CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

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

This policy governs prior authorization, documentation, and clinical criteria for coverage of Increlex (mecasermin) for pediatric patients with severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to growth hormone. It applies to members seeking pharmacy benefit coverage under Neighborhood Health Plan of Rhode Island.

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 changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a prior authorization request for up to 12 months when the initial or continuation criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for initial and continuation therapy

≥ 3 SDheight and basal IGF-1 pretreatment thresholds

> 2 cm/yrgrowth rate threshold for continuation

≥ 2 yrsminimum pediatric age in FDA indication

Coverage Criteria for Increlex (mecasermin)

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Initial Authorization — Severe Primary IGF-1 Deficiency or GH gene deletion with neutralizing antibodies to GH

Authorization of 12 months may be granted when ALL of the following are met:

Initial criteria: A. Pretreatment height is ≥ 3 standard deviations (SD) below the mean for age and genderHeight SD score ≤ -3.0

Initial criteria: B. Pretreatment basal IGF-1 level is ≥ 3 SD below the mean for age and genderBasal IGF-1 SD score ≤ -3.0

Initial criteria: C. Pediatric GH deficiency has been ruled out with a provocative GH test (peak GH level ≥ 10 ng/mL)Peak GH level ≥ 10 ng/mL

Initial criteria: D. Epiphyses are open

Continuation of Therapy

Authorization of 12 months may be granted for continuation when ALL of the following are met:

Continuation criteria: B. Epiphyses are open (confirmed by X-ray or X-ray is not available).

Increlex (mecasermin) is not indicated for secondary forms of IGF‑1 deficiency. Examples of secondary causes include growth hormone (GH) deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti‑inflammatory corticosteroids. The product labeling specifies this limitation of use and clarifies that Increlex is not a substitute for GH in approved GH indications.

Requests for use of Increlex outside the FDA‑approved indications described in the labeling — including any non‑compendial or other off‑label indications — are considered experimental/investigational and not medically necessary and are not covered under this policy.

Clinical Thresholds and Test Criteria

inv-05: Height and IGF-1 pretreatment thresholds

Height pretreatment thresholdHeight SD score ≤ -3.0

Basal IGF-1 pretreatment thresholdBasal IGF-1 SD score ≤ -3.0

Supporting requirementCriteria apply to pediatric patients meeting FDA indication for severe primary IGF-1 deficiency

inv-06: Provocative GH test threshold

Provocative GH test thresholdPeak GH level ≥ 10 ng/mL

PurposeRule out pediatric GH deficiency prior to Increlex initiation

ContextRequired as part of initial authorization criteria for severe primary IGF-1 deficiency

inv-07: Continuation growth response threshold

Continuation growth response thresholdMember's growth rate is > 2 cm/year

Alternative documented reasons for lack of efficacyExamples include treatment < 1 year or nearing final adult height/late puberty

VerificationEpiphyses must be open for continuation authorization

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted for up to 12 months when the specified initial or continuation criteria are met for severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH.

Authorization duration: up to 12 months when criteria for initial or continuation therapy are satisfied.
Applies to members with severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH.

Denial Risk

Non‑covered Indications — Denial Risk

Requests for indications that are not FDA‑approved or supported by accepted compendia (e.g., uses outside severe primary IGF‑1 deficiency or GH gene deletion with neutralizing antibodies to GH) may be denied as experimental/investigational and not medically necessary.

Non‑covered: all indications other than the FDA‑approved indications for Increlex (severe primary IGF‑1 deficiency as defined, or GH gene deletion with neutralizing antibodies to GH).

Documentation Required

Required Documentation for Continuation

For continuation of therapy prior authorization review, submit the following documentation to support the request.

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

Background on Increlex (mecasermin)

Increlex (mecasermin) is indicated for treatment of growth failure in pediatric patients aged ≥ 2 years with severe primary IGF‑1 deficiency or with GH gene deletion who have developed neutralizing antibodies to GH. Severe primary IGF‑1 deficiency is characterized by a height SD score ≤ -3.0, a basal IGF‑1 SD score ≤ -3.0, and normal or elevated GH. The therapy provides exogenous IGF‑1 replacement and is not a substitute for growth hormone therapy when GH is the indicated treatment.