By Counterforce Health Team in Naglazyme (galsulfase) —

How to Get Naglazyme (Galsulfase) Covered by UnitedHealthcare in Washington: Appeals Guide & Templates

Answer Box: Getting Naglazyme Covered by UnitedHealthcare in Washington

UnitedHealthcare requires prior authorization for Naglazyme (galsulfase) enzyme replacement therapy for MPS VI. To get approval: (1) Submit PA with confirmed diagnosis via enzyme assay or genetic testing, (2) Include baseline functional measures like 6-minute walk test, and (3) If denied, file internal appeal within 180 days. Washington residents can request external review through an Independent Review Organization (IRO) within 60 days of final denial. Start by having your doctor submit PA documentation via the UnitedHealthcare provider portal.

Table of Contents

Understanding Your Coverage

Naglazyme (galsulfase) is a life-saving enzyme replacement therapy for Mucopolysaccharidosis VI (Maroteaux-Lamy syndrome) that costs roughly $600,000 to $1.8 million annually depending on patient weight. UnitedHealthcare, managed through OptumRx, requires prior authorization for this specialty medication across all plan types.

Coverage at a Glance

Requirement What it means Where to find it Source
Prior Authorization Required for all plans UnitedHealthcare provider portal UHC PA Requirements
Formulary Tier Specialty tier (high cost-sharing) Plan formulary document OptumRx formulary
Step Therapy May apply to new Medicare enrollees Plan documents UHC policy updates
Diagnosis Confirmation Enzyme assay or genetic testing required Lab reports UHC Enzyme Policy
Site of Care Hospital or infusion center Provider network UHC directory
Appeals Deadline 180 days from denial Denial letter Washington state law

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, identifies specific denial reasons, and drafts point-by-point rebuttals aligned to each payer's own rules—helping patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for medications like Naglazyme.

Read the Denial Letter

When UnitedHealthcare denies Naglazyme, the denial letter will specify the exact reason. Common denial codes include:

  • Medical necessity not established: Missing diagnostic confirmation or functional assessments
  • Step therapy required: Must try preferred alternatives first (rare for MPS VI)
  • Site of care restriction: Must be administered in approved facility
  • Insufficient documentation: Missing enzyme assay, genetic testing, or clinical notes

Look for these key details in your denial:

  • Reference number for tracking
  • Specific reason code and description
  • Appeal deadline (typically 180 days)
  • Required documentation for reconsideration
  • Contact information for appeals

Fixable Causes

Many denials can be resolved by addressing missing information:

Missing Documents

  • Enzyme assay results: N-acetylgalactosamine-4-sulfatase deficiency confirmation
  • Genetic testing: ARSB gene mutation identification
  • Baseline functional measures: 6-minute walk test, pulmonary function tests
  • Clinical notes: Specialist consultation documenting MPS VI diagnosis

Coding Issues

  • Ensure HCPCS code J1458 is used for billing
  • Verify ICD-10 codes for MPS VI (E76.29)
  • Confirm site of care meets UHC requirements

Benefit vs. Medical Policy

  • Check if denial is pharmacy benefit (OptumRx) vs. medical benefit issue
  • Verify in-network provider administration
  • Confirm plan covers enzyme replacement therapies

First-Level Appeal

Step-by-Step: Filing Your Appeal

  1. Gather Documentation (Patient/Caregiver)
    • Original denial letter
    • Insurance card and member ID
    • Complete medical records from treating physician
    • Timeline: Start immediately after denial
  2. Request Medical Records (Patient/Clinic)
    • Enzyme assay results showing deficiency
    • Genetic testing confirming ARSB mutations
    • Functional assessments (6-minute walk test, etc.)
    • Timeline: 3-5 business days
  3. Draft Medical Necessity Letter (Physician)
    • Document MPS VI diagnosis with lab confirmation
    • Explain clinical rationale for Naglazyme therapy
    • Include baseline and expected functional improvements
    • Timeline: 1-2 business days
  4. Submit Appeal Package (Clinic/Patient)
    • Via UnitedHealthcare provider portal or member portal
    • Include all supporting documentation
    • Timeline: Submit within 180 days of denial
  5. Track Submission (Patient)
    • Record confirmation number
    • Note submission date and method
    • Timeline: Follow up within 1 week
  6. Await Decision (All parties)
    • Standard review: up to 30 days
    • Expedited review: 72 hours if urgent
    • Timeline: UHC must notify of decision

Medical Necessity Letter Checklist

Your physician should include:

  • Confirmed diagnosis: "Patient has confirmed MPS VI via [enzyme assay/genetic testing] showing [specific results]"
  • Clinical presentation: Document specific symptoms and functional limitations
  • Treatment rationale: Explain why Naglazyme is medically necessary
  • Expected outcomes: Reference clinical studies showing walking capacity improvements
  • Monitoring plan: Describe ongoing assessment strategy
  • FDA indication: Cite approved labeling for MPS VI treatment

Peer-to-Peer Review

UnitedHealthcare offers peer-to-peer clinical discussions after denials. Your physician can request this within one business day of denial notification.

Scheduling Process

  • Call OptumRx prescriber line: 800-711-4555
  • Request peer-to-peer review for Naglazyme denial
  • UHC will schedule within 1 business day
  • Review typically occurs by phone with UHC medical director

Physician Talking Points

  • Diagnosis confirmation: "Patient has confirmed MPS VI with [specific test results]"
  • Clinical severity: Describe functional limitations and disease progression
  • Treatment urgency: Explain risks of delayed enzyme replacement therapy
  • Alternative failures: Document why other approaches are insufficient
  • Evidence base: Reference clinical trials showing Naglazyme efficacy
From our advocates: We've seen peer-to-peer reviews succeed when physicians emphasize the progressive nature of MPS VI and cite specific walking capacity improvements from clinical studies. Having exact enzyme levels and functional test results readily available during the call significantly strengthens the case.

Second-Level & External Review

If your first appeal fails, Washington state provides strong consumer protections through external review.

Internal Second-Level Appeal

  • Must be filed within 180 days of first-level denial
  • Include any new clinical evidence or specialist opinions
  • UnitedHealthcare has up to 30 days to respond
  • Required before proceeding to external review

External Review in Washington

Washington residents can request Independent Review Organization (IRO) review after exhausting internal appeals.

Timeline: 60 days from final internal denial to request external review Process: Submit request to Washington Insurance Commissioner Decision time: 20 days for standard review, 72 hours for expedited Outcome: IRO decision is binding on UnitedHealthcare

Contact the Washington Insurance Commissioner at 1-800-562-6900 for external review assistance.

Appeal Templates

Basic Appeal Letter Structure

[Date]

UnitedHealthcare Appeals Department
[Address from denial letter]

RE: Appeal for [Member Name], ID: [Member ID]
Claim/Reference Number: [From denial letter]
Medication: Naglazyme (galsulfase)

Dear Appeals Review Team,

I am writing to formally appeal the denial of coverage for Naglazyme (galsulfase) enzyme replacement therapy dated [denial date]. This medication is medically necessary for the treatment of confirmed Mucopolysaccharidosis VI (MPS VI).

DIAGNOSIS CONFIRMATION:
[Include specific enzyme assay results and/or genetic testing]

CLINICAL RATIONALE:
[Physician documentation of medical necessity]

SUPPORTING EVIDENCE:
[List attached documentation]

REQUEST:
I respectfully request reconsideration and approval of Naglazyme coverage based on the enclosed medical evidence demonstrating clear medical necessity.

Sincerely,
[Signature]
[Name and relationship to patient]

Peer-to-Peer Request Script

"This is Dr. [Name] calling to request a peer-to-peer review for my patient [Name], member ID [Number]. UnitedHealthcare denied coverage for Naglazyme for confirmed MPS VI. I have enzyme assay results showing N-acetylgalactosamine-4-sulfatase deficiency and functional assessments demonstrating the medical necessity for enzyme replacement therapy. When can we schedule the clinical discussion?"

Tracking & Escalation

Appeal Tracking Log

Date Action Method Confirmation # Follow-up Date Status
Initial PA submitted Portal
Denial received Mail
Appeal filed Fax
Peer-to-peer requested Phone

When to Escalate to Washington Regulators

Contact the Washington Insurance Commissioner if:

  • UnitedHealthcare misses appeal deadlines
  • You're denied external review eligibility
  • The appeals process seems unfair or biased
  • You need help understanding your rights

Washington Insurance Commissioner Consumer Advocacy: 1-800-562-6900

Win-Rate Boosters

Strong Evidence Elements

  • Quantified functional impairment: Specific 6-minute walk test distances
  • Progressive disease documentation: Show worsening without treatment
  • Specialist consensus: Letters from MPS specialists supporting treatment
  • Guideline citations: Reference FDA labeling and EMA approval documents
  • Contraindication evidence: Document why alternatives aren't suitable

Clinical Documentation Tips

  • Include urinary glycosaminoglycan levels showing elevation
  • Document specific functional improvements expected with therapy
  • Cite published studies showing walking capacity improvements
  • Reference long-term survival benefits from early treatment initiation

If the Appeal Fails

Alternative Options

  • Manufacturer support: Contact BioMarin's patient assistance program
  • Foundation grants: Explore rare disease foundation funding
  • Clinical trials: Investigate research study participation
  • Second opinion: Consult another MPS specialist for additional evidence

Formulary Alternatives

Unfortunately, no pharmacologic alternatives exist for MPS VI enzyme replacement. Supportive care includes:

  • Orthopedic management for skeletal complications
  • Cardiopulmonary monitoring and intervention
  • Physical therapy for mobility maintenance

Counterforce Health can help analyze failed appeals and identify new evidence or procedural issues that might support a successful resubmission.

FAQ

Q: How long does UnitedHealthcare prior authorization take for Naglazyme in Washington? A: Standard PA decisions are typically made within 72 hours to 14 days. Expedited reviews for urgent cases are completed within 24-72 hours.

Q: What if Naglazyme is non-formulary on my UnitedHealthcare plan? A: You can request a formulary exception with medical necessity documentation. The process is similar to prior authorization but may require additional justification.

Q: Can I request an expedited appeal if my condition is worsening? A: Yes, if delay in treatment could seriously jeopardize your health, you can request expedited review with a decision within 72 hours.

Q: Does step therapy apply to Naglazyme for MPS VI? A: Step therapy is uncommon for MPS VI since no alternative enzyme replacement therapies exist, but some Medicare Advantage plans may require documentation of medical necessity.

Q: What happens if UnitedHealthcare still denies after external review? A: If the IRO upholds the denial, you may need to explore alternative funding sources or consider legal consultation for potential coverage disputes.

Q: How much does Naglazyme cost without insurance? A: Annual costs range from $600,000 to $1.8 million depending on patient weight. Contact BioMarin's patient assistance program for potential support options.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan documents for specific coverage details. For personalized assistance with Washington insurance appeals, contact the Washington Insurance Commissioner at 1-800-562-6900.

Sources & Further Reading

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