By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (asfotase alfa) Covered by Aetna CVS Health in North Carolina: Appeals Guide & Templates

Answer Box: Getting Strensiq Covered by Aetna CVS Health in North Carolina

Aetna CVS Health covers Strensiq (asfotase alfa) for pediatric-onset hypophosphatasia with prior authorization. Key requirements: ALPL gene mutation OR low alkaline phosphatase plus elevated substrates, proof of onset before age 18, and specialist prescription. If denied, you have 180 days to appeal internally, then 120 days for North Carolina's external review through Smart NC.

Your next step: Contact your prescriber to ensure complete documentation (genetic testing, lab results, radiographs) is submitted with the prior authorization request.

Table of Contents

Understanding Aetna's Strensiq Coverage

Strensiq (asfotase alfa) is the only FDA-approved enzyme replacement therapy for hypophosphatasia (HPP), a rare genetic bone disease. With annual costs potentially reaching $4.9 million for infants, Aetna CVS Health requires strict prior authorization before coverage.

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed
Diagnosis Perinatal/infantile or juvenile-onset HPP Clinical signs, symptoms onset before age 18
Genetic Evidence ALPL gene mutation OR biochemical proof Genetic test results OR low ALP + elevated substrates
Prescriber Specialist involvement required Geneticist, endocrinologist, or metabolic specialist
Dosing Limits Max 9 mg/kg/week (infantile) or 6 mg/kg/week (juvenile) FDA labeling compliance
Radiographic Evidence Skeletal abnormalities consistent with HPP X-rays, bone scans showing mineralization defects

Source: Aetna Medical Policy 0901

Reading Your Denial Letter

Your Aetna denial letter will contain specific reason codes. Here's how to decode the most common ones:

"Experimental/Investigational" - Aetna only covers Strensiq for pediatric-onset HPP. If you're over 18, ensure documentation proves symptoms began before age 18.

"Medical Necessity Not Established" - Missing genetic testing, inadequate lab results, or insufficient clinical documentation.

"Non-Formulary" - Strensiq requires specialty pharmacy dispensing and prior authorization regardless of formulary status.

"Dosing Exceeds Guidelines" - Requested dose above FDA-approved maximums without clinical justification.

Tip: Save your denial letter and note the appeal deadline—typically 180 days from the denial date.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Adult-onset HPP Prove pediatric onset Medical records showing symptoms before age 18
Missing genetic testing Submit ALPL results OR biochemical evidence Gene test OR (low ALP + elevated PLP/PEA + radiographs)
Insufficient specialist involvement Get specialist consultation Letter from geneticist/endocrinologist
Dosing concerns Justify higher doses Clinical response data, growth charts, functional assessments
Incomplete prior authorization Resubmit with all requirements Complete PA form with all supporting documents

First-Level Appeal Process

Step-by-Step: Filing Your Aetna Appeal

  1. Gather Documentation (Patient/Caregiver)
    • Denial letter and member ID
    • Complete medical records
    • Genetic testing results
    • Prescription history
  2. Request Medical Records (Within 1 week)
    • Contact all treating physicians
    • Obtain lab results, imaging, consultation notes
    • Timeline: 3-5 business days
  3. Draft Appeal Letter (Prescriber/Clinic)
    • Use Aetna's official forms
    • Address each denial reason specifically
    • Include medical necessity justification
  4. Submit Appeal (Within 180 days of denial)
    • Providers: Fax to 859-455-8650 or use Availity Portal
    • Members: Fax to 859-425-3379 or mail to PO Box 14463, Lexington, KY 40512
  5. Track Your Appeal (Ongoing)
    • Standard appeals: 45 business days for decision
    • Expedited appeals: 72 hours if urgent
    • Follow up weekly if no response

Medical Necessity Letter Checklist

Your prescriber's letter should include:

  • Diagnosis: HPP with onset before age 18
  • Failed alternatives: Document why supportive care is insufficient
  • Clinical rationale: Reference FDA labeling and treatment guidelines
  • Dosing justification: Explain weight-based calculations
  • Monitoring plan: How response will be measured

Peer-to-Peer Review Strategy

If your written appeal is denied, request a peer-to-peer review where your prescriber speaks directly with Aetna's medical director.

Preparation Checklist

  • Clinical summary: 1-2 pages highlighting key points
  • Guideline references: FDA labeling, specialist society recommendations
  • Patient impact: Functional decline without treatment
  • Response metrics: How you'll measure treatment success

Key Talking Points

  1. Rarity and severity: HPP affects 1 in 100,000 births; untreated infantile HPP has high mortality
  2. No alternatives: Strensiq is the only disease-modifying therapy
  3. Early intervention: Better outcomes when started promptly
  4. Objective measures: Growth velocity, radiographic improvement, functional assessments

North Carolina External Review

If Aetna denies your internal appeals, North Carolina's Smart NC program provides independent review through the Department of Insurance.

External Review Process

Timeline Action Details
Within 120 days File external review request After exhausting internal appeals
45 calendar days Standard review decision Independent Review Organization (IRO)
4 business days Expedited review decision If delay could jeopardize health

How to Request External Review

  1. Contact Smart NC: Call 855-408-1212 for guidance
  2. Complete forms: Available on NCDOI website
  3. Submit documentation: Include all medical records, denial letters, appeal responses
  4. Wait for assignment: IRO assigned on rotating basis
Note: Smart NC's decision is binding on Aetna. If they approve coverage, Aetna must provide it within 3 business days.

Appeal Letter Templates

Template: Medical Necessity Appeal

[Date]
Aetna CVS Health Appeals Department
PO Box 14020
Lexington, KY 40512

RE: Appeal for Prior Authorization Denial
Member: [Name], ID: [Number]
Medication: Strensiq (asfotase alfa)
Denial Date: [Date]

Dear Medical Director,

I am writing to appeal the denial of coverage for Strensiq (asfotase alfa) for my patient with perinatal-onset hypophosphatasia (HPP).

**Patient meets all Aetna coverage criteria:**

1. **Confirmed HPP diagnosis:** [Include genetic testing results or biochemical evidence]
2. **Pediatric onset:** Symptoms documented at [age] months/years
3. **Specialist involvement:** Prescribed by [specialist name and credentials]
4. **Appropriate dosing:** [X] mg/kg/week within FDA guidelines

**Clinical justification:**
[Patient-specific details about severity, failed supportive measures, expected benefits]

**Supporting documentation attached:**
- Genetic testing results
- Laboratory values (low ALP, elevated substrates)
- Radiographic evidence
- Growth charts and functional assessments

This medication is medically necessary and meets all policy requirements. I respectfully request immediate approval.

Sincerely,
[Prescriber name and credentials]

Patient Phone Script

When calling Aetna member services:

"I'm calling about a denied prior authorization for Strensiq for hypophosphatasia. My member ID is [number]. Can you tell me the specific denial reasons and help me understand the appeal process? I'd also like to request a peer-to-peer review with the medical director."

Tracking Your Appeal

Appeal Log Template

Date Action Taken Contact Method Response Next Steps
[Date] Filed appeal Fax 859-455-8650 Confirmation received Wait 45 days
[Date] Follow-up call Member services Under review Call back in 1 week
[Date] Peer-to-peer requested Provider portal Scheduled [date] Prepare talking points

When to Escalate

Contact North Carolina Department of Insurance if:

  • Aetna misses appeal deadlines
  • You suspect procedural violations
  • Need help with external review process

Smart NC Contact: 855-408-1212

When Appeals Fail: Alternative Options

Financial Assistance Programs

  1. Alexion Access Navigator
  2. Foundation Grants
    • National Organization for Rare Disorders (NORD)
    • Patient Access Network Foundation
    • Good Days (formerly Chronic Disease Fund)
  3. State Programs
    • North Carolina Medicaid (if eligible)
    • State pharmaceutical assistance programs

Alternative Coverage Strategies

  • Formulary exception: Request non-formulary drug coverage
  • Step therapy override: If other treatments failed
  • Site of care appeal: If requiring specific administration location

At Counterforce Health, we help patients and clinicians turn insurance denials into successful appeals by creating targeted, evidence-backed rebuttals. Our platform analyzes denial letters and drafts point-by-point appeals aligned with each plan's specific requirements, significantly improving approval rates for complex specialty medications like Strensiq.

FAQ

How long does Aetna prior authorization take for Strensiq in North Carolina? Standard prior authorization decisions take 15 business days. Expedited requests (urgent medical need) are processed within 72 hours.

What if Strensiq is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. Aetna must cover non-formulary drugs when medically necessary and no suitable alternatives exist.

Can I request expedited appeals for Strensiq? Yes, if delay in treatment could seriously jeopardize your health. Include physician attestation of urgency with your appeal.

Does step therapy apply to Strensiq? No traditional step therapy exists since Strensiq is the only approved HPP treatment. However, document any supportive care attempts.

What happens if I move from another state to North Carolina? Previous treatment history and documentation remain valid. Ensure continuity by transferring all medical records to your new North Carolina providers.

How much does Strensiq cost without insurance? Approximately $10,000 per vial, with annual costs potentially exceeding $1 million depending on weight and dosing frequency.

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 decisions. Coverage policies and procedures may change; verify current requirements with Counterforce Health or your insurance carrier.

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