By Counterforce Health Team in Elaprase (idursulfase) —

How to Get Elaprase (idursulfase) Covered by Cigna in Ohio: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Elaprase Covered by Cigna in Ohio

Cigna requires prior authorization for Elaprase (idursulfase) with no step therapy alternatives. To get approved in Ohio: 1) Submit PA with enzymatic and genetic test results confirming Hunter syndrome (MPS II), 2) Include specialist prescription with weight-based dosing (0.5 mg/kg weekly), and 3) Provide infusion monitoring plan. If denied, file internal appeal within 180 days, then request external review through Ohio Department of Insurance. Start today: Call Cigna at the number on your insurance card to request PA forms or submit through your provider's portal.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Always required, no exceptions Cigna PA Policy
Step Therapy Not required (Elaprase is only FDA-approved ERT for MPS II) Same policy document
Diagnosis Confirmation Enzymatic testing + genetic testing required FDA label requirements
Specialist Prescription Must be prescribed by or with MPS specialist Cigna coverage criteria
Weight-Based Dosing 0.5 mg/kg IV weekly FDA prescribing information
Infusion Monitoring Plan required for adverse reaction management Cigna specialty drug requirements
Appeals Deadline 180 days from denial (Ohio) Ohio DOI External Review

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: Patient and healthcare team
Timeline: 1-2 weeks before PA submission

Collect these essential documents:

  • Enzymatic test results showing iduronate-2-sulfatase deficiency
  • Genetic testing confirming IDS gene mutation
  • Current weight for dosing calculations
  • Specialist consultation notes or referral

2. Submit Prior Authorization

Who: Prescribing physician or clinic staff
Timeline: Submit immediately once documents are ready

Submit through:

  • CoverMyMeds portal (fastest)
  • Cigna provider portal
  • Fax to specialty pharmacy PA line (verify current number with Cigna)

3. Include Complete Clinical Package

Who: Healthcare provider
What to attach:

  • Completed PA form with all required fields
  • Lab results and genetic testing reports
  • Specialist attestation letter
  • Weight-based dosing calculations
  • Infusion center information and monitoring protocols

4. Track Your Request

Who: Patient or clinic
Timeline: Check status after 72 hours

Call Cigna member services or check provider portal for:

  • PA reference number
  • Review status
  • Additional information requests
  • Expected decision timeline

5. If Approved: Coordinate Care

Who: Patient, clinic, and specialty pharmacy
Next steps:

  • Confirm coverage with Accredo or designated specialty pharmacy
  • Schedule infusion appointments
  • Verify prior authorization number for billing

6. If Denied: Begin Appeals Process

Who: Patient with provider support
Timeline: Must start within 180 days

  • Review denial letter for specific reasons
  • Gather additional supporting evidence
  • File internal appeal with Cigna
  • Prepare for external review if needed

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Insufficient diagnostic evidence" Submit complete test results Enzymatic assay results + genetic testing
"Not prescribed by appropriate specialist" Get specialist consultation Letter from geneticist, metabolic specialist, or endocrinologist
"Incorrect dosing" Recalculate based on current weight 0.5 mg/kg weekly with weight documentation
"Missing infusion monitoring plan" Provide detailed safety protocols Infusion center policies, emergency procedures
"Lack of medical necessity" Submit comprehensive clinical rationale Treatment goals, expected outcomes, disease progression data
Tip: Cigna's internal appeals have a higher success rate when additional clinical evidence addresses the specific denial reason. Don't just resubmit the same documents.

Appeals Process for Cigna in Ohio

Internal Appeals (First Level)

  • Deadline: 180 days from denial date
  • Timeline: Decision within 30 days (expedited: 72 hours for urgent cases)
  • How to file: Call Cigna member services or submit written appeal
  • Required: Copy of denial letter, additional supporting evidence, member statement

Internal Appeals (Second Level)

  • Automatic: If first level is denied
  • Timeline: Additional 30 days for review
  • Review: Independent medical reviewers not involved in original decision

External Review (Ohio Department of Insurance)

  • When: After exhausting internal appeals
  • Deadline: 180 days from final internal denial
  • Cost: Free to patients
  • Process: Independent Review Organization (IRO) conducts medical review
  • Timeline: 30 days standard, 72 hours expedited
  • Contact: Ohio Department of Insurance Consumer Services at 1-800-686-1526
Ohio Advantage: Even if Cigna claims your case isn't eligible for external review, the Ohio Department of Insurance can independently determine eligibility and order a review.

Clinician Corner: Medical Necessity Documentation

Essential Elements for PA Success

Diagnosis Documentation:

  • Enzymatic testing: Iduronate-2-sulfatase activity levels
  • Genetic testing: IDS gene mutation analysis
  • Clinical presentation consistent with Hunter syndrome
  • ICD-10 code: E76.1 (Mucopolysaccharidosis II)

Treatment Rationale:

  • Current disease manifestations and progression
  • Treatment goals (organ size reduction, improved mobility, respiratory function)
  • Expected clinical benefits based on patient phenotype
  • Monitoring plan for treatment response

Specialist Attestation Should Include:

  • Board certification in relevant specialty
  • Experience treating Hunter syndrome/MPS disorders
  • Clinical assessment of patient's need for ERT
  • Dosing rationale: 0.5 mg/kg weekly IV infusion

Supporting Evidence:

Billing Codes: Use HCPCS J1743 for Elaprase administration and appropriate infusion codes for reimbursement.

Cost Assistance and Support Programs

Manufacturer Support

  • Elaprase CARE Program: Patient assistance and copay support
  • Contact: 1-866-435-2773
  • Eligibility: Income-based qualification, insurance coverage requirements
  • Services: Copay cards, patient assistance program, infusion support

Foundation Assistance

  • National MPS Society: Emergency financial assistance
  • HealthWell Foundation: Copay assistance for rare diseases
  • Patient Access Network: MPS-specific grants

Ohio State Resources

  • Ohio Medicaid: Coverage for eligible patients
  • UHCAN Ohio: Consumer advocacy and assistance navigating appeals
  • Contact: Verify current programs through Ohio Department of Insurance

Frequently Asked Questions

How long does Cigna prior authorization take in Ohio? Standard PA decisions are made within 72 hours to 5 business days. Expedited reviews (for urgent medical situations) are completed within 24 hours.

What if Elaprase is non-formulary on my Cigna plan? Elaprase requires PA but is typically covered as a specialty drug. If listed as non-formulary, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal in Ohio? Yes, expedited appeals are available if a delay would seriously jeopardize your health. Both Cigna internal appeals and Ohio external reviews offer expedited timelines.

Does step therapy apply to Elaprase? No. Elaprase is the only FDA-approved enzyme replacement therapy for Hunter syndrome, so Cigna doesn't require trying alternative treatments first.

What happens if I move from another state to Ohio? Your Cigna coverage terms remain the same, but Ohio's external review process will apply to any appeals. Contact the Ohio Department of Insurance for state-specific appeal rights.

How much does Elaprase cost without insurance? The wholesale acquisition cost is approximately $3,229.90 per 6 mg vial (as of June 2025), with patients typically requiring multiple vials per infusion based on weight.

Can my pediatrician prescribe Elaprase? While pediatricians can technically prescribe Elaprase, Cigna requires prescription by or consultation with a specialist experienced in treating Hunter syndrome for PA approval.

When to Contact Ohio Regulators

Contact the Ohio Department of Insurance if:

  • Cigna improperly denies your external review request
  • Appeals deadlines are not being met
  • You need help understanding your appeal rights
  • You suspect improper claim handling practices

Consumer Hotline: 1-800-686-1526
Online Complaints: Available through ODI website
What to provide: Policy number, denial letters, appeal correspondence, timeline of events

For complex cases involving potential bad faith or regulatory violations, consider contacting UHCAN Ohio or consulting with a healthcare attorney experienced in insurance appeals.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific requirements, pulling the right clinical evidence and citations to support medical necessity arguments.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider. Coverage policies and procedures may change; always verify current requirements with Cigna and Ohio regulators. For personalized assistance with your specific situation, contact Counterforce Health or consult with a healthcare attorney specializing in insurance appeals.

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