By Counterforce Health Team in Increlex (mecasermin) —

How to Get Increlex (mecasermin) Covered by Aetna (CVS Health) in California: Timeline, Requirements & Appeal Process

Quick Answer: Getting Increlex Approved by Aetna in California

Aetna (CVS Health) requires strict prior authorization for Increlex (mecasermin) with specific lab values and diagnostic criteria. Your child must have severe primary IGF-1 deficiency with height ≤3 SD below normal, IGF-1 levels ≤3 SD below normal, and normal growth hormone (≥10 ng/ml). The fastest path: gather all required documentation upfront, submit through your pediatric endocrinologist, and request expedited review if medically urgent. California residents have strong appeal rights through Independent Medical Review (IMR) with 50-68% success rates for specialty drugs.

First step today: Contact your pediatric endocrinologist to order IGF-1 labs, growth hormone stimulation testing, and bone age X-rays if not already completed.

Table of Contents

What Affects Approval Timing

Several factors determine how quickly Aetna (CVS Health) processes your Increlex prior authorization in California:

Benefit Type & Plan Structure

  • CVS Caremark specialty pharmacy handles most Increlex requests
  • Commercial plans: 72-hour standard review, 24-hour expedited
  • Medicaid plans: Similar timelines but may require additional state-specific documentation

Complexity of Criteria Aetna's prior authorization criteria for Increlex are highly specific. Your child must meet ALL requirements:

  • Severe primary IGF-1 deficiency diagnosis
  • Height at least 3 standard deviations below normal (SDS ≤ -3.0)
  • IGF-1 level at least 3 SD below normal (SDS ≤ -3.0)
  • Normal growth hormone (peak ≥10 ng/ml on stimulation test)
  • Open epiphyses confirmed by X-ray
  • Age 2 years or older
  • Prescription by pediatric endocrinologist

Documentation Completeness Missing any required element triggers an information request, adding 1-7 days to the process.

Pre-Submission Preparation (0-2 days)

Essential Documentation Checklist

Clinical Records:

  • IGF-1 levels with standard deviation scores
  • Growth hormone stimulation test results (peak ≥10 ng/ml)
  • Height measurements with standard deviation calculations
  • Bone age X-ray confirming open epiphyses
  • Complete medical history ruling out secondary causes

Prescriber Requirements:

  • Prescription from pediatric endocrinologist
  • Medical necessity letter addressing all Aetna criteria
  • Hypoglycemia monitoring plan (required for safety)
  • Dosing schedule (starting 0.04-0.08 mg/kg twice daily)
Tip: Use Aetna's medical exception form to ensure all required fields are completed.

Verification Steps

  1. Confirm your child's Aetna plan covers specialty medications through CVS Caremark
  2. Verify the prescribing physician is a pediatric endocrinologist
  3. Double-check all lab values meet the ≤3 SD threshold requirements

Submission to Initial Review (1-5 days)

California State Requirements

Under California law, CVS Caremark must process urgent prior authorizations within one business day. If they don't respond within this timeframe, the request is automatically approved.

Submission Methods:

  • Fastest: Aetna provider portal (Availity)
  • Phone: 1-866-814-5506 (Specialty)
  • Fax: 1-866-249-6155
  • Mail: Medical Exception to Pharmacy Prior Authorization Unit, 1300 East Campbell Road, Richardson, TX 75081

What Reviewers Check First

  1. Diagnosis verification - Primary vs. secondary IGF-1 deficiency
  2. Lab values - IGF-1 and GH levels with proper documentation
  3. Growth measurements - Height standard deviations
  4. Safety plan - Hypoglycemia monitoring protocol
  5. Prescriber credentials - Pediatric endocrinology specialty

Additional Information Requests (1-7 days)

If Aetna requests additional information, respond immediately to avoid delays. Common requests include:

Missing Lab Results

  • IGF-1 binding protein levels
  • Additional growth hormone stimulation tests
  • Thyroid function tests to rule out secondary causes

Inadequate Safety Documentation

  • Detailed hypoglycemia monitoring plan
  • Patient/caregiver education documentation
  • Meal timing protocols (Increlex must be given within 20 minutes of eating)

How to Respond Quickly:

  1. Contact your endocrinologist's office immediately
  2. Submit all requested documents within 24-48 hours
  3. Follow up by phone to confirm receipt
Note: Each information request resets the review clock, so completeness on first submission is crucial.

Decision Window & Outcomes

Typical Approval Timeline

  • Standard review: 72 hours from complete submission
  • Expedited review: 24 hours for urgent medical necessity
  • Automatic approval: If Aetna doesn't respond within required timeframes

Reading Approval Letters

Approved requests will specify:

  • Covered dosage range (typically 0.04-0.12 mg/kg twice daily)
  • Duration of approval (usually 12 months)
  • Pharmacy restrictions (CVS Specialty)
  • Required monitoring parameters

Common Partial Approvals

Aetna may approve Increlex with conditions such as:

  • Lower initial dose requiring titration documentation
  • Shortened approval period (6 months instead of 12)
  • Enhanced monitoring requirements

If Denied: California Appeal Process

California residents have exceptionally strong appeal rights with high success rates for specialty drug denials.

Step 1: Internal Appeal with Aetna

Timeline: Must file within 180 days of denial Process: Submit additional clinical evidence addressing denial reasons Expected response: 15 days (standard) or 72 hours (expedited)

Step 2: California Independent Medical Review (IMR)

If Aetna upholds the denial, California's IMR process offers binding external review.

Success Rates: 50-68% of specialty drug appeals are overturned through California IMR Timeline:

  • Standard IMR: 45 days maximum
  • Expedited IMR: 72 hours for urgent cases Cost: Free to patients Process: Independent physician experts review your case

How to File IMR:

  1. Call DMHC Help Center: 1-888-466-2219
  2. Complete online application at healthhelp.ca.gov
  3. Submit all medical records and denial letters
From our advocates: "We've seen many Increlex denials overturned at the California IMR level when families provided comprehensive growth charts showing the child's declining growth velocity and detailed documentation of the primary IGF-1 deficiency diagnosis. The key is demonstrating that this isn't secondary to malnutrition or other treatable causes."

Appeal Documentation Strategy

For Internal Appeals:

  • Address each specific denial reason point-by-point
  • Include peer-reviewed studies supporting IGF-1 therapy
  • Provide updated growth measurements showing continued need

For California IMR:

  • Submit complete medical timeline
  • Include photos showing physical manifestations of growth delay
  • Provide school records documenting functional impacts

Renewal Cycles & Reauthorization

Increlex requires annual reauthorization with specific documentation:

Required for Renewal:

  • Growth velocity ≥2 cm/year (or documented clinical reasons for slower growth)
  • Continued open epiphyses (X-ray confirmation)
  • Ongoing safety monitoring records
  • Treatment adherence documentation

Timing Strategy: Submit renewal requests 30-45 days before expiration to avoid treatment gaps.

What Speeds Renewals:

  • Consistent growth response documentation
  • No safety issues or hospitalizations
  • Stable dosing without frequent adjustments

Timeline Visual & Milestones

Milestone Timeline Key Actions Expected Outcome
Pre-submission 0-2 days Gather all documentation Complete application ready
Initial submission Day 1 Submit via portal/fax Confirmation received
Under review Days 2-3 Aetna clinical review Approval or info request
Info request response Days 4-6 Submit additional docs Review continues
Final decision Days 7-10 Approval/denial issued Coverage begins or appeal
Appeal (if needed) Days 11-25 Internal appeal process Reversal or IMR referral
California IMR Days 26-70 External review Binding decision

Time-Saving Tips

Portal Usage

  • Use Aetna's Availity portal for fastest submission
  • Upload all documents in single session
  • Request confirmation receipt immediately

Bundled Evidence Strategy

  • Submit comprehensive documentation package upfront
  • Include "additional supporting information" section
  • Provide more than minimum requirements

Direct Specialty Routing

  • Ensure requests go directly to CVS Caremark specialty team
  • Use specialty-specific phone numbers: 1-866-814-5506
  • Reference "Increlex mecasermin specialty prior authorization"

Expedited Processing

  • Document medical urgency clearly
  • Use phrases like "failure to thrive" and "declining growth velocity"
  • Request expedited review in writing

California-Specific Advantages

  • Leverage one-business-day urgent approval requirement
  • Cite California automatic approval rules if deadlines missed
  • Prepare for IMR from the beginning with comprehensive records

Counterforce Health: Streamlining Your Appeal Process

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals that align with Aetna's specific requirements. For complex cases like Increlex, where multiple clinical criteria must be met, having professional appeal assistance can significantly improve approval odds while reducing the administrative burden on families and clinicians.

Frequently Asked Questions

How long does Aetna prior authorization take for Increlex in California? Standard review takes 72 hours, expedited review 24 hours. California law requires one-business-day response for urgent requests, with automatic approval if deadlines are missed.

What if Increlex is non-formulary on my Aetna plan? You can request a formulary exception with medical necessity documentation. California members have strong override rights for medically necessary non-formulary drugs.

Can I request an expedited appeal for Increlex? Yes, if treatment delay could worsen your child's condition. Document declining growth velocity and functional impacts to support expedited processing.

Does step therapy apply to Increlex? Aetna may require trial of growth hormone therapy first, but this can be overridden if your child has primary IGF-1 deficiency with normal GH levels.

What happens if my child turns 18 during treatment? Coverage typically continues if the patient remains on a family plan and meets adult criteria, though transition planning with your endocrinologist is essential.

How much does Increlex cost without insurance? Retail prices average ~$16,000 per 4 mL vial. Ipsen's patient assistance programs may help with costs during the approval process.

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 plan for specific coverage details. For assistance with appeals and coverage issues, contact the California DMHC Help Center at 1-888-466-2219.

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