By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (mecasermin) Covered by Aetna CVS Health in North Carolina: Requirements, Appeals, and Timeline

Answer Box: Getting Increlex Covered by Aetna CVS Health in North Carolina

Aetna CVS Health requires prior authorization for Increlex (mecasermin) in children ages 2-18 with severe primary IGF-1 deficiency. Key requirements: height ≤3 SD below normal, IGF-1 ≤3 SD below normal (confirmed twice), normal GH stimulation test (≥10 ng/mL), and prescription by pediatric endocrinologist. Submit complete documentation via CVS Caremark Specialty (1-866-814-5506) for 72-hour expedited review. If denied, North Carolina residents can appeal through Smart NC within 180 days internally, then external review within 120 days.

First step today: Gather growth charts, IGF-1 lab results, and GH stimulation test results before your endocrinology appointment.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Checklist
  4. Coding & Billing Information
  5. Documentation Packet Requirements
  6. Submission Process
  7. CVS Specialty Pharmacy Enrollment
  8. After Submission: What to Expect
  9. Appeals Process in North Carolina
  10. Common Denial Reasons & Solutions
  11. Costs & Patient Assistance
  12. Frequently Asked Questions

Who Should Use This Guide

This guide is designed for North Carolina families with children diagnosed with severe primary IGF-1 deficiency who need Increlex (mecasermin) coverage through Aetna CVS Health plans. You should use this if:

  • Your child is between 2-18 years old with open growth plates
  • A pediatric endocrinologist has diagnosed severe primary IGF-1 deficiency
  • Your child's height is significantly below normal (≤3 standard deviations)
  • You have an Aetna CVS Health commercial plan regulated by North Carolina

Expected outcome: With complete documentation meeting Aetna's criteria, most prior authorization requests are approved within 72 hours for expedited cases or 30-45 days for standard review.

Member & Plan Basics

Coverage Requirements

  • Active Aetna CVS Health membership with pharmacy benefits through CVS Caremark
  • State-regulated commercial plan (not self-funded employer plans, unless they opt into North Carolina's external review system)
  • Specialty pharmacy benefit that covers injectable medications

Plan Type Verification

Check your Summary of Benefits to confirm:

  • Specialty medications are covered (typically Tier 4 or 5)
  • Prior authorization requirements apply to specialty injectables
  • CVS Specialty Pharmacy is the preferred specialty pharmacy
Tip: Call Aetna member services at 1-800-872-3862 to verify your specific plan covers specialty medications and confirm your deductible status.

Clinical Criteria Checklist

Aetna CVS Health requires all of the following criteria for Increlex approval:

Primary Diagnosis Requirements

  • Severe primary IGF-1 deficiency OR GH gene deletion with neutralizing GH antibodies
  • Age 2-18 years with open growth plates (confirmed by bone age X-ray)
  • Height ≤3 standard deviations below mean for age and gender (WHO growth charts)

Laboratory Evidence

  • IGF-1 levels ≤3 SD below normal for age and gender (confirmed on 2+ separate occasions)
  • Normal GH stimulation test with peak ≥10 ng/mL
  • Exclusion of secondary causes: Normal thyroid function, adequate nutrition, no underlying malignancy

Prescriber Requirements

  • Board-certified pediatric endocrinologist prescription
  • Medical necessity letter addressing all criteria and safety monitoring plan

Coding & Billing Information

Diagnosis Codes (ICD-10)

  • E34.3 - Short stature due to endocrine disorder (primary code for severe primary IGF-1 deficiency)
  • R62.52 - Short stature (child) (supporting code)

Drug Codes

  • HCPCS J-code: J2170 (Injection, mecasermin, 1 mg)
  • NDC: 15054-1040-05 (40 mg per 4 mL vial)
  • Administration: Subcutaneous injection, twice daily

Dosing Information

  • Starting dose: 0.04-0.08 mg/kg subcutaneously twice daily
  • Maximum dose: 0.12 mg/kg twice daily
  • Administration: Before meals to reduce hypoglycemia risk

Documentation Packet Requirements

Medical Necessity Letter Components

Your pediatric endocrinologist's letter must include:

  1. Patient demographics and growth history
  2. Diagnosis confirmation with specific criteria met
  3. Laboratory results (IGF-1 levels, GH stimulation test, thyroid function)
  4. Growth charts demonstrating height ≤3 SD below normal
  5. Treatment rationale referencing FDA labeling and clinical guidelines
  6. Safety monitoring plan including hypoglycemia prevention
  7. Expected outcomes and monitoring schedule

Required Attachments

  • Growth charts (WHO standards preferred)
  • IGF-1 laboratory results (minimum 2 tests)
  • GH stimulation test results
  • Bone age X-ray showing open epiphyses
  • Thyroid function tests
  • Nutritional assessment
  • Prior treatment records (if applicable)

Counterforce Health specializes in helping families and clinicians prepare comprehensive prior authorization packets for complex medications like Increlex. Their platform analyzes denial patterns and creates evidence-backed appeals that address payer-specific requirements, potentially reducing approval timelines and improving success rates.

Submission Process

Primary Submission Route

CVS Caremark Specialty Pharmacy

  • Phone: 1-866-814-5506
  • Online: CVS Caremark provider portal (verify current link)
  • Fax: 1-855-633-7673

Required Forms

  • Aetna prior authorization request form
  • Medical necessity letter from pediatric endocrinologist
  • All supporting documentation listed above

Timeline Expectations

  • Standard review: 30-45 days
  • Expedited review: 72 hours (for urgent cases with declining growth velocity)
  • Incomplete submissions: Additional 10-15 days for document requests
Note: Request expedited review in writing if your child has documented failure to thrive or rapidly declining growth velocity.

CVS Specialty Pharmacy Enrollment

Increlex is distributed through a closed network of specialty pharmacies. Upon prior authorization approval:

Automatic Enrollment Process

  1. CVS Specialty contacts you within 24-48 hours of PA approval
  2. Enrollment verification using your Aetna member ID and prescriber details
  3. Delivery scheduling for temperature-controlled home or clinic delivery
  4. Training provided on injection technique and safety monitoring

What's Included

  • Pre-filled syringes or injection supplies
  • Alcohol swabs and sharps container
  • Patient education materials
  • 24/7 pharmacist support hotline
  • Automatic refill coordination

Contact Information

After Submission: What to Expect

Confirmation Process

  1. Submission confirmation within 24 hours (save confirmation number)
  2. Status updates available through member portal or phone
  3. Decision notification via mail and/or phone call

Status Check Schedule

  • Week 1: Confirm receipt and completeness
  • Week 2-3: Follow up if no status update received
  • Day 30: Escalate if no decision on standard review
  • Day 72: Escalate if no decision on expedited review

Documentation to Keep

  • Prior authorization confirmation number
  • All submission documents (copies)
  • Communication logs with dates and representative names
  • Decision letters (approval or denial)

Appeals Process in North Carolina

North Carolina provides strong consumer protections through the Smart NC program for insurance appeals.

Internal Appeals (Aetna)

Timeline: File within 180 days of denial

  • Standard internal appeal: 30 days for decision
  • Expedited internal appeal: 72 hours for urgent cases
  • Submission: Aetna member portal, mail, or fax to 1-888-267-3277

External Review (Smart NC)

Timeline: File within 120 days of final internal denial

  • Standard external review: 45 days for decision
  • Expedited external review: 72 hours for urgent cases
  • Contact: Smart NC helpline at 1-855-408-1212

External Review Eligibility

  • State-regulated Aetna plan (not self-funded employer plans)
  • Denial based on medical necessity or experimental treatment determination
  • Exhausted internal appeals (or qualified for expedited bypass)
Important: Smart NC's decision is binding on Aetna. If approved, coverage must begin within 3 business days.

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Insufficient IGF-1 documentation Submit multiple lab results showing ≤3 SD below normal At least 2 IGF-1 tests from different dates
Missing GH stimulation test Provide complete test results showing normal GH response GH stimulation test with peak ≥10 ng/mL
Secondary IGF-1 deficiency not ruled out Submit comprehensive workup excluding other causes Thyroid function, nutritional assessment, malignancy screening
Non-formulary status Request formulary exception with medical necessity Letter explaining why alternatives are inappropriate
Age or growth plate concerns Provide bone age X-ray confirming open epiphyses Recent bone age study with radiologist interpretation

Costs & Patient Assistance

Retail Pricing

  • Approximate cost: $16,000 per 4 mL vial (40 mg)
  • Monthly cost: Varies based on weight and dosing (typically 2-4 vials per month)

Patient Assistance Programs

  • Ipsen Cares - Manufacturer copay assistance and patient support
  • HealthWell Foundation - Financial assistance for eligible patients
  • North Carolina pharmaceutical assistance programs - State-specific resources

Insurance Coverage

  • Typical copay with coverage: $50-200 per month (varies by plan)
  • Deductible considerations: May apply before copay assistance

When navigating complex prior authorization requirements and potential denials, Counterforce Health helps families turn insurance denials into successful appeals by identifying specific denial reasons and crafting targeted rebuttals using the insurer's own policies and clinical evidence.

Frequently Asked Questions

Q: How long does Aetna CVS Health prior authorization take for Increlex in North Carolina? A: Standard review takes 30-45 days, while expedited review (for urgent cases) takes 72 hours. Submit complete documentation to avoid delays.

Q: What if Increlex is non-formulary on my Aetna plan? A: Request a formulary exception with medical necessity documentation. Your endocrinologist must explain why formulary alternatives are inappropriate for your child's condition.

Q: Can I request an expedited appeal in North Carolina? A: Yes, both Aetna internal appeals and Smart NC external reviews offer expedited options (72 hours) for urgent medical situations where delays could jeopardize health.

Q: Does step therapy apply to Increlex? A: Aetna may require documentation that growth hormone therapy is inappropriate or has failed before approving Increlex for severe primary IGF-1 deficiency.

Q: What happens if my child outgrows the age limit? A: Increlex is typically discontinued when growth plates close (bone age assessment) or the patient reaches adult height, usually by age 18.

Q: How do I find out if my plan is state-regulated for Smart NC appeals? A: Check your Summary Plan Description or call Aetna member services. Self-funded employer plans may not be eligible unless the employer opted into North Carolina's system.

Q: Can I use a different specialty pharmacy besides CVS? A: Increlex has restricted distribution. With Aetna coverage, CVS Specialty is typically the designated pharmacy, though other approved specialty pharmacies in the network may be available.

Q: What should I do if CVS Specialty delays shipment? A: Contact CVS Specialty immediately at 1-800-237-2767. For urgent situations, ask your endocrinologist to contact Aetna for expedited pharmacy coordination.

Printable Checklist: Before You Start

Insurance Information:

  • Aetna member ID and policy details
  • Confirm specialty pharmacy benefits active
  • Verify deductible status and copay structure

Clinical Documentation:

  • Growth charts showing height ≤3 SD below normal
  • IGF-1 lab results (minimum 2 tests) ≤3 SD below normal
  • GH stimulation test results (peak ≥10 ng/mL)
  • Bone age X-ray confirming open growth plates
  • Thyroid function tests and nutritional assessment

Provider Information:

  • Board-certified pediatric endocrinologist identified
  • Medical necessity letter addressing all Aetna criteria
  • Provider contact information for potential peer-to-peer review

Submission Readiness:

  • CVS Caremark Specialty contact information saved
  • All required forms completed
  • Expedited review justification prepared (if applicable)

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Prior authorization requirements and appeal processes may vary by plan type and can change over time.

Sources & Further Reading

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