By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (asfotase alfa) Covered by UnitedHealthcare in Pennsylvania: Complete PA Forms, Appeals Timeline & Success Scripts

Answer Box: Getting Strensiq Covered by UnitedHealthcare in Pennsylvania

UnitedHealthcare requires prior authorization for Strensiq (asfotase alfa) with strict pediatric-onset hypophosphatasia criteria. Fastest path: Submit PA through OptumRx with documented onset before age 18, genetic/biochemical confirmation, and specialist attestation. If denied, use Pennsylvania's external review program within 4 months—50% success rate. Start today: Call UnitedHealthcare at the number on your card to request current PA forms and confirm your plan's specialty pharmacy requirements.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Requirements
  5. Cost-Share Dynamics
  6. Submission Process & Forms
  7. Common Approval Patterns
  8. Appeals Playbook for Pennsylvania
  9. FAQ: Common Questions
  10. Sources & Verification

Plan Types & Coverage Implications

UnitedHealthcare offers multiple plan types in Pennsylvania, each with different Strensiq coverage rules. Commercial plans (employer-sponsored HMO/PPO/EPO) typically follow UnitedHealthcare's standard medical necessity policy requiring pediatric-onset documentation. Medicare Advantage plans may have additional CMS oversight but use similar clinical criteria. Community Plan (Medicaid) members face both UnitedHealthcare's policies and Pennsylvania's state Medicaid specialty pharmacy program requirements.

Key Difference: Self-funded employer plans can modify or exclude coverage entirely, while fully-insured plans must follow Pennsylvania insurance regulations. Always verify your specific plan documents.

Referral requirements vary by plan type. HMO members typically need specialist referrals before seeing endocrinologists or geneticists, while PPO members can self-refer but may face higher out-of-network costs if they bypass UnitedHealthcare's preferred providers.

Formulary Status & Tier Placement

Strensiq appears on UnitedHealthcare formularies as a specialty tier medication requiring prior authorization. It's typically placed on the highest cost-sharing tier due to its ultra-rare indication and seven-figure annual cost potential. The drug is not subject to standard step therapy since there are no therapeutic alternatives for hypophosphatasia enzyme replacement.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all plan types UHC PA Forms
Formulary Tier Specialty/High-cost tier Plan-specific formulary
Age Restriction Onset before age 18 required UHC Medical Policy
Quantity Limits Weight-based dosing limits UHC Supply Limits
Specialty Pharmacy Required in most cases UHC Specialty Requirements

Prior Authorization Requirements

UnitedHealthcare's Strensiq prior authorization centers on pediatric-onset hypophosphatasia documentation. Adults can only qualify by proving disease onset before age 18 with retrospective clinical evidence.

Medical Necessity Criteria

Required Documentation:

  • Confirmed diagnosis of perinatal/infantile or juvenile-onset HPP
  • Evidence of persistently low alkaline phosphatase (age-adjusted)
  • Compatible clinical features (fractures, growth issues, dental problems)
  • ALPL genetic testing results when available
  • Specialist evaluation (endocrinology, genetics, or metabolic)

Dosing Restrictions:

  • Maximum 6 mg/kg/week for juvenile-onset HPP
  • Maximum 9 mg/kg/week for perinatal/infantile-onset HPP
  • Weight-based quantity limits enforced
Clinician Corner: Medical Necessity Letter Checklist

✓ Problem Statement: Document specific HPP subtype and age at onset ✓ Prior Treatments: List supportive care tried (vitamin D, calcium, etc.) ✓ Clinical Rationale: Reference FDA labeling and HPP treatment guidelines ✓ Objective Measures: Include baseline ALP levels, imaging findings, fracture history ✓ Monitoring Plan: Specify follow-up schedule and response metrics

Specialty Pharmacy Requirements

Pennsylvania UnitedHealthcare members must obtain Strensiq through designated specialty pharmacies in most cases. This requirement applies to commercial plans but may vary for self-funded employers.

Approved Specialty Pharmacies typically include:

  • Optum Specialty Pharmacy (UnitedHealthcare's preferred partner)
  • Select national specialty pharmacy networks
  • Hospital-affiliated specialty pharmacies (case-by-case)

Patient Setup Process:

  1. Prescriber submits PA approval
  2. UnitedHealthcare authorizes coverage
  3. Prescription routed to approved specialty pharmacy
  4. Patient completes specialty pharmacy enrollment
  5. First injection often requires medical supervision
Note: Providers cannot "buy and bill" Strensiq if it's on UnitedHealthcare's specialty sourcing requirement list, as payment for the drug will be denied.

Cost-Share Dynamics

Strensiq's placement on specialty tiers means high cost-sharing even with coverage approval. Typical structures include:

Commercial Plans:

  • Specialty tier coinsurance: 20-40% after deductible
  • Annual out-of-pocket maximums apply
  • Deductibles often $1,000-$5,000+ for specialty drugs

Medicare Advantage:

  • Specialty tier copays: $200-$500+ per month
  • Coverage gap/"donut hole" may apply
  • Catastrophic coverage after $8,000+ out-of-pocket

Cost-Saving Resources:

  • Alexion Access Navigator patient assistance
  • Manufacturer copay support programs
  • Pennsylvania pharmaceutical assistance programs
  • Non-profit foundations for rare disease support

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Family)
    • Insurance card and policy details
    • Complete medical records showing onset timing
    • Genetic testing results if available
    • Timeline: 1-2 weeks
  2. Specialist Evaluation (Clinic)
    • Endocrinology, genetics, or metabolic consultation
    • Comprehensive HPP assessment
    • Timeline: 2-4 weeks for appointment
  3. Submit Prior Authorization (Prescriber)
    • Complete UnitedHealthcare PA forms
    • Include detailed medical necessity letter
    • Submit via UnitedHealthcare provider portal
    • Timeline: 15-30 days for decision
  4. Arrange Specialty Pharmacy (Clinic/Patient)
    • Coordinate with approved specialty pharmacy
    • Complete patient enrollment process
    • Timeline: 1-2 weeks
  5. First Injection Setup (Medical Team)
    • Schedule supervised administration
    • Monitor for allergic reactions
    • Timeline: Within 1 week of drug receipt

Key Forms and Portals

Common Approval Patterns

Strong Submissions Include:

  • Clear documentation of pediatric onset (medical records, growth charts, imaging)
  • Genetic confirmation with pathogenic ALPL variants
  • Specialist attestation from appropriate subspecialty
  • Objective disease severity measures
  • Weight-appropriate dosing requests

Common Denial Reasons & Fixes

Denial Reason How to Overturn
"Adult-onset HPP not covered" Provide childhood medical records, growth charts, or imaging showing pre-18 onset
"Insufficient genetic testing" Submit ALPL sequencing results or request genetic counseling referral
"Dosing exceeds guidelines" Justify higher dosing with clinical response data and specialist rationale
"Alternative treatments not tried" Document that no alternatives exist for HPP enzyme replacement

Appeals Playbook for Pennsylvania

Pennsylvania offers one of the strongest patient appeal systems in the country. If UnitedHealthcare denies Strensiq coverage, you have multiple appeal levels with high success rates.

Internal Appeals (UnitedHealthcare)

Timeline: 180 days from denial to file Process:

  1. Submit written appeal with additional clinical documentation
  2. Request peer-to-peer review with UnitedHealthcare medical director
  3. Include updated specialist letters addressing denial reasons

Expedited Appeals: Available when delay poses serious health risk

  • Timeline: 24-72 hours for urgent decisions
  • Requires physician certification of urgency

Pennsylvania External Review

After exhausting UnitedHealthcare's internal appeals, Pennsylvania's Independent External Review Program offers strong patient protections.

Key Statistics: 50% of external appeals are overturned in favor of patients

Timeline and Process:

Required Documents:

  • Final denial letter from UnitedHealthcare
  • All previous denial notices
  • Complete medical records
  • Updated physician statements
  • Insurance card copy
From Our Advocates: "We've seen Pennsylvania external reviews succeed for ultra-rare drugs when families submitted comprehensive medical timelines showing pediatric onset. The key is organizing records chronologically and having specialists write letters specifically addressing the insurer's denial reasons. Don't give up after the first denial—Pennsylvania's independent reviewers often understand rare disease complexities better than insurance company reviewers."

When working with Counterforce Health, patients gain access to specialized expertise in turning insurance denials into successful appeals. The platform helps identify the specific denial basis and crafts targeted rebuttals aligned to UnitedHealthcare's own policies, increasing approval chances significantly.

FAQ: Common Questions

How long does UnitedHealthcare PA take for Strensiq in Pennsylvania? Standard prior authorization decisions are typically issued within 15-30 days. Expedited reviews for urgent medical situations can be completed within 24-72 hours when properly documented.

What if Strensiq is non-formulary on my plan? Strensiq appears on most UnitedHealthcare formularies but at high specialty tiers. Non-formulary status may require formulary exception requests with enhanced clinical justification.

Can I request an expedited appeal? Yes, both UnitedHealthcare internal appeals and Pennsylvania external reviews offer expedited pathways when delays could seriously jeopardize health. Requires physician certification of urgency.

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

What happens if I'm over 18 but had childhood HPP? Adults can qualify for Strensiq coverage by documenting disease onset before age 18. Gather childhood medical records, growth charts, and imaging to support pediatric-onset claims.

How much will Strensiq cost with UnitedHealthcare coverage? Cost-sharing varies significantly by plan type and tier placement. Specialty tier coinsurance typically ranges from 20-40% after deductible, but manufacturer assistance programs can help reduce out-of-pocket costs.

Sources & Verification

Always verify current information with these official sources:

Getting Help: Pennsylvania residents can contact the Pennsylvania Insurance Department consumer line for appeal assistance or reach out to Counterforce Health for specialized support in navigating complex prior authorization and appeals processes.

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance.

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