By Counterforce Health Team in Naglazyme (galsulfase) — 29 Nov 2025

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

Quick Answer: Getting Naglazyme Covered by Humana in Pennsylvania

Naglazyme (galsulfase) likely requires prior authorization from Humana. Start by having your specialist submit a PA request with enzyme assay results, genetic testing, and baseline functional assessments. If denied, you have 65 days to appeal internally, then 4 months for Pennsylvania's external review program, which overturns about 50% of denials. Contact Humana's prior authorization line first to confirm current requirements.

First step today: Call Humana at their pharmacy prior authorization number or have your provider use their Prior Authorization Search Tool to verify Naglazyme's current coverage status.

Why Pennsylvania State Rules Matter
Humana Prior Authorization Requirements
Pennsylvania Step Therapy Protections
Medical Necessity Documentation
Appeals Process and Timelines
Pennsylvania External Review Program
Practical Scripts and Templates
When to Escalate

Why Pennsylvania State Rules Matter

Pennsylvania has strengthened patient protections for specialty medications like Naglazyme through several key reforms. Senate Bill 225 streamlines prior authorization processes and establishes clear timelines for appeals determinations. More importantly, Pennsylvania's new Independent External Review Program, launched in January 2024, gives you a state-supervised path to challenge denials after exhausting internal appeals.

These protections apply differently depending on your plan type:

Humana Medicare Advantage: Subject to federal Medicare rules plus Pennsylvania consumer protections
Humana Commercial Plans: Full Pennsylvania state protections apply
Self-funded employer plans: Limited state protections (ERISA preemption applies)

The key difference: Pennsylvania's external review program has overturned approximately 50% of appealed denials in its first year, making it a powerful tool for expensive specialty medications.

Humana Prior Authorization Requirements

While specific Naglazyme prior authorization requirements aren't publicly detailed in Humana's current formulary documents, enzyme replacement therapies typically require comprehensive documentation. Based on Humana's Clinical Pharmacy Review process, expect these requirements:

Coverage at a Glance

Requirement	What It Means	Where to Find It
Prior Authorization	Likely required for all ERT medications	Humana Prior Auth Search Tool
Formulary Status	May be non-formulary, requiring exception	Humana Drug Lists
Medical Necessity	Confirmed MPS VI diagnosis required	Provider clinical documentation
Site of Care	Hospital/infusion center administration	Humana medical policy
Appeals Timeline	65 days for Medicare; varies for commercial	Humana Appeals Process

Initial Authorization Requirements

Your specialist will need to provide:

Confirmed MPS VI diagnosis via enzyme assay showing arylsulfatase B activity <10% of normal
Genetic testing confirming ARSB gene mutations
Baseline assessments including pulmonary function tests, cardiac evaluation, and mobility measurements
Treatment plan detailing infusion schedule and monitoring protocols
FDA-compliant dosing at 1 mg/kg IV weekly

Pennsylvania Step Therapy Protections

Good news: Naglazyme is exempt from traditional step therapy requirements because it's the only FDA-approved enzyme replacement therapy for MPS VI. Pennsylvania's step therapy legislation provides additional protections by requiring clear exemption criteria and timely appeals processes.

Medical Exception Criteria

Even without step therapy requirements, Humana may still ask why other approaches aren't appropriate. Document these points:

No therapeutic alternatives: Naglazyme is the only FDA-approved ERT for MPS VI
Disease progression: Without treatment, MPS VI causes irreversible organ damage
Clinical urgency: Early intervention prevents permanent disability

Medical Necessity Documentation

Clinician Corner: Essential Documentation

Your healthcare provider's medical necessity letter should include:

Diagnostic Confirmation:

Enzyme assay results showing arylsulfatase B deficiency
Genetic testing confirming ARSB gene mutations
Elevated urinary dermatan sulfate levels

Clinical Justification:

Current symptoms and functional limitations
Evidence of disease progression
Expected treatment outcomes based on FDA labeling

Treatment Plan:

Dosing per FDA guidelines (1 mg/kg weekly)
Infusion site and monitoring protocols
Plans for ongoing assessment

Supporting Evidence:

Reference FDA approval for MPS VI
Cite clinical studies showing improved walking capacity
Include baseline functional assessments

From Our Advocates: We've seen the strongest approvals when providers emphasize that MPS VI is a progressive, life-threatening condition with only one FDA-approved treatment. Including specific enzyme levels and functional decline measurements helps demonstrate medical urgency. While outcomes aren't guaranteed, comprehensive documentation significantly improves approval odds.

Appeals Process and Timelines

Internal Appeals with Humana

If your initial request is denied, you have clear appeal rights:

Medicare Advantage Plans:

Timeline: 65 days from denial notice
Standard review: 30 days for decision
Expedited review: 72 hours for urgent cases
Contact: Humana Appeals (verify current phone number)

Commercial Plans:

Timeline: Varies by plan (typically 180 days)
Review period: 15-30 days standard
Expedited: 72 hours for urgent situations

Required Appeal Documentation

Include these items with your appeal:

Original denial letter with claim/reference numbers
Updated medical necessity letter addressing denial reasons
Additional clinical evidence (recent labs, imaging, functional assessments)
Peer-reviewed literature supporting Naglazyme use in MPS VI
Patient impact statement describing functional decline without treatment

Pennsylvania External Review Program

Pennsylvania's Independent External Review Program provides your strongest appeal option after exhausting internal reviews.

Eligibility and Process

Who can use it: Commercially insured Pennsylvania residents who've received a Final Adverse Benefit Determination

Timeline:

File within: 4 months of final internal denial
Standard review: 45 days for decision
Expedited review: 72 hours for urgent cases

Success rate: Approximately 50% of appeals are successful

How to File

Complete internal appeals first and obtain final denial letter
Submit request via PA Insurance Department website or by mail
Provide documentation within 15 days of assignment to Independent Review Organization
Await decision - if successful, Humana must provide coverage immediately

Practical Scripts and Templates

Patient Phone Script for Humana

"Hello, I'm calling about prior authorization requirements for Naglazyme, also called galsulfase, for my MPS VI condition. My member ID is [number]. Can you tell me if this medication requires prior authorization and what documentation my doctor needs to submit? I also need to know if it's covered under my formulary or if I need a formulary exception."

Formulary Exception Request

If Naglazyme isn't on Humana's formulary, your provider can request an exception. Humana's formulary exception process requires:

Supporting statement from prescriber explaining medical necessity
Evidence that formulary alternatives would be less effective or cause adverse effects
Timeline: 72 hours for standard decisions

Tip: For formulary exceptions, emphasize that there are no therapeutic alternatives to Naglazyme for MPS VI - it's the only FDA-approved enzyme replacement therapy for this condition.

When to Escalate

Pennsylvania Insurance Department

Contact the Pennsylvania Insurance Department if:

Humana doesn't respond within required timelines
You need help with the external review process
You believe Humana isn't following Pennsylvania insurance laws

Consumer Services: Available via PA.gov with dedicated external review guidance

Additional Resources

Pennsylvania Health Law Project: Provides free appeals assistance for low-income individuals
Counterforce Health: Specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Naglazyme. Their platform helps patients and providers navigate the prior authorization process by identifying denial reasons and crafting point-by-point rebuttals aligned with payer policies.

Medicare Resources (for Medicare Advantage plans)

1-800-MEDICARE: Federal Medicare helpline
State Health Insurance Assistance Program (SHIP): Free local counseling

FAQ

Q: How long does Humana prior authorization take for Naglazyme in Pennsylvania? A: Standard reviews typically take up to 30 days for Medicare Advantage plans. Expedited reviews for urgent cases are decided within 72 hours when physician-certified.

Q: What if Naglazyme is non-formulary on my Humana plan? A: You can request a formulary exception. Your prescriber must provide a supporting statement explaining why formulary alternatives wouldn't be effective. Decisions are made within 72 hours.

Q: Can I get expedited review for Naglazyme appeals? A: Yes, if your physician certifies that standard timelines could seriously jeopardize your health. Both Humana internal appeals and Pennsylvania external reviews offer expedited options.

Q: Does Pennsylvania's external review apply to Medicare Advantage plans? A: Pennsylvania's external review primarily applies to commercial plans. Medicare Advantage has federal appeal rights, but some Pennsylvania protections may still apply (verify with PA Insurance Department).

Q: What happens if I'm already taking Naglazyme and Humana denies continuation? A: You may qualify for transition coverage while pursuing appeals. Contact Humana about temporary coverage during the appeal process.

Checklist: What to Gather Before You Start

Before beginning the prior authorization process:

Insurance card with member/policy ID
Complete prescriber information (NPI, contact details)
Enzyme assay results showing arylsulfatase B deficiency
Genetic testing confirming MPS VI diagnosis
Baseline functional assessments (6-minute walk test, pulmonary function)
Documentation of current symptoms and disease progression
Any previous denial letters or EOBs
List of prior treatments attempted (if any)

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan and medical situation. Always consult with your healthcare provider and insurance company for personalized guidance.

For additional help with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department Consumer Services or visit their external review resources online.

Sources & Further Reading

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform specializes in complex prior authorization cases like enzyme replacement therapies, identifying denial reasons and crafting comprehensive rebuttals that align 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.