By Counterforce Health Team in Increlex (mecasermin) —

Getting Increlex (Mecasermin) Covered by Cigna in Washington: Prior Authorization, Appeals & Cost Savings

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

Fastest Path to Approval: Cigna requires prior authorization for Increlex through a pediatric endocrinologist. Your child must be ≥2 years old with severe primary IGF-1 deficiency (height ≤-3.0 SD, IGF-1 below normal range). First step today: Contact your pediatric endocrinologist to initiate the PA request with documented IGF-1 labs and growth measurements. If denied, Washington's external review process provides a binding second opinion within 45 days. Ipsen offers $0 copay assistance for commercially insured patients through their CARES program.

Table of Contents

Understanding Increlex Coverage Requirements

Increlex (mecasermin) is a specialized growth hormone therapy that requires careful documentation and approval from Cigna. The medication costs approximately $16,000 per 4mL vial at retail prices, making insurance coverage essential for most families.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before dispensing Cigna PA Policy
Specialist Requirement Pediatric endocrinologist must prescribe Same policy document
Age Restriction Patient must be ≥2 years old FDA labeling requirements
Height Requirement Height SD score ≤-3.0 Clinical documentation needed
IGF-1 Labs Below normal range for age/gender Laboratory reports required
Approval Duration 1 year initially, then annual reviews Cigna policy guidelines

Medical Necessity Criteria

Cigna covers Increlex specifically for severe primary IGF-1 deficiency when all these conditions are met:

  • Age requirement: Patient is 2 years or older
  • Growth failure: Height standard deviation score of -3.0 or lower
  • Laboratory evidence: IGF-1 levels below the lower limits of normal for the reporting laboratory
  • Growth hormone status: Normal or increased growth hormone levels
  • Specialist oversight: Prescribed by or in consultation with a pediatric endocrinologist
Important: Increlex is NOT covered for growth hormone deficiency, malnutrition, hypothyroidism, or idiopathic short stature. These conditions require different treatments.

Step-by-Step: Fastest Path to Approval

1. Gather Essential Documentation (Patient/Family)

  • Insurance card and member ID
  • Complete medical history of growth concerns
  • Previous growth hormone testing results
  • Any prior treatment attempts and outcomes

2. Schedule Pediatric Endocrinology Consultation (Family)

Contact a pediatric endocrinologist who can evaluate your child and order necessary tests. This specialist consultation is required for Cigna approval.

3. Complete Diagnostic Testing (Clinic)

Your endocrinologist will order:

  • IGF-1 levels (must be below normal range)
  • Growth hormone stimulation tests
  • Comprehensive growth assessment
  • Height and weight measurements with standard deviation calculations

4. Submit Prior Authorization Request (Clinic)

Timeline: 2-3 business days for standard review, 24 hours for expedited Method: Cigna provider portal or fax submission Required documents: Clinical notes, lab results, growth charts, medical necessity letter

5. Monitor Authorization Status (Family/Clinic)

Track the request through Cigna's provider portal or by calling member services. Cigna typically responds within 2-3 business days for standard requests.

6. Coordinate Specialty Pharmacy (Family)

Once approved, Cigna typically requires Increlex to be dispensed through their specialty pharmacy network, often Express Scripts/Accredo.

7. Apply for Patient Assistance (Family)

Enroll in Ipsen CARES program for $0 copay assistance if you have commercial insurance.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documentation Needed
"Not primary IGF-1 deficiency" Provide comprehensive endocrine workup Growth hormone stimulation tests, complete hormone panel
"Missing IGF-1 labs" Submit laboratory results Age-appropriate IGF-1 levels from certified lab
"No specialist involvement" Get pediatric endocrinology consultation Referral and evaluation notes
"Insufficient growth failure" Document severe short stature Growth charts showing height SD ≤-3.0
"Safety concerns not addressed" Provide monitoring plan Hypoglycemia prevention protocol

Clinician Corner: Medical Necessity Letter Checklist

Healthcare providers should include these elements in their authorization requests:

Clinical Documentation:

  • Patient's current height and weight with standard deviation scores
  • IGF-1 laboratory values with reference ranges
  • Growth hormone testing results
  • Previous treatment history and outcomes
  • Contraindications to alternative therapies

Supporting Evidence:

  • FDA labeling for Increlex
  • Pediatric Endocrine Society guidelines on IGF-1 deficiency
  • Published literature on mecasermin efficacy

Appeals Process in Washington

Washington state provides strong consumer protections for insurance denials. If Cigna denies your Increlex request, you have multiple appeal options.

Internal Appeals with Cigna

First-Level Appeal:

  • Deadline: 180 days from denial date
  • Timeline: 30 days for standard, 72 hours for expedited
  • Method: Written appeal with additional clinical documentation
  • Contact: Use number on your Cigna member ID card

Second-Level Appeal:

  • Timeline: 30 days for Cigna's response
  • Review: Independent medical review by external physician
  • Documentation: Include any new clinical evidence or specialist opinions

External Review in Washington

If internal appeals are unsuccessful, Washington law provides access to Independent Review Organizations (IROs).

External Review Process:

  • Eligibility: After completing Cigna's internal appeals
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Cost: Free to the patient
  • Outcome: Binding decision on Cigna
  • Request method: Submit to Washington Insurance Commissioner
Washington Advantage: The state's external review process has helped many families overturn rare disease medication denials. IRO reviewers include specialists familiar with complex pediatric conditions.

Cost-Saving Strategies

Manufacturer Assistance Programs

Ipsen CARES Program:

  • Eligibility: Commercially insured patients
  • Benefit: $0 copay for eligible patients
  • Enrollment: IpsenCares.com or call 1-855-463-5127
  • Income limits: No specific income requirements for copay assistance
Note: Government insurance (Medicaid, Medicare) patients aren't eligible for manufacturer copay cards but may qualify for patient assistance programs.

Foundation Support

Several foundations provide grants for rare disease medications:

  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

Specialty Pharmacy Coordination

Express Scripts/Accredo Benefits:

  • Clinical support and monitoring
  • Coordination with your healthcare team
  • Insurance authorization assistance
  • Home delivery of temperature-controlled medications

Tips for Success:

  • Enroll early in the specialty pharmacy program
  • Maintain regular communication with your clinical coordinator
  • Keep emergency contact information updated

When Coverage is Denied: Your Rights

Washington residents have strong rights when facing insurance denials. The state's Office of the Insurance Commissioner provides free assistance with appeals and complaints.

Your Rights Include:

  • Clear explanation of denial reasons
  • Access to internal and external appeals
  • Expedited review for urgent medical needs
  • Free external review by independent specialists
  • Consumer advocacy support from the state

When to Contact the Insurance Commissioner:

  • Cigna doesn't respond within required timeframes
  • You believe the denial violates state or federal law
  • You need help understanding your appeal rights
  • The external review process isn't working properly

Contact Information:

Helpful Scripts & Templates

Calling Cigna Member Services

"Hi, I'm calling about prior authorization for Increlex, also called mecasermin, for my child [name]. Our member ID is [number]. Can you tell me the current status of our authorization request submitted by Dr. [name] on [date]? If it's been denied, I'd like to understand the specific reasons and start the appeal process."

Requesting Expedited Review

"My child has severe IGF-1 deficiency and needs Increlex urgently. Delaying treatment could seriously affect their growth and development. I'm requesting an expedited review of this prior authorization. What documentation do you need from our pediatric endocrinologist?"

Following Up with Your Doctor's Office

"I wanted to follow up on the Increlex prior authorization you submitted to Cigna. The authorization was [approved/denied/still pending]. If there are any additional documents or information Cigna needs, please let me know so we can provide them quickly."

FAQ

Q: How long does Cigna's prior authorization take for Increlex? A: Standard reviews take 2-3 business days. Expedited reviews (for urgent medical needs) are completed within 24 hours.

Q: What if Increlex isn't on Cigna's formulary? A: You can request a formulary exception through your doctor. The process requires clinical justification for why formulary alternatives aren't appropriate.

Q: Can I appeal if step therapy is required? A: Yes. If Cigna requires you to try other medications first, your doctor can request a step therapy override by documenting why alternative treatments are inappropriate or have already failed.

Q: Does Washington have special protections for rare disease medications? A: Washington's external review process includes specialists familiar with rare diseases. The state also requires clear timelines for insurance decisions and provides free consumer advocacy.

Q: What if my employer plan is self-insured? A: Self-insured plans may not be subject to Washington state appeals laws. Check with your benefits administrator about available appeal options, which may include federal ERISA protections.

Q: How much does Increlex cost without insurance? A: Retail prices are approximately $16,000 per 4mL vial. The Ipsen CARES program may provide assistance for uninsured patients based on financial need.

Q: Can I use mail-order pharmacy for Increlex? A: Increlex typically requires specialty pharmacy dispensing due to storage requirements and clinical monitoring needs. Cigna usually directs patients to Express Scripts/Accredo.

Q: What happens if my child's growth improves on Increlex? A: Cigna requires annual reviews showing continued growth (≥4 cm/year) to maintain authorization. Treatment continues until growth plates close.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to create compelling medical necessity arguments that align with payer requirements. For families facing complex prior authorization challenges like Increlex approval, Counterforce Health provides the expertise needed to navigate insurance barriers and secure coverage for essential medications.

When dealing with Cigna's prior authorization requirements, having the right documentation and understanding Washington's appeals process can make the difference between approval and denial. The combination of strong state consumer protections and manufacturer assistance programs provides multiple pathways to access this critical medication for children with severe IGF-1 deficiency.

If you're still facing coverage challenges after following this guide, Counterforce Health can help create targeted appeals that address specific payer requirements and increase your chances of approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies and state regulations may change. Always consult with your healthcare provider and insurance company for the most current information regarding your specific situation. For assistance with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.

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