Subject: Increlex SGM 1740-A P2026

Drug

INCRELEX  (mecasermin)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no contraindications or exclusions to the prescribed therapy.

FDA-approved Indications¹

Increlex is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary insulin-like growth factor-1 (IGF-1) deficiency or growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Severe primary IGF-1 deficiency (IGFD) is defined by:

·        Height standard deviation (SD) score ≤ –3.0 and

·        Basal IGF-1 SD score ≤ –3.0 and

·        Normal or elevated GH.

Limitations of use: Increlex is not a substitute to GH for approved GH indications. Increlex is not indicated for use in patients with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory corticosteroids.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Initial requests

·        Growth chart, chart notes, or medical record documentation showing heights and growth velocities.

·        Laboratory test result or medical record documentation of pretreatment insulin-like growth factor-1 (IGF-1) level with laboratory-specific values to determine whether the value is within the normal range.

·        Laboratory test or medical record documentation of provocative growth hormone test result(s).

Continuation requests

·        Total duration of treatment (approximate duration is acceptable)

·        Date of last dose administered

·        Approving health plan/pharmacy benefit manager

·        Date of prior authorization/approval

·        Prior authorization approval letter

Prescriber Specialties

This medication must be prescribed by or in consultation with an endocrinologist.

Coverage Criteria

Severe Primary IGF-1 Deficiency^1-3

Authorization of 12 months may be granted to members with severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH when all of the following criteria are met:

·        Pretreatment height is ≥ 3 standard deviations (SD) below the mean for age and gender

·        Pretreatment basal IGF-1 level is ≥ 3 SD below the mean for age and gender

·        Pediatric GH deficiency has been ruled out with a provocative GH test (i.e., peak GH level ≥ 10 ng/mL)

·        Epiphyses are open

Continuation of Therapy

Authorization of 12 months may be granted for continuation of therapy for severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH when both of the following criteria are met:

·        The member’s growth rate is > 2 cm/year or there is a documented clinical reason for lack of efficacy (e.g., on treatment less than 1 year, nearing final adult height/late stages of puberty).

·        Epiphyses are open (confirmed by X-ray or X-ray is not available).

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Increlex [package insert]. Deer Park, IL: Eton Pharmaceuticals, Inc.; July 2025.

2.     Grimberg A, DiVall SA, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-I treatment in children and adolescents: growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency. Horm Res Paediatr. 2016;86:361-397.

3.     Yuen KCJ, Johannsson G, Ho KKY, et al. Diagnosis and testing for growth hormone deficiency across the ages: a global view of the accuracy, caveats, and cut-offs for diagnosis. Endocr Connect. 2023;12(7):e220504.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 29, 2026