By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (asfotase alfa) Covered by UnitedHealthcare in Texas: Complete Appeals Guide with Templates

Answer Box: Getting Strensiq Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Strensiq (asfotase alfa) through OptumRx, with no step therapy for existing users. Initial approval requires documented perinatal/infantile-onset or juvenile-onset hypophosphatasia before age 18, persistent low alkaline phosphatase levels, and specialist prescriber. If denied, you have 65 days for internal appeals and can request Texas external review through an Independent Review Organization. First step today: Contact your prescriber to gather diagnostic documentation and submit the PA request via UnitedHealthcare Provider Portal or call 866-889-8054.

Table of Contents

  1. Coverage at a Glance
  2. Understanding Your Denial
  3. Step-by-Step: Fastest Path to Approval
  4. Medical Necessity Documentation
  5. Appeals Process in Texas
  6. Common Denial Reasons & Solutions
  7. External Review Process
  8. Cost Assistance Options
  9. FAQ

Coverage at a Glance

Requirement Details Where to Find Source
Prior Authorization Required for all Strensiq prescriptions OptumRx specialty tier UHC PA Requirements
Step Therapy Not required for existing users Commercial formulary OptumRx Formulary
Age Requirement Disease onset before age 18 PA medical necessity form Strensiq PA Form
Prescriber Endocrinologist or metabolic specialist Medical necessity criteria Strensiq PA Form
Authorization Period 12 months (initial and renewal) PA notification letter PA Notification
Dosing Limits ≤9 mg/kg/week (infantile); ≤6 mg/kg/week (juvenile) Medical necessity form Strensiq PA Form

Understanding Your Denial

When UnitedHealthcare denies Strensiq coverage, the denial letter will specify the reason. Common codes include:

  • Medical necessity not established: Missing diagnostic documentation or clinical evidence
  • Age criteria not met: Insufficient proof of pediatric-onset disease
  • Prescriber requirements: Non-specialist prescriber or missing credentials
  • Dosing exceeded: Request above approved weight-based limits
Tip: Your denial letter includes specific deadlines and required documentation. Keep this letter—you'll need it for appeals.

Step-by-Step: Fastest Path to Approval

1. Gather Diagnostic Evidence (Patient & Clinic)

Timeline: 1-2 weeks
Documents needed:

  • Medical records showing HPP diagnosis before age 18
  • Laboratory results: persistent low alkaline phosphatase (ALP) below age/gender norms
  • Genetic testing results (ALPL mutations) if available
  • Radiographic evidence of bone disease

2. Confirm Prescriber Qualifications (Clinic)

Timeline: Same day
Requirement: Endocrinologist or specialist experienced in metabolic bone disease
Action: If current prescriber doesn't meet criteria, obtain referral or specialist co-signature

3. Submit Prior Authorization (Clinic)

Timeline: 72 hours for decision
How to submit: UnitedHealthcare Provider Portal or call 866-889-8054
Forms needed: Complete medical necessity form with all required documentation

4. Request Peer-to-Peer Review if Denied (Clinic)

Timeline: Request within 21 days of denial
Process: Clinical pharmacist or medical director discusses case directly with prescriber
Preparation: Have patient history, lab values, and treatment rationale ready

5. File Internal Appeal if Still Denied (Patient or Clinic)

Timeline: Must file within 65 days of denial
Submission: Electronic via provider portal (mandatory since 2023) or written appeal
Decision timeframe: 7 days standard, 72 hours expedited

6. Request External Review if Internal Appeal Fails (Patient)

Timeline: File within timeframe specified in final denial letter
Process: Submit TDI Form LHL009 to Texas Department of Insurance
Decision: 20 days standard, 3 days for life-threatening conditions

7. Monitor and Follow Up (Patient & Clinic)

Ongoing: Track all submissions, maintain documentation, prepare for reauthorization

Medical Necessity Documentation

A strong medical necessity letter should include these key elements:

Patient Information

  • Age at HPP symptom onset (must be <18)
  • Current age and weight (for dosing calculations)
  • ICD-10 codes: M89.06- (hypophosphatasia)

Diagnostic Evidence

  • Laboratory findings: Serial alkaline phosphatase levels below normal ranges
  • Clinical manifestations: Bone pain, fractures, dental issues, growth delays
  • Genetic confirmation: ALPL gene mutations (if tested)
  • Imaging: Radiographic evidence of rickets, osteomalacia, or fractures

Treatment History

  • Previous therapies attempted and outcomes
  • Contraindications to alternative treatments
  • Documentation of disease progression without treatment

Expected Benefits

  • Improvement in bone mineralization
  • Reduced fracture risk
  • Enhanced quality of life and functional status
  • Prevention of disease complications
Clinician Corner: Include specific alkaline phosphatase values with reference ranges, document functional impairments using validated tools like SF-36v2 or 6-minute walk test, and cite FDA labeling for approved indications.

Appeals Process in Texas

Internal Appeals with UnitedHealthcare

Filing deadline: 65 calendar days from denial notice (shorter than most insurers)

Submission methods:

  • Electronic via UnitedHealthcare Provider Portal (required for providers since 2023)
  • Written appeal with supporting documentation
  • Phone: 877-842-3210 for Provider Service Advocate assistance

Decision timelines:

  • Standard appeals: 7 calendar days
  • Expedited appeals: 72 hours
  • Part D drug appeals: 7-14 days

Required documentation:

  • Original denial letter
  • Complete medical records supporting medical necessity
  • Prescriber attestation of treatment need
  • Any additional clinical evidence

At Counterforce Health, we help patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and creates point-by-point rebuttals aligned to each plan's specific requirements, pulling the right medical citations and clinical evidence to strengthen your case.

Texas External Review Process

If UnitedHealthcare denies your internal appeal, Texas law provides access to Independent Review Organizations (IROs) through the Texas Department of Insurance.

Eligibility: Complete internal appeals first (unless expedited/urgent cases)

Filing process:

  1. Submit TDI Form LHL009 to UnitedHealthcare for forwarding
  2. Include all medical records and internal appeal correspondence
  3. Request expedited review if treatment delay would jeopardize health

Timelines:

  • Life-threatening/specialty drug denials: 3 days
  • Standard preauthorization denials: 20 days
  • Retrospective denials: 20-30 days

Contact information:

  • Texas Department of Insurance: 1-800-252-3439
  • IRO information line: 1-866-554-4926
  • TDI Consumer Portal

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Adult-onset HPP without pediatric documentation Provide childhood medical records or specialist attestation of early symptoms School health records, growth charts, early dental issues
Insufficient genetic/biochemical confirmation Submit ALPL mutation testing or comprehensive metabolic panel Genetic counselor report, serial ALP measurements
Non-specialist prescriber Obtain endocrinologist consultation or co-signature Specialist evaluation letter, credentials verification
Dosing above approved limits Justify higher dose with clinical response data Treatment response documentation, safety monitoring
Missing clinical severity documentation Provide functional assessments and quality of life measures SF-36v2 scores, 6-minute walk test, fracture history

External Review Process

Texas provides robust external review rights for specialty drug denials. The process is designed to ensure independent medical review when insurers deny coverage.

Key advantages in Texas:

  • Immediate IRO access for prescription drug denials
  • No requirement to complete internal appeals for life-threatening conditions
  • Expedited timelines for urgent cases
  • Binding decisions that insurers must follow

Success factors:

  • Complete medical documentation
  • Specialist support letters
  • Evidence of functional impairment
  • Documentation of failed alternatives
From our advocates: "We've seen Texas IRO reviews succeed when families provide comprehensive functional assessments alongside clinical lab values. One case involved a teenager whose SF-36v2 scores and 6-minute walk test results clearly demonstrated disability that improved markedly after three months of treatment—this objective evidence was key to overturning the denial."

Cost Assistance Options

While pursuing coverage approval, explore these financial assistance programs:

Manufacturer Support:

  • Alexion Access Navigator provides prior authorization assistance and copay support
  • Patient assistance programs for eligible uninsured/underinsured patients

Foundation Grants:

  • National Organization for Rare Disorders (NORD) patient assistance programs
  • HealthWell Foundation rare disease fund
  • Patient Access Network (PAN) Foundation specialty drug assistance

Texas-Specific Resources:

  • Texas Department of Insurance consumer assistance: 1-800-252-3439
  • Office of Public Insurance Counsel (OPIC) help line: 1-877-611-6742

For families facing coverage challenges, Counterforce Health offers comprehensive support in navigating prior authorization requirements and appeals processes, helping ensure patients get access to critical treatments like Strensiq.

FAQ

How long does UnitedHealthcare prior authorization take in Texas? Standard PA decisions are made within 72 hours, with expedited reviews completed within 24 hours for urgent cases.

What if Strensiq is non-formulary on my plan? Strensiq is typically covered as a specialty tier medication. If non-formulary, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal for Strensiq? Yes, if treatment delay would jeopardize your health. Expedited internal appeals receive decisions within 72 hours.

Does step therapy apply if I've failed treatments outside Texas? UnitedHealthcare doesn't require step therapy for Strensiq, but document any prior treatment failures to strengthen your case.

What happens if I miss the 65-day appeal deadline? Contact UnitedHealthcare immediately—exceptions may be granted for serious illness or hospitalization that prevented timely filing.

How much does Strensiq cost without insurance? Annual costs can range from $890,000 to $4.9 million depending on dosing requirements. Manufacturer assistance programs are essential.

Can I get help with the appeals process in Texas? Yes, contact the Texas Department of Insurance consumer hotline (1-800-252-3439) or OPIC (1-877-611-6742) for assistance.

What documentation is most important for approval? Proof of pediatric-onset HPP with persistent low alkaline phosphatase levels and specialist prescriber evaluation are critical.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual circumstances and plan terms. Always consult with your healthcare provider and insurance plan for specific guidance regarding your situation. For additional assistance with insurance appeals in Texas, contact the Texas Department of Insurance at 1-800-252-3439.

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