Subject: Increlex 1740-A SGM P2022

Drug

INCRELEX  (mecasermin)

Policy:

I.   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 Indications
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 with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. 

Severe primary IGF-1 deficiency 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. 

II.  DOCUMENTATION 

Submission of the following information is necessary to initiate the prior authorization review for continuation of therapy requests:
A.   Total duration of treatment (approximate duration is acceptable)
B.   Date of last dose administered
C.   Approving health plan/pharmacy benefit manager
D.   Date of prior authorization/approval
E.   Prior authorization approval letter 

III. CRITERIA FOR INITIAL APPROVAL 

Severe Primary IGF-1 Deficiency
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:
A.   Pretreatment height is ≥ 3 standard deviations (SD) below the mean for age and gender
B.   Pretreatment basal IGF-1 level is ≥ 3 SD below the mean for age and gender
C.   Pediatric GH deficiency has been ruled out with a provocative GH test (i.e., peak GH level ≥ 10 ng/mL)
D.   Epiphyses are open 

IV. 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 ALL of the following criteria are met:
A.   The member’s growth rate is > 2 cm/year ² 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).
B.   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:

Increlex [package insert]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; December 2019.

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.

June 26, 2022