By Counterforce Health Team in Strensiq (asfotase alfa) —

How to Get Strensiq (Asfotase Alfa) Covered by Humana in Virginia: PA Forms, Appeals, and Approval Strategy

Answer Box: Getting Strensiq Covered by Humana in Virginia

Strensiq (asfotase alfa) requires prior authorization from Humana for pediatric-onset hypophosphatasia (HPP). The fastest path: 1) Confirm genetic testing shows pathogenic ALPL mutation, 2) Document persistently low age-adjusted alkaline phosphatase levels, 3) Submit PA request through Humana's provider portal with complete clinical documentation. Start today by gathering genetic test results, ALP lab values, and clinical notes showing HPP symptoms. Appeals must be filed within 65 days if denied.

Table of Contents

Plan Types & Coverage Implications

Humana operates primarily Medicare Advantage (Part C) and Medicare Part D plans in Virginia, with some commercial offerings. Your plan type affects your appeal rights and timelines:

  • Medicare Advantage (Part C): Covers Strensiq as a medical benefit when administered by healthcare providers. Appeals must be filed within 65 days of denial.
  • Medicare Part D: Covers self-administered specialty drugs through pharmacy benefit. Same 65-day appeal deadline applies.
  • Commercial Plans: Follow Virginia state insurance regulations for external review after internal appeals are exhausted.
Note: Humana's PA denial rate is approximately 3.5% for Medicare Advantage—among the lowest of major insurers—but denials often involve documentation gaps rather than medical necessity disputes.

Formulary Status & Tier Placement

Strensiq is not explicitly listed in publicly available Humana formulary documents, which is common for ultra-rare disease therapies. Based on current formulary guidance, specialty biologics like Strensiq typically fall under:

  • Tier 4 or 5: Specialty medications requiring prior authorization
  • Non-formulary status: Requiring formulary exception requests
  • Limited distribution: Must be dispensed through approved specialty pharmacies

To verify current status: Contact Humana member services or check your plan's formulary through MyHumana portal (verify with the source linked).

Prior Authorization Requirements

Medical Necessity Criteria

Humana requires comprehensive documentation for pediatric-onset HPP, aligned with FDA labeling requirements:

Requirement Documentation Needed Where to Find
Genetic Confirmation Pathogenic/likely pathogenic ALPL mutation Genetic testing report
Biochemical Evidence Persistently low age-adjusted ALP levels Serial lab results
Substrate Elevation Elevated PLP and/or PEA levels Specialized lab testing
Clinical Features Early tooth loss, bone deformities, growth delays Clinical notes, dental records
Age of Onset Symptoms before age 18 Medical history documentation
Specialist Evaluation Assessment by geneticist or endocrinologist Consultation notes

Dosing Limits

Humana covers FDA-approved dosing:

  • Perinatal/Infantile-onset: Up to 9 mg/kg/week (standard 6 mg/kg/week)
  • Juvenile-onset: Up to 6 mg/kg/week maximum
  • Weight-based calculations: Total weekly dose = patient weight (kg) × prescribed mg/kg/week

Specialty Pharmacy Network

Strensiq distribution is managed exclusively through PANTHERx Rare, Alexion's contracted specialty pharmacy, rather than Humana's CenterWell Specialty Pharmacy. Based on manufacturer guidance:

Patient Enrollment Process

  1. Prescription: Provider prescribes directly to PANTHERx Rare
  2. Benefit Investigation: PANTHERx conducts coverage verification with Humana
  3. Prior Authorization: PANTHERx coordinates PA submission with clinical documentation
  4. Patient Support: Enrollment in Alexion OneSource™ program for injection training and financial assistance
  5. Home Delivery: Direct shipping with 24/7 patient support
Important: Do not route prescriptions through CenterWell Specialty Pharmacy or other networks—Strensiq requires manufacturer's designated distribution channel.

Cost-Share Dynamics

Strensiq carries substantial cost implications, with annual treatment costs potentially exceeding $1-4 million depending on patient weight and dosing. Cost-sharing varies by plan type:

  • Medicare Part D: Subject to specialty tier coinsurance (typically 25-33%)
  • Medicare Advantage: May have different cost-sharing structure
  • Commercial Plans: Vary widely in specialty drug coverage

Financial Assistance Options:

  • Alexion OneSource™: Copay assistance and patient support programs
  • Foundation Grants: Various rare disease foundations offer assistance
  • Humana's Patient Assistance: CenterWell Specialty helps identify assistance programs

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Clinic)
    • Genetic test results showing pathogenic ALPL mutation
    • Serial ALP lab values (age-adjusted reference ranges)
    • PLP/PEA elevation results
    • Clinical notes documenting HPP features
    • Timeline: 1-2 weeks
  2. Complete PA Request (Provider)
    • Submit through Humana provider portal
    • Include weight-based dosing calculations
    • Attach specialist consultation notes
    • Timeline: 1-2 business days
  3. Coordinate with PANTHERx (Provider/Patient)
    • Send prescription to PANTHERx Rare specialty pharmacy
    • Enroll patient in OneSource™ support program
    • Timeline: 3-5 business days
  4. Humana Review (Automatic)
    • Standard PA review: 7 days for Part D, 30 days for Part C
    • Expedited review available: 72 hours if medically urgent
    • Timeline: Variable based on request type
  5. Appeal if Denied (Patient/Provider)
    • File within 65 days of denial notice
    • Submit additional clinical documentation
    • Request peer-to-peer review if needed
    • Timeline: 65-day deadline to initiate

Common Approval Patterns

Strong submissions typically include:

  • Comprehensive genetic report with clear pathogenic classification
  • Multiple ALP measurements showing consistent low values with pediatric reference ranges
  • Photographic evidence of clinical features (dental, skeletal abnormalities)
  • Growth charts demonstrating failure to thrive or delayed milestones
  • Specialist attestation confirming diagnosis and treatment necessity
  • Exclusion of alternatives documenting why supportive care alone is insufficient

Clinician Corner: Medical Necessity Letter Checklist

✓ Problem Statement: Clear diagnosis of pediatric-onset HPP with onset age
✓ Genetic Evidence: ALPL mutation classification and laboratory details
✓ Biochemical Confirmation: ALP levels with age-appropriate reference ranges
✓ Clinical Manifestations: Specific HPP features observed in patient
✓ Treatment Rationale: Why Strensiq is medically necessary vs. supportive care
✓ Dosing Justification: Weight-based calculations within FDA-approved limits
✓ Monitoring Plan: How treatment response will be assessed

Appeals Process in Virginia

Internal Appeals (Humana)

Timeline and Process:

  • Deadline: 65 days from denial notice for both Part C and Part D
  • Standard Review: 7 days (Part D), 30 days (Part C pre-service)
  • Expedited Review: 72 hours if waiting could harm health
  • Submission: Online through member portal, phone, fax, or mail

External Review (Virginia)

After exhausting Humana's internal appeals, Virginia residents can request external review through the State Corporation Commission Bureau of Insurance:

Key Features:

  • Deadline: 120 days from final internal denial
  • Process: Independent Review Organization (IRO) conducts medical necessity review
  • Timeline: 45 days standard, 72 hours expedited for urgent cases
  • Cost: Free to consumers
  • Decision: Binding on insurer if overturned

Contact Information:

From Our Advocates: "We've seen several HPP cases succeed at external review when the initial PA focused too heavily on cost rather than medical necessity. One family's case was overturned when the IRO pediatric endocrinologist recognized that the child's progressive skeletal deterioration met clear treatment criteria, despite the plan's cost concerns. The key was submitting updated imaging showing disease progression during the appeal period."

FAQ

How long does Humana PA take for Strensiq in Virginia?
Standard PA review takes 7 days for Part D, 30 days for Part C. Expedited review available within 72 hours if medically urgent.

What if Strensiq is non-formulary on my Humana plan?
Submit formulary exception request with medical necessity documentation. Non-formulary status doesn't prevent coverage if medically necessary.

Can I request expedited appeal for Strensiq denial?
Yes, if waiting for standard review could seriously harm health. Contact Humana provider services at 800-867-6601 to request expedited review.

Does step therapy apply to Strensiq?
No established step therapy for HPP since Strensiq is the only FDA-approved disease-modifying therapy. However, documentation of supportive care limitations may be required.

What happens if I move from Virginia while on Strensiq?
Coverage continues under your Humana plan, but external review rights may change based on new state regulations. Contact member services for guidance.

How do I prove pediatric onset if I'm now an adult?
Gather childhood medical records, dental records showing early tooth loss, family history, and genetic counseling documentation of symptom timeline.

Can my doctor request peer-to-peer review?
Yes, providers can request clinical discussion with Humana's medical director during the PA or appeal process to clarify medical necessity.

What if PANTHERx Rare isn't in my network?
Strensiq's limited distribution through PANTHERx is typically covered as an exception. Humana should process as in-network when medically necessary.

Getting specialized help with complex insurance appeals can make a significant difference in approval success rates. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific requirements. Their platform pulls the right citations for medications like Strensiq—FDA labeling, peer-reviewed studies, and specialty guidelines—and weaves them into appeals with required clinical facts and payer-specific procedural requirements.

For patients navigating Humana's PA process for Strensiq, having expert support can be invaluable when dealing with the complex documentation requirements for rare disease therapies. Counterforce Health specializes in these exact scenarios, helping ensure that appeals meet both medical necessity standards and procedural requirements while tracking deadlines and required attachments.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan specifics, and medical necessity determinations. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional support with Virginia insurance issues, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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