By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by UnitedHealthcare in Virginia: Complete Prior Authorization Guide

Answer Box: Getting Strensiq Covered by UnitedHealthcare in Virginia

UnitedHealthcare requires prior authorization for Strensiq (asfotase alfa) with strict medical necessity criteria. You'll need confirmed pediatric-onset hypophosphatasia, low serum alkaline phosphatase levels, genetic testing results, and prescription by an endocrinologist. Submit via the OptumRx Provider Portal or call 1-800-711-4555. If denied, you have 180 days for internal appeals and can request Virginia external review using Form 216-A within 120 days of final denial.

First step today: Verify your plan type and gather diagnostic documentation including ALPL genetic testing and serum ALP lab results below age-appropriate ranges.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Plan Verification
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Management
  6. If You Need More Information
  7. If Your Request Is Denied
  8. Virginia External Review Process
  9. Renewal and Reauthorization
  10. Quick Reference Checklist

What This Guide Covers

This comprehensive guide helps patients with hypophosphatasia (HPP) and their healthcare providers navigate UnitedHealthcare's prior authorization process for Strensiq (asfotase alfa) in Virginia. We'll walk through every step from initial documentation to appeals, including Virginia-specific external review rights.

Who this helps:

  • Patients diagnosed with perinatal, infantile, or juvenile-onset HPP
  • Healthcare providers submitting PA requests
  • Families facing coverage denials
  • Anyone needing to understand Virginia's insurance appeal process

Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset hypophosphatasia, making proper coverage navigation essential for patients who need this life-changing treatment.

Before You Start: Plan Verification

Confirm Your Coverage Type

UnitedHealthcare operates different plan types with varying requirements:

  • Commercial plans: Standard PA process through OptumRx
  • Medicare Advantage: May have additional CMS requirements
  • Medicaid managed care: State-specific formulary considerations
Tip: Call the member services number on your insurance card to confirm whether Strensiq requires medical or pharmacy benefit coverage under your specific plan.

Check Formulary Status

Strensiq is typically classified as a Tier 4 or Specialty Medication under UnitedHealthcare formularies, requiring prior authorization regardless of tier placement. The drug appears on the 2025 Commercial Prescription Drug List with coverage determination based on individual benefit plans.

Verify Provider Network Status

Ensure your prescribing physician (endocrinologist or metabolic bone disease specialist) is in-network with UnitedHealthcare to avoid additional coverage complications.

Gather Required Documentation

UnitedHealthcare's medical necessity criteria for Strensiq require comprehensive documentation:

Diagnostic Requirements

Requirement Documentation Needed Where to Find
HPP Diagnosis Confirmed perinatal/infantile or juvenile-onset with onset before age 18 Medical records, specialist notes
Low Serum ALP Lab results below age- and gender-appropriate ranges Laboratory reports with reference ranges
TNSALP Substrates Elevated serum PLP, serum/urine PEA, or urinary PPi Specialized lab testing
Genetic Testing ALPL mutation analysis (if available) Genetic testing report
Clinical Evidence Craniosynostosis, rickets, fractures, or other HPP features Imaging studies, clinical notes

Prescriber Requirements

  • Specialist prescription: Must be prescribed by an endocrinologist or physician experienced in metabolic bone diseases
  • Dosing documentation: Weight-based calculations not exceeding 6 mg/kg/week for juvenile-onset HPP
  • Treatment plan: Clear monitoring and response assessment strategy

Prior Therapy Documentation

While Strensiq has no direct alternatives for HPP, document any supportive treatments attempted and their outcomes, including:

  • Vitamin D supplementation
  • Calcium management
  • Physical therapy interventions
  • Pain management approaches

Submit Your Prior Authorization Request

  1. Access the OptumRx Provider Portal at uhcprovider.com
  2. Navigate to Prior Authorization section
  3. Complete the electronic PA form with all required fields
  4. Upload supporting documents as PDF attachments
  5. Submit and note confirmation number

Phone Submission

Call the OptumRx Prior Authorization line: 1-800-711-4555

  • Have patient information, prescriber details, and clinical summary ready
  • Request expedited review if clinically urgent
  • Document reference number and follow-up timeline

Required Documentation Package

Essential attachments:

  • Completed PA form with prescriber signature
  • Laboratory reports (serum ALP, TNSALP substrates)
  • Genetic testing results (if available)
  • Medical records documenting HPP diagnosis and severity
  • Prescriber attestation of medical necessity
  • Patient weight and dosing calculations
Note: Incomplete submissions are the most common cause of PA delays. Double-check all required fields and attachments before submitting.

Follow-Up and Timeline Management

Standard Processing Times

  • Initial determination: 15 business days for non-urgent requests
  • Expedited review: 72 hours for urgent medical situations
  • Additional information requests: 14 days to respond

Proactive Follow-Up Strategy

Week 1: Confirm receipt and completeness of submission Week 2: Check processing status and address any outstanding requests Week 3: If no decision, escalate to supervisor and document delays

Sample Follow-Up Script

"I'm calling to check the status of prior authorization request #[reference number] for Strensiq for patient [name], DOB [date]. The request was submitted on [date]. Can you provide a status update and expected decision timeline?"

If You Need More Information

UnitedHealthcare may request additional clinical information to support medical necessity:

Common Information Requests

Clinical progression documentation:

  • Growth charts showing failure to thrive
  • Radiographic evidence of worsening bone disease
  • Functional assessment scores
  • Quality of life impact measures

Treatment rationale:

  • Explanation of why supportive care is insufficient
  • Expected treatment outcomes and monitoring plan
  • Literature supporting Strensiq efficacy in similar cases

Clinician Corner: Medical Necessity Letter

Essential elements for a strong medical necessity letter:

  1. Patient background: Age, weight, HPP subtype, age of onset
  2. Diagnostic evidence: Specific lab values, genetic results, imaging findings
  3. Disease progression: Clinical deterioration despite supportive care
  4. Treatment rationale: Why Strensiq is medically necessary now
  5. Monitoring plan: How treatment response will be assessed
  6. Literature support: FDA labeling, clinical guidelines, peer-reviewed studies
From our advocates: "We've seen the strongest approvals when providers include specific alkaline phosphatase values compared to age-normal ranges, genetic testing results with pathogenic variant classification, and clear documentation of functional decline. The key is painting a complete clinical picture that demonstrates both diagnosis certainty and treatment urgency."

If Your Request Is Denied

Understanding Denial Reasons

Common Denial Code Meaning How to Address
Experimental/Investigational Plan considers treatment unproven Provide FDA approval documentation, clinical guidelines
Not Medically Necessary Insufficient clinical justification Submit additional clinical evidence, specialist letter
Step Therapy Required Must try alternatives first Request step therapy exception with contraindication documentation
Dosing Exceeds Guidelines Requested dose above formulary limits Provide clinical rationale for specific dosing needs

Internal Appeals Process

First-Level Appeal (within 180 days of denial):

  1. Submit written appeal with additional clinical evidence
  2. Include peer-reviewed literature supporting Strensiq use in HPP
  3. Request peer-to-peer review with plan medical director
  4. Document all communications with reference numbers and dates

Expedited Appeals: Available when treatment delay could seriously jeopardize health. Decisions within 72 hours for urgent cases.

Peer-to-Peer Review Strategy

Preparation checklist:

  • Review patient's complete medical history
  • Prepare specific clinical examples and lab values
  • Have FDA labeling and treatment guidelines readily available
  • Document functional decline and expected treatment benefits

Virginia External Review Process

If UnitedHealthcare upholds their denial after internal appeals, Virginia residents have strong external review rights through the State Corporation Commission Bureau of Insurance.

Eligibility and Timeline

  • Deadline: 120 days from final internal denial
  • Required: Must exhaust internal appeals (except for cancer treatment)
  • Cost: No fee for external review in Virginia

How to File External Review

Submit Form 216-A to:

  • Mail: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
  • Fax: (804) 371-9915
  • Email: [email protected]

Required documents:

  • Completed Form 216-A (External Review Request)
  • Copy of final denial notice from UnitedHealthcare
  • All medical records and supporting documentation
  • Authorized representative form (if filing on behalf of patient)

Virginia External Review Timeline

Review Type Decision Timeline When Available
Standard 45 days All eligible cases
Expedited 72 hours Life/health endangering delays
Cancer Treatment 6 business days Experimental/investigational denials

Expedited Review Process

If treatment delay could seriously jeopardize life or health, submit Form 216-C with physician certification. Virginia's expedited review is particularly valuable for pediatric patients with progressive HPP.

Note: Virginia's external review decision is final and binding on UnitedHealthcare. If overturned, the plan must authorize coverage within 24 hours for expedited cases, 1-3 days for standard cases.

Renewal and Reauthorization

UnitedHealthcare Reauthorization Schedule

  • Initial authorization: 6 months
  • Subsequent reauthorizations: 12 months if criteria met

Documentation for Renewal

Clinical response evidence:

  • Growth velocity improvements
  • Radiographic healing or stabilization
  • Functional status assessments
  • Reduced fracture incidence
  • Quality of life measures

Ongoing monitoring data:

  • Regular weight and dosing adjustments
  • Safety monitoring (injection site reactions, ectopic calcification screening)
  • Specialist follow-up notes
  • Treatment adherence documentation

Renewal Timeline Management

Calendar reminder: Submit renewal request 30-45 days before authorization expiration to prevent treatment gaps.

Quick Reference Checklist

Before Submitting PA Request

  • Verify UnitedHealthcare plan type and Strensiq formulary status
  • Confirm prescriber is in-network endocrinologist or metabolic specialist
  • Gather serum ALP lab results with age-appropriate reference ranges
  • Obtain ALPL genetic testing results (if available)
  • Document clinical HPP features and functional impact
  • Calculate weight-based dosing (≤6 mg/kg/week for juvenile-onset)
  • Prepare medical necessity letter with literature support

Submission Process

  • Submit via OptumRx Provider Portal or call 1-800-711-4555
  • Upload complete documentation package
  • Request expedited review if clinically urgent
  • Document confirmation/reference number
  • Schedule follow-up in 7-10 business days

If Denied

  • Review denial reason and required additional evidence
  • Submit first-level internal appeal within 180 days
  • Request peer-to-peer review with plan medical director
  • If upheld, file Virginia external review (Form 216-A) within 120 days
  • Consider expedited external review if treatment delay endangers health

Financial Assistance and Support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Strensiq. Their platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with UnitedHealthcare's specific requirements, potentially saving months of back-and-forth during the appeals process.

Additional support options:

  • Alexion Access Navigator: Patient support program offering case management and financial assistance
  • Patient Advocate Foundation: Copay assistance and appeals support
  • Virginia Poverty Law Center: Legal assistance for insurance appeals

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider about treatment decisions and verify current coverage requirements with UnitedHealthcare. For personalized appeals assistance, consider working with Counterforce Health or consulting with a patient advocate familiar with Virginia insurance regulations.

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