By Counterforce Health Team in Naglazyme (galsulfase) —

Renewing Naglazyme (Galsulfase) Approval with Aetna (CVS Health) in Michigan: 2025 Timeline and Documentation Guide

Quick Answer: Renewing Your Naglazyme Coverage

Start renewal 60-90 days before expiration. Contact your metabolic specialist to update functional assessments (6-minute walk test, stair climbing capacity) and prepare a medical necessity letter documenting continued clinical benefit. Submit through CVS Specialty Pharmacy or CoverMyMeds portal. If denied, you have 180 days for internal appeal, then 127 days for Michigan DIFS external review. Contact BioMarin RareConnections for coverage support throughout the process.

Table of Contents

When to Start Your Renewal Process

Most Aetna (CVS Health) prior authorizations for Naglazyme (galsulfase) are approved for 6-12 months. Set a calendar reminder for 60-90 days before your current approval expires to avoid treatment interruptions.

Early Warning Signs to Act Now

  • Your CVS Specialty Pharmacy mentions upcoming expiration during routine calls
  • You receive a 30-day advance notice from Aetna about formulary changes
  • Your metabolic specialist's office mentions renewal timing during routine visits
  • You're approaching the end of your approval period (check your original authorization letter)
Tip: If you can't locate your original approval letter, contact CVS Specialty Pharmacy at 1-800-237-2767 to verify your current authorization end date.

Evidence Updates You'll Need

Successful Naglazyme renewals require demonstrating continued clinical benefit and ongoing medical necessity. Your metabolic specialist will need current data showing treatment response.

Required Functional Assessments

  • 6-Minute Walk Test (6MWT): Annual assessment measuring walking distance; stable or improved distance (target >440m in treated patients) indicates positive response
  • Stair Climbing Capacity: Timed 3-minute or 6-minute stair climb test showing maintained or improved performance
  • Additional measures: Shoulder flexion, hand grip strength, and respiratory function tests

Clinical Documentation Updates

  • Current weight for dosing verification (1 mg/kg IV weekly)
  • Urinary glycosaminoglycan (GAG) levels if monitored
  • Documentation of treatment adherence and infusion tolerance
  • Any adverse events or infusion reactions managed per protocol
  • Confirmation that no alternative treatments are appropriate for MPS VI
From our advocates: One family's renewal was initially denied because their specialist submitted outdated functional test results from 18 months prior. Always ensure assessments are within the past 6-12 months, as insurers want current evidence of ongoing benefit.

Essential Renewal Documentation

Your renewal packet should mirror the thoroughness of your initial approval but focus on continuity of benefit rather than establishing diagnosis.

Medical Necessity Letter Components

Your metabolic specialist should include:

  1. Patient demographics and confirmed MPS VI diagnosis (ICD-10: E76.3)
  2. Treatment history: Start date, current dose, infusion schedule
  3. Clinical response evidence: Functional test improvements or stability
  4. Ongoing medical necessity: Why continued treatment is essential
  5. No suitable alternatives: Confirmation that supportive care alone is insufficient
  6. Monitoring plan: Ongoing safety and efficacy assessments

Supporting Documentation

  • Recent clinic notes showing stable or improved clinical status
  • Updated functional assessment results
  • Current laboratory values if relevant
  • Infusion center records confirming regular treatment
  • Any specialist consultation notes (cardiology, pulmonology, orthopedics)

Billing Information

  • HCPCS code: J1458 (galsulfase injection, 1 mg)
  • Administration site: Hospital outpatient or infusion center
  • Frequency: Weekly infusions over 4+ hours with premedication

Submission Timeline and Process

Standard Review Timeline

  • Submission: 60-90 days before expiration
  • Aetna review: 15-30 business days for standard prior authorization
  • Decision notification: Via mail, phone, or provider portal
  • Effective coverage: Typically aligns with current authorization expiration

How to Submit

  1. Provider portal: Most efficient method through CoverMyMeds or Aetna provider portal
  2. CVS Specialty coordination: Your specialty pharmacy can often facilitate submission
  3. Fax submission: To Aetna prior authorization department (verify current fax number)

Expedited Review Options

If your current authorization expires soon, request expedited review with physician certification that delay would harm the patient. Michigan allows 72-hour expedited external reviews if medically urgent.

If Your Coverage Lapses

Don't panic if your renewal is delayed. Several options can bridge temporary coverage gaps.

Immediate Actions

  1. Contact CVS Specialty Pharmacy to discuss temporary supply options
  2. Call Aetna member services to verify renewal status and request expedited processing
  3. Reach out to BioMarin RareConnections for emergency access assistance

Bridge Coverage Options

  • Manufacturer assistance: BioMarin may provide temporary supply during appeals
  • Hospital emergency protocols: Some infusion centers can provide urgent doses
  • Provider samples: Limited availability through metabolic specialist offices
Note: Treatment interruptions for MPS VI can lead to clinical deterioration, so pursue all available options to maintain continuity.

Annual Plan Changes to Monitor

Aetna (CVS Health) formulary changes can affect your Naglazyme coverage, even mid-year.

Key Changes to Watch

  • Prior authorization requirements: New or modified PA criteria
  • Formulary tier changes: Affecting copay amounts
  • Site of care restrictions: Requirements for specific infusion locations
  • Quantity limits: Changes to approved dosing or frequency

How to Stay Informed

  • Review Summary of Changes (SOC) letters from Aetna (typically January, July, October)
  • Check Aetna's formulary search tool periodically
  • Monitor CVS Specialty Pharmacy communications about coverage changes

If Changes Affect You

  • Request formulary exception if Naglazyme becomes non-preferred
  • File step therapy exception if new requirements are added
  • Appeal coverage restrictions using medical necessity documentation

Appeals Process in Michigan

If your renewal is denied, Michigan offers robust appeal rights under the Patient's Right to Independent Review Act (PRIRA).

Internal Appeal with Aetna

  • Timeline: 180 days from denial notice to file
  • Review period: 30 days for pre-service denials, 60 days for post-service
  • Submission: Online portal, mail, or fax to Aetna appeals department

Michigan External Review

  • Eligibility: After completing internal appeal or if Aetna misses deadlines
  • Filing deadline: 127 days from final denial notice
  • Process: File online with Michigan DIFS or call 877-999-6442
  • Timeline: 60 days maximum (72 hours for expedited reviews)
  • Decision: Binding on Aetna if upheld

Required Documents for Appeals

  • Original denial letter
  • Medical necessity documentation
  • Functional assessment results
  • Physician letter supporting continued treatment
  • Any additional clinical evidence

Organizations like Counterforce Health specialize in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to plan policies.

Personal Renewal Tracker

Use this template to stay organized throughout your renewal process:

Key Dates

  • Current authorization expires: ___________
  • Renewal reminder set for: ___________ (60-90 days prior)
  • Functional assessments scheduled: ___________
  • Specialist appointment for renewal letter: ___________
  • Submission target date: ___________

Documentation Checklist

  • Updated 6-minute walk test results
  • Current stair climbing assessment
  • Medical necessity letter from specialist
  • Recent clinic notes
  • Current weight and dosing confirmation
  • Infusion center records
  • Insurance card and member ID

Submission Tracking

  • Submitted via: ___________
  • Confirmation number: ___________
  • Expected decision date: ___________
  • Follow-up call scheduled: ___________

Frequently Asked Questions

How long does Aetna (CVS Health) take to review renewals? Standard prior authorization reviews typically take 15-30 business days. Expedited reviews for urgent medical needs are completed within 72 hours.

What if my functional test results show decline? Document the reasons (illness, injury, natural disease progression) and emphasize that discontinuing Naglazyme would likely worsen outcomes. Include specialist assessment of continued benefit.

Can I request a longer authorization period? Some approvals extend to 12 months, especially for stable patients. Your specialist can request extended authorization in the medical necessity letter.

What if Naglazyme becomes non-formulary? File a formulary exception with documentation that no suitable alternatives exist for MPS VI. BioMarin RareConnections can assist with this process.

Does Michigan have special protections for rare disease medications? While Michigan doesn't have specific rare disease laws, the PRIRA external review process ensures independent medical review of denials, which often favors patients with well-documented rare diseases.

How do I know if my appeal was successful? Aetna will send written notification of approval or denial. For external reviews, Michigan DIFS sends binding decisions to both you and Aetna.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan directly for coverage determinations. For personalized assistance with complex coverage appeals, consider consulting with healthcare advocacy services like Counterforce Health, which helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals.

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