By Counterforce Health Team in Strensiq (asfotase alfa) —

How Long Does It Take to Get Strensiq (asfotase alfa) Approved by UnitedHealthcare in Washington? Complete Timeline & Appeals Guide

Answer Box: Getting Strensiq Approved by UnitedHealthcare in Washington

UnitedHealthcare typically takes 15-30 days to decide on Strensiq (asfotase alfa) prior authorization for pediatric-onset hypophosphatasia, with expedited decisions in 24-72 hours for urgent cases. Washington residents have strong appeal rights, including binding external review by an Independent Review Organization (IRO) within 20-45 days if UnitedHealthcare denies coverage.

First step today: Contact your specialist to gather genetic testing (ALPL mutation), low alkaline phosphatase lab results, and evidence of pediatric-onset symptoms. Submit the PA through UnitedHealthcare's Provider Portal with complete documentation to avoid delays.

Table of Contents

What Affects Approval Timeline

Several factors influence how quickly UnitedHealthcare approves Strensiq in Washington:

Benefit Type & Plan Structure

  • Commercial plans: Standard 15-30 day review under Washington state utilization review laws
  • Medicare Advantage: Similar timeframes but may require additional CMS compliance steps
  • Self-funded employer plans: May follow different timelines than fully-insured plans

Documentation Completeness

The most critical factor is having all required evidence upfront:

  • Genetic confirmation: ALPL gene mutation testing results
  • Biochemical proof: Persistently low alkaline phosphatase levels with elevated substrates (pyridoxal-5'-phosphate, phosphoethanolamine)
  • Pediatric onset evidence: Medical records showing symptoms began before age 18
  • Specialist involvement: Prescription from endocrinologist or metabolic bone disease specialist

Medical Urgency

UnitedHealthcare offers expedited review (24-72 hours) when delay could seriously jeopardize health, common in infantile hypophosphatasia cases with respiratory complications.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before submitting your prior authorization, gather these materials:

Clinical Records

  • Complete medical history showing pediatric-onset symptoms (fractures, rickets, respiratory issues)
  • Growth charts and developmental milestones
  • Imaging reports (skeletal radiographs, fracture documentation)
  • Current weight for dosing calculations

Laboratory Evidence

  • Serial alkaline phosphatase (ALP) levels below age/sex reference ranges
  • Elevated TNSALP substrates (PLP, phosphoethanolamine) if available
  • Calcium, phosphate, and vitamin D levels

Genetic Testing

  • ALPL gene pathogenic mutation results (verify UnitedHealthcare covers genetic testing before ordering)

Specialist Documentation

  • Prescription from qualified specialist (endocrinology, metabolic genetics)
  • Medical necessity letter addressing diagnosis, onset age, and treatment rationale
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing payer policies and crafting point-by-point rebuttals aligned to each plan's specific requirements.

Submission to Initial Review (1-5 Days)

UnitedHealthcare's PA Process

UnitedHealthcare processes Strensiq requests through their Prior Authorization/Medical Necessity Program (2025 P 2136-10) with specific criteria:

Initial Approval Requirements

  1. Confirmed pediatric-onset HPP diagnosis (perinatal/infantile or juvenile-onset)
  2. Objective confirmation through genetic testing or biochemical markers
  3. Appropriate prescriber (endocrinologist or metabolic bone specialist)
  4. Dosing within limits: ≤9 mg/kg/week (infantile-onset) or ≤6 mg/kg/week (juvenile-onset)

Submission Methods

What Reviewers Check First

  1. Member eligibility and plan coverage
  2. Formulary status and specialty pharmacy requirements
  3. Diagnosis codes matching pediatric-onset HPP
  4. Prescriber credentials and specialty

Decision Window & Outcomes

Standard Timeline Expectations

Review Type Timeline When Available
Standard PA 15-30 days Most cases
Expedited Review 24-72 hours Medical urgency documented
Additional Information Request 1-7 days to respond Missing documentation

Reading Your Approval Letter

If Approved

  • Authorization duration (typically 12 months for Strensiq)
  • Approved dosing and frequency
  • Required specialty pharmacy (usually OptumRx-contracted)
  • Reauthorization requirements

If Denied

  • Specific denial reasons
  • Required documentation for appeal
  • Internal appeal deadlines (typically 180 days)
  • External review rights in Washington

If Denied: Washington Appeals Process

Washington provides robust consumer protections for insurance denials, including binding external review.

Internal Appeals (UnitedHealthcare)

Timeline: File within 180 days of denial Decision: Standard appeals typically decided within 15-30 days; urgent appeals within 24-72 hours

Required Elements

  • Written appeal letter addressing denial reasons point-by-point
  • Updated clinical documentation
  • Specialist letter emphasizing Strensiq as the only FDA-approved disease-modifying therapy for HPP

External Review (Independent Review Organization)

Washington's external review process provides a powerful appeal option when UnitedHealthcare maintains their denial.

Timeline to Request: 60-120 days from final internal denial (check your specific denial letter for exact deadline)

IRO Decision Timeline

  • Fully insured plans: Decision within 20 days
  • Self-insured plans: Decision within 45 days
  • Expedited cases: Decision within 72 hours

How to File External Review

  1. Contact Washington Office of the Insurance Commissioner: 1-800-562-6900
  2. Submit request through Washington OIC IRO process
  3. Include comprehensive medical records, specialist letters, and literature supporting Strensiq use in HPP

IRO Decision Impact

  • Binding on UnitedHealthcare if denial is overturned
  • Must provide coverage according to IRO determination
  • Typically high success rates for well-documented rare disease cases
From our advocates: We've seen Washington families successfully overturn UnitedHealthcare denials through external review by providing comprehensive genetic testing results, clear pediatric-onset documentation, and specialist letters emphasizing the lack of therapeutic alternatives for HPP. The key is thorough preparation and meeting all procedural requirements.

Renewal Cycles & Reauthorization

Standard Reauthorization Requirements

Timeline: Submit 2-4 weeks before current authorization expires (typically 12-month approvals)

Required Documentation for Renewal

  • Evidence of positive clinical response to Strensiq:
    • Improved growth parameters
    • Reduced fracture rate
    • Better Radiographic Global Impression of Change scores
    • Improved respiratory function or mobility
  • Continued specialist management
  • Updated weight and dosing calculations

What Speeds Renewals

  • Objective response measures (growth charts, imaging improvements)
  • Consistent specialist oversight
  • No dose escalations above policy limits
  • Clean claims history without adherence issues

Timeline Visual Summary

Phase Duration Key Milestones
Preparation 0-2 days Gather genetic testing, labs, specialist letter
Submission 1-5 days Submit via Provider Portal, track reference number
Initial Review 15-30 days UnitedHealthcare medical necessity determination
If Approved 1-2 weeks Specialty pharmacy enrollment and first shipment
If Denied - Internal Appeal 15-30 days File appeal with additional documentation
If Still Denied - External Review 20-45 days Washington IRO binding decision

Total Time to Treatment: 3-8 weeks for straightforward approvals; 3-4 months if appeals are needed

Time-Saving Tips

Portal Usage Best Practices

  • Use UnitedHealthcare Provider Portal for fastest processing
  • Track case numbers and respond immediately to information requests
  • Upload all supporting documents in initial submission

Evidence Bundling Strategy

  • Submit genetic testing, biochemical confirmation, and imaging together
  • Include comprehensive medical necessity letter addressing all PA criteria
  • Provide pediatric-onset timeline with specific symptom dates

Direct Specialty Routing

  • Ensure prescription comes from qualified specialist (endocrinology, metabolic genetics)
  • Include specialist CV if there's any question about credentials
  • Request peer-to-peer review if initial denial occurs

Washington-Specific Advantages

  • Leverage strong state external review rights
  • Contact OIC Consumer Hotline (1-800-562-6900) for free assistance
  • Use Washington's proactive regulatory environment to your advantage

FAQ

How long does UnitedHealthcare PA take in Washington? Standard prior authorization decisions typically take 15-30 days, with expedited review available in 24-72 hours for urgent cases involving respiratory compromise or rapid disease progression.

What if Strensiq is non-formulary on my plan? Strensiq is typically on UnitedHealthcare formularies as a specialty-tier medication requiring prior authorization. If truly non-formulary, you can request a formulary exception with the same clinical documentation.

Can I request an expedited appeal in Washington? Yes, if delay would seriously jeopardize health or cause severe deterioration. Your specialist must certify the urgency in writing, and decisions come within 24-72 hours.

Does step therapy apply to Strensiq? No standard step therapy is required since Strensiq is the only FDA-approved enzyme replacement therapy for hypophosphatasia. However, UnitedHealthcare may require documentation of supportive care attempts.

What happens if I'm on a self-funded employer plan? Washington state law may not automatically apply, but many employers voluntarily use external review. Contact the U.S. Department of Labor for ERISA plan appeals if needed.

How much does Strensiq cost with UnitedHealthcare? Costs vary by plan, but specialty-tier medications typically have higher copays or coinsurance. Contact member services for specific cost-sharing details and ask about manufacturer copay assistance programs.

At Counterforce Health, we help patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create targeted appeals that align with each payer's specific criteria. Our platform identifies denial reasons and drafts evidence-backed rebuttals using the right citations and clinical facts to maximize approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms, medical circumstances, and current policies. Always consult with your healthcare provider and insurance plan directly for specific coverage determinations. Washington residents can contact the Office of the Insurance Commissioner at 1-800-562-6900 for personalized assistance with insurance appeals.

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