By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (Mecasermin) Covered by UnitedHealthcare in Texas: Prior Authorization, Appeals, and Cost Savings

Answer Box: Getting Increlex Covered by UnitedHealthcare in Texas

Increlex (mecasermin) requires prior authorization from UnitedHealthcare and must be dispensed through specific specialty pharmacies (Accredo, BriovaRx, CVS Specialty, or Walgreens Specialty). To get approved:

  1. Submit prior authorization with documented severe primary IGF-1 deficiency diagnosis, growth charts, and lab results
  2. Use designated specialty pharmacy - OptumRx cannot dispense Increlex due to manufacturer restrictions
  3. File internal appeal within 180 days if denied, followed by external review through Texas Department of Insurance if needed

First step today: Contact your pediatric endocrinologist to initiate the prior authorization request through UnitedHealthcare's provider portal.

Table of Contents

  1. Understanding Increlex Coverage Requirements
  2. Prior Authorization Process
  3. Specialty Pharmacy Requirements
  4. Common Denial Reasons and Solutions
  5. Appeals Process in Texas
  6. Cost Reduction Strategies
  7. Medical Necessity Documentation
  8. Timeline and Deadlines
  9. When to Escalate
  10. Frequently Asked Questions

Understanding Increlex Coverage Requirements

Increlex (mecasermin) is a specialty medication for treating severe primary IGF-1 deficiency in pediatric patients. UnitedHealthcare classifies it as a specialty tier drug requiring both prior authorization and dispensing through designated specialty pharmacies.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Clinical review required before coverage UHC provider portal UHC PA Requirements
Specialty Tier Higher copay/coinsurance Member benefits summary Plan documents
Designated Pharmacy Must use Accredo, BriovaRx, CVS Specialty, or Walgreens Specialty Ipsen provider resources Increlex Coding Guide
Age Restriction Pediatric patients 2+ years FDA labeling FDA-approved indication
Diagnosis Requirement Severe primary IGF-1 deficiency Clinical documentation Medical records

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documentation (Patient/Family)
    • Insurance card and policy information
    • Complete medical records showing growth failure
    • Laboratory results confirming IGF-1 deficiency
    • Timeline: Complete before provider submission
  2. Provider Submits PA Request (Pediatric Endocrinologist)
    • Submit via UnitedHealthcare provider portal
    • Include detailed clinical documentation
    • Timeline: UHC responds within 72 hours (24 hours for urgent cases)
    • Source: UHC PA Guidelines
  3. Clinical Review Process (UnitedHealthcare)
    • Medical director reviews against coverage criteria
    • May request additional information
    • Timeline: Decision within regulatory timeframes
  4. Approval or Denial Notification (All Parties)
    • Written notice provided to patient and provider
    • If approved, specialty pharmacy coordinates dispensing
    • If denied, appeal rights included in notice
Tip: Request expedited review if treatment delay would jeopardize the patient's health. UnitedHealthcare must respond to urgent requests within 24 hours.

Specialty Pharmacy Requirements

Critical: Increlex cannot be dispensed through OptumRx or regular retail pharmacies due to manufacturer distribution restrictions.

Approved Specialty Pharmacies for Increlex

  • Accredo Specialty Pharmacy
  • BriovaRx
  • CVS Health Specialty Pharmacy
  • Walgreens Specialty Pharmacy

Why This Matters

Attempting to fill Increlex at any other pharmacy, including OptumRx, will result in claim denial and potential delays in treatment. The manufacturer (Ipsen) maintains a closed distribution network for safety and monitoring purposes.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Not primary IGF-1 deficiency Provide differential diagnosis documentation Lab results, genetic testing, growth hormone stimulation tests
Insufficient growth failure evidence Submit comprehensive growth charts Height velocity data, percentile tracking over time
Missing safety monitoring plan Develop hypoglycemia management protocol Glucose monitoring plan, emergency procedures
Alternative treatments not tried Document contraindications or failures Previous therapy records, adverse event reports

Medical Necessity Criteria

UnitedHealthcare requires documentation that the patient meets FDA-approved indications:

  • Severe primary IGF-1 deficiency (growth failure plus IGF-1 deficiency not secondary to GH deficiency, malnutrition, or other causes)
  • Growth hormone gene deletion with neutralizing antibodies to GH

Appeals Process in Texas

Texas provides strong patient rights for insurance appeals, with specific timelines and escalation options.

Internal Appeals (UnitedHealthcare)

  • Filing deadline: 180 days from denial notice
  • Decision timeline: 30 days for pre-service requests
  • How to file: UnitedHealthcare member portal, phone, or written request
  • Required: Supporting clinical documentation

External Review (Texas Department of Insurance)

If internal appeal is denied, Texas law provides independent external review:

  • Filing deadline: 4 months from final internal denial
  • Decision timeline: 20 days (5 days for urgent cases)
  • Cost: Paid by the insurance company
  • Binding: UnitedHealthcare must comply with favorable decisions
Note: The external review is conducted by an Independent Review Organization (IRO) contracted through the Texas Department of Insurance.

Texas Appeals Resources

  • Texas Department of Insurance Consumer Hotline: 1-800-252-3439
  • Office of Public Insurance Counsel (OPIC): 1-877-611-6742
  • IRO Information Line: 1-866-554-4926

Cost Reduction Strategies

Increlex can cost approximately $16,000 per 4 mL vial, making financial assistance crucial for most families.

Manufacturer Assistance Programs

Ipsen CARES Copay Assistance Program

  • Eligibility: Commercial insurance (not Medicare/Medicaid)
  • Benefit: Up to $12,000 annually in copay assistance
  • Contact: 1-866-435-5677
  • Application: Available at ipsencares.com

Foundation Support

HealthWell Foundation

  • Program: Growth Hormone Deficiency fund (currently closed to new applicants)
  • Eligibility: Up to 500% of Federal Poverty Level
  • Status: Check for reopening alerts

Patient Advocate Foundation Co-Pay Relief

  • Eligibility: Up to 400-500% of Federal Poverty Level
  • Application: copays.org
  • Coverage: May include rare endocrine conditions
From our advocates: "Families often qualify for multiple assistance programs simultaneously. We've seen patients reduce their annual out-of-pocket costs from over $50,000 to under $1,000 by combining manufacturer copay cards with foundation grants and proper insurance tier placement."

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements:

  • Diagnosis: Severe primary IGF-1 deficiency with ICD-10 codes
  • Growth data: Height velocity, growth charts, percentiles
  • Laboratory results: IGF-1 levels, IGFBP-3, growth hormone testing
  • Prior treatments: Growth hormone trials (if applicable) and outcomes
  • Clinical rationale: Why Increlex is medically necessary
  • Safety monitoring: Hypoglycemia prevention and management plan
  • Treatment goals: Expected outcomes and monitoring parameters

Supporting Guidelines:

  • FDA labeling for Increlex (mecasermin)
  • Pediatric Endocrine Society recommendations
  • Growth hormone deficiency management guidelines

Timeline and Deadlines

Key Timeframes in Texas

Prior Authorization:

  • Standard review: 72 hours
  • Urgent review: 24 hours
  • Auto-approval if UHC misses deadline

Appeals Process:

  • Internal appeal filing: 180 days from denial
  • Internal appeal decision: 30 days
  • External review filing: 4 months from final denial
  • External review decision: 20 days (5 days urgent)

Reauthorization:

  • Annual review required
  • Must demonstrate height increase ≥2 cm/year
  • Submit 30 days before current authorization expires

When to Escalate

Contact Texas regulators if:

  • UnitedHealthcare misses response deadlines
  • Denial appears to violate state or federal law
  • Appeals process is not followed properly

Texas Department of Insurance

  • Consumer Protection: 1-800-252-3439
  • File complaint online at TDI website
  • Required documents: denial letters, medical records, correspondence

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to the plan's own rules. For complex cases involving specialty medications like Increlex, Counterforce Health can help families navigate the appeals process with the right clinical evidence and procedural expertise.

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Increlex in Texas? A: Standard requests receive decisions within 72 hours; urgent requests within 24 hours. If UHC misses these deadlines, the request is automatically approved.

Q: What if Increlex is not on my UnitedHealthcare formulary? A: You can request a formulary exception with medical necessity documentation. The prescriber must demonstrate that formulary alternatives would be less effective or cause adverse effects.

Q: Can I request an expedited appeal if my child needs Increlex urgently? A: Yes. Both internal appeals and external reviews can be expedited if delays would jeopardize health. Urgent external reviews are decided within 5 days in Texas.

Q: Does step therapy apply to Increlex? A: Step therapy may require trying growth hormone first if the patient has GH deficiency. However, exceptions are available if GH is contraindicated or has failed.

Q: What happens during reauthorization? A: UnitedHealthcare requires annual reauthorization with evidence of positive response (height increase ≥2 cm/year) and confirmation that treatment goals haven't been achieved.

Q: Can I use OptumRx specialty pharmacy for Increlex? A: No. Increlex is restricted to Accredo, BriovaRx, CVS Specialty, or Walgreens Specialty pharmacies due to manufacturer distribution requirements.

Q: What financial assistance is available for Increlex? A: The Ipsen CARES program offers up to $12,000 annually in copay assistance for commercially insured patients. Foundation grants may also be available through organizations like the Patient Advocate Foundation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider regarding treatment decisions. For additional assistance with insurance appeals, Counterforce Health provides specialized support for complex prescription drug coverage cases.

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