CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Increlex (mecasermin) — coverage criteria for severe primary IGF-1 deficiency

Defines medical necessity criteria, documentation, and authorization periods for Increlex (mecasermin) for pediatric patients with severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIncrelex (mecasermin) — coverage criteria for severe primary IGF-1 deficiency

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFor continuation, submit date of last dose, total duration of treatment, approving health plan/PBM, prior authorization approval letter, and date of prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

≥2 yrsminimum age

< -3.0IGF-1 SD threshold

< -3.0Height SD threshold

≥10 ng/mLProvocative GH peak

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIncrelex (mecasermin) — coverage criteria for severe primary IGF-1 deficiency

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFor continuation, submit date of last dose, total duration of treatment, approving health plan/PBM, prior authorization approval letter, and date of prior authorization.

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 Therapy - Severe Primary IGF-1 Deficiency

Covered when ALL of the following are met:

Initial therapy criteria: 1) Patient is ≥ 2 years of age; 2) Basal IGF-1 SD score < -3.0; 3) Pretreatment height SD score < -3.0; 4) Normal or elevated GH (pediatric GH deficiency has been ruled out with a provocative GH test showing peak GH ≥ 10 ng/mL); 5) Epiphyses are open.see individual nodes

Increlex is not a substitute for growth hormone and is not indicated for secondary forms of IGF-1 deficiency (e.g., GH deficiency, malnutrition, hypothyroidism, chronic pharmacologic corticosteroid therapy).

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation therapy criteria: 1) Epiphyses are open (confirmed by X-ray or if X-ray not available); 2) The member's growth rate is > 2 cm/year or there is a documented clinical reason for lack of efficacy (e.g., 1 year of therapy with inadequate response, nearing final adult height/late stages of puberty); 3) Other approval criteria met as for initial therapy.see individual nodes

Authorization may be granted for 12 months when criteria are met.

Increlex (mecasermin) is not indicated for secondary forms of IGF-1 deficiency. Examples of excluded causes include GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti‑inflammatory corticosteroids. The product is also not a substitute for growth hormone (GH) for approved GH indications.

Any use of Increlex for indications other than the FDA‑approved population is considered experimental/investigational and not medically necessary and may be denied.

Key Clinical Thresholds and Coding Values

Basal IGF-1 SD score — threshold value

Basal IGF-1 SD score threshold< -3.0

Measurement basisBasal IGF-1 level is measured as standard deviation (SD) below the mean for age and gender

Use in initial authorizationRequired for initial therapy for severe primary IGF-1 deficiency

Pretreatment height SD score — threshold value

Pretreatment height SD score threshold< -3.0

Measurement basisHeight expressed as standard deviation (SD) below the mean for age and gender

Use in initial authorizationRequired for initial therapy for severe primary IGF-1 deficiency

Provocative GH test peak — threshold value

Provocative GH test peak threshold≥ 10 ng/mL

PurposeUsed to rule out pediatric GH deficiency prior to diagnosing severe primary IGF-1 deficiency

ApplicationRequired as part of initial authorization criteria

Continuing growth rate — threshold for continuation (> 2 cm/year)

Continuing growth rate threshold> 2 cm/year

ContextRequired for continuation of therapy unless there is documented clinical reason for lack of efficacy

Authorization period linkIf met, continuation authorization may be granted for 12 months

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization period — 12 months

Prior authorization may be granted for 12 months when all approval criteria are met for severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH.

Step Therapy

Step therapy — not specified

No step therapy requirements are specified in this policy.

Documentation Required

Required documentation for continuation

For continuation requests, submit the date of the last dose administered, total duration of treatment (approximate duration acceptable), approving health plan/pharmacy benefit manager, prior authorization approval letter, and date of prior authorization/approval.

Date of last dose administered
Total duration of treatment (approximate acceptable)
Approving health plan/pharmacy benefit manager
Prior authorization approval letter
Date of prior authorization/approval

Denial Risk

Non‑approved indications — may be denied

Use of Increlex for indications other than FDA‑approved or compendial uses is considered experimental/investigational and not medically necessary and may be denied.

Background on Increlex (mecasermin)

Increlex (mecasermin) is indicated for treatment of growth failure in pediatric patients aged ≥ 2 years with severe primary insulin‑like growth factor‑1 (IGF‑1) deficiency or with growth hormone gene deletion. Severe primary IGF‑1 deficiency is defined by basal IGF‑1 SD score < -3.0, height SD score < -3.0, and normal or elevated GH. The agent is intended for this specific primary IGF‑1 deficiency population and is not a substitute for GH.

Definitions and Diagnostic Thresholds

Severe primary IGF-1 deficiency — definition

DefinitionSevere primary IGF-1 deficiency: basal IGF-1 SD score < -3.0 and height SD score < -3.0 with normal or elevated GH

Normal/elevated GH requirementPediatric GH deficiency must be ruled out (provocative GH test peak ≥ 10 ng/mL)

Use limitationIncrelex is not indicated for secondary forms of IGF-1 deficiency (e.g., GH deficiency, malnutrition, hypothyroidism, chronic corticosteroid therapy)

Provocative GH test threshold — definition used to rule out pediatric GH deficiency

Provocative GH test thresholdPeak GH ≥ 10 ng/mL

PurposeUsed to rule out pediatric GH deficiency when evaluating for severe primary IGF-1 deficiency

Role in authorizationRequired as part of initial authorization criteria for Increlex

OpenPayer

Increlex (mecasermin) — coverage criteria for severe primary IGF-1 deficiency

Coverage Criteria for Increlex (mecasermin)

Key Clinical Thresholds and Coding Values

Prior Authorization and Documentation Requirements

Background on Increlex (mecasermin)

Definitions and Diagnostic Thresholds