By Counterforce Health Team in Strensiq (asfotase alfa) —

The Complete Requirements Checklist to Get Strensiq (Asfotase Alfa) Covered by Blue Cross Blue Shield in Virginia

Answer Box: Your Path to Strensiq Coverage in Virginia

Getting Strensiq (asfotase alfa) covered by Blue Cross Blue Shield in Virginia requires prior authorization with genetic or biochemical confirmation of pediatric-onset hypophosphatasia. The fastest path: have your doctor submit genetic testing (ALPL mutation) or low alkaline phosphatase levels plus elevated substrates, along with clinical evidence of symptoms before age 18. Start today by calling BCBS member services to confirm your plan's specialty pharmacy network and request the current prior authorization form. If denied, Virginia's Bureau of Insurance offers external review within 120 days.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Medical Coding Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Common Pitfalls to Avoid
  10. Virginia Appeals Process
  11. Quick Reference Checklist
  12. FAQ

Who Should Use This Checklist

This guide is designed for patients with confirmed or suspected hypophosphatasia and their healthcare providers seeking Strensiq coverage through Blue Cross Blue Shield plans in Virginia. You'll benefit most if you have:

  • Perinatal, infantile, or juvenile-onset hypophosphatasia symptoms
  • Low alkaline phosphatase levels or confirmed ALPL gene mutations
  • Active BCBS Virginia coverage (including Anthem Blue Cross Blue Shield)
  • A prescribing physician willing to complete prior authorization requirements

Expected Outcome: With complete documentation, most patients with confirmed pediatric-onset HPP receive approval. Insurance denial rates for specialty drugs average 7-12%, with appeal success rates exceeding 80%.

Member & Plan Basics

Coverage Requirements

Active Coverage Verification: Call the member services number on your insurance card to confirm:

  • Your plan covers specialty medications
  • Strensiq is on your plan's formulary (may require prior authorization)
  • Your deductible status and out-of-pocket maximums

Plan Types: Most BCBS Virginia commercial plans require prior authorization for Strensiq. Medicaid and Medicare Advantage plans may have additional requirements.

Note: Anthem Blue Cross Blue Shield Virginia is the largest BCBS plan in the state, covering approximately 43% of the commercial insurance market.

Authorization Requirements

All BCBS plans require prior authorization for Strensiq due to its specialty status and high cost. No step therapy is required since Strensiq is the only FDA-approved treatment for hypophosphatasia.

Clinical Criteria Requirements

Indication and Label Status

Strensiq is FDA-approved for perinatal/infantile-onset and juvenile-onset hypophosphatasia. Adult-onset HPP is not covered unless you can document pediatric-onset symptoms.

Diagnostic Confirmation Requirements

Your doctor must provide one of the following:

Option 1: Genetic Testing

  • Pathogenic ALPL gene mutations confirming hypophosphatasia

Option 2: Biochemical Evidence

  • Low serum alkaline phosphatase (below age/sex normal range)
  • PLUS elevated levels of at least one substrate:
    • Serum pyridoxal 5'-phosphate (PLP)
    • Serum or urinary phosphoethanolamine (PEA)
    • Urinary inorganic pyrophosphate (PPi)

Clinical Manifestations

Documentation must show pediatric-onset disease (symptoms before age 18) through:

  • Clinical signs: Respiratory insufficiency, vitamin B6-responsive seizures, hypotonia, failure to thrive, delayed walking, waddling gait, dental abnormalities, or low-trauma fractures
  • Radiographic evidence: Craniosynostosis, infantile rickets, or non-traumatic fractures

Dosing Requirements

Maximum approved doses:

  • Perinatal/infantile-onset HPP: 9 mg/kg/week
  • Juvenile-onset HPP: 6 mg/kg/week

Administered subcutaneously 3-6 times per week. Higher doses require additional justification.

Medical Coding Requirements

ICD-10 Diagnosis Codes

Primary code: E83.31 (Familial hypophosphatemia) Alternative: E83.39 (Other disorders of phosphorus metabolism)

HCPCS/J-Codes

Strensiq is typically billed using:

  • J3490 (Unclassified drugs) - most common
  • C9399 (Unclassified drugs or biologicals) - hospital use

NDC Codes

Strensiq is available in multiple strengths:

  • 18 mg/0.45 mL: NDC 25682-0010-01
  • 28 mg/0.7 mL: NDC 25682-0013-01
  • 40 mg/mL: NDC 25682-0016-01
  • 80 mg/0.8 mL: NDC 25682-0019-01

Documentation Packet Essentials

Medical Necessity Letter Components

Your prescribing physician should include:

  1. Patient identification: Name, DOB, insurance ID
  2. Diagnosis confirmation: Genetic testing results OR biochemical findings
  3. Clinical manifestations: Pediatric-onset symptoms and/or radiographic findings
  4. Laboratory results: Specific ALP levels and elevated substrate values
  5. Treatment rationale: Why Strensiq is medically necessary
  6. Proposed dosing: Specific mg/kg/week and frequency

Required Attachments

  • Laboratory reports (ALP levels, substrate measurements)
  • Genetic testing results (if available)
  • Radiographic reports showing HPP-related changes
  • Clinical notes documenting pediatric-onset symptoms
  • Growth charts (if applicable for pediatric patients)
Clinician Corner: Include FDA labeling citations and relevant medical literature supporting off-label dosing if requesting above standard doses. Reference the Strensiq prescribing information for approved indications.

Submission Process

Form Requirements

Contact your BCBS Virginia plan to obtain the current prior authorization form. Common submission methods:

  • Online: Through provider portal (confirm current link with your plan)
  • Fax: Submit completed forms to the number provided by your plan
  • Phone: Some plans accept verbal prior authorizations

Required Fields That Cause Rejections

Ensure these fields are complete:

  • Patient insurance ID and group number
  • Prescribing physician NPI number
  • Specific diagnosis code (E83.31 or E83.39)
  • Exact medication name and NDC code
  • Detailed dosing regimen
  • Clinical justification narrative

Timeline Expectations

  • Initial review: 2-5 business days for standard requests
  • Expedited review: 24-72 hours if medically urgent
  • Additional information requests: May extend timeline by 5-10 days

Specialty Pharmacy Routing

Preferred Vendors

Strensiq is available through PANTHERx Rare, the designated specialty pharmacy for this medication. Verify with your BCBS plan if PANTHERx is in-network.

Transfer Steps

  1. Your doctor prescribes Strensiq with prior authorization
  2. Prescription is sent to designated specialty pharmacy
  3. Pharmacy contacts you to coordinate delivery
  4. First dose may require healthcare provider supervision

Shipment Verification

  • Confirm delivery address and preferred delivery times
  • Verify refrigeration requirements are met
  • Check that injection supplies are included

After Submission: What to Expect

Confirmation Numbers

Always request and record:

  • Prior authorization reference number
  • Date of submission
  • Contact information for status updates

Status Check Schedule

  • Day 3: Call to confirm receipt of submission
  • Day 5: Check for any additional information requests
  • Day 10: If no decision, request status update
  • Day 14: Consider escalation if no response

What to Record

Keep detailed records of:

  • All phone calls (date, time, representative name)
  • Reference numbers and case IDs
  • Any additional documentation requests
  • Approval or denial notifications

Common Pitfalls to Avoid

1. Insufficient Diagnostic Documentation

Problem: Submitting without genetic testing or complete biochemical panel Solution: Ensure you have ALPL mutation results OR low ALP plus elevated substrates

2. Adult-Onset Claims

Problem: Requesting coverage for adult-onset HPP Solution: Document symptoms that began before age 18, even if diagnosed later

3. Incomplete Clinical History

Problem: Missing evidence of pediatric-onset manifestations Solution: Include detailed symptom timeline and any childhood medical records

4. Incorrect Dosing Requests

Problem: Requesting doses above approved limits without justification Solution: Start with standard dosing; provide clinical rationale for higher doses

5. Missing Specialty Pharmacy Coordination

Problem: Not confirming in-network specialty pharmacy Solution: Verify PANTHERx or other approved vendors before submission

Virginia Appeals Process

If your initial prior authorization is denied, Virginia provides robust appeal rights through the State Corporation Commission Bureau of Insurance.

Internal Appeals Timeline

  • First level: 30 days to file after denial
  • Second level: If applicable, additional 30 days

External Review Process

Timeline: Must file within 120 days of final internal denial Forms: Complete Form 216-A for external review request Submission:

  • Fax: (804) 371-9915
  • Email: [email protected]
  • Mail: SCC Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218

Decision Timeline:

  • Standard review: 45 days
  • Expedited review: 72 hours (if medically urgent)
Virginia Advantage: Cancer treatment denials can bypass internal appeals and go directly to external review, though this doesn't apply to Strensiq.

Counterforce Health helps patients navigate complex prior authorization and appeal processes by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific requirements, saving time for both patients and clinicians.

State Resources

  • Consumer Services: (877) 310-6560 for guidance on appeal rights
  • Managed Care Ombudsman: Available through same number for HMO/managed care issues
  • Virginia Poverty Law Center: Provides legal assistance for insurance appeals

Quick Reference Checklist

Before You Start

  • Active BCBS Virginia coverage confirmed
  • Insurance card and policy information gathered
  • Prescribing physician identified and willing to complete PA

Clinical Documentation

  • Genetic testing (ALPL mutations) OR biochemical confirmation
  • Low alkaline phosphatase levels documented
  • Elevated substrate levels (PLP, PEA, or PPi) if no genetic testing
  • Clinical evidence of pediatric-onset symptoms
  • Radiographic evidence (if available)

Submission Requirements

  • Current prior authorization form obtained
  • All required fields completed
  • Medical necessity letter written
  • Supporting documentation attached
  • Specialty pharmacy coordination confirmed

After Submission

  • Confirmation number recorded
  • Status check schedule established
  • Appeal deadlines noted (120 days for Virginia external review)

FAQ

How long does BCBS prior authorization take in Virginia? Standard prior authorization requests are typically processed within 2-5 business days. Expedited requests for urgent medical situations are processed within 24-72 hours.

What if Strensiq is non-formulary on my plan? Even if non-formulary, you can request a formulary exception with medical necessity documentation. BCBS plans must provide a pathway for coverage of medically necessary treatments.

Can I request an expedited appeal if denied? Yes, if your doctor certifies that waiting for standard review could seriously jeopardize your health. Virginia processes expedited external reviews within 72 hours.

Does step therapy apply to Strensiq? No, step therapy does not apply because Strensiq is the only FDA-approved treatment for hypophosphatasia.

What if I don't have genetic testing? You can still qualify with biochemical confirmation: low alkaline phosphatase levels plus elevated substrates (PLP, PEA, or PPi), combined with clinical evidence of pediatric-onset HPP.

How much will Strensiq cost with BCBS coverage? Costs vary by plan, but expect specialty tier copays or coinsurance. Annual costs can range from $890,000 to $4.9 million before insurance, making coverage crucial.

What happens if my appeal is denied? After exhausting internal appeals, you can file for external review with Virginia's Bureau of Insurance within 120 days. The independent review organization's decision is binding on your insurer.

Can I use manufacturer assistance programs? Yes, Alexion Access Navigator offers patient support programs that may help with copays and coverage navigation, even with insurance.

This guide is for informational purposes only and does not constitute medical or legal advice. For specific coverage questions, contact your BCBS plan directly. For appeals assistance in Virginia, contact the State Corporation Commission Bureau of Insurance at (877) 310-6560.

Need help with your Strensiq prior authorization or appeal? Counterforce Health specializes in turning insurance denials into successful approvals by drafting evidence-backed appeals tailored to your specific payer's requirements.

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