Subject: Increlex 1740-A SGM P2023
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 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 11, 2023
