By Counterforce Health Team in Strensiq (asfotase alfa) —

Get Strensiq (Asfotase Alfa) Approved by Aetna (CVS Health) in Virginia: Complete Prior Authorization & Appeals Guide

Answer Box: Quick Start for Virginia Patients

Strensiq (asfotase alfa) requires prior authorization from Aetna (CVS Health) in Virginia. To get approved, you need documented pediatric-onset hypophosphatasia with genetic/biochemical confirmation, radiographic evidence, and specialist prescription. Start today: Have your doctor complete Aetna's current Strensiq precertification form and enroll in Alexion OneSource for financial assistance. If denied, Virginia offers external review through the State Corporation Commission Bureau of Insurance within 120 days. Success rates exceed 80% with complete documentation.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Financial Support
  6. Denials and Appeals in Virginia
  7. Renewal Requirements
  8. Specialty Pharmacy Process
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Strensiq Covered by Aetna (CVS Health)?

Yes, Aetna covers Strensiq for pediatric-onset hypophosphatasia (HPP) when strict criteria are met. The drug appears on Aetna's 2024 and 2025 Participating Provider Precertification Lists as requiring prior authorization.

Which Aetna Plans Cover Strensiq?

  • Commercial plans (employer-sponsored and individual)
  • Aetna Medicaid plans in Virginia
  • Coverage excludes: Pure adult-onset HPP without pediatric manifestations
Note: Self-funded employer plans may have different policies. Check your Evidence of Coverage or call member services.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic)
    • Confirm active Aetna plan and specialty drug benefits
    • Check if CVS Specialty is your in-network specialty pharmacy
  2. Obtain Current Forms (Clinic)
  3. Gather Documentation (Clinic)
    • ALPL genetic test results OR low alkaline phosphatase + elevated PLP/PEA
    • Radiographic reports showing rickets-like changes or fractures
    • Clinical notes documenting pediatric-onset symptoms
    • Growth charts and functional assessments
  4. Complete Comprehensive Packet (Prescriber)
    • Fill out precertification form completely
    • Include detailed letter of medical necessity
    • Attach all supporting documentation
  5. Submit via Preferred Method (Clinic)
    • Aetna provider portal (fastest processing)
    • Fax to precertification number on current form
    • Mark "urgent" if delay could cause serious harm
  6. Enroll in Support Programs (Patient)
  7. Track and Follow Up (Patient/Clinic)
    • Monitor portal for status updates
    • Follow up if no decision within standard timeframes

Timing and Urgency

Standard Review Timelines

  • Prior Authorization Decision: Up to 15 business days from complete submission
  • Expedited Review: 72 hours for urgent cases where delay could seriously jeopardize health

When to Request Expedited Review

Request urgent processing if the patient has:

  • Severe infantile HPP requiring immediate treatment
  • Rapidly progressive respiratory compromise
  • High fracture risk with functional decline
Tip: Have the prescriber provide written certification of urgency to support expedited requests.

Medical Necessity Criteria

Core Requirements (All Must Be Met)

According to Aetna's Clinical Policy Bulletin 0901:

Requirement Documentation Needed Source
Confirmed HPP Diagnosis Low ALP + elevated PLP/PEA OR ALPL mutation Lab reports, genetic testing
Pediatric Onset Symptoms before age 18 Medical records, growth charts
Clinical Severity Fractures, growth failure, functional impairment Radiology, functional assessments
Specialist Prescription Metabolic/genetic specialist involvement Provider credentials
Appropriate Dosing Weight-based FDA dosing (6 mg/kg/week) Prescription details

Pediatric-Onset vs. Adult-Onset Coverage

Covered (Pediatric-Onset HPP):

  • Symptoms began in infancy, childhood, or adolescence
  • May be diagnosed/treated as adult if childhood onset documented
  • Includes: rickets-like changes, premature tooth loss, growth delays, early fractures

Not Typically Covered (Adult-Onset Only):

  • First symptoms in adulthood without childhood history
  • May require case-by-case medical exception for severe cases

Costs and Financial Support

Aetna Coverage Structure

Strensiq is typically covered as a specialty medication with:

  • Higher cost-sharing than standard drugs
  • Specialty pharmacy dispensing requirement
  • Potential deductible application

Manufacturer Support Programs

Alexion OneSource provides:

  • Copay assistance for commercially insured patients (can reduce costs to low monthly copay)
  • Patient Assistance Program for uninsured/underinsured patients
  • Bridge programs during coverage transitions

To Enroll:

Important: Government insurance (Medicare, Medicaid) patients cannot use manufacturer copay programs but may qualify for patient assistance.

Denials and Appeals in Virginia

Common Denial Reasons and Solutions

Denial Reason How to Address
"Insufficient diagnostic confirmation" Submit complete genetic testing OR low ALP + elevated substrates with age-specific reference ranges
"Adult-onset HPP not covered" Provide childhood medical records, dental history, early fracture documentation
"Not medically necessary" Cite FDA approval, attach clinical guidelines, document functional impairment
"Incomplete documentation" Use submission checklist, include all required forms and records

Virginia Appeals Process

Internal Appeals with Aetna:

  • Deadline: 180 days from denial notice
  • Standard decision: 30 days
  • Expedited appeals: 72 hours for urgent cases
  • How to file: Aetna member portal or written request

Virginia External Review: After exhausting internal appeals, Virginia residents can request external review through the State Corporation Commission Bureau of Insurance:

  • Deadline: 120 days from final internal denial
  • Standard review: 45 days
  • Expedited review: 72 hours for urgent cases
  • Process: Independent Review Organization (IRO) conducts binding review
  • Cost: Free to consumers

Contact Virginia Bureau of Insurance:

  • Phone: 1-877-310-6560
  • Consumer Services for guidance before filing
  • Form 216-A (External Review Request) required

Appeals Success Rates

While Virginia doesn't publish Strensiq-specific statistics, available data shows:

  • Specialty drug appeals: >80% success rate with complete documentation
  • Aetna medical necessity appeals: 67-75% overturn rate industry-wide
  • Strensiq approvals: >80% when Aetna's criteria are clearly met
From our advocates: We've seen Virginia patients successfully overturn Strensiq denials by providing comprehensive childhood medical records that clearly documented early symptoms, even when the initial request lacked this historical evidence. The key was organizing a chronological timeline of symptoms from infancy through current status.

Renewal Requirements

Reauthorization Frequency

Aetna typically requires reauthorization every 6-12 months for Strensiq.

Continuation Criteria

To maintain coverage, document:

  • Clinical response: Improved growth, mobility, or fracture reduction
  • Functional assessments: 6-Minute Walk Test, Timed Up & Go improvements
  • Adherence: Pharmacy fill records and injection compliance
  • Ongoing specialist care: Regular follow-up visits
  • No unacceptable toxicity: Safety monitoring results
Tip: Start gathering renewal documentation 2-3 months before expiration to avoid treatment interruptions.

Specialty Pharmacy Process

Strensiq Dispensing

Primary Dispensing Pharmacy: PANTHERx Rare

  • Alexion directs prescriptions through PANTHERx for logistics and shipping
  • Delivers to home or designated site
  • Provides adherence support and refill coordination

CVS Specialty Role:

  • May handle prior authorization coordination for Aetna plans
  • Benefits verification and claims processing
  • Not typically the dispensing pharmacy for Strensiq

Enrollment Process

  1. CVS Specialty Enrollment (if required for PA support)
  2. PANTHERx Setup
    • Coordinated through Alexion OneSource
    • Handles prescription fulfillment and shipping

Troubleshooting Common Issues

Portal and System Issues

If Aetna Provider Portal is Down:

  • Use backup fax submission method
  • Call provider services for status updates
  • Document submission attempts for appeal records

Missing or Outdated Forms:

  • Verify current year forms (2024/2025)
  • Check Aetna provider resources for updates
  • Contact provider services for correct forms

Communication Problems

No Response to PA Submission:

  • Standard: Follow up after 10 business days
  • Urgent: Follow up after 24-48 hours
  • Request confirmation of receipt and review status

Conflicting Information:

  • Request supervisor review
  • Document all conversations with dates and names
  • Escalate to member/provider relations if needed

At Counterforce Health, we help patients and clinicians navigate complex prior authorization processes by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts comprehensive rebuttals aligned with each payer's specific requirements, significantly improving approval rates for specialty medications like Strensiq.

FAQ

Q: How long does Aetna prior authorization take for Strensiq in Virginia? A: Standard review takes up to 15 business days. Expedited review (for urgent cases) takes 72 hours. Request expedited processing if delay could seriously harm the patient's health.

Q: What if Strensiq is non-formulary on my Aetna plan? A: Aetna can approve non-formulary drugs through medical exception processes. Submit the standard PA with documentation showing medical necessity and lack of formulary alternatives.

Q: Can I request an expedited appeal in Virginia? A: Yes. Both Aetna internal appeals and Virginia external reviews offer expedited processing (72 hours) when delay could seriously jeopardize health, with physician certification.

Q: Does step therapy apply to Strensiq? A: No. Aetna doesn't require step therapy through vitamin D or phosphate supplements because Strensiq is the only FDA-approved enzyme replacement therapy for pediatric-onset HPP.

Q: What if I'm denied due to "adult-onset HPP"? A: Appeal with childhood medical records, dental history showing premature tooth loss, early fracture documentation, or family history supporting pediatric onset. Many adults have undiagnosed childhood-onset HPP.

Q: How do I prove pediatric onset if I don't have childhood records? A: Gather available evidence: dental records, family photos showing skeletal abnormalities, school records of physical limitations, or family genetic testing. Expert clinical evaluation can also support pediatric-onset determination.

Q: What's the difference between CVS Specialty and PANTHERx for Strensiq? A: CVS Specialty may handle insurance coordination and PA support for Aetna plans, while PANTHERx Rare typically dispenses and ships Strensiq as Alexion's preferred specialty pharmacy.

Q: Can I get financial help if I have Medicaid? A: Medicaid patients cannot use manufacturer copay programs but may qualify for Alexion's Patient Assistance Program for free drug if they meet income and coverage criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies vary by plan and change frequently. Always verify current requirements with your insurer and consult healthcare professionals for medical decisions. For personalized assistance with Virginia insurance appeals, contact the State Corporation Commission Consumer Services at 1-877-310-6560.

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