensitivity

Severe primary IGFD diagnostic thresholdsHeight standard deviation score ≤ -3.0 AND basal IGF-1 standard deviation score ≤ -3.0 (per FDA indication)

Age range for criteriaPediatric patients ≥2 and <18 years (required for initial approval)

Height documentation requirementHeight, SD, date, and age in months must be documented within the last 90 days for initial approval

Alternative thresholds for GH insensitivityFor GH insensitivity/GH gene deletion with neutralizing antibodies, growth criteria may include height >2 SD below mean or specified growth-velocity/serial measurement criteria as detailed in policy

Dosing — initial and maximum recommended dosing

Initial dosing (recommended)0.04 mg/kg to 0.08 mg/kg subcutaneously twice daily (SC BID)

Titration incrementMay increase by 0.04 mg/kg (40 mcg/kg) per dose

Maximum recommended doseUp to 0.12 mg/kg subcutaneously twice daily (SC BID)

Dosing populationChildren with severe primary IGFD or GH gene deletion with neutralizing GH antibodies

Product concentration

Concentration (per vial)10 mg/mL

Multi-dose vial size40 mg/4 mL

Product nameMecasermin (Increlex) multi-dose vial

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — documentation supporting that member meets initial approval criteria. Provider must submit documentation (such as office chart notes, lab results, growth measurements including standard deviations, height, date, and age in months within the last 90 days) and other clinical information demonstrating the member meets the policy's initial approval criteria.

Office notes and clinical history
Recent lab results including IGF-1 and GH levels
Growth data: SD, height, date, age in months (within last 90 days)
If applicable, genetic testing or antibody documentation for GH insensitivity cases

Note

Off‑label / Non‑Formulary Routing

Off‑label / non‑formulary routing: If the requested use is not listed in the policy or the drug is not on the plan formulary/PDL, route the request per the appropriate line‑of‑business policy. Refer to the stated formulary/non‑formulary and off‑label policies for the correct review pathway.

For formulary drugs: commercial CP.CPA.190; HIM.PA.33 (HIM); CP.PMN.255 (Medicaid)
For non‑formulary drugs: CP.CPA.190 (commercial); HIM.PA.103 (HIM); CP.PMN.16 (Medicaid)
For off‑label uses not listed in this policy: CP.CPA.09 (commercial); HIM.PA.154 (HIM); CP.PMN.53 (Medicaid)

Documentation Required

Required Documentation

Required documentation to support prior authorization and clinical review. Provide all relevant records to demonstrate diagnostic criteria and safety considerations have been met.

Office chart notes documenting diagnosis and specialist consultation (pediatric endocrinologist when required)
Laboratory results including IGF‑1 and GH serum levels
Growth measurements with SD, height, date, and age in months (within required timeframes)
Imaging or X‑ray to document open epiphyses when indicated (>10 years)
Genetic testing or neutralizing GH antibody documentation when applicable

Denial Risk

Contraindications / Denial Triggers

Contraindications / Denial Triggers — requests meeting any of the following will be denied. Confirm absence of these before submitting a request.

Active malignant neoplasia or history of malignancy
Known hypersensitivity to mecasermin
Closed epiphyses (for growth promotion)
Intravenous administration route requests
Requests for treatment of secondary forms of IGF‑1 deficiency (e.g., GH deficiency, malnutrition, hypothyroidism, chronic pharmacologic corticosteroid therapy)

Billing Rule

Coding Guidance Reminder

Coding and billing reminder. HCPCS J2170 (Injection, mecasermin) is referenced for informational purposes only. Inclusion or exclusion of codes does not guarantee coverage — providers must verify and use the most up‑to‑date professional coding guidance when submitting claims.

Codes listed are informational only; verify payer-specific billing guidance prior to claim submission
Reference current coding manuals and payer instructions when billing

Definitions and Clinical Terms

Severe primary IGF-1 deficiency (IGFD) — definition & notes

DefinitionSevere primary IGF-1 deficiency is defined by height standard deviation score ≤ -3.0 AND basal IGF-1 standard deviation score ≤ -3.0 (FDA indication)

Required GH statusNormal or elevated GH serum level (required for severe primary IGFD indication)

Prescriber requirementPrescribed by or in consultation with a pediatric endocrinologist for initial approval

Exclusion/contraindication noteNot indicated for secondary causes of IGF-1 deficiency (e.g., GH deficiency, malnutrition, hypothyroidism, chronic corticosteroid therapy) and contraindicated in patients with malignant neoplasia or history of malignancy

GH insensitivity / Laron syndrome — definition

DefinitionGH insensitivity (Laron syndrome) includes GH receptor mutations or post-receptor signaling defects leading to inability to respond to exogenous GH

Clinical implicationPatients may have normal or elevated GH but remain growth-impaired; mecasermin may be indicated when receptor/post-receptor defects exist

Non‑responsive conditionsIGF-1 receptor mutations result in normal/elevated IGF-1 and render mecasermin ineffective

Mecasermin 10 mg/mL (40 mg/4 mL) — product concentration

Concentration10 mg/mL

Vial presentationMulti-dose vial: 40 mg/4 mL

ProductMecasermin (Increlex)

Clinical references — guidelines and literature

Prescribing informationIncrelex Prescribing Information, Ipsen Biopharmaceuticals; March 2024 (full prescribing information cited)

Guideline referenceGrimberg A et al., Guidelines for GH and IGF-I treatment in children and adolescents: Horm Res Paediatr 2016

Clinical studiesChernausek SD et al., Long-term treatment with recombinant IGF-I in children with severe IGF-I deficiency; J Clin Endocrinol Metab. 2007

Auxology and growth standardsWHO and CDC growth chart resources and related auxology literature cited for growth assessment

OpenPayer

Clinical Policy: Mecasermin (Increlex) coverage

Coverage Criteria for Mecasermin (Increlex)

Coding, Dosing, and Product Information

Provider Actions, Prior Authorization & Documentation

Background

Definitions and Clinical Terms

Revision History