By Counterforce Health Team in Increlex (mecasermin) —

Myths vs. Facts: Getting Increlex (Mecasermin) Covered by Cigna in North Carolina

Answer Box: Getting Increlex (Mecasermin) Covered by Cigna in North Carolina

Cigna requires prior authorization for Increlex (mecasermin) with strict criteria: severe primary IGF-1 deficiency, height ≤-3.0 SDS, normal/elevated growth hormone, and pediatric endocrinologist involvement. If denied, you have 180 days for internal appeals, then can request external review through Smart NC. First step today: Contact your pediatric endocrinologist to ensure all IGF-1 labs, growth hormone testing, and hypoglycemia monitoring plans are documented before submission.

Table of Contents

Why Myths About Rare Disease Coverage Persist

When your child needs Increlex (mecasermin) for severe primary IGF-1 deficiency, you're entering unfamiliar territory. This ultra-rare growth disorder affects fewer than 1 in 100,000 children, and the treatment—recombinant human IGF-1—carries a retail price of approximately $16,000 per 4 mL vial.

In this high-stakes environment, myths spread quickly. Well-meaning parents share outdated information in support groups. Clinic staff may remember old policies that no longer apply. Even some healthcare providers aren't fully current on Cigna's specific requirements for this rare medication.

The result? Families waste precious time pursuing strategies that don't work, while their children wait for treatment. Let's separate fact from fiction so you can navigate Cigna's approval process efficiently.

Myth vs. Fact: Common Misconceptions

Myth 1: "If my pediatric endocrinologist prescribes Increlex, Cigna has to cover it"

Fact: Prescription alone doesn't guarantee coverage. Cigna requires prior authorization with specific documentation proving severe primary IGF-1 deficiency. Your doctor must submit lab results showing IGF-1 levels below normal range for age/sex, height standard deviation score ≤-3.0, and normal or elevated growth hormone levels.

Myth 2: "Growth hormone deficiency and IGF-1 deficiency are the same thing for coverage purposes"

Fact: They're completely different conditions with different treatments. Cigna explicitly excludes patients with growth hormone deficiency from Increlex coverage. If your child has GH deficiency, the appropriate treatment is growth hormone therapy, not Increlex. The coverage policy requires normal or elevated GH levels on stimulation testing.

Myth 3: "Any doctor can prescribe Increlex for my child"

Fact: Cigna requires the prescription to be from, or in consultation with, a pediatric endocrinologist. Family doctors and general pediatricians cannot independently secure approval, even with proper documentation.

Myth 4: "If Cigna denies coverage, there's nothing I can do"

Fact: North Carolina offers robust appeal rights. After exhausting Cigna's internal appeals (typically two levels), you can request external review through Smart NC at no cost. The Independent Review Organization's decision is binding on Cigna.

Myth 5: "I need to pay out-of-pocket while appealing"

Fact: You have options. Ipsen CARES offers a Patient Assistance Program providing Increlex at no cost for eligible families experiencing financial hardship. This can bridge coverage gaps during appeals.

Myth 6: "Cigna will approve any dose the doctor prescribes"

Fact: Cigna has quantity limits. The medication must be dosed appropriately for the child's weight and administered subcutaneously twice daily. Excessive dosing requests may trigger denials.

Myth 7: "Once approved, I don't need to worry about renewal"

Fact: Cigna requires annual renewal documentation showing continued growth response (≥4 cm/year height increase) and that epiphyseal closure hasn't occurred. Without proper renewal submission, coverage stops.

Myth 8: "The hypoglycemia risk doesn't affect coverage decisions"

Fact: Cigna requires a detailed hypoglycemia monitoring and management plan. This includes pre-meal dosing instructions, glucose monitoring protocols, and caregiver education documentation. Missing safety plans can trigger denials.

What Actually Influences Increlex Approval

Understanding Cigna's actual decision-making process helps you submit winning applications from the start.

Required Clinical Documentation

Laboratory Evidence:

  • IGF-1 levels below normal range for age and sex (typically ≤-3.0 SDS)
  • Growth hormone stimulation test showing normal or elevated levels (>10 ng/mL)
  • Height measurements documenting severe short stature (≤-3.0 SDS)

Medical History:

  • Comprehensive growth charts showing consistent growth failure
  • Documentation ruling out secondary causes (malnutrition, hypothyroidism, chronic disease)
  • Prior treatment history and outcomes

Safety Planning:

  • Detailed hypoglycemia monitoring protocol
  • Caregiver education plan
  • Emergency management procedures

Submission Routing

Cigna processes Increlex through their specialty pharmacy network, typically Accredo. The prior authorization flows through Express Scripts' system, with standard review taking 1-5 business days for straightforward cases.

From our advocates: We've seen families succeed by having their pediatric endocrinologist use electronic prior authorization platforms like CoverMyMeds for faster processing. One family's approval came through in 48 hours when all documentation was submitted electronically with complete lab results and a comprehensive safety plan.

Coverage Determination Factors

Cigna's medical reviewers evaluate:

  1. Diagnosis specificity: Primary vs. secondary IGF-1 deficiency
  2. Age appropriateness: Must be ≥2 years old
  3. Growth potential: Open epiphyses confirmed
  4. Safety readiness: Hypoglycemia management plan
  5. Specialist involvement: Pediatric endocrinologist oversight

Avoid These Preventable Mistakes

1. Submitting Incomplete Lab Work

The mistake: Sending prior authorization without recent IGF-1 levels or growth hormone testing results.

The fix: Ensure all labs are current (within 6 months) and include reference ranges. Request copies for your records.

2. Missing the Hypoglycemia Safety Plan

The mistake: Focusing only on diagnosis documentation while overlooking safety requirements.

The fix: Work with your endocrinologist to create a detailed monitoring protocol including glucose checking schedules, meal timing, and emergency procedures.

3. Using the Wrong Prescriber

The mistake: Having your child's pediatrician submit the request without pediatric endocrinology involvement.

The fix: Establish care with a pediatric endocrinologist before submitting. If access is limited, arrange for consultation/co-management.

4. Ignoring Quantity Limits

The mistake: Requesting excessive quantities or unusual dosing schedules.

The fix: Follow FDA-approved dosing guidelines: 0.04-0.08 mg/kg subcutaneously twice daily. Calculate monthly needs based on your child's weight.

5. Waiting Too Long to Appeal

The mistake: Assuming the first denial is final or delaying appeals beyond deadlines.

The fix: Start internal appeals immediately upon denial. Cigna typically allows 180 days for the first level, but don't wait—earlier appeals preserve more options.

Quick Action Plan: Three Steps to Take Today

Step 1: Verify Your Child's Diagnosis Documentation

Call your pediatric endocrinologist's office and confirm they have:

  • Recent IGF-1 levels with laboratory reference ranges
  • Growth hormone stimulation test results
  • Current height and weight measurements
  • Growth charts showing growth failure pattern

Timeline: Complete within 1 week

Step 2: Request Prior Authorization Submission

Ask your doctor to submit the prior authorization through Cigna's system, including:

  • All required lab documentation
  • Medical necessity letter citing Cigna's coverage criteria
  • Hypoglycemia monitoring and management plan
  • Prescription for appropriate dosing

Timeline: Submit within 2 weeks of gathering documentation

Step 3: Prepare for Potential Appeals

While waiting for initial determination:

  • Gather all medical records related to your child's growth disorder
  • Research Counterforce Health's platform for evidence-backed appeal assistance
  • Save Smart NC's contact information: 855-408-1212
  • Apply for Ipsen CARES patient assistance as backup coverage

Timeline: Complete within 1 month

North Carolina Appeals Process

If Cigna denies your initial request, North Carolina provides strong consumer protections through a two-tier system.

Internal Appeals with Cigna

First Level: Submit within 180 days of denial

  • Use Cigna's member portal or call customer service
  • Include additional clinical documentation addressing denial reasons
  • Request peer-to-peer review with pediatric endocrinologist

Second Level: If first appeal fails

  • Automatic right to second internal review
  • Consider requesting expedited review if medically urgent
  • Gather additional evidence or expert opinions

External Review through Smart NC

After exhausting internal appeals, contact Smart NC for independent review:

Eligibility:

  • State-regulated plan (most Cigna plans qualify)
  • Medical necessity dispute
  • Completed internal appeals

Process:

  • Call 855-408-1212 or submit online request
  • Smart NC assigns Independent Review Organization
  • Decision within 45 days (72 hours for urgent cases)
  • IRO decision is binding on Cigna

Cost: Free to consumers

Note: Smart NC staff can help you complete the external review application and gather supporting documentation, though they cannot serve as your official representative.

Resources and Patient Assistance

Manufacturer Support

Ipsen CARES provides comprehensive assistance:

  • Patient Assistance Program (free medication for eligible families)
  • Copay support for insured patients
  • Coverage and reimbursement guidance
  • Educational resources

Contact: 1-866-435-5677 or visit ipsencares.com

Professional Appeal Assistance

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, potentially saving families months of back-and-forth with insurers.

State Resources

Smart NC Consumer Assistance:

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals, consider consulting with qualified patient advocates or legal professionals.

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