By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (Mecasermin) Covered by Aetna CVS Health in Florida: Complete Prior Authorization Guide

Quick Answer: Getting Increlex (Mecasermin) Covered by Aetna CVS Health in Florida

Aetna CVS Health covers Increlex (mecasermin) for Florida children with severe primary IGF-1 deficiency when specific criteria are met. Your pediatric endocrinologist must submit prior authorization showing height ≥3 standard deviations below normal, IGF-1 levels ≥3 SD below normal on two tests, and open growth plates. First step: Gather growth charts, lab results, and schedule an appointment with your endocrinologist to begin the PA process through CVS Specialty Pharmacy. Standard approval takes 30-45 days; expedited decisions available within 72 hours for urgent cases.

Table of Contents

  1. Coverage Basics: Is Increlex Covered?
  2. Prior Authorization Process
  3. Required Documentation and Criteria
  4. Timing and Deadlines
  5. Costs and Copay Information
  6. Common Denial Reasons and Solutions
  7. Appeals Process in Florida
  8. Renewal Requirements
  9. Specialty Pharmacy Requirements
  10. Frequently Asked Questions

Coverage Basics: Is Increlex Covered?

Yes, Aetna covers Increlex (mecasermin) for members with severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to growth hormone. The medication is classified as a specialty drug requiring prior authorization and is dispensed through CVS Specialty Pharmacy for most Aetna plans in Florida.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before first fill Aetna PA Lists
Specialty Tier High copay/coinsurance Plan formulary document
Age Limit Typically 2-18 years FDA prescribing information
Diagnosis Severe primary IGF-1 deficiency ICD-10 E34.3
Prescriber Pediatric endocrinologist Aetna medical policy

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Schedule Appointment (Patient/Family)
    • Contact your pediatric endocrinologist
    • Request growth chart review and IGF-1 testing
    • Timeline: 1-2 weeks for appointment
  2. Complete Required Testing (Clinic)
    • Height/weight measurements with standard deviation calculations
    • IGF-1 levels (minimum 2 tests showing ≥3 SD below normal)
    • Growth hormone stimulation test (peak ≥10 ng/mL)
    • Bone age X-ray to confirm open epiphyses
    • Timeline: 2-3 weeks for results
  3. Gather Documentation (Clinic Staff)
    • Growth charts from birth to present
    • Laboratory results and reports
    • Previous treatment records (if any)
    • Timeline: 1 week
  4. Submit Prior Authorization (Provider)
    • Complete Aetna PA form
    • Submit via provider portal or fax to CVS Caremark Specialty
    • Include all supporting documentation
    • Timeline: Same day submission
  5. CVS Specialty Review (Automated)
    • Initial review for completeness
    • Medical necessity determination
    • Timeline: 30-45 days standard; 72 hours expedited
  6. Approval and Fulfillment (CVS Specialty)
    • Patient enrollment and education
    • Home delivery setup
    • Copay assistance enrollment
    • Timeline: 3-5 days after approval

Required Documentation and Criteria

Medical Necessity Criteria

Aetna requires all of the following conditions for approval:

  • Height: ≥3 standard deviations below the mean for age and gender
  • IGF-1 Levels: ≥3 SD below normal on at least 2 separate tests
  • Growth Plates: Open epiphyses confirmed by bone age X-ray
  • Primary Deficiency: Severe primary IGF-1 deficiency (not secondary to GH deficiency, malnutrition, hypothyroidism, or chronic steroid use)
  • GH Response: Normal growth hormone stimulation test (peak ≥10 ng/mL)
Clinician Corner: Your medical necessity letter should address each criterion point-by-point, include specific lab values with reference ranges, and explain why growth hormone therapy is inappropriate or has failed. Reference the FDA prescribing information and relevant endocrine society guidelines.

Required Documents Checklist

  • Completed PA form from Aetna
  • Growth charts from birth to present with WHO/CDC standard deviations
  • IGF-1 laboratory results (minimum 2 tests, different dates)
  • Growth hormone stimulation test results
  • Bone age X-ray report
  • Thyroid function tests (TSH, T4)
  • Nutritional assessment
  • Medical necessity letter from pediatric endocrinologist
  • Previous treatment records (if applicable)
  • Insurance card copy
  • Patient demographics and contact information

Timing and Deadlines

Standard Timeline

Phase Duration Notes
Documentation gathering 2-4 weeks Depends on test scheduling
PA submission Same day Via portal or fax
Aetna review 30-45 days Standard processing
CVS Specialty setup 3-5 days After approval
First delivery 1-2 days Overnight shipping available

Expedited Processing

For urgent cases where delayed treatment could harm the child's growth potential:

  • Timeline: 72-hour decision
  • Requirements: Physician must document medical urgency
  • Contact: Call Aetna provider services to request expedited review

Costs and Copay Information

Understanding Your Costs

Increlex is typically classified as a Tier 4 or 5 specialty medication, resulting in higher out-of-pocket costs. Your actual cost depends on:

  • Plan deductible: Often $0-$5,000+ for specialty drugs
  • Coinsurance: Usually 20-50% after deductible
  • Maximum out-of-pocket: Annual cap varies by plan
Tip: Call Aetna member services at 1-800-872-3862 with your member ID for an exact cost estimate before starting treatment.

Cost Assistance Options

  1. Manufacturer Support: Contact Ipsen for patient assistance programs
  2. CVS Specialty Discounts: Automatically applied when available
  3. Florida Medicaid: May provide additional coverage for eligible families
  4. Foundation Grants: Organizations like the HealthWell Foundation offer assistance

When you're dealing with insurance coverage for a rare disease treatment like Increlex, the process can feel overwhelming. That's where specialized support becomes invaluable. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, identifies the specific basis for denial, and creates point-by-point rebuttals aligned with the insurer's own policies and medical evidence.

Common Denial Reasons and Solutions

Top Denial Reasons and How to Overturn Them

Denial Reason Solution Strategy Required Documentation
"Not primary IGF-1 deficiency" Provide genetic testing or detailed workup ruling out secondary causes Comprehensive endocrine evaluation, genetic testing results
"Insufficient IGF-1 testing" Submit additional lab results from different dates Minimum 2 IGF-1 tests showing consistent deficiency
"Missing safety plan" Include hypoglycemia monitoring protocol Glucose monitoring plan, caregiver education documentation
"Step therapy not met" Document GH therapy failure or contraindication Previous treatment records, adverse event documentation
"Quantity limits exceeded" Justify dosing based on weight and FDA guidelines Weight-based dosing calculations, prescriber rationale

Appeals Process in Florida

Internal Appeals with Aetna CVS Health

Filing Deadline: 180 days from denial notice

Standard Appeal Process:

  1. Submit written appeal with additional documentation
  2. Request peer-to-peer review with medical director
  3. Include updated clinical information
  4. Timeline: 30 days for decision

Expedited Appeals:

  • When to use: Delay could harm child's growth potential
  • Timeline: 72 hours for decision
  • Contact: Aetna member services

Florida External Review

If Aetna's internal appeal is unsuccessful, Florida law provides external review rights:

Eligibility:

  • Exhausted internal appeals
  • State-regulated plan (not self-funded employer plan)
  • Denial based on medical necessity

How to File:

Timeline:

  • Standard: 45 days
  • Expedited: 72 hours for urgent cases

Outcome: Binding decision; Aetna must comply if approved

Note: For additional support with appeals, Counterforce Health specializes in creating evidence-backed appeal letters that address the specific reasons for denial and provide the documentation insurers require for approval.

Renewal Requirements

Based on industry standards for similar specialty drugs, Increlex reauthorization typically occurs every 6-12 months. While specific Aetna CVS Health renewal timelines weren't available in our research, prepare for renewal by:

Renewal Timeline (General Industry Standard)

  • 6 weeks before expiration: Schedule follow-up appointment
  • 4 weeks before: Complete required lab work
  • 2 weeks before: Submit renewal documentation
  • Decision timeframe: 5-15 business days

Required Renewal Documentation

  • Updated growth charts showing treatment response
  • Current IGF-1 levels
  • Bone age X-ray (confirm open growth plates)
  • Safety monitoring records
  • Physician assessment of continued medical necessity

Specialty Pharmacy Requirements

CVS Specialty Pharmacy

Aetna requires Increlex to be dispensed through CVS Specialty Pharmacy for most plans. Benefits include:

  • Clinical support: Pharmacist consultation and monitoring
  • Home delivery: Overnight shipping with cold-chain management
  • Injection training: For patients and caregivers
  • Copay assistance: Automatic enrollment when available
  • Refill coordination: Proactive prescription management

Contact CVS Specialty: 1-800-237-2767

Frequently Asked Questions

Q: How long does Aetna CVS Health prior authorization take in Florida? A: Standard processing is 30-45 days. Expedited reviews for urgent cases are completed within 72 hours.

Q: What if Increlex is not on my formulary? A: Request a formulary exception with medical necessity documentation. Your doctor must demonstrate why formulary alternatives are inappropriate.

Q: Can I get an expedited appeal if denied? A: Yes, if delayed treatment could harm your child's growth potential. Your doctor must document the medical urgency.

Q: Does step therapy apply if we've tried treatments in another state? A: Previous treatment records from any state should be accepted. Include complete documentation of prior therapies and outcomes.

Q: What happens if we move within Florida? A: Coverage continues as long as you maintain Aetna coverage. Notify CVS Specialty of address changes for delivery.

Q: Are there age limits for coverage? A: Increlex is FDA-approved for children ages 2-18 years. Coverage typically ends when growth plates close.

Q: What if our pediatric endocrinologist leaves the practice? A: You may need a new prior authorization from the new prescriber. Request medical records transfer to maintain continuity.

Q: Can we appeal if Aetna says the treatment is experimental? A: Yes. Increlex has FDA approval for severe primary IGF-1 deficiency. Include FDA labeling and clinical guidelines in your appeal.

From Our Advocates

A family in Tampa successfully appealed an Aetna denial by providing comprehensive genetic testing that clearly differentiated their child's primary IGF-1 deficiency from growth hormone deficiency. The key was working with their endocrinologist to document why standard growth hormone therapy was inappropriate and including peer-reviewed studies supporting mecasermin use for their specific genetic variant. The appeal was approved within two weeks of submission.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Insurance coverage policies change frequently. Always verify current requirements with Aetna CVS Health and consult with your healthcare provider for medical decisions. For assistance with insurance problems in Florida, contact the Department of Financial Services at 1-877-693-5236.

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