By Counterforce Health Team in Elaprase (idursulfase) —

How to Get Elaprase (idursulfase) Covered by UnitedHealthcare in Washington: Prior Authorization Guide and Appeal Process

Answer Box: Getting Elaprase (idursulfase) Covered in Washington

To get Elaprase (idursulfase) approved by UnitedHealthcare in Washington, you need: (1) prior authorization with genetic/enzymatic confirmation of Hunter syndrome (MPS II), (2) weight-based dosing calculations, and (3) an infusion monitoring plan. If denied, Washington gives you 60 days to request external review by an independent organization. Start today: Contact your doctor to submit the PA request through the UnitedHealthcare provider portal at uhcprovider.com, ensuring all required documentation is included.

Table of Contents

Why Washington State Rules Matter

Washington's insurance laws provide stronger consumer protections than many states, especially for rare disease medications like Elaprase (idursulfase). Under RCW 48.43.535, you have the right to independent external review after internal appeals are exhausted. The state also mandates specific timelines for prior authorization decisions and step therapy exceptions.

These protections apply to fully-insured plans purchased through Washington Healthplanfinder or employer-sponsored plans. However, self-funded employer plans (governed by federal ERISA law) may have different appeal processes, though many voluntarily follow Washington's standards.

Note: UnitedHealthcare operates both Medicare Advantage and commercial plans in Washington. Medicare Advantage follows federal Medicare rules, while commercial plans must comply with Washington state law.

UnitedHealthcare Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Documentation Needed Timeline
Prior Authorization Required for all Elaprase prescriptions PA form via provider portal 3-5 calendar days
Genetic Testing Confirmed Hunter syndrome diagnosis Enzymatic assay or genetic test results Must be current
Weight-Based Dosing 0.5 mg/kg weekly IV infusion Patient weight, BSA calculations Updated quarterly
Infusion Plan Site of care and monitoring protocol Infusion center details, safety measures Before first dose

UnitedHealthcare requires prior authorization for Elaprase through OptumRx. The medication is typically placed on a specialty tier with higher cost-sharing. Based on recent data, UnitedHealthcare's prior authorization denial rate for specialty medications runs approximately 9% for Medicare Advantage plans, though commercial plan rates may vary.

Medical Necessity Criteria

Your doctor must demonstrate:

  • Confirmed diagnosis of Hunter syndrome (MPS II) through enzymatic or genetic testing
  • Appropriate candidate for enzyme replacement therapy
  • Weight-based dosing calculations (0.5 mg/kg weekly)
  • Infusion monitoring plan with qualified healthcare facility
  • Documentation that patient can tolerate IV infusions

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Family)
    • Insurance card and member ID
    • Complete medical records confirming Hunter syndrome diagnosis
    • Previous treatment history and outcomes
    • Current weight and vital signs
  2. Submit Prior Authorization (Healthcare Provider)
    • Access UnitedHealthcare Provider Portal
    • Complete PA request with all required documentation
    • Include genetic/enzymatic test results and weight-based dosing
    • Timeline: 3 calendar days for electronic submissions
  3. Include Clinical Evidence (Healthcare Provider)
    • FDA labeling for Elaprase showing approved indication
    • Clinical guidelines from medical societies
    • Patient-specific medical necessity rationale
    • Infusion site capabilities and monitoring plan
  4. Track Status (Patient/Provider)
    • Monitor through provider portal or call OptumRx at 800-310-6826
    • Expect decision within 3-5 calendar days
    • Request expedited review if urgent (1 calendar day)
  5. If Approved (Patient)
    • Coordinate with specialty pharmacy for delivery
    • Schedule infusion appointments
    • Understand cost-sharing responsibilities
  6. If Denied (Patient/Provider)
    • Review denial letter for specific reasons
    • Prepare internal appeal within 180 days
    • Gather additional supporting documentation
  7. Appeal if Necessary (Patient/Provider)
    • Submit internal appeal with new evidence
    • Request peer-to-peer review if available
    • Escalate to external review if internal appeals fail

Washington's Appeal Timeline Standards

Washington law sets specific timeframes for prior authorization decisions under WAC 284-43A-010:

Prior Authorization Timelines

Submission Type Standard Review Expedited Review
Electronic 3 calendar days 1 calendar day
Non-electronic 5 calendar days 2 calendar days

Appeal Deadlines

  • Internal Appeals: 180 days from denial notice
  • External Review: 60 days from final internal denial
  • Expedited External Review: 72 hours for urgent cases

For Hunter syndrome patients, expedited review may be appropriate if delaying treatment could cause serious deterioration in health status or ability to regain maximum function.

Step Therapy Protections in Washington

Washington provides stronger step therapy protections than federal minimums. Under state law, you can request an exception to step therapy requirements if:

  • You've previously tried and failed the required first-line therapy
  • The first-line drug is contraindicated or likely to cause adverse reactions
  • You're currently stable on the prescribed medication (continuity of care)
  • The first-line therapy is not in your best medical interest

Since Elaprase is the only FDA-approved enzyme replacement therapy for Hunter syndrome, step therapy typically doesn't apply. However, insurers may still require documentation that supportive care alone is insufficient.

Medical Exception Process

Your doctor can request a step therapy exception by:

  1. Documenting medical contraindications to alternatives
  2. Providing evidence of previous treatment failures
  3. Citing clinical guidelines supporting Elaprase as first-line therapy
  4. Demonstrating urgent medical need

Continuity of Care Rights

If you're switching to a UnitedHealthcare plan while already receiving Elaprase, Washington law provides continuity protections:

  • 90-day transition period for ongoing treatments
  • No interruption in therapy during plan transition
  • Same cost-sharing as your previous plan during transition

To invoke continuity rights:

  1. Notify UnitedHealthcare within 30 days of enrollment
  2. Provide documentation of current treatment
  3. Request continuation of existing therapy
  4. Work with your provider to submit ongoing PA request

External Review Process

When internal appeals fail, Washington's external review process provides an independent evaluation of your case.

Eligibility Requirements

You can request external review if:

  • You've exhausted internal appeals (or insurer missed deadlines)
  • The denial involves medical necessity or experimental treatment
  • You submit within 60 days of final internal denial
  • Your case involves covered services under your plan

How to Request External Review

  1. Submit Written Request to UnitedHealthcare within 60 days
  2. Include New Evidence not previously submitted
  3. UnitedHealthcare Assigns certified Independent Review Organization (IRO)
  4. You Have 5 Business Days to submit additional information to IRO
  5. IRO Decision within 20 days (fully-insured) or 45 days (self-insured)
Expedited Review: If your health could be seriously jeopardized by waiting, request expedited external review. The IRO must decide within 72 hours.

The IRO's decision is binding on UnitedHealthcare. If they overturn the denial, your insurer must provide coverage.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit clinical evidence and guidelines FDA labeling, peer-reviewed studies, specialist letter
"Missing genetic confirmation" Provide enzymatic or genetic testing Lab results confirming iduronate-2-sulfatase deficiency
"Inappropriate dosing" Recalculate based on current weight Updated weight, BSA, dosing calculations
"No infusion plan" Detail monitoring and safety protocols Infusion center credentials, emergency procedures
"Experimental/investigational" Cite FDA approval and clinical use FDA labeling showing approved indication

Appeals Playbook for UnitedHealthcare

Internal Appeals

Level 1: Standard Internal Appeal

  • Deadline: 180 days from denial
  • Timeline: 30 days for decision (15 days for urgent)
  • How to Submit: Provider portal, mail, or fax
  • Required: Completed appeal form, clinical documentation, member authorization

Level 2: Second Internal Appeal (if available)

  • Deadline: 60 days from Level 1 denial
  • Timeline: 30 days for decision
  • Include: Additional clinical evidence, peer-reviewed literature, specialist consultation

External Review

Standard External Review

  • Deadline: 60 days from final internal denial
  • Timeline: 20 days for decision (fully-insured plans)
  • Cost: Free to patient
  • Outcome: Binding on UnitedHealthcare

Expedited External Review

  • When: Urgent medical situations
  • Timeline: 72 hours for decision
  • Trigger: Serious jeopardy to health, life, or ability to regain function

When to Escalate to State Regulators

Contact the Washington Office of the Insurance Commissioner if:

  • UnitedHealthcare misses appeal deadlines
  • You suspect unfair claim practices
  • The external review process isn't working properly
  • You need help navigating the appeals process

Washington OIC Consumer Advocacy: 1-800-562-6900
Website: insurance.wa.gov

The OIC provides template appeal letters and can investigate complaints about insurer practices. They also certify the Independent Review Organizations and monitor their performance.

Costs & Patient Assistance

Elaprase costs approximately $3,230 per 6mg vial (based on recent WAC pricing), with most patients requiring multiple vials per infusion based on weight.

Financial Assistance Options

Takeda Patient Assistance Program

  • Income-based eligibility
  • May cover copays and coinsurance
  • Contact: Takeda Oncology Patient Support at 1-844-617-6468

Specialty Pharmacy Support

  • Many specialty pharmacies offer copay assistance
  • Financial counselors help navigate insurance coverage
  • Prior authorization support services

Washington State Programs

  • Apple Health (Medicaid) may provide coverage for eligible patients
  • Washington Healthplanfinder for marketplace plan options
From Our Advocates: "We've seen families successfully appeal Elaprase denials by emphasizing the lack of therapeutic alternatives and providing detailed documentation of disease progression. The key is demonstrating that enzyme replacement therapy is the standard of care for Hunter syndrome, not an experimental treatment."

FAQ

How long does UnitedHealthcare prior authorization take in Washington? Electronic submissions: 3 calendar days for standard review, 1 calendar day for expedited. Non-electronic: 5 calendar days standard, 2 days expedited.

What if Elaprase is non-formulary on my plan? You can request a formulary exception with clinical documentation showing medical necessity. Since there's no FDA-approved alternative for Hunter syndrome, exceptions are often granted.

Can I request an expedited appeal? Yes, if delaying treatment could seriously jeopardize your health. Expedited external review decisions come within 72 hours.

Does step therapy apply to Elaprase? Typically no, since it's the only approved enzyme replacement therapy for Hunter syndrome. However, insurers may require documentation that supportive care alone is insufficient.

What happens during the external review process? An independent medical expert reviews your case and makes a binding decision. If they overturn the denial, UnitedHealthcare must provide coverage.

Can my doctor request a peer-to-peer review? Yes, many UnitedHealthcare policies allow peer-to-peer discussions between your doctor and the insurer's medical director before or during appeals.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes. Their platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific insurer requirements. For rare disease medications like Elaprase, having the right clinical documentation and appeals strategy can make the difference between approval and prolonged delays in treatment.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For personalized help with appeals and prior authorization, consider working with organizations like Counterforce Health that specialize in navigating insurance coverage challenges.

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