By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (asfotase alfa) Covered by UnitedHealthcare in Ohio: Complete PA Guide with Forms and Appeals

Answer Box: Quick Path to Strensiq Coverage

UnitedHealthcare requires prior authorization for Strensiq (asfotase alfa) with specific documentation of perinatal/infantile or juvenile-onset hypophosphatasia. Key requirements: persistent low alkaline phosphatase, elevated substrate markers (PLP/PEA), clinical/radiographic features, and prescribing by an endocrinologist or metabolic bone specialist. First step today: Contact PANTHERx Rare at (888) 765-4747 to initiate benefits verification and PA support. If denied, Ohio allows 180 days for external review through Independent Review Organizations. Success rates improve significantly with complete genetic testing (ALPL mutation) and documented clinical response criteria.

Table of Contents

Plan Types & Coverage Implications

UnitedHealthcare covers Strensiq across multiple plan types in Ohio, but requirements vary significantly:

Commercial Plans (Employer/Individual)

  • Prior authorization through OptumRx formulary system
  • 60-day appeal deadlines from denial
  • Network specialty pharmacy requirements

Medicare Advantage

  • Enhanced step therapy programs for Part B specialty drugs
  • Expedited appeals available (72 hours for urgent cases)
  • IRE reconsideration after internal denials

Medicaid Community Plans

  • State fair hearing process available
  • Different PA criteria may apply
Note: Self-funded employer plans follow federal ERISA rules, not Ohio state external review processes.

Formulary Status & Tier Placement

Strensiq appears on UnitedHealthcare formularies with consistent restrictions:

Formulary Tier Restrictions Source
2025 Select Standard Specialty PA, SP OptumRx PDF
2024 Premium Standard Specialty PA, SP OptumRx PDF
Basic HMO Plans Variable PA, ST, QL possible CalPERS PDF

Key: PA = Prior Authorization, SP = Specialty Pharmacy, ST = Step Therapy, QL = Quantity Limit

Prior Authorization Requirements

UnitedHealthcare's current Strensiq PA policy (Program 2025 P 2136-10) requires comprehensive documentation:

Initial Authorization Checklist

1. Diagnosis Documentation

  • Medical records confirming perinatal/infantile-onset OR juvenile-onset hypophosphatasia
  • If patient ≥18 years: proof that disease onset was <18 years old

2. Laboratory Confirmation (All Required)

  • Persistent low serum alkaline phosphatase below age/sex reference range (≥2 measurements)
  • Evidence of substrate accumulation:
    • Elevated plasma pyridoxal 5'-phosphate (PLP), AND/OR
    • Elevated urinary phosphoethanolamine (PEA)

3. Clinical/Radiographic Evidence

  • Poor bone mineralization or rickets-like changes
  • Fractures, premature tooth loss, bone pain, or growth failure
  • Characteristic skeletal abnormalities on imaging

4. Prescriber Requirements

  • Must be prescribed by endocrinologist OR specialist experienced in metabolic bone disorders

5. Dosing Documentation

  • Perinatal/infantile-onset: ≤9 mg/kg/week using 40 mg/mL vials
  • Patients on 80 mg/0.8 mL vials: weight ≥40 kg documented

6. Genetic Testing (Optional but Helpful)

  • ALPL mutation results can confirm HPP diagnosis
  • Check plan coverage for genetic testing before ordering

Reauthorization Requirements

  • Documentation of positive clinical response (symptom improvement, radiographic changes)
  • Continued prescribing by appropriate specialist
  • Same dosing and vial criteria
  • 12-month authorization periods

Specialty Pharmacy Network

Strensiq requires dispensing through UnitedHealthcare's contracted specialty pharmacies:

Primary Network Vendor: PANTHERx Rare

  • Phone: (888) 765-4747
  • Services: Benefits verification, PA support, patient education, 24/7 clinical support
  • Handles shipments, refills, and self-administration training

Secondary Vendor: Optum Specialty

Important: Coverage is unavailable outside this specialty pharmacy network.

Step-by-Step: Fastest Path to Approval

Step 1: Contact Specialty Pharmacy (Patient/Clinic)

Call PANTHERx Rare at (888) 765-4747 for immediate benefits verification and PA initiation support.

Step 2: Gather Required Documentation (Clinic)

Collect all lab reports (ALP, PLP, PEA), genetic testing results, radiology reports, and specialist consultation notes.

Step 3: Submit PA via UHC Provider Portal (Prescriber)

Use UnitedHealthcare Provider Portal with complete clinical summary letter referencing Program 2025 P 2136-10.

Step 4: Request Expedited Review if Urgent (Prescriber)

For severe infantile HPP cases, request expedited review with physician certification of health risk.

Step 5: Monitor Decision Timeline (Clinic/Patient)

Standard PA decisions: 72 hours for Part B drugs; expedited: 24 hours. Call 1-866-604-3267 if overdue.

Step 6: Prepare Appeal if Denied (All Parties)

File within 60 days using denial letter, additional evidence, and medical necessity arguments.

Step 7: Pursue External Review if Needed (Patient)

Ohio residents have 180 days post-final denial to request external review through Independent Review Organizations.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Evidence
"Adult-onset HPP not covered" Document pediatric disease onset Chart notes showing symptoms <18 years
"Insufficient genetic confirmation" Submit ALPL mutation testing Pathogenic/likely pathogenic variant report
"Dosing above label" Justify infantile HPP severity Clinical response data, specialist notes
"Step therapy required" Document contraindications Evidence that alternatives are inappropriate for HPP
"Not medically necessary" Emphasize orphan drug status FDA approval letter, lack of alternatives

Appeals Process in Ohio

Internal Appeals (UnitedHealthcare)

Filing Deadlines:

  • Commercial plans: 60 days from denial notice
  • Medicare Part D: 60 days from denial
  • Provider appeals: 21 days for outpatient cases

Response Times:

  • Standard internal: 30-60 days
  • Expedited: 72 hours (with health risk certification)
  • Medicare Part D redetermination: 7 days

Submission Methods:

  • UHC Provider Portal (preferred)
  • Member services phone line
  • Written appeals to address on denial letter

Ohio External Review

Ohio residents with state-regulated plans can request external review after exhausting internal appeals:

Eligibility: State-regulated plans (not self-funded ERISA plans) Deadline: 180 days from final internal denial Process: Submit to UHC; they notify Ohio Department of Insurance Timeline: 30 days standard; 72 hours expedited Outcome: Binding on UHC if approved

Ohio DOI Consumer Hotline: 1-800-686-1526

From our advocates: We've seen several hypophosphatasia cases succeed on external review when the initial denial focused on cost rather than medical necessity. The key was emphasizing that Strensiq is the only FDA-approved disease-modifying therapy for pediatric-onset HPP, making alternatives clinically inappropriate rather than just less preferred.

Cost-Share Considerations

Strensiq's annual cost can range from $890,000 to $4.9 million depending on dosing, making cost-sharing a significant concern:

Potential Support Resources:

  • Alexion patient assistance programs
  • Copay assistance cards (if eligible)
  • State pharmaceutical assistance programs
  • Foundation grants for rare diseases

2025 Medicare Changes:

  • $2,000 annual out-of-pocket cap may significantly reduce patient costs
  • Specialty tier placement affects monthly costs
Note: This information is educational only. Consult with your insurance plan and financial counselor for specific cost projections.

When to Escalate

Contact these resources if standard appeals fail:

Ohio Department of Insurance

Federal Resources (Self-Funded Plans)

  • Department of Labor ERISA complaints
  • Federal external review processes

Additional Support

  • UHCAN Ohio (Universal Health Care Action Network)
  • Legal aid organizations for health coverage issues

FAQ

How long does UnitedHealthcare PA take for Strensiq in Ohio? Standard decisions within 72 hours for Part B drugs; expedited within 24 hours with physician certification of health risk.

What if Strensiq is non-formulary on my plan? Non-formulary drugs can still be covered through medical necessity appeals, especially for orphan drugs with no alternatives.

Can I request expedited appeals in Ohio? Yes, both UnitedHealthcare internal appeals and Ohio external reviews offer expedited timelines (72 hours) when delay threatens life, health, or function.

Does step therapy apply if I've used Strensiq before? UnitedHealthcare exempts "existing utilizers" (paid claims within 365 days) from new step therapy requirements.

What genetic testing is most helpful for PA approval? ALPL mutation analysis showing pathogenic or likely pathogenic variants provides strongest genetic confirmation of HPP diagnosis.

How do I find my exact UHC formulary in Ohio? Check your plan documents or call the member services number on your insurance card. OptumRx formularies are available at optumrx.com.

What happens if I miss the 60-day appeal deadline? Deadlines are strictly enforced, but you may be able to request good cause exceptions in extraordinary circumstances. Contact Ohio DOI for guidance.

Can my doctor request a peer-to-peer review? Yes, providers can request peer-to-peer discussions with UHC medical directors, often within 24 hours for urgent cases.

Getting Help with Complex Cases

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific denial reasons—whether PA criteria, step therapy, or "not medically necessary" determinations—then drafts point-by-point rebuttals aligned to the plan's own rules. For medications like Strensiq, this includes pulling the right citations from FDA labeling, peer-reviewed studies, and specialty guidelines, while weaving in required clinical facts like diagnosis codes, prior treatment failures, and dosing justification. The system understands payer-specific workflows and produces letters that meet procedural requirements while tracking deadlines and required documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical, legal, or financial advice. Insurance coverage varies by plan and individual circumstances. Always verify current policies with your insurance provider and consult healthcare professionals for medical decisions. For official guidance on Ohio insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.

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