By Counterforce Health Team in Naglazyme (galsulfase) —

How to Get Naglazyme (galsulfase) Covered by Aetna (CVS Health) in Washington: Complete PA Guide & Appeal Scripts

Answer Box: Getting Naglazyme (galsulfase) Covered by Aetna (CVS Health) in Washington

Naglazyme (galsulfase) requires prior authorization from Aetna (CVS Health) as a Tier 5 specialty medication for MPS VI (Maroteaux-Lamy syndrome). Your fastest path to approval: (1) Submit PA with confirmed enzyme/genetic testing showing ARSB deficiency, (2) Include baseline functional assessments (6-minute walk test), and (3) Document medical necessity via your MPS specialist. If denied, Washington offers robust appeal rights including free external review by independent specialists. First step today: Have your prescriber contact CVS Specialty at 1-800-237-2767 to initiate the PA process.

Table of Contents

Plan Types & Coverage Implications

Aetna (CVS Health) offers several plan types in Washington, each with different coverage rules for Naglazyme:

  • Commercial HMO/PPO: Standard prior authorization applies; no referral needed for specialty care
  • Medicare Advantage: Part D coverage with formulary restrictions; may require step therapy documentation
  • Medicaid (Apple Health): Managed through coordinated care organizations with state-specific criteria
  • Self-funded employer plans: May follow Aetna guidelines but aren't bound by Washington state protections
Note: Self-funded plans often voluntarily use Washington's external review process, but verify appeal rights with your HR department.

Formulary Status & Tier Placement

Naglazyme sits on Tier 5 (specialty drugs) across most Aetna plans, meaning:

Coverage Aspect Details Source
Prior authorization Required for all indications Aetna formulary guidelines
Specialty pharmacy CVS Specialty mandatory CVS Caremark specialty drugs
Quantity limits Weight-based dosing (1 mg/kg weekly) FDA labeling
Site of care Infusion center or hospital preferred Clinical requirements

No generic alternatives exist for MPS VI enzyme replacement therapy, making medical necessity documentation critical for approval.

Prior Authorization Requirements

Essential Documentation Checklist

Your prescriber must submit these elements for PA approval:

✅ Diagnostic confirmation:

  • Enzyme assay showing ARSB deficiency (<10% normal activity)
  • Genetic testing confirming biallelic ARSB mutations
  • Elevated urinary GAGs (dermatan sulfate)

✅ Clinical assessment:

  • MPS VI diagnosis with ICD-10 code E76.29
  • Baseline functional testing (6-minute walk test, 3-minute stair climb)
  • Documentation of disease progression

✅ Treatment plan:

  • Weight-based dosing calculation (1 mg/kg weekly)
  • Infusion site and monitoring plan
  • Expected clinical outcomes

Medical Necessity Criteria

Based on available payer policies, Aetna typically requires:

  1. Confirmed MPS VI diagnosis via enzyme and genetic testing
  2. Functional impairment documented through objective measures
  3. Appropriate dosing per FDA-approved labeling
  4. Qualified infusion site with emergency management capabilities
Clinician Corner: Include peer-reviewed studies showing Naglazyme's efficacy in improving endurance (92-meter average gain on 12-minute walk test) and reducing urinary GAG levels by 75% at 24 weeks.

Specialty Pharmacy Setup

CVS Specialty Pharmacy handles all Naglazyme distribution for Aetna members. Here's the setup process:

Step-by-Step Enrollment

  1. Prescriber initiates: Contact CVS Specialty at 1-800-237-2767
  2. Patient enrollment: CVS will call within 24-48 hours to verify insurance and coordinate delivery
  3. Infusion scheduling: Work with your infusion center to receive and prepare medication
  4. Ongoing management: CVS tracks refills and coordinates with your care team

Important Details

  • Delivery timeline: 7-10 business days after PA approval
  • Storage requirements: Refrigerated until use; stable 24 hours after dilution
  • Billing: CVS bills Aetna directly using J-code J1457

Cost-Share Dynamics

Understanding your out-of-pocket costs helps with financial planning:

Typical Cost Structure

  • Tier 5 coinsurance: Usually 25-40% after deductible
  • Annual cost: $600,000-$1.8M+ based on weight
  • Out-of-pocket maximum: $8,000-$9,450 for most commercial plans

Financial Assistance Options

  • BioMarin RareConnections: Copay assistance and patient support (verify eligibility)
  • Washington state programs: Apple Health for eligible low-income residents
  • Charitable foundations: National Organization for Rare Disorders (NORD) assistance

Submission Process & Forms

How to Submit Your PA

For prescribers:

  1. Use Aetna provider portal (Availity) for fastest processing
  2. Alternative: Fax completed forms to CVS Specialty
  3. Include all supporting documentation in initial submission

Required forms (verify current versions):

  • Aetna Prior Authorization Request Form
  • Clinical notes from MPS specialist
  • Lab results (enzyme assay, genetic testing)
  • Functional assessment results

Timeline Expectations

  • Standard PA: 30-45 days
  • Expedited review: 72 hours with clinical urgency documentation
  • Appeal timeline: 60 days for internal, then external review available

Appeals Playbook for Washington

Washington residents have strong appeal protections through state law RCW 48.43.535.

Internal Appeal Process

Step 1: File Internal Appeal

  • Deadline: 60 days from denial notice
  • Method: Submit via Aetna member portal or mail
  • Required: Denial letter, additional medical records, provider letter

Step 2: Gather Documentation

  • Medical necessity letter from MPS specialist
  • Peer-reviewed studies supporting Naglazyme efficacy
  • Functional assessment showing disease progression
  • Documentation of alternative treatment failures (if applicable)

External Review (IRO Process)

If your internal appeal is denied, Washington offers free, binding external review:

Timeline: File within 60 days of final internal denial Process: Washington Office of the Insurance Commissioner assigns independent medical specialist Cost: Free to patient Decision: Binding on Aetna if approved

Contact for assistance: Washington OIC Consumer Advocacy at 1-800-562-6900

Patient Phone Script for Aetna

"Hi, I'm calling about my prior authorization denial for Naglazyme. My member ID is [ID number]. I have MPS VI confirmed by enzyme and genetic testing, and my specialist says this medication is medically necessary. I'd like to start the internal appeal process and get information about expedited review options. Can you help me understand the next steps?"

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Insufficient diagnostic proof Submit complete testing panel Enzyme assay + genetic testing + uGAG levels
Lack of functional assessment Provide baseline measurements 6-minute walk test, stair climb test results
Missing medical necessity Specialist letter with clinical rationale MPS specialist attestation with treatment goals
Site of care concerns Address safety monitoring plan Infusion center credentials, emergency protocols
Experimental/investigational Cite FDA approval and guidelines FDA labeling, clinical trial data, ACMG guidelines

Success Tips from Coverage Advocates

From our advocates: "The strongest appeals include chronological treatment records showing disease progression, objective functional decline, and clear documentation that Naglazyme is the only FDA-approved treatment for MPS VI. Payers respond well when specialists explain why supportive care alone is insufficient and include specific treatment goals with measurable outcomes."

When to Escalate

Contact Washington State Regulators

If you're facing unreasonable delays or denials:

Washington Office of the Insurance Commissioner

Red Flags for Escalation

  • PA taking longer than 45 days without explanation
  • Denial citing non-covered diagnosis when MPS VI is established
  • Refusal to consider external review
  • Inappropriate step therapy requirements for orphan disease

Counterforce Health: Turning Denials into Approvals

When facing complex prior authorization challenges for specialty medications like Naglazyme, Counterforce Health helps patients and clinicians build evidence-backed appeals. The platform analyzes denial letters and plan policies to create targeted rebuttals that address specific PA criteria, cite relevant medical literature, and include the operational details payers expect for buy-and-bill therapies.

FAQ

How long does Aetna PA take for Naglazyme in Washington? Standard processing is 30-45 days, with expedited review available in 72 hours for urgent cases requiring clinical documentation.

What if Naglazyme is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Aetna covers medically necessary non-formulary drugs at standard copay after deductible.

Can I request expedited appeal if denied? Yes, if delay would seriously jeopardize your health. Your specialist must provide clinical documentation supporting urgency.

Does step therapy apply to MPS VI treatment? Generally no, since Naglazyme is the only FDA-approved enzyme replacement therapy for MPS VI. However, some plans may require documentation of supportive care attempts.

What happens during external review in Washington? An independent medical specialist reviews your case and makes a binding decision. If approved, Aetna must provide coverage.

How much will I pay out-of-pocket? Depends on your specific plan, but Tier 5 medications typically have 25-40% coinsurance. Financial assistance programs can help reduce costs.

Can I switch infusion sites if needed? Yes, but the new site must meet Aetna's network and safety requirements. Coordinate changes through CVS Specialty.

What if I move to another state? Coverage continues, but appeal rights may differ. Washington's external review protections are among the strongest nationally.

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. For personalized guidance, consult your healthcare provider and insurance representative. Counterforce Health can provide additional support with prior authorization and appeals processes.

Sources & Further Reading

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