By Counterforce Health Team in Naglazyme (galsulfase) —

Myths vs. Facts: Getting Naglazyme (Galsulfase) Covered by Blue Cross Blue Shield in Washington

Quick Answer: Getting Naglazyme (galsulfase) covered by Blue Cross Blue Shield in Washington requires prior authorization with confirmed MPS VI diagnosis via enzyme assay, genetic testing, and clinical documentation. If denied, you have 180 days to appeal internally, then can request external review through Washington's Insurance Commissioner within 60 days. Start by contacting your BCBS plan directly for their specific PA requirements and forms.

Table of Contents

Why Myths About Naglazyme Coverage Persist

When facing a rare disease like MPS VI (Maroteaux-Lamy syndrome), families often receive conflicting information about insurance coverage. Naglazyme (galsulfase), the only FDA-approved enzyme replacement therapy for MPS VI, costs roughly $600,000 to $1.8 million annually depending on patient weight. With stakes this high, misinformation spreads quickly through online forums, well-meaning friends, and even some healthcare providers unfamiliar with specialty drug coverage.

The complexity of Blue Cross Blue Shield's structure—33 independent plans across the country—adds another layer of confusion. What works for BCBS North Carolina may not apply to your Washington plan. Meanwhile, Counterforce Health helps patients navigate these exact challenges by turning insurance denials into targeted, evidence-backed appeals that align with each plan's specific requirements.

Let's separate fact from fiction so you can focus your energy on the strategies that actually work.

Common Myths vs. Reality

Myth 1: "If my doctor prescribes Naglazyme, insurance has to cover it"

Fact: Even with a prescription from a metabolic specialist, Blue Cross Blue Shield requires prior authorization for Naglazyme. The FDA approval doesn't guarantee coverage—your plan evaluates medical necessity based on their own criteria, which typically include confirmed MPS VI diagnosis via enzyme assay showing arylsulfatase B deficiency and genetic testing of ARSB gene mutations.

Myth 2: "Rare disease drugs are automatically covered under orphan drug laws"

Fact: Orphan drug designation helps with FDA approval and provides market exclusivity, but it doesn't mandate insurance coverage. Blue Cross Blue Shield plans still require documentation that Naglazyme is medically necessary for your specific case. About 20% of plans add additional restrictions even for orphan drugs.

Myth 3: "I need to try cheaper alternatives first (step therapy)"

Fact: There are no alternative enzyme replacement therapies for MPS VI. However, some BCBS plans may require documentation that supportive care alone (physical therapy, orthopedic interventions, cardiac monitoring) is insufficient before approving Naglazyme. This isn't traditional step therapy since no pharmaceutical alternatives exist.

Myth 4: "Appeals never work for expensive drugs like Naglazyme"

Fact: Washington's external review process through independent review organizations (IROs) has approximately a 40-50% success rate for high-cost specialty drugs, according to Office of Insurance Commissioner reports. The key is providing the right clinical evidence and following proper procedures.

Myth 5: "I can only get Naglazyme at certain hospitals"

Fact: While Naglazyme requires IV infusion over several hours with premedication to prevent infusion reactions, many BCBS plans allow administration at qualified infusion centers, not just hospitals. Site-of-care restrictions vary by plan, so verify your specific coverage.

Myth 6: "If BCBS denies coverage, I'm out of options"

Fact: Washington provides multiple appeal levels. After internal appeals, you can request external review where an independent medical expert—not your insurance company—makes the final decision. This process is free and legally binding on the insurer.

Myth 7: "I need a lawyer to appeal a Naglazyme denial"

Fact: Washington's appeals process is designed for patients to navigate without legal representation. The Office of Insurance Commissioner provides free assistance at 1-800-562-6900, and platforms like Counterforce Health help draft evidence-backed appeals that address specific denial reasons.

What Actually Influences Approval

Understanding what Blue Cross Blue Shield actually evaluates can dramatically improve your approval odds:

Clinical Documentation Requirements

  • Confirmed MPS VI diagnosis: Enzyme assay showing arylsulfatase B activity less than 10% of normal, plus elevated urinary dermatan sulfate glycosaminoglycans
  • Genetic confirmation: ARSB gene mutations (biallelic) via blood or saliva testing
  • Baseline functional assessments: 6-minute walk test, stair climbing capacity, joint range of motion, cardiac function
  • Treatment goals: Clear documentation of what improvement is expected and how it will be measured

Provider Qualifications

Most BCBS plans require Naglazyme prescriptions from metabolic specialists or geneticists familiar with MPS disorders. Community physicians may need to coordinate with specialty centers for proper documentation.

Site of Care Considerations

BCBS may have preferred infusion centers or require hospital-based administration initially. Verify your plan's site-of-care requirements before scheduling treatment, as this affects both coverage and out-of-pocket costs.

Ongoing Monitoring Requirements

Plans typically require regular assessments to demonstrate clinical benefit, including:

  • Functional capacity measures (walking distance, stair climbing)
  • Cardiac monitoring (echocardiograms)
  • Growth parameters in pediatric patients
  • Quality of life assessments

Avoid These Critical Mistakes

1. Not Verifying Your Specific BCBS Plan Requirements

Blue Cross Blue Shield operates 33 independent plans. BCBS of Washington (Regence BlueShield or Premera Blue Cross) has different requirements than BCBS of another state. Always confirm your plan's specific prior authorization criteria by calling the number on your member ID card.

2. Submitting Incomplete Diagnostic Documentation

The most common denial reason is insufficient proof of MPS VI diagnosis. Ensure you have both biochemical confirmation (enzyme assay) and genetic testing results. Clinical suspicion alone isn't sufficient for approval.

3. Missing Prior Authorization Deadlines

Submit PA requests at least 48-72 hours before planned infusion. Emergency coverage for Naglazyme is extremely difficult to obtain since it's not a life-threatening emergency medication in the traditional sense.

4. Not Appealing Denials Promptly

Washington gives you 180 days from denial to file internal appeals, but acting quickly is crucial. Each level has specific deadlines, and missing them can forfeit your appeal rights.

5. Failing to Use Washington's External Review Process

Many families give up after internal appeals fail. Washington's external review through IROs provides an independent medical opinion and has helped many patients access expensive specialty drugs that were initially denied.

Your 3-Step Action Plan

Step 1: Gather Essential Documentation (Do This Today)

Contact your metabolic specialist's office and request:

  • Enzyme assay results showing arylsulfatase B deficiency
  • Genetic testing confirming ARSB mutations
  • Complete clinical notes documenting MPS VI symptoms and progression
  • Baseline functional assessments (6-minute walk test, cardiac function)
  • Any prior treatment attempts and outcomes

Step 2: Contact Your BCBS Plan Directly

Call the member services number on your insurance card and ask specifically for:

  • Prior authorization requirements for Naglazyme (galsulfase)
  • Required forms and submission process
  • Timeline for PA decisions
  • Preferred infusion centers in your area
  • Appeal procedures if denied

Step 3: Prepare for Potential Denial

While working toward approval, simultaneously prepare for appeals by:

  • Documenting all communication with your insurance plan
  • Gathering peer-reviewed studies supporting Naglazyme's effectiveness
  • Identifying potential external review resources
  • Considering platforms like Counterforce Health that specialize in turning denials into successful appeals

Washington-Specific Appeals Process

Washington provides robust consumer protections for insurance denials, including rare disease medications:

Internal Appeals

  • Timeline: 30 days for pre-service denials, 60 days for post-service
  • Expedited: 72 hours for urgent situations
  • How to file: Written request to your BCBS plan within 180 days of denial

External Review

  • When to use: After internal appeal denial or if insurer misses deadlines
  • Timeline: Request within 60 days of final internal denial
  • Process: Submit to your insurer, who assigns an Independent Review Organization (IRO)
  • Decision timeline: 20 days for fully-insured plans, 45 days for self-insured
  • Cost: Free to you; insurer pays IRO fees

IRO Decision Process

The IRO assigns medical experts familiar with MPS VI and enzyme replacement therapies. They review:

  • Your complete medical record
  • BCBS's denial rationale
  • Current medical literature on Naglazyme
  • Clinical guidelines for MPS VI treatment

State Resources

  • Office of Insurance Commissioner: 1-800-562-6900 for free assistance
  • Consumer advocacy: Help with appeal letters and process guidance
  • Complaint filing: If insurers don't follow proper procedures

Resources and Support

Official Sources

Patient Support

  • BioMarin patient services for copay assistance and prior authorization support
  • MPS Society for peer support and advocacy resources
  • Counterforce Health for specialized appeal assistance

Clinical Resources

  • Enzyme assay testing through specialized laboratories
  • Genetic testing for ARSB mutations
  • MPS specialty centers for comprehensive care coordination

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. For personalized assistance with insurance appeals, contact the Washington Office of Insurance Commissioner at 1-800-562-6900.

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