By Counterforce Health Team in Naglazyme (galsulfase) —

How to Get Naglazyme (Galsulfase) Covered by Cigna in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Naglazyme (Galsulfase) Covered by Cigna in Washington

Cigna requires prior authorization for Naglazyme (galsulfase) with strict medical necessity criteria. To get approved in Washington: (1) Have your genetics/metabolism specialist complete Cigna's CCRD PA form with confirmed MPS VI diagnosis via enzyme assay or genetic testing, (2) Submit via CoverMyMeds or fax (855) 840-1678 with baseline functional assessments (12-minute walk test, pulmonary function), and (3) If denied, file internal appeal within 180 days, then external review via Washington's IRO within 120 days. Start today by downloading the PA form and scheduling baseline testing.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather What You Need
  4. Submit the Prior Authorization Request
  5. Follow-Up and Tracking
  6. Typical Timelines in Washington
  7. If You're Asked for More Information
  8. If Denied: Appeals Process
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. Frequently Asked Questions

What This Guide Covers

This guide helps patients with MPS VI (Maroteaux-Lamy syndrome) and their healthcare teams navigate Cigna's prior authorization process for Naglazyme (galsulfase) in Washington state. Whether you're facing an initial request or dealing with a denial, we'll walk through the exact forms, documentation, and appeal rights specific to Washington residents.

Naglazyme is the only FDA-approved enzyme replacement therapy for MPS VI, costing approximately $600,000-$1.8 million annually depending on patient weight. Given this cost, Cigna requires comprehensive documentation proving medical necessity before approval.

Who this helps:

  • Patients diagnosed with MPS VI needing Naglazyme
  • Healthcare providers submitting prior authorizations
  • Families navigating insurance denials and appeals
  • Specialty pharmacies coordinating coverage

Before You Start: Verify Your Coverage

Check Your Plan Type

Washington residents with Cigna coverage need to verify whether they have a fully-insured plan (subject to Washington state laws) or a self-funded employer plan (subject to federal ERISA rules). This determines your appeal rights.

How to check: Call the member services number on your insurance card and ask: "Is this a fully-insured plan or self-funded employer plan?"

Confirm Network Status

Naglazyme requires specialty pharmacy dispensing and infusion center administration. Verify:

  • Your prescriber is in-network with Cigna
  • Accredo (Cigna's preferred specialty pharmacy) is covered
  • Your planned infusion site accepts Cigna

Medical vs. Pharmacy Benefit

Naglazyme is typically covered under the medical benefit (not pharmacy benefit) since it's administered via IV infusion. This means different forms, approval processes, and appeal pathways than oral medications.

Gather What You Need

Required Clinical Documentation

Requirement Details Where to Get It
MPS VI Diagnosis ICD-10 code E76.29 (Other mucopolysaccharidoses) Medical records
Enzyme Testing ARSB activity <10% of normal in fibroblasts or leukocytes Lab results
Genetic Testing Pathogenic ARSB gene variants (alternative to enzyme testing) Genetic counselor/lab
Baseline Assessments 12-minute walk test, 3-minute stair climb test, pulmonary function tests Specialist visit
Specialist Prescription From genetics, endocrinology, or metabolism specialist Current provider
Prior Therapies Documentation of supportive care attempts Medical records

Forms and Submission Materials

  1. Cigna CCRD Prior Authorization Form for Naglazyme - Download and complete all sections
  2. Medical necessity letter from prescribing specialist
  3. Chart notes documenting diagnosis and disease progression
  4. Lab results confirming ARSB deficiency or genetic testing
  5. Baseline functional assessments (walking tests, pulmonary function)
Tip: Counterforce Health specializes in turning insurance denials into successful appeals by identifying the exact denial basis and crafting targeted, evidence-backed responses aligned to each plan's specific requirements.

Submit the Prior Authorization Request

Step-by-Step Submission Process

1. Complete the CCRD Form

  • Patient information: Full name, Cigna member ID, date of birth, address
  • Medication details: Naglazyme 1 mg/kg IV weekly, vial quantity needed
  • Administration site: Specify infusion center, hospital outpatient, or home
  • Clinical criteria: Attach all supporting documentation

2. Choose Your Submission Method

Method Details Timeline
CoverMyMeds (Preferred) www.covermymeds.com 2-5 business days
Fax (855) 840-1678 5 business days
Accredo Direct Fax 888.302.1028 or call 866.759.1557 5 business days

3. Include Required Attestations

  • Prescriber signature confirming accuracy
  • Statement that no contraindications exist
  • Confirmation of specialist credentials

Medical Necessity Letter Checklist

Your specialist should include:

  • Problem: MPS VI diagnosis with specific symptoms affecting mobility/breathing
  • Prior treatments: Supportive care attempts (physical therapy, respiratory support)
  • Clinical rationale: Why Naglazyme is medically necessary now
  • Guidelines: Reference FDA labeling and MPS treatment guidelines
  • Monitoring plan: How functional improvements will be tracked

Follow-Up and Tracking

When to Call Cigna

  • Day 3: Confirm receipt if submitted via fax
  • Day 6: Check status if no response to standard submission
  • Day 2: For urgent requests (declining function)

Sample Phone Script

"I'm calling about a prior authorization for Naglazyme for [patient name], member ID [number]. The request was submitted on [date] via [method]. Can you confirm receipt and provide the reference number? When should I expect a decision?"

Tracking Your Request

  • CoverMyMeds users: Check status via provider portal
  • Cigna members: Log into MyCigna.com and check "Authorizations"
  • Reference numbers: Document all confirmation numbers for appeals

Typical Timelines in Washington

Standard Prior Authorization

  • Cigna's timeline: 5 business days for medical benefit requests
  • Washington requirement: Insurers must respond within timeframes that don't jeopardize health
  • Expedited requests: 24 hours if health at risk

Urgent/Expedited Process

Call Cigna at (800) 882-4462 to request expedited review if:

  • Patient has declining respiratory function
  • Mobility is rapidly deteriorating
  • Delay could cause irreversible harm

If You're Asked for More Information

Cigna may request additional documentation before making a decision. Common requests include:

Additional Clinical Evidence

  • More recent functional assessments: Updated walk tests or pulmonary function
  • Imaging studies: X-rays showing skeletal involvement
  • Specialist consultation notes: Second opinion from MPS expert

Administrative Clarifications

  • Site of care justification: Why specific infusion center is needed
  • Dosing calculations: Weight-based dosing verification
  • Insurance verification: Confirming member eligibility
Note: Respond to information requests within 14 days to avoid automatic denial.

If Denied: Appeals Process

Understanding Your Denial

Common denial reasons for Naglazyme include:

  • Insufficient diagnosis documentation: Missing enzyme assay or genetic testing
  • Lack of functional baselines: No walking tests or pulmonary function data
  • Site of care issues: Requesting home infusion when not appropriate
  • Missing specialist involvement: Primary care provider prescription instead of specialist

Internal Appeals (First Level)

Deadline: 180 days from denial notice How to file:

What to include:

  • Original denial letter
  • Additional clinical evidence addressing denial reason
  • Peer-reviewed studies supporting Naglazyme use
  • Updated functional assessments

Peer-to-Peer Review

Request immediate peer-to-peer review by calling Cigna and asking to speak with the medical director. Your specialist can discuss the case directly with Cigna's reviewing physician, often resolving issues same-day.

External Review (Washington IRO Process)

If internal appeals fail, Washington residents have strong external review rights:

Eligibility: Fully-insured Cigna plans (verify with member services) Deadline: 120 days from final internal denial Process:

  1. Submit written request to Cigna (they forward to state IRO)
  2. State assigns independent medical experts
  3. Submit additional evidence within 5 business days
  4. IRO decides within 45 days (72 hours if expedited) Cost: Free to patient

Washington Insurance Commissioner support: Call 1-800-562-6900 for help with appeals or to file complaints about delays.

Renewal and Re-Authorization

When to Resubmit

Most Naglazyme authorizations require annual renewal. Calendar reminders for:

  • 90 days before expiration: Begin renewal paperwork
  • 60 days before: Submit renewal request
  • 30 days before: Follow up if no response

Renewal Documentation

Include evidence of clinical benefit:

  • Functional improvements: Comparing current walk tests to baseline
  • Urinary GAG reduction: Lab evidence of treatment response
  • Pulmonary stability: Maintaining or improving lung function
  • Quality of life: Documented improvements in daily activities

From our advocates: We've seen many MPS VI patients initially denied for Naglazyme get approved on appeal when their specialist provided detailed functional assessment comparisons—before and after treatment photos of mobility, walking distance improvements, and respiratory function data really help the medical reviewers understand the clinical benefit. The key is showing objective improvement, not just subjective reports.

Quick Reference Checklist

Before submitting:

  • MPS VI diagnosis confirmed (ICD-10 E76.29)
  • ARSB enzyme <10% normal OR pathogenic genetic variants
  • Baseline 12-minute walk test completed
  • Baseline pulmonary function tests done
  • Specialist (genetics/metabolism/endocrinology) involved
  • CCRD PA form completed
  • Medical necessity letter drafted
  • Submission method chosen (CoverMyMeds preferred)

After submission:

  • Confirmation number documented
  • Follow-up call scheduled (Day 3-6)
  • Appeal deadline noted (180 days)
  • Renewal date calendared (if approved)

Frequently Asked Questions

Q: How long does Cigna prior authorization take for Naglazyme in Washington? A: Standard requests: 5 business days. Expedited requests (if health at risk): 24 hours. Call (800) 882-4462 for expedited review.

Q: What if Naglazyme is non-formulary on my Cigna plan? A: Request a formulary exception using the same CCRD form. Include documentation that no formulary alternatives exist for MPS VI.

Q: Can I request an expedited appeal in Washington? A: Yes. Both internal appeals and external IRO reviews can be expedited if delays could jeopardize your health (72-hour timeline).

Q: Does step therapy apply to Naglazyme? A: No. Naglazyme is the only FDA-approved enzyme replacement therapy for MPS VI, so no step therapy requirements apply.

Q: What if my employer plan is self-funded? A: Self-funded plans aren't subject to Washington state external review laws. Contact the U.S. Department of Labor for ERISA plan appeals guidance.

Q: How much does Naglazyme cost without insurance? A: Approximately $600,000-$1.8 million annually depending on patient weight. Check BioMarin's patient assistance programs for support options.

Q: Can I switch infusion sites after approval? A: Yes, but notify Cigna of site changes. Some plans require re-authorization for different administration locations.

Q: What's the success rate for Naglazyme appeals in Washington? A: While specific Naglazyme data isn't published, Washington's external review process has helped many rare disease patients access needed treatments when proper clinical evidence is provided.

Sources & Further Reading

This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and contact Washington's Insurance Commissioner at 1-800-562-6900 for assistance with insurance appeals.

When facing complex prior authorization challenges, 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 craft point-by-point rebuttals aligned with each payer's specific requirements.

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