CurrentColorado Rocky Mountain Health PlansPolicy N/A

Increlex (mecasermin) prior authorization — Florida Medicaid

This document is a Florida Medicaid prior authorization form and instructions for Increlex (mecasermin) used for treatment of pediatric severe primary IGF‑1 deficiency or GH gene deletion with neutralizing antibodies; it governs prior authorization submissions for Florida Medicaid recipients and the prescribing providers (typically endocrinologists).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIncrelex (mecasermin) prior authorization — Florida Medicaid

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with required supporting documentation including growth chart, labs, and recent chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2primary covered indications listed

>=2 cmgrowth progression required

5 yrsdocumentation retention

>2 yrsminimum age queried

Coverage Criteria for Increlex (mecasermin)

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIncrelex (mecasermin) prior authorization — Florida Medicaid

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with required supporting documentation including growth chart, labs, and recent chart notes.

SourceLink

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Initial therapy criteria

Covered when ALL of the following are met

Primary IGFD criteria: Patient has severe primary insulin-like growth factor-1 (IGF-1) deficiency defined by: height standard deviation score (SDS) <= -3; AND basal IGF-1 SDS <= -3; AND normal or elevated growth hormone level (greater than 10 ng/mL on standard GH stimulation tests)Height SDS <= -3; Basal IGF-1 SDS <= -3; GH stimulation > 10 ng/mL

Submit supporting lab work and documentation

Alternate covered indication: Patient has growth hormone gene deletion and has developed neutralizing antibodies to growth hormoneMust submit supporting documentation

Listed as an alternative covered indication

Age and skeletal status: Child older than two years of age with open epiphysesAge > 2 years and open epiphyses

Form requires provider confirmation

Specialist involvement: Patient is receiving ongoing care from an endocrinologist (or current prescriber is an endocrinologist)Specialist care required

Form asks provider to confirm

Correction of other causes: Thyroid and nutritional deficiencies and other correctable causes of growth failure (e.g., malnutrition, hypothyroidism, chronic anti-inflammatory steroid use) have been addressed prior to initiationCorrectable conditions corrected or ruled out

Verification required before initiation

Continuation therapy criteria

Covered when ALL of the following are met for continuation

Documented growth progression: Growth chart demonstrating progression of growth >= 2 cm total in one year>= 2 cm in 1 year

Required for continuation requests; include growth chart with submission

Final adult height has not been reachedFinal adult height not attained

Must be documented on request

Supporting documentation: Submit all required supporting documentation including completed PA form, copies of medical records (diagnostic evaluations and recent chart notes), and the most recent related labsComplete records; provider must retain copies for five years

Incomplete form or missing documentation may be returned or lead to denial

Clinical Thresholds and Coding-related Criteria

inv-05: Growth progression for continuation — >= 2 cm total in one year

Growth progression for continuation>= 2 cm total in one year (growth chart demonstrating progression)

Documentation requiredSubmit growth chart showing >= 2 cm growth in one year for continuation requests

Final adult heightFinal adult height must not have been reached (documented) for continuation

inv-06: Height SDS — <= -3

Height SDS thresholdHeight standard deviation score (SDS) <= -3

Role in diagnosisRequired as part of criteria defining severe primary IGF-1 deficiency

DocumentationMust submit supporting lab work and documentation demonstrating height SDS

inv-07: Basal IGF-1 SDS — <= -3

Basal IGF-1 SDS thresholdBasal IGF-1 standard deviation score (SDS) <= -3

Role in diagnosisRequired as part of criteria defining severe primary IGF-1 deficiency

DocumentationSubmit supporting laboratory results showing basal IGF-1 SDS

inv-08: GH stimulation test threshold — > 10 ng/mL (normal or elevated GH)

GH stimulation test threshold> 10 ng/mL on standard GH stimulation tests (normal or elevated GH)

InterpretationNormal or elevated GH on stimulation testing is required to distinguish primary IGF-1 deficiency

DocumentationSubmit results of standard GH stimulation testing showing GH > 10 ng/mL

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for both initiation and continuation of therapy. Submit a completed PA form and all supporting documentation to avoid delays.

Submit completed PA form
Fax to designated PA fax or portal as specified by payer

Note

Pre-initiation Checks

Verify and correct other causes of growth failure before initiating therapy. Ensure patient is older than two years with open epiphyses and is under the care of an endocrinologist (or the prescriber is an endocrinologist).

Confirm open epiphyses and age > 2 years
Confirm ongoing endocrinology care or prescriber specialty
Correct thyroid and nutritional deficiencies and address chronic steroid use prior to initiation

Documentation Required

Required Documentation

Include the following with the PA submission: completed PA form, copies of medical records (diagnostic evaluations and recent chart notes), most recent related labs, and growth chart documentation showing progression (e.g., ≥2 cm in 1 year for continuation). Retain copies of documentation for five years.

Completed PA form
Medical records: diagnostic evaluations and recent chart notes
Most recent related labs
Growth chart demonstrating growth progression (for continuation requests)
Documentation of diagnoses and supporting lab work

Denial Risk

Incomplete Submission Risk

Incomplete or missing documentation may result in the PA form being returned, delays, or denial of the request. Ensure all fields on the form are completed (including patient identifiers, prescriber NPI, and signatures) and include all supporting labs and notes.

Include patient Medicaid/ID, DOB, patient name, prescriber name, NPI, phone, fax, and signature
Omit no required supporting labs or chart notes
Incomplete submissions may be returned or denied

Background on Increlex (mecasermin)

Increlex (mecasermin) is indicated for pediatric patients with severe primary insulin‑like growth factor‑1 (IGF‑1) deficiency and for patients with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone. The PA form used by Florida Medicaid captures the diagnostic thresholds and treatment prerequisites required to support medical necessity, including confirmation of age (>2 years with open epiphyses), specialist (endocrinology) care, documentation of diagnostic labs, and verification that correctable causes of growth failure have been addressed. Providers must submit supporting records and recent labs with the completed form for review.

Key Definitions

inv-14: Definition of severe primary IGF-1 deficiency — Height SDS <= -3 and basal IGF-1 SDS <= -3 with normal/elevated GH on stimulation testing

DefinitionSevere primary IGF-1 deficiency defined by: Height SDS <= -3 AND Basal IGF-1 SDS <= -3 with normal or elevated GH on stimulation testing (GH > 10 ng/mL)

PurposeUsed to determine eligibility for Increlex (mecasermin) therapy

Required evidenceSupporting lab work and documentation (height SDS, basal IGF-1 SDS, and GH stimulation test results) must be submitted