By Counterforce Health Team in Aldurazyme (laronidase) —

Aldurazyme (laronidase) Approval with Cigna in Washington: Complete Guide with Forms, Appeals, and Timelines

Answer Box: Getting Aldurazyme Covered by Cigna in Washington

Cigna covers Aldurazyme (laronidase) for MPS I with prior authorization requiring genetic/enzymatic confirmation and specialist involvement. Submit through Cigna's provider portal with completed PA form, genetic test results showing IDUA gene variants or enzyme deficiency, and specialist consultation notes. Standard approval takes 72 hours; expedited reviews complete in 24 hours. If denied, file internal appeal within 180 days, then external review through Washington's Independent Review Organization (IRO) if needed. Start today: Have your specialist gather genetic/enzyme lab reports and complete Cigna's Aldurazyme PA form.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Required Documentation
  4. Timing and Turnaround
  5. Medical Necessity Criteria
  6. Cost Structure
  7. Denials and Appeals
  8. Washington External Review
  9. Specialty Pharmacy Requirements
  10. Troubleshooting Common Issues
  11. FAQ

Coverage Basics

Is Aldurazyme Covered by Cigna?

Yes, Cigna covers Aldurazyme (laronidase) under its Coverage Policy IP0445 for mucopolysaccharidosis type I (MPS I). The drug is typically covered under the medical benefit as an infused specialty medication, not through standard pharmacy benefits.

Which Cigna Plans Cover Aldurazyme?

  • Commercial Cigna plans: Covered under medical benefit with prior authorization
  • Cigna Medicare Advantage: Usually covered as Part B drug with PA requirements
  • Cigna Medicare Part D plans: Listed on formulary with prior authorization requirements
Note: Coverage specifics vary by plan design. Verify your exact benefits through the Cigna member portal or by calling the number on your ID card.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician (typically a geneticist, endocrinologist, or metabolic specialist) must submit the PA request. Cigna requires that Aldurazyme be prescribed by or in consultation with a specialist in lysosomal storage disorders.

Step-by-Step: Fastest Path to Approval

  1. Confirm MPS I diagnosis - Obtain genetic testing showing biallelic pathogenic IDUA variants OR enzyme assay demonstrating α-L-iduronidase deficiency
  2. Schedule specialist consultation - Geneticist, endocrinologist, or metabolic specialist must evaluate and prescribe
  3. Complete PA documentation - Download Cigna's Aldurazyme PA form
  4. Submit through provider portal - Use Cigna's electronic system or CoverMyMeds for fastest processing
  5. Include all supporting documents - Genetic reports, enzyme assays, specialist notes, baseline assessments
  6. Request expedited review if urgent - Mark as expedited if disease progression makes delay risky
  7. Follow up within 72 hours - Standard reviews complete in 3 business days

Required Documentation

Coverage at a Glance

Requirement What It Means Where to Find It Source
Genetic confirmation Biallelic pathogenic IDUA variants Genetic testing lab report Cigna PA criteria
OR enzyme deficiency Low α-L-iduronidase activity Enzyme assay (leukocytes/plasma) Medicare PA requirements
Specialist prescriber Genetics/endocrine/metabolic expert Provider credentials/consultation Cigna formulary
Baseline assessments Pulmonary, cardiac, functional status PFTs, echo, mobility tests Clinical monitoring guidance

Clinician Corner: Medical Necessity Letter Checklist

Your specialist's documentation should include:

  • Confirmed MPS I diagnosis with specific test results (enzyme levels or genetic variants)
  • Clinical manifestations documenting disease severity and organ involvement
  • Treatment rationale explaining why enzyme replacement therapy is medically necessary
  • Baseline assessments including pulmonary function, cardiac status, and functional capacity
  • Monitoring plan for infusion reactions and clinical response
  • Dosing justification based on weight and FDA labeling (0.58 mg/kg weekly IV)

Timing and Turnaround

Standard Review Timeline

  • Complete PA submission: 72 hours for decision
  • Expedited/urgent review: 24 hours when delay may jeopardize health
  • Missing information: Additional 1-3 business days after submission of complete documentation

When to Request Expedited Review

Request expedited processing if:

  • Rapid disease progression is documented
  • Delay in treatment could worsen organ function
  • Patient is experiencing acute complications of MPS I
Tip: Include specific clinical evidence of urgency in your expedited request, such as declining pulmonary function tests or progressive cardiac involvement.

Medical Necessity Criteria

Cigna's Approval Requirements

Based on Cigna's coverage policy, approval requires:

  1. Confirmed MPS I diagnosis through laboratory testing
  2. Moderate to severe symptoms warranting enzyme replacement therapy
  3. Appropriate prescriber (specialist in relevant field)
  4. FDA-approved indication (enzyme replacement therapy for MPS I)
  5. Proper dosing consistent with labeling

Common Denial Reasons & Fixes

Denial Reason How to Overturn
Missing genetic confirmation Submit IDUA gene sequencing results showing pathogenic variants
Insufficient specialist involvement Obtain consultation from geneticist or metabolic specialist
Lack of baseline assessments Provide pulmonary function tests, echocardiogram, functional evaluations
Unclear medical necessity Document specific MPS I manifestations and disease burden
Dosing questions Reference FDA labeling for weight-based dosing (0.58 mg/kg weekly)

Cost Structure

Medicare Advantage vs. Commercial Coverage

Cigna Medicare Advantage:

  • Usually covered under Part B (medical benefit)
  • Typical 20% coinsurance until annual out-of-pocket maximum reached
  • Strong protection against mid-year coverage changes

Cigna Commercial Plans:

  • Medical benefit coverage with plan-specific coinsurance (10-50%)
  • Coinsurance and out-of-pocket maximums vary by employer plan design
  • Less predictable than Medicare standardized benefits

Cost-Saving Options

  • Manufacturer support: Contact Sanofi for patient assistance programs
  • Specialty pharmacy coordination: Accredo may offer copay assistance
  • Foundation grants: Investigate rare disease foundations for financial support
  • Site of care optimization: Home infusion may reduce overall costs vs. hospital outpatient

Denials and Appeals

Appeals Playbook for Cigna in Washington

Internal Appeal (First Level):

  • Deadline: 180 days from denial date
  • How to file: Submit via Cigna member portal or mail to address on denial letter
  • Required documents: Denial letter, additional clinical evidence, specialist attestation
  • Timeline: Varies by plan (typically 30 days for standard, 72 hours for expedited)

External Review (Washington IRO):

  • When to use: After internal appeals are exhausted
  • Deadline: 180 days from final internal denial
  • How to file: Request through Cigna or directly to Washington Office of Insurance Commissioner
  • Cost: Free to patient
  • Timeline: 30 days standard, 72 hours expedited
Washington residents: The state's external review process is particularly strong for rare disease medications. Call the OIC Consumer Advocacy line at 1-800-562-6900 for assistance.

Washington External Review

Independent Review Process

Washington State provides robust protection through its Independent Review Organization (IRO) system. When Cigna denies coverage, you have the right to independent medical review by specialists not employed by the insurer.

Key advantages:

  • Independent medical experts review your case
  • No cost to the patient
  • Binding decision on the insurer if overturned
  • Expedited process available for urgent cases

How to Request External Review

  1. Complete internal appeals with Cigna first
  2. Submit request within 180 days of final denial
  3. Provide medical records supporting medical necessity
  4. Wait for IRO assignment (automatic through state registry)
  5. Receive decision within 30 days (or 72 hours if expedited)

Counterforce Health helps patients navigate complex prior authorization and appeal processes by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and creates point-by-point rebuttals using the right medical evidence and payer-specific requirements.

Specialty Pharmacy Requirements

Accredo and Express Scripts

Cigna typically requires Aldurazyme to be dispensed through Accredo, their specialty pharmacy partner. This ensures:

  • Proper handling of temperature-sensitive medication
  • Infusion coordination with your treatment center
  • Prior authorization support from specialized pharmacists
  • Patient education and monitoring assistance

Enrollment Process

  • Automatic transfer: Your prescription will be transferred to Accredo after PA approval
  • Patient contact: Accredo will call to schedule delivery and provide education
  • Insurance verification: They handle insurance billing and copay assistance programs
  • 24/7 support: Pharmacists and nurses available around the clock

Troubleshooting Common Issues

Portal and System Problems

If Cigna's provider portal is down:

  • Fax PA request to backup number (verify current fax with customer service)
  • Call provider services line for alternative submission methods
  • Document submission attempts for appeal purposes if needed

Missing forms or unclear requirements:

Patient Phone Script for Cigna

"Hello, I'm calling about prior authorization for Aldurazyme for MPS I. My member ID is [ID number]. Can you tell me the status of PA request [reference number if available]? If it's been denied, I'd like to understand the specific reasons and how to file an appeal. I'd also like to confirm the correct forms and submission process for my plan."

FAQ

Q: How long does Cigna PA take in Washington? A: Standard review is 72 hours; expedited review is 24 hours. Complex cases may take longer if additional clinical information is needed.

Q: What if Aldurazyme is non-formulary on my plan? A: Request a formulary exception with clinical justification. Your prescriber must demonstrate medical necessity and why formulary alternatives are inappropriate.

Q: Can I request an expedited appeal? A: Yes, if delay in treatment could seriously jeopardize your health. Both internal and external appeals offer expedited timelines (72 hours vs. standard 30 days).

Q: Does step therapy apply if I've failed treatments outside Washington? A: Prior treatment failures from other states should be documented and submitted as part of your medical history. Cigna generally accepts out-of-state medical records for step therapy documentation.

Q: What happens if my employer changes insurance mid-year? A: Contact your new insurer immediately to initiate PA for continuity of care. Many plans offer temporary coverage during transition periods for ongoing treatments.

Q: Can I appeal to Washington state if I have an ERISA plan? A: Self-funded employer plans are governed by federal ERISA law, not state insurance regulations. However, many employers voluntarily use external review processes similar to state requirements.

From our advocates: We've seen many Washington patients successfully overturn Aldurazyme denials by ensuring complete genetic testing documentation and specialist involvement from the start. The key is having all required elements in the initial submission rather than trying to add them during appeals. This composite experience reflects common patterns, not guaranteed outcomes.

When to Escalate

Contact the Washington Office of Insurance Commissioner if:

  • Cigna fails to respond within required timeframes
  • You believe the denial violates state insurance laws
  • The appeals process is not being handled properly
  • You need assistance navigating the external review process

Consumer Advocacy Line: 1-800-562-6900

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 additional support with complex prior authorization challenges, Counterforce Health specializes in helping patients and providers navigate insurance approval processes for specialty medications like Aldurazyme.

Sources & Further Reading

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