By Counterforce Health Team in Increlex (mecasermin) —

Work With Your Doctor to Get Increlex (mecasermin) Approved by Aetna (CVS Health) in Illinois: Provider Collaboration Guide

Answer Box: Getting Increlex (mecasermin) Covered by Aetna (CVS Health) in Illinois

Aetna (CVS Health) requires prior authorization for Increlex (mecasermin) in pediatric patients with severe primary IGF-1 deficiency. Success depends on strong provider collaboration: your pediatric endocrinologist must document height ≤3 SD below mean, IGF-1 ≤3 SD below normal, normal growth hormone (≥10 ng/mL), and open growth plates. Submit complete documentation via CVS Caremark Specialty (1-866-814-5506). If denied, you have 180 days for internal appeal, then 4 months for Illinois external review. Start today: Schedule an appointment with your pediatric endocrinologist to review diagnostic criteria and gather required lab results.

Table of Contents

  1. Set Your Goal: Understanding Aetna's Approval Requirements
  2. Visit Preparation: What to Bring Your Doctor
  3. Building Your Evidence Kit
  4. The Medical Necessity Letter Structure
  5. Supporting Peer-to-Peer Reviews
  6. After Your Visit: Documentation and Follow-Up
  7. Respectful Persistence: When to Follow Up
  8. Appeals Process in Illinois
  9. FAQ
  10. Sources & Further Reading

Set Your Goal: Understanding Aetna's Approval Requirements

Aetna (CVS Health) covers Increlex (mecasermin) for children with severe primary IGF-1 deficiency, but the approval process requires precise documentation and strong provider advocacy. Here's what you're working toward together:

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all patients CVS Caremark Specialty Aetna Policy
Age Requirement ≥2 years, <18 years with open growth plates Growth charts, bone age X-ray FDA Label
Height Criteria ≤3 SD below mean for age/gender WHO growth charts Aetna Policy
IGF-1 Level ≤3 SD below normal (2+ occasions) Lab results Aetna Policy
Growth Hormone Normal peak ≥10 ng/mL on stimulation GH stimulation test Aetna Policy
Prescriber Pediatric endocrinologist Board certification Aetna Policy

Your partnership with your pediatric endocrinologist is crucial because Aetna requires specialist-level documentation that demonstrates your child meets very specific diagnostic criteria for severe primary IGF-1 deficiency.

Visit Preparation: What to Bring Your Doctor

Come prepared with a comprehensive timeline that helps your doctor build the strongest possible case:

Symptom and Growth Timeline

  • Growth measurements: Bring any growth charts from previous pediatricians, school records, or family documentation
  • Symptom progression: When did you first notice growth concerns? How has this affected daily activities, school performance, or social interactions?
  • Family history: Heights of parents, siblings, and extended family members
  • Treatment attempts: Any previous evaluations, treatments, or referrals related to growth

Previous Medical Records

  • Lab results: Any previous IGF-1, growth hormone, or related endocrine testing
  • Imaging: X-rays, bone age studies, or MRI results
  • Specialist reports: Previous endocrinology, genetics, or growth clinic visits
  • Nutritional assessment: Documentation ruling out malnutrition or other secondary causes
Tip: Request records from previous providers 2-3 weeks before your appointment. Many offices require written requests and processing time.

Building Your Evidence Kit

Your pediatric endocrinologist will need specific documentation to meet Aetna's criteria. Here's what you're working together to gather:

Required Laboratory Evidence

  • IGF-1 levels: Must be ≤3 SD below normal on at least 2 separate occasions
  • IGFBP-3 levels: Supporting evidence of IGF-1 deficiency
  • Growth hormone stimulation test: Peak ≥10 ng/mL to rule out GH deficiency
  • Comprehensive metabolic panel: To exclude other causes of growth failure

Clinical Documentation

  • Growth charts: Demonstrating height ≤3 SD below mean using WHO or CDC charts
  • Bone age X-ray: Confirming open growth plates (required for treatment)
  • Genetic testing: If indicated to rule out specific syndromes
  • Nutritional assessment: Ruling out malnutrition as a secondary cause

Supporting Guidelines and References

Your doctor will reference these in the medical necessity letter:

The Medical Necessity Letter Structure

Clinician Corner: Medical Necessity Letter Checklist

Your pediatric endocrinologist's letter to Aetna should include:

1. Patient Demographics and Diagnosis

  • Age, current height/weight with percentiles
  • Primary diagnosis: Severe primary IGF-1 deficiency (ICD-10: E34.3)
  • Date of diagnosis confirmation

2. Clinical Evidence

  • Height standard deviation score (≤-3.0)
  • IGF-1 levels with reference ranges and dates
  • Growth hormone stimulation test results
  • Bone age and growth plate status

3. Exclusion of Secondary Causes

  • Normal growth hormone secretion documented
  • Nutritional status assessment
  • Absence of chronic diseases affecting growth
  • Genetic testing results if performed

4. Treatment Rationale

  • Expected benefit based on clinical trials
  • Dosing plan (starting 0.04-0.08 mg/kg BID)
  • Monitoring plan for hypoglycemia and other side effects
  • Duration of treatment (until growth plate closure)

5. Safety Monitoring Plan

  • Pre-meal timing requirements
  • Glucose monitoring protocol
  • Regular growth and development assessments
  • Plan for dose adjustments

Supporting Peer-to-Peer Reviews

If Aetna initially denies coverage, your pediatric endocrinologist can request a peer-to-peer review with Aetna's medical director. Here's how you can support this process:

Prepare Your Doctor for Success

  • Offer flexible scheduling: Peer-to-peer calls often happen with short notice
  • Provide a case summary: Help organize key points about your child's case
  • Gather comparison data: Information about failed alternatives or contraindications to growth hormone

Key Points for Peer-to-Peer Discussion

Your doctor will emphasize:

  • Confirmed severe primary IGF-1 deficiency diagnosis
  • Normal growth hormone levels ruling out GH deficiency
  • Potential for meaningful growth improvement
  • Safety monitoring plan in place
  • Alignment with FDA-approved indication

Counterforce Health specializes in helping families and providers navigate these complex prior authorization processes, turning insurance denials into targeted, evidence-backed appeals that align with each payer's specific requirements.

After Your Visit: Documentation and Follow-Up

What to Save

  • Visit summary: Copy of your doctor's notes and assessment
  • Lab orders: Keep copies of all test requisitions
  • Prior authorization submission: Confirmation numbers and submission dates
  • Communication records: Save all portal messages and phone call summaries

Portal Communication Tips

  • Use your patient portal to ask specific questions about test results
  • Request copies of all submitted documentation
  • Ask for updates on prior authorization status
  • Save screenshots of important messages

Respectful Persistence: When to Follow Up

Timeline for Check-ins

  • Week 1: Confirm all documentation was submitted
  • Week 2-3: Check on prior authorization status
  • Week 4+: If no response, escalate through provider office
  • Month 2: Consider peer-to-peer review if initial denial

How to Escalate Politely

  • Start with your doctor's nurse or care coordinator
  • Request specific timelines for next steps
  • Ask about expedited review options if clinically appropriate
  • Document all communications with dates and contact names

Appeals Process in Illinois

If Aetna denies coverage for Increlex, Illinois provides strong patient rights for appeals:

Step-by-Step: Illinois Appeals Process

1. Internal Appeal (Required First Step)

  • Timeline: 180 days from denial to file
  • Process: Submit through Aetna member portal or written request
  • Decision time: 15 business days (standard), 24 hours (expedited)
  • Required: Copy of denial letter, medical records, provider support

2. External Review (After Internal Appeal)

  • Timeline: 4 months from final internal denial
  • Authority: Illinois Department of Insurance
  • Process: Independent physician reviewer
  • Decision time: 45 days (standard), 72 hours (expedited)
  • Cost: Free to patients

Required Forms for External Review

When External Review Applies

  • Medical necessity determinations
  • Experimental/investigational treatment denials
  • Coverage disputes involving medical judgment
  • Specialty drug denials like Increlex
Important: Illinois has a shorter external review deadline (4 months) compared to some other states. Don't delay if you receive a final denial.

FAQ

How long does Aetna (CVS Health) prior authorization take for Increlex in Illinois? Standard decisions typically take 30-45 days from complete submission. Expedited reviews (for urgent cases) are decided within 24-72 hours.

What if Increlex is non-formulary on my plan? You can request a formulary exception with documentation that alternative treatments failed or are contraindicated. Your pediatric endocrinologist must provide clinical justification.

Can I request an expedited appeal if my child is failing to thrive? Yes. If delays would seriously jeopardize your child's health, your doctor can request expedited review at both internal appeal and external review levels.

Does step therapy apply to Increlex in Illinois? Aetna may require documentation that growth hormone therapy is inappropriate (due to normal GH levels) before approving Increlex for primary IGF-1 deficiency.

What costs should I expect if approved? Increlex typically costs around $16,000 per 4mL vial without insurance. With Aetna coverage, your costs depend on your plan's specialty tier copay or coinsurance.

Are there patient assistance programs available? Yes. Ipsen Cares offers patient assistance programs, and organizations like HealthWell Foundation may provide copay assistance for qualifying families.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not replace medical advice from your healthcare provider. Always consult with your pediatric endocrinologist about treatment decisions and work with your insurance company directly for coverage determinations. For assistance with complex appeals, consider consulting with organizations like Counterforce Health that specialize in turning insurance denials into successful, evidence-backed appeals.

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