By Counterforce Health Team in Increlex (mecasermin) —

UnitedHealthcare's Coverage Criteria for Increlex (Mecasermin) in Georgia: What Counts as "Medically Necessary"?

Answer Box: Getting Increlex Covered by UnitedHealthcare in Georgia

UnitedHealthcare requires prior authorization for Increlex (mecasermin) through OptumRx for pediatric patients with severe primary IGF-1 deficiency. Key criteria: height ≤ -3.0 standard deviation scores, IGF-1 levels ≤ -3.0 SDS, normal/elevated growth hormone levels, and pediatric endocrinologist prescription. If denied, Georgia residents have 60 days to file external review with the Georgia Department of Insurance after exhausting internal appeals.

First step today: Contact your pediatric endocrinologist to gather required labs (IGF-1, growth hormone stimulation test) and submit prior authorization through the UHC Provider Portal with a comprehensive medical necessity letter.

Table of Contents

  1. UnitedHealthcare Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Quantity Limits and Dosing
  5. Required Diagnostics
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Approval
  8. Sample Medical Necessity Narrative
  9. Appeals Process in Georgia
  10. Common Denial Reasons and Solutions
  11. FAQ

UnitedHealthcare Policy Overview

UnitedHealthcare classifies Increlex (mecasermin) as a specialty tier medication requiring mandatory prior authorization across all plan types—HMO, PPO, and Medicare Advantage plans in Georgia. The drug cannot be dispensed through OptumRx directly due to manufacturer restrictions and must be obtained through designated specialty pharmacies.

Note: UnitedHealthcare's 2025-2026 plan documents don't explicitly detail Increlex-specific criteria, so prescribers should verify current requirements via the UHC Provider Portal or by calling provider services.

Plan Types and Coverage

  • Commercial Plans (HMO/PPO): Standard prior authorization through OptumRx
  • Medicare Advantage: Similar PA requirements with potential additional CMS guidelines
  • Exchange Plans: Follow commercial criteria with state-specific protections

Medical Necessity Requirements

Increlex is FDA-approved for treating growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency (Primary IGFD) or growth hormone gene deletion with neutralizing antibodies to GH. It is explicitly not indicated for secondary IGF-1 deficiency caused by growth hormone deficiency, malnutrition, hypothyroidism, or chronic steroid use.

Core Diagnostic Criteria

All of the following must be documented for approval:

Requirement Specific Threshold Documentation Needed
Age ≥ 2 years, < 18 years preferred Birth certificate or medical records
Height ≤ -3.0 standard deviation score (SDS) Growth charts, measurements
IGF-1 Level ≤ -3.0 SDS below mean for age/gender Lab results from certified lab
Growth Hormone Normal or elevated (≥ 10 ng/mL peak) GH stimulation test results
Epiphyses Must be open X-ray confirmation
Prescriber Pediatric endocrinologist Board certification verification

Step Therapy and Exceptions

UnitedHealthcare typically requires a trial of growth hormone therapy before approving Increlex, as GH is considered first-line treatment for most pediatric growth disorders. However, exceptions apply for primary IGF-1 deficiency where growth hormone is ineffective due to receptor or post-receptor defects.

Exception Pathways

  • Medical contraindication to growth hormone therapy
  • Previous failure or inadequate response to GH treatment
  • Confirmed primary IGF-1 deficiency with normal/elevated GH levels
  • Adverse reactions to growth hormone therapy
Tip: Document any previous GH therapy trials with specific outcomes, including growth velocity measurements and adverse events.

Quantity Limits and Dosing

While specific quantity limits aren't detailed in available UnitedHealthcare documents, Increlex dosing follows strict FDA guidelines that can justify appropriate quantities during appeals.

FDA-Approved Dosing

  • Starting dose: 0.04-0.08 mg/kg subcutaneously twice daily
  • Maximum dose: 0.12 mg/kg twice daily
  • Administration: Within 20 minutes before or after meals to prevent hypoglycemia
  • Injection sites: Rotate to prevent lipohypertrophy

Renewal Requirements

  • Annual reauthorization required
  • Must demonstrate ≥ 2 cm/year height velocity for continued coverage
  • Submit renewal requests 30 days before expiration

Required Diagnostics

Comprehensive laboratory and clinical documentation is essential for approval. Missing any component often results in automatic denial.

Laboratory Requirements

Test Timing Acceptable Values Notes
Basal IGF-1 Within 6 months ≤ -3.0 SDS for age/gender Use age-appropriate assay
GH Stimulation Within 12 months Peak ≥ 10 ng/mL Rules out GH deficiency
Thyroid Function Within 6 months Normal TSH, T4 Exclude hypothyroidism
Comprehensive Metabolic Panel Within 3 months Normal glucose, kidney function Safety monitoring

Additional Testing

  • Bone age X-ray confirming open epiphyses
  • Genetic testing if available (GH receptor mutations, IGF-1 gene defects)
  • Growth velocity documentation over 6-12 months

Specialty Pharmacy Requirements

Increlex must be dispensed through UnitedHealthcare's designated specialty pharmacy network, as OptumRx cannot directly dispense this medication due to manufacturer restrictions.

Approved Specialty Pharmacies

  • Accredo Specialty Pharmacy
  • CVS Specialty Pharmacy
  • Walgreens Specialty Pharmacy
  • BriovaRx (in select regions)

Setup Process

  1. Prior authorization approval from UnitedHealthcare
  2. Prescription sent to designated specialty pharmacy
  3. Patient enrollment and benefits verification
  4. Delivery coordination (typically 3-5 business days)
  5. Glucose monitoring supplies coordination

Evidence to Support Approval

Strong clinical documentation significantly improves approval chances. Counterforce Health helps patients and providers compile evidence-based appeals that align with payer requirements and clinical guidelines.

Key Supporting Evidence

  • FDA prescribing information demonstrating on-label use
  • Peer-reviewed studies on primary IGF-1 deficiency outcomes
  • Endocrine Society guidelines on growth hormone disorders
  • Previous therapy documentation showing GH inadequacy
  • Growth velocity data demonstrating treatment need

Clinical Documentation Checklist

  • Detailed medical history and physical examination
  • Growth charts with percentile tracking
  • Previous treatment attempts and outcomes
  • Family history of growth disorders
  • Psychosocial impact assessment
  • Treatment goals and monitoring plan

Sample Medical Necessity Narrative

From our advocates: We've found that appeals with comprehensive diagnostic documentation and clear treatment rationale have significantly higher success rates. One key is addressing each denial reason specifically with clinical evidence rather than generic statements about medical necessity.

Template Structure

"Patient is a [age]-year-old with severe primary IGF-1 deficiency meeting all FDA criteria for Increlex therapy. Height measures [X] cm (≤ -3.0 SDS), with IGF-1 level of [X] ng/mL (≤ -3.0 SDS for age). Growth hormone stimulation testing revealed peak GH of [X] ng/mL, confirming normal GH production and ruling out GH deficiency. Previous growth hormone therapy [if applicable] resulted in [specific outcome]. Bone age X-ray confirms open epiphyses. Patient requires Increlex per FDA labeling for primary IGF-1 deficiency, with careful hypoglycemia monitoring and twice-daily administration with meals."

Appeals Process in Georgia

Georgia residents have robust appeal rights through both UnitedHealthcare's internal process and the state's external review system managed by the Georgia Department of Insurance.

Internal Appeals Timeline

Stage Deadline to File Decision Timeline How to Submit
Standard Internal 180 days from denial 30 calendar days UHC Provider Portal, fax, or mail
Expedited Internal 180 days from denial 72 hours Phone + written follow-up

Georgia External Review Process

If UnitedHealthcare denies your internal appeal, you have 60 days from the final denial letter to request external review through the Georgia Department of Insurance.

Contact Information:

  • Phone: 1-800-656-2298
  • Email: [email protected]
  • Address: 2 Martin Luther King Jr. Dr. SE, Suite 704 West Tower, Atlanta, GA 30334

External Review Benefits

  • No cost to the patient
  • Independent medical review by specialists in the same field
  • Binding decision that UnitedHealthcare must honor
  • 30 business days for standard review (72 hours for urgent cases)

Common Denial Reasons and Solutions

Understanding typical denial reasons helps you prepare stronger initial submissions and targeted appeals.

Denial Reason Solution Strategy Required Documentation
Step therapy not completed Document GH failure/contraindication Previous GH therapy records, adverse events
Insufficient diagnostic criteria Resubmit complete lab panel IGF-1 ≤ -3.0 SDS, GH stimulation results
Missing safety monitoring plan Provide hypoglycemia protocol Meal timing plan, glucose monitoring schedule
Age restrictions Confirm FDA-approved age range Birth certificate, current age verification
Not primary IGF-1 deficiency Rule out secondary causes Thyroid function, nutritional assessment

Appeal Documentation Package

  • Original denial letter with specific reasons
  • Updated medical necessity letter addressing each denial point
  • Complete laboratory results with reference ranges
  • Growth charts and velocity calculations
  • Previous treatment records and outcomes
  • Prescriber's board certification and specialty confirmation

FAQ

How long does UnitedHealthcare prior authorization take in Georgia? Standard prior authorization decisions are typically rendered within 72 hours for non-urgent requests and 24 hours for expedited reviews. If UnitedHealthcare misses these deadlines, the request may be deemed approved in certain states.

What if Increlex is non-formulary on my plan? Non-formulary medications can still be covered through the medical exception process. Submit a prior authorization request with comprehensive medical necessity documentation showing why formulary alternatives are inappropriate.

Can I request an expedited appeal if my child needs immediate treatment? Yes, if delaying treatment poses serious health risks, you can request expedited internal appeals (72-hour decision) and urgent external review (72-hour decision) in Georgia.

Does step therapy apply if we've tried growth hormone therapy in another state? Previous therapy trials from other states should be accepted as meeting step therapy requirements. Include complete documentation of the trial, duration, outcomes, and reasons for discontinuation.

What support is available for families who can't afford Increlex? Ipsen, the manufacturer, offers patient assistance programs. Additionally, organizations like Counterforce Health provide guidance on navigating insurance appeals and accessing financial assistance programs.

How do I find my UnitedHealthcare plan's specific formulary? Log into your UHC member portal or call the customer service number on your insurance card. You can also ask your pharmacy to check formulary status and prior authorization requirements.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for medications like Increlex, ensuring that clinical evidence aligns with payer-specific criteria for optimal approval outcomes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for plan-specific requirements. Coverage policies and appeal processes may vary by plan type and can change. For personalized assistance with appeals, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.