By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by UnitedHealthcare in North Carolina: Complete Guide to Prior Authorization, Appeals, and State Protections

Answer Box: Getting Strensiq Covered by UnitedHealthcare in North Carolina

Eligibility: UnitedHealthcare covers Strensiq (asfotase alfa) for pediatric-onset hypophosphatasia with prior authorization. Requirements: ALPL gene mutation documentation, low alkaline phosphatase levels, and specialist prescription (endocrinologist/geneticist). First step: Submit PA through OptumRx with complete genetic testing results and clinical documentation. If denied: Request peer-to-peer review within 3 business days, then file internal appeals within 180 days. State protection: North Carolina's Smart NC program provides external review within 120 days of final denial, with expedited 72-hour decisions for urgent cases.

Table of Contents

  1. Why North Carolina State Rules Matter
  2. UnitedHealthcare Prior Authorization Requirements
  3. North Carolina Turnaround Standards
  4. Step Therapy Protections in NC
  5. Continuity of Care Protections
  6. Appeals Process: Internal to External Review
  7. Smart NC External Review Program
  8. Practical Scripts and Documentation
  9. Cost Assistance and Support Programs
  10. When to Escalate to State Regulators

Why North Carolina State Rules Matter

North Carolina's insurance laws provide significant protections for patients seeking coverage of rare disease medications like Strensiq. These state regulations work alongside UnitedHealthcare's internal policies to ensure fair review processes and reasonable timelines.

Key North Carolina Protections:

  • Step therapy exceptions with 24-72 hour review requirements
  • External review rights through Smart NC for medical necessity denials
  • Continuity of care protections during provider transitions (up to 90 days)
  • Consumer assistance through dedicated helplines and advocacy
Note: Self-funded employer plans (ERISA) may not be subject to all state protections. Check with your HR department or plan documents to confirm your plan type.

UnitedHealthcare Prior Authorization Requirements

UnitedHealthcare requires prior authorization for Strensiq through OptumRx. The coverage criteria are strict but clearly defined for pediatric-onset hypophosphatasia.

Medical Necessity Criteria

Required Documentation:

  • Genetic confirmation: ALPL gene mutation report from certified laboratory
  • Laboratory evidence: Low serum alkaline phosphatase levels for age/gender
  • Clinical presentation: Bone pain, fractures, growth failure, or skeletal abnormalities
  • Radiographic imaging: X-rays showing HPP-related bone changes
  • Specialist involvement: Prescription by endocrinologist, geneticist, or bone specialist

Dosing Limits:

  • Perinatal/infantile onset: ≤9 mg/kg/week
  • Juvenile onset: ≤6 mg/kg/week
  • Subcutaneous injection 3-6 times weekly
Tip: Gather all diagnostic documentation before submitting your initial PA request. Incomplete submissions are the most common cause of delays.

North Carolina Turnaround Standards

North Carolina law establishes specific timelines that UnitedHealthcare must follow for prior authorization decisions and appeals.

Request Type Standard Review Expedited Review
Initial PA 15 calendar days 72 hours
PA Appeal 30 calendar days 72 hours
Step Therapy Exception 72 hours 24 hours
Continuity of Care 72 hours 24 hours

Urgent/Expedited Criteria:

  • Immediate threat to life or health
  • Risk of serious impairment to bodily function
  • Current treatment course would be ineffective

Step Therapy Protections in NC

Under North Carolina General Statutes §58-3-221, patients have clear rights to step therapy exceptions when clinically appropriate.

Medical Exception Criteria

You qualify for a step therapy exception if:

  • Previously tried the required drug under current or prior coverage
  • Required drug has been ineffective for your condition
  • Required drug causes or is expected to cause harmful reactions
  • You had previous detrimental effects from the required medication
  • The drug is contraindicated or not medically appropriate
  • You're stable on current medication and switching poses risks

Documentation for Exceptions

Required Elements:

  • Medical history and prior treatment records
  • Clinical rationale for exception request
  • Provider attestation with supporting evidence
  • Clear labeling as "urgent" when medically appropriate

Submit using: North Carolina Step Therapy Exception Form (verify with the source linked)

Continuity of Care Protections

North Carolina provides strong continuity of care protections when your provider or specialty pharmacy leaves UnitedHealthcare's network.

Eligible Conditions:

  • Serious acute illnesses
  • Chronic life-threatening conditions
  • Terminal illness (≤6 months life expectancy)
  • Pregnancy (second trimester and beyond)

Coverage Period: Up to 90 days at in-network rates

Application Requirements:

  • Submit request within 45 days of provider termination or plan enrollment
  • Complete UnitedHealthcare's Transition/Continuity of Care form
  • Provide medical documentation of ongoing condition

Appeals Process: Internal to External Review

Understanding the complete appeals pathway helps you navigate denials effectively and preserve all your rights under North Carolina law.

Internal Appeals with UnitedHealthcare

Level 1: Peer-to-Peer Review (Optional but Recommended)

  • Request within 3 business days of denial
  • Direct discussion between your doctor and UHC medical director
  • Can provide clarifying information or new clinical data

Level 2: Formal Internal Appeal

  • Submit within 180 days of denial notice
  • Use UnitedHealthcare Provider Portal for fastest processing
  • Include all supporting documentation and clinical rationale

Level 3: Second Internal Appeal

  • Available if first internal appeal is denied
  • Same 180-day deadline from original denial
  • Consider adding new evidence or specialist opinions

Required Documentation for Appeals

Medical Records Package:

  • Complete diagnostic workup (genetic testing, labs, imaging)
  • Clinical notes documenting HPP symptoms and severity
  • Prior treatment history and failures/intolerances
  • Specialist evaluations and recommendations
  • Growth charts or functional assessments (pediatric cases)

Administrative Documents:

  • Original denial letter with specific reasons
  • Insurance card and member ID information
  • Prescriber attestation of medical necessity

Smart NC External Review Program

After exhausting UnitedHealthcare's internal appeals, North Carolina residents can request an independent external review through Smart NC.

Eligibility and Timeline

Who Can Apply:

  • Members with state-regulated health plans (not self-funded ERISA plans)
  • Must have completed all internal appeals (or qualify for expedited waiver)
  • Denial based on medical necessity, experimental treatment, or similar coverage issues

Application Deadline: 120 days from final internal denial

Decision Timeline:

  • Standard review: 45 calendar days
  • Expedited review: 4 business days (72 hours for urgent medication needs)

How to Apply

Required Forms and Documents:

  • Smart NC External Review Request Form (verify with source)
  • Signed authorization for medical record release
  • Copy of UnitedHealthcare's final denial letter
  • All supporting medical documentation
  • Provider letters supporting medical necessity

Submission Options:

  • Online through NC Department of Insurance portal
  • Mail to Smart NC program office
  • Fax (confirm current number with Smart NC)

Contact for Assistance:

  • Smart NC Helpline: 1-855-408-1212
  • Email support and form assistance available
  • Free advocacy to help complete applications
From our advocates: "We've seen many Strensiq denials overturned at external review when families submitted comprehensive genetic testing results alongside detailed clinical progression notes. The key is showing how the medication addresses the specific manifestations of HPP that other treatments cannot manage. Don't assume the reviewer understands this rare disease—spell out every connection between the diagnosis and treatment need."

Practical Scripts and Documentation

Phone Script for UnitedHealthcare Member Services

"I'm calling about a prior authorization denial for Strensiq for my child's hypophosphatasia. The denial letter referenced [specific reason from letter]. Under North Carolina law, I'd like to request a peer-to-peer review with your medical director within the required 3 business days. Can you schedule this and provide the reference number?"

Medical Necessity Letter Checklist

Essential Elements:

  • Patient demographics and diagnosis (include ICD-10 codes)
  • ALPL gene mutation details and laboratory confirmation
  • Clinical presentation and symptom progression
  • Prior treatments attempted and outcomes
  • Rationale for Strensiq based on FDA labeling and clinical guidelines
  • Dosing rationale and monitoring plan
  • Prognosis without treatment vs. with treatment

Supporting Citations:

Documentation Gathering Checklist

Before Starting Your Appeal:

  • Insurance card and member ID
  • Complete genetic testing report showing ALPL mutations
  • Laboratory results (alkaline phosphatase levels)
  • Radiology reports showing skeletal abnormalities
  • Clinical notes from specialist appointments
  • Growth charts or developmental assessments
  • Photos of clinical manifestations (dental issues, deformities)
  • Prior therapy documentation and failure records
  • Original denial letter with specific reasons

Cost Assistance and Support Programs

Even with insurance coverage, Strensiq can involve significant out-of-pocket costs. Several programs can help reduce financial burden.

Manufacturer Support:

  • Alexion Access Navigator - Patient support program
  • Coverage investigation and appeal assistance
  • Copay assistance for eligible patients
  • Free drug program for qualifying uninsured patients

Foundation Grants:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs:

  • North Carolina Medicaid (expansion effective 2024)
  • State pharmaceutical assistance programs
  • Hospital charity care programs
Note: Copay assistance programs may not be available for government insurance (Medicare, Medicaid). Check program eligibility requirements carefully.

When to Escalate to State Regulators

If you encounter procedural violations or unreasonable delays, North Carolina's Department of Insurance can investigate and take action.

File a Complaint When:

  • UnitedHealthcare misses required review deadlines
  • Appeals are denied without proper clinical review
  • You're not provided required forms or information
  • Step therapy exceptions are improperly denied
  • External review rights are not honored

Contact Information:

What to Include:

  • Detailed timeline of events
  • Copies of all correspondence
  • Documentation of missed deadlines
  • Evidence of procedural violations

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Strensiq in North Carolina? Standard PA decisions must be made within 15 calendar days. Expedited requests (for urgent medical needs) require decisions within 72 hours under NC law.

What if Strensiq is not on UnitedHealthcare's formulary? Non-formulary medications can still be covered through the medical exception process. Submit detailed clinical documentation showing medical necessity and lack of formulary alternatives.

Can I request an expedited appeal if my child's condition is worsening? Yes. North Carolina law requires expedited appeals (72-hour decisions) when delays could jeopardize health or ability to regain function. Clearly mark your request as "urgent."

Does step therapy apply if we tried other treatments outside of UnitedHealthcare? Yes, under NC law, prior treatments under any coverage (including other insurers) count toward step therapy requirements. Submit documentation of previous trials and outcomes.

What happens if Smart NC external review overturns the denial? UnitedHealthcare must provide coverage within 3 business days of the external review decision. The IRO's decision is binding on the insurer.

How much does Strensiq cost without insurance? Cash prices can exceed $10,000 per vial, with annual costs potentially reaching $500,000 to $4.9 million depending on patient weight and dosing requirements. This underscores the importance of pursuing all coverage options.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Strensiq. Their platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that address payer requirements point-by-point. For families navigating rare disease coverage challenges, Counterforce Health provides the expertise to build compelling cases that meet both clinical and administrative standards.

The appeals process for rare disease medications can be complex, but North Carolina's consumer protections and UnitedHealthcare's structured review process provide multiple pathways to coverage. Success often depends on thorough documentation, understanding specific requirements, and persistence through the appeals process. Counterforce Health's targeted approach helps ensure that appeals address the exact criteria payers use to make coverage decisions.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies vary by plan and individual circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance appeals and coverage issues in North Carolina, contact Smart NC at 1-855-408-1212.

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