CurrentMass General Brigham Health PlanPolicy N/A

Increlex (mecasermin) — Coverage Criteria

Policy governing prior authorization, specialty pharmacy routing, quantity limits, and medical benefit considerations for Increlex (mecasermin) for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyIncrelex (mecasermin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeOperational classification revised to Custom

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization including diagnostic data (height and basal IGF‑1) and documentation of open epiphyses.

SourceLink

POLICY UPDATE CHANGES

Policy was reviewed and switched from SGM to Custom effective 01/01/2024.

12 monthsapproval duration

>=2 yrsmin patient age

Height SD < -3.0height threshold

IGF‑1 SD < -3.0IGF-1 threshold

Coverage Criteria for Increlex (mecasermin)

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. These situations are explicitly excluded from the FDA‑approved indications for Increlex and should not be considered appropriate uses for therapy.

Requests for use of Increlex outside the FDA‑approved populations (severe primary IGF‑1 deficiency or GH gene deletion with neutralizing antibodies to GH) are considered experimental/investigational and not medically necessary. Authorization should not be approved for indications beyond those specified by the FDA.

Coding and Diagnostic Thresholds

No codes listedmixed

No codes listed

Diagnostic thresholds — Increlex (mecasermin)

Height standard deviation (SD)Pretreatment height SD < -3.0

Basal IGF-1Pretreatment basal IGF-1 SD < -3.0

Policy Summary

PayerMass General Brigham Health Plan

PolicyIncrelex (mecasermin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeOperational classification revised to Custom

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization including diagnostic data (height and basal IGF‑1) and documentation of open epiphyses.

SourceLink

On This Page

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Increlex (mecasermin). Requests for members new to the plan may be authorized if the member is currently receiving the medication (excludes samples or manufacturer patient assistance programs).

Contact (Medical & Specialty Medications): Phone: 877-519-1908; Fax: 855-540-3693
Non-Specialty Medications Contact: Phone: 800-711-4555

Billing Rule

Specialty Pharmacy Dispensing

This medication has been designated as specialty and must be dispensed through a contracted specialty pharmacy.

Medical and Specialty Medications contact: Phone: 877-519-1908; Fax: 855-540-3693
Exceptions: none specified

Denial Risk

Failure to Meet Diagnostic Criteria

Authorization will be denied if required diagnostic criteria are not met or if essential diagnostic testing has not been performed.

Required diagnostics include: pretreatment basal IGF-1 level ≥ -3 SD below mean for age/gender; pretreatment height ≥ -3 SD below mean for age/gender; provocative GH test to rule out pediatric GH deficiency (peak GH ≥ 10 ng/mL); confirmation that epiphyses are open (radiograph).
Requests lacking documentation of these diagnostics or documentation showing criteria not met are not medically necessary.

Documentation Required

Documentation Required for Continuation

For continuation of therapy, provide documentation of total duration of treatment (approximate duration acceptable) and date of last dose administered. Also document growth response (>2 cm/year) or a clinical reason for lack of efficacy (e.g., treatment <1 year, nearing final adult height/late puberty).

Epiphyses must be open (confirmed by X-ray or note that X-ray is not available).

Denial Risk

Non‑FDA Indications Not Covered

Requests for non–FDA‑approved indications are considered experimental/investigational and are not medically necessary.

Increlex is FDA‑approved only for severe primary IGF‑1 deficiency in pediatric patients ≥2 years and for patients with GH gene deletion who have developed neutralizing antibodies to GH.

OpenPayer

Increlex (mecasermin) — Coverage Criteria

Coverage Criteria for Increlex (mecasermin)

Coding and Diagnostic Thresholds

Provider Actions and Authorization Requirements

Background

Key Definitions