By Counterforce Health Team in Strensiq (asfotase alfa) —

Do You Qualify for Strensiq (asfotase alfa) Coverage by Cigna in Virginia? Decision Tree & Next Steps

Answer Box: Your Path to Strensiq Coverage in Virginia

Yes, Cigna covers Strensiq (asfotase alfa) for perinatal/infantile- and juvenile-onset hypophosphatasia when criteria are met. To qualify, you need confirmed HPP diagnosis (low ALP + ALPL gene mutation OR elevated substrates), pediatric-onset symptoms, and specialist involvement. Start today: Contact your endocrinologist/geneticist to request prior authorization through Cigna's provider portal with complete lab results and medical records. If denied, Virginia's Bureau of Insurance offers external review within 120 days using Form 216-A.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Decision Tree
  3. If "Likely Eligible" - Your Action Plan
  4. If "Possibly Eligible" - Tests to Complete
  5. If "Not Yet Eligible" - Alternative Paths
  6. If Denied - Virginia Appeals Strategy
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Solutions
  9. FAQ: Strensiq Coverage in Virginia
  10. Cost Assistance Programs

How to Use This Guide

This decision tree helps Virginia patients and their clinicians navigate Cigna's Strensiq (asfotase alfa) prior authorization process efficiently. Start with the eligibility questions below, then follow your specific pathway.

Note: Cigna's policy IP0308 (effective 11/1/2024) requires prior authorization for all Strensiq requests and limits coverage to pediatric-onset hypophosphatasia cases.

Eligibility Decision Tree

Step 1: Diagnosis Confirmation

Do you have confirmed hypophosphatasia (HPP)?

✅ YES if you have ONE of these:

  • Pathogenic ALPL gene variants (genetic testing required)
  • Serum alkaline phosphatase below age/sex-adjusted normal range
  • Elevated tissue non-specific ALP substrates (serum pyridoxal 5'-phosphate, urinary phosphoethanolamine)

❌ NO → Complete diagnostic testing first

Step 2: Onset Timing

Did your HPP symptoms begin before age 18?

✅ YES → Continue to Step 3 ❌ NO (adult-onset only) → Cigna typically denies; consider appeal with pediatric symptom documentation

Step 3: Clinical Manifestations

Do you have documented HPP symptoms?

Examples: seizures, fractures, dental loss, respiratory issues, delayed walking, skeletal abnormalities, muscle weakness, vitamin B6-dependent seizures

✅ YES → Continue to Step 4 ❌ NO → Gather medical records documenting symptoms

Step 4: Specialist Involvement

Is your prescription from or with consultation from:

  • Endocrinologist
  • Geneticist
  • Metabolic specialist

✅ YES → LIKELY ELIGIBLE - proceed to action plan ❌ NO → POSSIBLY ELIGIBLE - obtain specialist consultation

If "Likely Eligible" - Your Action Plan

Document Checklist

Before submitting your prior authorization, gather:

Required Document Where to Obtain Timeline
ALPL genetic test results Genetics lab (Prevention Genetics, Invitae, Labcorp) 2-3 weeks
Lab reports (low ALP, elevated substrates) Your physician's office Same day
Medical records proving pediatric-onset symptoms Primary care/specialist records 1-2 weeks
Specialist consultation notes Endocrinologist/geneticist Current visit
Patient weight (within 30 days) Any healthcare visit Same day
Imaging results (if available) Radiology department 1 week

Submission Process

  1. Provider submits PA through Cigna's provider portal
  2. Standard response: 72 hours for routine requests
  3. Urgent response: 24 hours if medically urgent
  4. Plan for delays: 6-8 weeks total if initial submission incomplete
Tip: Contact Alexion OneSource at 844-787-6747 for PA submission support and forms assistance.

If "Possibly Eligible" - Tests to Complete

Missing Genetic Testing

  • Order ALPL sequencing through Prevention Genetics, Blueprint Genetics, or Invitae
  • Timeline: 2-3 weeks for results
  • Coverage: Often covered by insurance for diagnostic confirmation

Insufficient Lab Documentation

  • Request age/sex-adjusted ALP reference ranges from your lab
  • Consider additional substrate testing: serum pyridoxal 5'-phosphate, urinary phosphoethanolamine
  • Retest if levels borderline with proper fasting/timing

Incomplete Specialist Evaluation

  • Schedule consultation with endocrinologist or geneticist
  • Bring all records: family history, prior treatments, imaging
  • Request comprehensive letter addressing Cigna's criteria

If "Not Yet Eligible" - Alternative Paths

Formulary Exception Request

If Strensiq is non-formulary on your specific Cigna plan:

  • Submit exception request with clinical rationale
  • Emphasize: No therapeutic alternatives exist for HPP
  • Include: FDA approval documentation, specialist letter

Step Therapy Override

While Cigna doesn't typically require step therapy for Strensiq:

  • Document supportive care trials (vitamin B6, orthopedic interventions)
  • Emphasize urgency of enzyme replacement therapy
  • Reference: Strensiq as only FDA-approved disease-modifying therapy

If Denied - Virginia Appeals Strategy

Virginia provides robust patient protections through the State Corporation Commission Bureau of Insurance.

Internal Appeals (First Step)

  • Timeline: 180 days from denial notice
  • Submit to: Cigna member services or provider portal
  • Include: Point-by-point rebuttal, additional evidence, specialist letter

Peer-to-Peer Review

  • Request: Medical director discussion with your specialist
  • Talking points: No alternatives exist, FDA-approved indication, irreversible damage risk
  • Outcome: Often resolves denials for rare disease therapies

External Review (Virginia Bureau of Insurance)

From our advocates: "We've seen Virginia external reviews overturn Cigna denials for rare disease therapies when patients include comprehensive genetic testing and specialist documentation. The key is demonstrating that Strensiq meets FDA-approved indications with no therapeutic alternatives."

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all requests Cigna Policy IP0308
Formulary Status Specialty tier, varies by plan Contact Cigna
Age Restriction Pediatric-onset only (symptoms before 18) Cigna Policy IP0308
Specialist Requirement Endocrinologist, geneticist, or metabolic specialist Cigna Policy IP0308
Dosing Limits 6-9 mg/kg/week subcutaneously per FDA label FDA Label
Renewal Period Annual with response documentation Cigna Policy IP0308

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
"Experimental/investigational" Cite FDA approval 2015, pediatric indication FDA label, approval letter
"Not medically necessary" Emphasize no alternatives, irreversible damage Specialist letter, guidelines
"Adult-onset HPP" Document childhood symptoms, family history Pediatric records, genetic counseling
"Insufficient diagnosis proof" Complete genetic testing, adjusted lab ranges ALPL mutation, age-adjusted ALP
"Dosing exceeds guidelines" Justify with weight, response data Patient weight, efficacy monitoring

When dealing with insurance coverage challenges, Counterforce Health helps patients and clinicians turn denials into targeted, evidence-backed appeals by analyzing payer policies and crafting point-by-point rebuttals aligned to each plan's specific requirements.

FAQ: Strensiq Coverage in Virginia

How long does Cigna prior authorization take in Virginia? Standard PA decisions within 72 hours; urgent requests within 24 hours. Allow 6-8 weeks total if resubmission needed.

What if Strensiq is non-formulary on my plan? Submit formulary exception request emphasizing medical necessity and lack of alternatives. Virginia external review available if denied.

Can I request expedited appeal in Virginia? Yes, if delay could jeopardize life/health. Virginia Bureau of Insurance provides 72-hour expedited external review.

Does step therapy apply for Strensiq? Cigna typically doesn't require step therapy as Strensiq is the only FDA-approved HPP therapy, but document any prior supportive care.

What happens if I move to Virginia with existing Strensiq coverage? Contact Cigna immediately to transfer authorization. Virginia's external review protects against coverage disruptions.

How much does Strensiq cost without insurance? Approximately $10,000 per 10mL vial; annual costs can exceed $500,000 depending on weight-based dosing.

Cost Assistance Programs

Manufacturer Support

  • Alexion OneSource: Copay assistance up to program limits for eligible commercial patients
  • Phone: 844-787-6747
  • Eligibility: Commercial insurance, income requirements apply

Foundation Grants

  • PAN Foundation: Up to $14,700 copay assistance, $4,800 premium support
  • NORD: Premium and copay assistance for rare disease patients
  • Eligibility: ≤400% Federal Poverty Level typically

Virginia State Resources

  • Virginia Medicaid: Covers Strensiq for eligible patients
  • FAMIS: Children's coverage program
  • Contact: Virginia Department of Medical Assistance Services

For patients navigating complex prior authorization requirements, Counterforce Health specializes in transforming insurance denials into successful appeals by identifying denial basis and crafting targeted rebuttals using payer-specific policies and clinical evidence.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult your healthcare provider and insurance plan for specific coverage decisions. For official Virginia insurance regulations and appeal rights, contact the Virginia State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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