By Counterforce Health Team in Elaprase (idursulfase) —

How to Get Elaprase (Idursulfase) Covered by Humana in Ohio: Prior Authorization Guide and Appeal Process

Answer Box: Getting Elaprase Covered by Humana in Ohio

Humana Medicare Advantage typically requires prior authorization for Elaprase (idursulfase) for Hunter syndrome. First step: Use Humana's Prior Authorization Search Tool to confirm PA requirements for your specific plan. Submit: Confirmed MPS II diagnosis (enzyme deficiency + genetic testing), weight-based dosing calculation (0.5 mg/kg weekly), and infusion monitoring plan. If denied: You have 65 days for internal appeals, then 180 days for Ohio external review. Timeline: Standard PA decisions take up to 30 days; expedited reviews within 72 hours for urgent cases.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Medical Necessity Documentation
  4. Common Denial Reasons & Solutions
  5. Appeals Process in Ohio
  6. Cost Assistance Options
  7. When to Escalate
  8. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for most Humana MA plans PA Search Tool Humana Provider Portal
Confirmed Diagnosis MPS II via enzyme deficiency + genetic testing Lab reports showing low I2S activity Mayo Clinic Labs
Weight-Based Dosing 0.5 mg/kg IV weekly maximum FDA prescribing information FDA Label
Infusion Monitoring Anaphylaxis precautions required Hospital or qualified infusion center Elaprase Prescribing Info
Appeal Deadline 65 days for internal, 180 days for external Denial letter instructions Ohio DOI

Step-by-Step: Fastest Path to Approval

1. Verify Your Plan's Requirements

Who: Patient or clinic staff
Action: Check if your specific Humana plan requires PA using their search tool
Timeline: 5 minutes
Note: Medicare Advantage PFFS plans may not require PA, but notification is still requested

2. Gather Diagnostic Documentation

Who: Treating physician
Required documents:

  • Lab report showing deficient iduronate-2-sulfatase (I2S) enzyme activity
  • Genetic testing confirming IDS gene mutation
  • Elevated urinary glycosaminoglycans (dermatan + heparan sulfate)
  • Clinical assessment documenting MPS II manifestations

Timeline: May take 2-4 weeks if tests need to be ordered

3. Calculate Weight-Based Dosing

Who: Prescribing physician
Formula: Patient weight (kg) × 0.5 mg/kg = weekly dose
Example: 25 kg patient = 12.5 mg weekly (6.25 mL of 2 mg/mL solution)
Source: FDA prescribing information

4. Develop Infusion Monitoring Plan

Who: Treating physician
Requirements:

  • Site with resuscitation equipment and trained staff
  • Anaphylaxis monitoring protocol
  • Pre-medication plan if indicated
  • Post-infusion observation period

5. Submit Prior Authorization

Who: Provider's office
Method: Humana provider portal or designated PA system
Include: All diagnostic reports, weight-based dosing calculation, monitoring plan, medical necessity letter
Timeline: Submit at least 2 weeks before planned treatment start

6. Track Your Request

Who: Patient and provider
Action: Call Humana member services (number on insurance card) to confirm receipt and status
Timeline: Standard decisions within 30 days; expedited within 72 hours for urgent cases

7. Prepare for Potential Appeal

Who: Provider and patient
Action: If denied, review denial reason and gather additional evidence before 65-day internal appeal deadline
Resources: Ohio external review available within 180 days of final denial

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

✓ Confirmed MPS II diagnosis with enzyme and genetic testing results
✓ Clinical manifestations (organomegaly, joint contractures, airway disease, cardiac involvement)
✓ Weight-based dosing calculation showing compliance with 0.5 mg/kg weekly limit
✓ Treatment rationale explaining why ERT is medically necessary
✓ Monitoring plan addressing anaphylaxis risk and infusion safety
✓ Expected outcomes and plan for assessing treatment response

Key Elements to Include

Diagnosis Confirmation: "Hunter syndrome (MPS II) confirmed by markedly reduced iduronate-2-sulfatase activity (<5% of normal) and pathogenic IDS gene mutation [specify variant]. Urinary GAG analysis shows elevated dermatan and heparan sulfate consistent with MPS II."

Medical Necessity Rationale: "Elaprase is the only FDA-approved enzyme replacement therapy for Hunter syndrome. Without treatment, progressive accumulation of glycosaminoglycans leads to irreversible multi-organ damage including cardiac, respiratory, and skeletal complications."

Dosing Justification: "Requested dose of [X] mg weekly (0.5 mg/kg based on current weight of [Y] kg) is within FDA-labeled dosing and payer policy limits."

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Incomplete diagnostic workup Submit full testing panel Enzyme assay + genetic testing + GAG levels
Missing infusion monitoring plan Provide detailed safety protocol Site capabilities, staff training, emergency procedures
Dosing exceeds policy limits Recalculate and document Current weight, dose calculation showing ≤0.5 mg/kg
Experimental/investigational Emphasize FDA approval FDA label, prescribing information, clinical guidelines
Step therapy not completed Document contraindications No alternative ERTs exist for MPS II

Appeals Process in Ohio

Internal Appeals with Humana

Timeline: 65 days from denial notice
Process: Submit written appeal with additional clinical evidence
Expedited option: Available for urgent medical situations (72-hour decision)
Contact: Use member services number on insurance card

Ohio External Review

Eligibility: After exhausting internal appeals
Timeline: 180 days from final adverse determination
Process: Request through health plan, randomly assigned to Independent Review Organization (IRO)
Cost: Free to patient
Decision timeline: 30 days standard, 72 hours expedited
Binding: Yes, on the insurer

How to file: Submit written request to your health plan, which forwards to Ohio Department of Insurance. You have 10 business days after IRO assignment to submit additional evidence.

Contact for help: Ohio Department of Insurance Consumer Hotline: 1-800-686-1526

Cost Assistance Options

Manufacturer Support

  • Takeda Patient Support: Financial assistance programs may be available
  • Copay assistance: Check eligibility for commercial insurance plans
  • Patient access programs: Support with prior authorization process

Foundation Grants

  • National Organization for Rare Disorders (NORD): Patient assistance programs
  • HealthWell Foundation: Copay assistance for eligible patients
  • Patient Advocate Foundation: Financial aid and insurance appeals support

State Resources

  • Ohio Medicaid: May cover Elaprase for eligible patients
  • Bureau for Children with Medical Handicaps: Ohio program for children with chronic conditions

When to Escalate

Contact the Ohio Department of Insurance if:

  • Your health plan refuses to process an external review request
  • Appeal deadlines are not being honored
  • You're experiencing procedural violations during the review process

Ohio Department of Insurance
Consumer Services Division
Phone: 1-800-686-1526
Website: insurance.ohio.gov

For urgent situations where delay could seriously jeopardize health, request expedited review at every level and clearly document the medical urgency.

FAQ

Q: How long does Humana prior authorization take for Elaprase in Ohio?
A: Standard PA decisions take up to 30 days. Expedited reviews for urgent medical situations must be decided within 72 hours. Submit requests 2-3 weeks before planned treatment start.

Q: What if Elaprase is not on Humana's formulary?
A: Request a formulary exception based on medical necessity. Since no alternative ERTs exist for Hunter syndrome, this strengthens your case for coverage despite non-formulary status.

Q: Can I request an expedited appeal if my initial PA is denied?
A: Yes, if delaying treatment would seriously jeopardize your health or ability to regain maximum function. Document the medical urgency clearly in your appeal.

Q: Does Ohio's external review apply to all Humana plans?
A: Ohio external review applies to state-regulated plans. Self-funded employer plans are governed by federal ERISA law, though many voluntarily use similar review processes.

Q: What happens if the external review upholds the denial?
A: The IRO decision is binding on the insurer. If denied, you retain rights to pursue other remedies such as regulatory complaints or legal action, but external review is typically the final administrative step.

Q: How much does Elaprase cost without insurance coverage?
A: The wholesale acquisition cost is approximately $3,230 per 6mg vial as of 2025. Most patients require 1-3 vials per weekly infusion depending on weight.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Elaprase. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that address each payer's requirements. For patients and clinicians navigating the prior authorization process, we provide templates and guidance that can significantly improve approval rates for life-saving treatments.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Insurance coverage decisions vary by plan and individual circumstances. Always consult with your healthcare provider and insurance plan for specific coverage requirements and appeal procedures. For questions about Ohio insurance regulations, contact the Ohio Department of Insurance at 1-800-686-1526.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.