CurrentAvMedPolicy N/A

Increlex (mecasermin) prior authorization

Prior authorization form and clinical criteria for initiation and continuation of Increlex (mecasermin) through AvMed specialty pharmacy, including required documentation, initial and reauthorization durations, and clinical thresholds for approval.

Policy Summary

PayerAvMed

PolicyIncrelex (mecasermin) prior authorization

Policy CodePolicy N/A

Change TypeNo material change reported

Effective Date

Next Review Date

Key ActionPrescriber must sign and clearly print name on the request and provide all required member, prescriber, drug, dosing, diagnosis, weight, and lab information; fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

12Initial authorization duration (months)

12Reauthorization duration (months)

≥2.5 cm/yearRequired growth velocity

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Prior authorization form and clinical criteria for initiation and continuation of Increlex (mecasermin) through AvMed specialty pharmacy, including required documentation, initial and reauthorization durations, and clinical thresholds for approval. Subject: Increlex (mecasermin) prior authorization. Specialty pharmacy note: Medication is provided by Specialty Pharmacy - PropriumRx. Initial authorization duration: 12 months. Reauthorization duration: 12 months.

Initial Authorization (12 months)

All criteria must be met for approval. To support each line checked, documentation (labs, diagnostics, chart notes) must be provided.

Diagnosis is one of: Severe primary insulin-like growth factor-1 (IGF-1) deficiency; Growth hormone gene deletion; or other (specified)
Prescriber must check the applicable diagnosis box and provide ICD code if applicable.
Pre-treatment IGF-1 value is less than or equal to 3 standard deviations below the mean for age and gender≤ 3 standard deviations below mean for age and gender
Provide value, normal range, date.
Pre-treatment GH level: Pre-treatment growth hormone level is normal or elevated
Provide value(s) and date(s).
Neutralizing antibodies if GH gene deletion: For diagnosis of Growth hormone gene deletion: documentation of neutralizing antibodies to GH (Yes/No) and date if applicable
Prescriber must indicate presence/absence and date.
Prescriber signature: Prescriber information and signature provided on form
Form requires handwritten prescriber signature (preprinted stamps not valid).

Prior Authorization

Submit prior authorization form with signature

Fax the completed prior authorization form to 1-305-671-0200. The prescriber must sign and clearly print their name on the request (preprinted stamps are not valid). Ensure all required member, prescriber, drug, dosing, diagnosis, weight, and lab fields are provided and legible to avoid delays.

Fax to 1-305-671-0200
Handwritten prescriber signature and printed name required (preprinted stamps not valid)
All required fields (member, prescriber, drug, dosing, diagnosis, weight, labs) must be provided and legible

Documentation Required

Provide baseline labs and diagnostic documentation

Attach baseline laboratory and diagnostic documentation with the prior authorization request. Missing or incomplete documentation may delay review or result in denial.

Pre-treatment IGF-1 value with normal range and date (≤ 3 standard deviations below mean for age and gender)
Pre-treatment growth hormone level(s) with date(s) (show normal or elevated levels)
Diagnosis documentation (check applicable diagnosis box and provide ICD code if applicable)
Relevant chart notes
Note: Use of samples to initiate therapy does not meet preauthorization criteria

Documentation Required

Provide antibody status if GH gene deletion

If the diagnosis is growth hormone gene deletion, document the presence or absence of neutralizing antibodies to growth hormone and provide the date when applicable.

Document Yes/No for neutralizing antibodies to GH
Provide date of antibody testing if applicable

Reauthorization / Continuation (12 months)

Coverage for continuation requires meeting initial use criteria and documented clinical response.

Initial criteria met: Must meet current initial authorization criteria
Documentation must be provided again.
Evaluation of response demonstrated by growth rate velocityGrowth rate velocity must be ≥ 2.5 cm/year
Yearly reassessment required; coverage for growth promotion ceases when bony epiphyses have closed.
Epiphyseal documentation for ≥16: If 16 years of age or older, provide yearly documentation to confirm epiphyses are not closed
Required to continue coverage in patients ≥16 years.

Documentation Required

Yearly reassessment for reauthorization

For reauthorization, provide documentation demonstrating continued benefit. Yearly reassessment is required and coverage for growth promotion ends when bony epiphyses have closed.

Provide growth rate velocity data (growth rate velocity must be ≥ 2.5 cm/year)
If patient is ≥16 years old, provide yearly documentation confirming epiphyses are not closed
Coverage ends when epiphyses close

Provider Actions & Requirements

Prescriber must sign and clearly print name on the request form; preprinted stamps are not valid. All required member, prescriber, drug, dosing, diagnosis, weight, and lab information must be provided and be legible. The form must include the prescriber signature, prescriber contact information, and complete drug and dosing details. Fax the completed form to 1-305-671-0200.

Billing Rule

Specialty pharmacy dispensing

Medication is dispensed by the specialty pharmacy PropriumRx.

Specialty Pharmacy - PropriumRx

Background & Definitions

This policy is a form-based prior authorization for Increlex (mecasermin) requiring documentation to support diagnoses of severe primary IGF-1 deficiency or growth hormone gene deletion. The form requires pre-treatment IGF-1 and growth hormone values with dates and supporting documentation (labs, diagnostics, chart notes). Use of samples to initiate therapy does not meet preauthorization criteria, and prior therapies will be verified through pharmacy paid claims or submitted chart notes.

Increlex: Brand name for mecasermin used for severe primary IGF-1 deficiency and related indications.

OpenPayer

Increlex (mecasermin) prior authorization

Coverage Summary

Initial Authorization (12 months)

Reauthorization / Continuation (12 months)

Applicable Codes

Provider Actions & Requirements

Background & Definitions

Clinical Evidence

Revision History