By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by UnitedHealthcare in New Jersey: Complete Prior Authorization Guide with Appeals

Quick Answer: UnitedHealthcare covers Strensiq (asfotase alfa) for pediatric-onset hypophosphatasia through OptumRx with prior authorization. Submit PA documentation including diagnosis confirmation, low alkaline phosphatase levels, and specialist prescription. If denied, you have 60 days for internal appeals and 4 months for New Jersey's external review through Maximus Federal Services. Start by gathering genetic testing, lab results, and clinical notes showing pediatric onset before age 18.

Table of Contents

Is Strensiq Covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Strensiq (asfotase alfa) as a specialty tier medication requiring prior authorization through OptumRx. Coverage applies to commercial, Medicare Advantage, and Medicaid plans for patients with confirmed perinatal/infantile-onset or juvenile-onset hypophosphatasia.

Coverage at a Glance

Requirement Details Where to Find It Source
Prior Authorization Required for all plans UHC Provider Portal PA Policy 2025 P 2136-10
Formulary Tier Specialty (high copay/coinsurance) Member portal or ID card 2026 Formulary Updates
Step Therapy None for existing users Automatic bypass with prior claims OptumRx Policy
Age Requirement Pediatric-onset only (symptoms before age 18) Medical records, clinical notes FDA Label
Specialist Required Endocrinologist or metabolic bone specialist Provider credentials PA Criteria

UnitedHealthcare operates two PA pathways: Medical Necessity Program (comprehensive documentation) and Notification Program (streamlined for confirmed diagnosis). Both require 12-month reauthorization with documented clinical response.

Prior Authorization Requirements

Initial Authorization (12 months)

All patients must have:

  • Diagnosis of perinatal/infantile-onset OR juvenile-onset hypophosphatasia
  • Disease onset documented before age 18
  • Persistent serum alkaline phosphatase (ALP) below age/gender reference range (≥2 measurements)
  • Elevated tissue non-specific alkaline phosphatase (TNSALP) substrates
  • Clinical and/or radiographic features consistent with HPP
  • Prescription by endocrinologist or metabolic bone disease specialist

Dosing limits:

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

Reauthorization Requirements

Documentation of positive clinical response including:

  • Improvement in clinical symptoms
  • Radiographic changes showing bone mineralization
  • Growth velocity improvements (pediatric patients)
  • Functional status enhancements
Note: Patients with UnitedHealthcare claims within the past 365 days may qualify for automatic approval bypass.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Family)

  • Insurance card and member ID
  • Complete medical records showing symptoms before age 18
  • Laboratory results: alkaline phosphatase levels (≥2 tests)
  • Genetic testing results (ALPL mutation if available)
  • Previous treatment history and failures

2. Specialist Consultation (Provider)

  • Schedule with endocrinologist or metabolic bone specialist
  • Obtain comprehensive clinical assessment
  • Document radiographic findings (X-rays, bone scans)
  • Confirm diagnosis using established criteria

3. Submit Prior Authorization (Provider)

  • Access UHC Provider Portal
  • Complete PA form referencing Program 2025 P 2136-10
  • Upload clinical letter with ICD-10 codes
  • Include all laboratory and imaging results
  • Timeline: 72-hour standard decision (24-hour expedited if urgent)

4. Monitor Status (Both)

  • Check portal for updates
  • Call 1-866-604-3267 if overdue
  • Request peer-to-peer review if needed (<24 hours typically)

5. Handle Approval (Pharmacy)

  • Fill through OptumRx specialty pharmacy network
  • Coordinate delivery and injection training
  • Schedule follow-up monitoring appointments

6. Track Reauthorization (Ongoing)

  • Submit renewal 60-90 days before expiration
  • Document clinical response metrics
  • Update dosing if weight changes

7. Appeal if Denied (If Necessary)

  • File within 60 days of denial
  • Include additional evidence addressing denial reason
  • Consider expedited appeal for urgent cases

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documents
Adult-onset HPP not covered Prove pediatric onset Chart notes documenting symptoms before age 18, growth records, early X-rays
Insufficient genetic confirmation Submit ALPL testing Pathogenic/likely pathogenic variant report from certified lab
Inadequate ALP documentation Provide serial lab values ≥2 alkaline phosphatase results below age/gender reference range
Not medically necessary Emphasize orphan drug status FDA approval documentation, specialist rationale letter
Step therapy not met Show contraindications Documentation that alternatives are inappropriate for HPP
Dosing above guidelines Justify higher dose Clinical response data, specialist recommendation for dose escalation
From our advocates: We often see approvals after initially being denied for "adult-onset HPP." The key is providing childhood medical records—even growth charts showing failure to thrive can help establish pediatric onset when genetic testing confirms the diagnosis.

Appeals Process in New Jersey

Internal Appeals (UnitedHealthcare)

Timeline: 60 days from denial notice

How to file:

  1. Log into UHC member/provider portal
  2. Upload denial letter and new supporting evidence
  3. Include detailed clinical letter addressing denial reason
  4. Request expedited review if delay threatens health (72-hour decision)

Required documents:

  • Original denial letter
  • Additional medical evidence
  • Updated clinical assessment
  • Specialist recommendation

External Review (New Jersey IHCAP)

After completing internal appeals, New Jersey residents can access the Independent Health Care Appeals Program (IHCAP) managed by Maximus Federal Services.

Eligibility:

  • Completed UnitedHealthcare's internal appeal process
  • Denial based on medical necessity determination
  • Filed within 4 months of final internal denial

Process:

  1. Submit online at njihcap.maximus.com
  2. Include $25 filing fee (waivable for financial hardship)
  3. Timeline: 5 business days preliminary review, 45 calendar days standard decision (48 hours expedited)
  4. Binding decision: UnitedHealthcare must comply if overturned

Contact: NJ DOBI IHCAP Hotline 1-888-393-1062

Costs & Patient Assistance

UnitedHealthcare Coverage

Strensiq is classified as specialty tier with higher copays/coinsurance. Specific costs vary by plan design—check your member portal or call the number on your ID card.

Manufacturer Support

Alexion ONE Patient Assistance Program:

  • Copay support up to $15,000/year for commercially insured patients
  • Free drug program for uninsured/underinsured patients
  • Income-based eligibility requirements
  • Apply: alexion.com/one or 1-888-765-4747

Financial Assistance Options

  • UnitedHealthcare financial hardship programs (contact member services)
  • State of New Jersey pharmaceutical assistance programs
  • Disease-specific foundations and grants
  • Hospital charity care programs

When dealing with insurance denials and complex prior authorization processes, many families find value in specialized support. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's own rules.

Clinician Corner: Medical Necessity Documentation

Essential Components of PA Letter

Patient History:

  • Age at symptom onset (crucial: before age 18)
  • Clinical presentation (bone pain, fractures, dental issues, failure to thrive)
  • Family history of HPP or unexplained bone disease
  • Previous diagnostic workup and specialist consultations

Laboratory Evidence:

  • Serial alkaline phosphatase levels with reference ranges
  • Elevated substrates (PLP, PEA) if available
  • Genetic testing results (ALPL mutations)
  • Other relevant biochemical markers

Clinical Assessment:

  • Physical examination findings
  • Radiographic abnormalities (rickets-like changes, fractures, osteomalacia)
  • Functional limitations and quality of life impact
  • Growth and developmental concerns (pediatric patients)

Treatment Rationale:

  • Why Strensiq is medically necessary
  • Lack of alternative treatments for HPP
  • Expected clinical benefits and monitoring plan
  • Dosing justification based on weight and severity

Key References to Include

  • FDA prescribing information
  • American Society for Bone and Mineral Research guidelines
  • Pediatric endocrinology society recommendations
  • Published case series and clinical trial data

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in New Jersey? A: Standard PA decisions are made within 72 hours. Expedited reviews (for urgent cases) are completed within 24 hours. Complex cases may take the full 72-hour window.

Q: What if Strensiq is non-formulary on my plan? A: Strensiq appears on most UnitedHealthcare formularies as specialty tier. If non-formulary, request a formulary exception with medical necessity documentation.

Q: Can I request an expedited appeal? A: Yes, if waiting for approval would jeopardize your health or ongoing treatment. Expedited appeals are decided within 72 hours for internal appeals and 48 hours for New Jersey external reviews.

Q: Does step therapy apply if I've used Strensiq before? A: No. Patients with UnitedHealthcare claims for Strensiq within the past 365 days are exempt from new step therapy requirements and may qualify for automatic approval.

Q: What happens if I move from another state to New Jersey? A: Your UnitedHealthcare coverage should continue, but you may need new prior authorization. Gather all previous medical records and work with your new specialist to establish care.

Q: How often do I need reauthorization? A: Every 12 months. Submit renewal requests 60-90 days before expiration with documentation of clinical response and continued medical necessity.

Q: Can my doctor request a peer-to-peer review? A: Yes. Providers can request peer-to-peer discussions with UnitedHealthcare medical directors, typically scheduled within 24 hours of the request.

Q: What if my child ages out of pediatric coverage? A: Continue documenting pediatric onset. Adult patients with confirmed pediatric-onset HPP typically maintain coverage as long as they show continued clinical benefit.

When to Escalate

Contact New Jersey Regulators

If you've exhausted UnitedHealthcare's internal appeals and IHCAP external review:

New Jersey Department of Banking and Insurance:

What to include:

  • Complete denial and appeal history
  • Medical necessity documentation
  • IHCAP decision (if applicable)
  • Specific harm from coverage denial

Additional Resources

  • NJ Managed Care Ombudsman: For state employee health plans
  • Medicare Advantage complaints: 1-800-MEDICARE
  • Patient advocacy organizations: National Organization for Rare Disorders (NORD)

For ongoing support with complex insurance challenges, Counterforce Health specializes in transforming coverage denials into successful appeals through comprehensive analysis of plan policies and targeted clinical documentation strategies.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies and requirements may change—verify current information with official sources.

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