Increlex (mecasermin) — Coverage Criteria for Severe Primary IGF-1 Deficiency
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This policy governs medical necessity criteria, prior authorization documentation, prescriber requirements, and continuation/initial approval rules for Increlex (mecasermin) in pediatric patients with severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH for Blue Cross Blue Shield - Iowa members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Increlex (mecasermin)
Initial Therapy — 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:
supported by FDA indication
laboratory-specific values must be provided
rule out GH deficiency
confirmed by X-ray or clinical assessment
Continuation of Therapy
Authorization of 12 months may be granted for continuation when ALL of the following are met:
clinical exceptions allowed
can be confirmed by X-ray or if X-ray not available
Increlex (mecasermin) is indicated only for severe primary IGF-1 deficiency or for patients with a GH gene deletion who have developed neutralizing antibodies to growth hormone (GH). It is not indicated for secondary causes of low IGF‑1 such as pediatric GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti‑inflammatory corticosteroids. Additionally, Increlex is not a substitute for growth hormone for any approved GH indications.
Requests for Increlex that do not meet the policy criteria described for initial or continuation therapy are not medically necessary and will be denied. This includes cases where required continuation thresholds (for example, documented growth rate or open epiphyses) are not satisfied or when the diagnosis represents a secondary form of IGF‑1 deficiency rather than severe primary IGF‑1 deficiency.
Key Clinical Thresholds and Metrics
Prior Authorization, Documentation, and Prescriber Requirements
Prior authorization required (initial and continuation; up to 12 months)
Prior authorization is required for both initial and continuation therapy. When all coverage criteria are met, approvals of up to 12 months may be granted. Submit the required documentation with the authorization request for review; incomplete documentation may delay or prevent approval.
Therapy positioning — not a substitute for growth hormone
Increlex is indicated only for severe primary IGF-1 deficiency or for patients with GH gene deletion who have developed neutralizing antibodies to GH; it is not a substitute for growth hormone for approved GH indications.
Required documentation for initial and continuation requests
For initial requests, provide a growth chart/chart notes showing heights and growth velocities, pretreatment IGF‑1 laboratory report, and growth hormone provocative test results. For continuation requests, provide total duration of treatment, date of last dose, approving plan/pharmacy benefit manager, date of prior authorization/approval, and the prior authorization approval letter.
- Initial: growth chart or chart notes documenting heights and growth velocities
- Initial: pretreatment IGF‑1 laboratory report (include laboratory‑specific reference values)
- Initial: GH provocative test result(s) (laboratory report or documentation)
- Continuation: total duration of treatment and date of last dose
- Continuation: approving health plan/pharmacy benefit manager, date of prior authorization/approval, and prior authorization approval letter
Denial risk — not medically necessary if criteria unmet
If the member does not meet the policy criteria for severe primary IGF‑1 deficiency or continuation criteria, Increlex is considered not medically necessary and will be denied.
- Initial coverage requires: height SD ≤ -3.0, basal IGF‑1 SD ≤ -3.0, GH deficiency ruled out (peak GH ≥ 10 ng/mL), and open epiphyses
- Continuation coverage requires: growth rate > 2 cm/year (or documented clinical reason for lack of efficacy) and open epiphyses
Background on Increlex (mecasermin)
Increlex (mecasermin) is FDA‑approved for treatment of growth failure in pediatric patients aged 2 years and older with severe primary insulin‑like growth factor‑1 (IGF‑1) deficiency or with GH gene deletion who have developed neutralizing antibodies to GH. Severe primary IGF‑1 deficiency is defined by a pretreatment height SD score ≤ -3.0, a pretreatment basal IGF‑1 SD score ≤ -3.0, and normal or elevated GH. The product labeling also specifies that Increlex is not indicated for secondary forms of IGF‑1 deficiency and is not a substitute for GH for approved GH indications.
Definitions and Clarifications
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