How to Get Strensiq (asfotase alfa) Covered by Humana in Ohio: PA Forms, Appeals, and Approval Strategy

Answer Box: Getting Strensiq Covered by Humana in Ohio

Strensiq (asfotase alfa) is covered by select Humana plans in Ohio as a Tier 4 specialty drug with dispensing limits. To get approval: 1) Confirm pediatric-onset hypophosphatasia (HPP) with genetic testing showing ALPL mutation and low alkaline phosphatase levels, 2) Submit prior authorization through your prescriber with comprehensive clinical documentation, 3) Use CenterWell Specialty Pharmacy or PANTHERx Rare for dispensing. Appeals must be filed within 65 days if denied, with external review available through Ohio Department of Insurance within 180 days.

Table of Contents

Plan Types & Coverage Implications

Humana offers multiple plan types in Ohio, each with different coverage rules for Strensiq:

Medicare Advantage Plans: Ohio has 27+ Humana Medicare Advantage options including HumanaChoice PPO and Humana Gold Plus HMO. These plans combine Medicare Parts A, B, and often D, with additional benefits like dental and vision. Strensiq coverage follows Medicare Part B rules for injectable medications, requiring medical necessity documentation.

Commercial Insurance: Employer-sponsored Humana plans use separate formularies with potentially different prior authorization criteria. Check your specific Evidence of Coverage (EOC) document.

Medicaid Plans: Humana Healthy Horizons in Ohio uses Gainwell as the pharmacy benefit manager, not Humana's direct network.

Note: Self-funded employer plans follow federal ERISA rules rather than Ohio state regulations for appeals, though many voluntarily use similar processes.

Formulary Status & Tier Placement

Current Status: Strensiq appears on select 2025 Humana Medicare Employer Plan formularies as:

  • Tier 4 (Specialty Tier)
  • DL (Dispensing Limits) apply
  • Covered strengths: 18 mg/0.45 mL, 28 mg/0.7 mL, 80 mg/0.8 mL

What This Means:

  • Higher member cost-sharing than Tiers 1-3
  • Must be filled at network specialty pharmacy
  • Quantity limits based on 30/60/90-day supplies
  • Prior authorization may apply via medical necessity review

Verification: Use Humana's drug list tool at humana.com/pharmacy/medicare-drug-list or call your plan directly, as formularies update frequently.

Prior Authorization Requirements

While Strensiq shows "DL" rather than explicit "PA" marking on some formularies, prior authorization is typically required for this high-cost specialty medication.

Required Documentation

Clinical Evidence:

  • Confirmed diagnosis of pediatric-onset hypophosphatasia (perinatal, infantile, or juvenile)
  • Genetic testing results showing ALPL gene mutation
  • Laboratory results: ≥2 low alkaline phosphatase measurements below age/sex norms
  • Elevated substrate levels (PLP, PEA, or PPi preferred)

Medical Records:

  • Complete medical history and physical examination
  • Radiographic evidence (rickets, bone deformity, craniosynostosis)
  • Documentation of clinical symptoms meeting HPP criteria
  • Previous treatment attempts and outcomes

Specialty Pharmacy Network

Primary Options in Ohio:

  • CenterWell Specialty Pharmacy (Humana-owned, preferred)
    • Phone: 1-800-486-2668 or 855-746-0637
    • Hours: Mon-Fri 8am-11pm ET, Sat 8am-6:30pm ET
  • CVS Specialty
  • Walgreens Specialty
  • Accredo

Strensiq-Specific: PANTHERx Rare Pharmacy serves as the dedicated specialty provider for Strensiq distribution. Verify network status with Humana using their pharmacy finder.

Medical Necessity Criteria

Based on HPP International Working Group consensus and payer policies, medical necessity requires:

Coverage at a Glance

Requirement What It Means Where to Find It
Pediatric onset Disease started before age 18 Medical records, family history
ALPL mutation Genetic confirmation Genetic testing report
Low ALP levels ≥2 measurements below normal Lab results
Clinical symptoms Major/minor criteria met Physical exam, imaging
Substrate elevation PLP, PEA, or PPi elevated Specialized lab testing

Diagnostic Criteria Framework

Obligate Criterion: Persistently low alkaline phosphatase activity below age/sex-specific lower limit (≥2 measurements)

Plus either:

  • Two major criteria, OR
  • One major + two minor criteria

Major Criteria:

  • Pathogenic/likely pathogenic ALPL variant
  • Elevated TNSALP substrates (PLP, PEA, or PPi)
  • Early nontraumatic primary tooth loss (before age 5)
  • Radiographic rickets

Minor Criteria:

  • Short stature/linear growth failure
  • Delayed motor milestones
  • Chronic musculoskeletal pain
  • Impaired mobility
  • Craniosynostosis
  • Nephrocalcinosis/nephrolithiasis

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Family)
    • Insurance card and member ID
    • Complete medical records
    • Genetic testing results
    • Lab reports showing low ALP levels
    • Timeline: 1-2 weeks
  2. Prescriber Consultation (Physician)
    • Confirm HPP diagnosis meets criteria
    • Document medical necessity rationale
    • Complete prior authorization forms
    • Timeline: 1-2 office visits
  3. PA Submission (Clinic Staff)
    • Submit via Humana provider portal
    • Include all supporting documentation
    • Request expedited review if urgent
    • Timeline: Same day submission
  4. Humana Review
    • Standard review: 72 hours
    • Expedited review: 24 hours if urgent
    • May request additional information
  5. Pharmacy Setup (If Approved)
    • Contact CenterWell or PANTHERx Rare
    • Complete patient registration
    • Schedule delivery and training
    • Timeline: 3-5 business days
  6. Treatment Initiation
    • First injection under medical supervision
    • Monitor for anaphylaxis reactions
    • Establish ongoing monitoring plan

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Adult-onset HPP claimed Submit pediatric medical records, growth charts, early symptom documentation
Insufficient genetic testing Provide ALPL mutation analysis with pathogenic/likely pathogenic variants
Inadequate clinical severity Document major/minor criteria with imaging, functional assessments
Dosing above label Justify escalation with clinical response data, specialist consultation
Alternative treatments not tried Explain lack of approved alternatives for HPP enzyme replacement

Appeals Process for Ohio

Internal Appeals (Humana)

Timeline: File within 65 days of denial notice

Methods:

  • Online: MyHumana member portal
  • Phone: Plan-specific number on denial letter
  • Mail/Fax: Address provided in denial notice

Decision Timeline:

  • Standard: 30 days (Part C), 7 days (Part D)
  • Expedited: 72 hours if urgent

External Review (Ohio)

If Humana upholds the denial, Ohio residents can request external review through the Ohio Department of Insurance:

Timeline: 180 days from final internal denial Process: Submit request to your health plan, which notifies Ohio DOI Review: Independent Review Organization (IRO) conducts medical necessity review Decision: Binding on insurer if overturned

Contact: Ohio Department of Insurance Consumer Services

From Our Advocates: "We've seen strongest appeal success when families submit a comprehensive timeline showing symptom progression from early childhood, paired with current functional limitations and specialist recommendations. The key is connecting historical evidence to current medical necessity - payers want to see the complete clinical picture."

Cost Considerations

Strensiq Pricing: Annual costs range from $890,000 to $4.9 million depending on weight and dosing requirements.

Humana Cost-Sharing: As Tier 4 specialty drug, expect higher copays/coinsurance. Medicare Advantage plans have annual out-of-pocket maximums ($3,400-$8,850 range).

Financial Assistance:

  • Alexion patient support programs
  • State pharmaceutical assistance programs
  • Nonprofit rare disease foundations
  • Manufacturer copay assistance (eligibility restrictions may apply)

When to Escalate

Contact Ohio Department of Insurance if:

  • Humana delays responses beyond required timelines
  • Denial reasons seem inconsistent with policy
  • External review request is improperly rejected
  • Need help understanding appeal rights

UHCAN Ohio (Universal Health Care Action Network) provides consumer assistance for complex insurance issues.

FAQ

How long does Humana prior authorization take for Strensiq in Ohio? Standard review is 72 hours; expedited review is 24 hours if delay could harm your health. Contact provider services at 800-867-6601 to request expedited review.

What if Strensiq is not on my Humana formulary? Request a formulary exception by submitting medical necessity documentation. Include genetic testing, clinical severity evidence, and lack of therapeutic alternatives.

Can I appeal if I'm denied for adult-onset HPP? Yes, but focus your appeal on documenting pediatric symptom onset. Gather childhood medical records, growth charts, and early developmental concerns to establish pediatric-onset disease.

Does step therapy apply to Strensiq? No approved alternatives exist for HPP enzyme replacement therapy, so traditional step therapy doesn't apply. However, payers may require documentation that supportive care measures were insufficient.

How do I find a specialty pharmacy in Ohio? Use Humana's pharmacy finder or contact CenterWell Specialty Pharmacy at 1-800-486-2668. PANTHERx Rare Pharmacy also specializes in Strensiq distribution.

What happens during external review in Ohio? An Independent Review Organization (IRO) of medical experts reviews your case independently. The process takes up to 30 days (72 hours if expedited), and their decision is binding on Humana.


About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies navigate insurance denials for prescription drugs. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that turn denials into approvals. We specialize in complex prior authorizations for specialty medications like Strensiq, providing the clinical documentation and regulatory expertise needed for successful outcomes.

For additional support with your Strensiq appeal, Counterforce Health can help identify the specific denial basis and draft point-by-point rebuttals aligned to Humana's own coverage policies, increasing your chances of approval.

Sources & Further Reading


This article is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and formularies change frequently; verify current information with official sources.

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