By Counterforce Health Team in Cerezyme (imiglucerase) —

How to Get Cerezyme (Imiglucerase) Covered by Humana in Pennsylvania: Complete Coverage Guide

Answer Box: Your Path to Coverage

Humana classifies Cerezyme (imiglucerase) as a nonpreferred drug requiring prior authorization and step therapy to preferred agents (Elelyso or Vpriv) first. To get coverage in Pennsylvania: (1) Submit PA request with Type 1 Gaucher disease diagnosis and step therapy documentation, (2) If denied, file internal appeal within 60 days, (3) Use Pennsylvania's external review within 4 months of final denial—this state program overturns ~50% of denials. Start with your prescriber submitting PA forms to Humana at 1-877-486-2621.

Table of Contents

Coverage Policy Overview

Humana Medicare Advantage plans classify Cerezyme (imiglucerase, HCPCS J7210) as a nonpreferred drug under Part B coverage for 2025. This means:

  • Prior authorization required before any coverage
  • Step therapy mandate to try preferred alternatives first
  • Medical necessity review for all requests
  • Specialty pharmacy dispensing through CenterWell network

Plan Types Affected

All Humana Medicare Advantage plans in Pennsylvania follow these requirements. Commercial Humana plans may have different policies—verify your specific formulary through your member portal.

Note: Pennsylvania's external review process applies only to commercial plans, not Medicare. Medicare members use federal appeal rights.

Medical Necessity Requirements

Diagnosis Confirmation

Humana requires documented Type 1 Gaucher disease confirmed by:

Primary Diagnostic Test:

Supporting Tests:

Clinical Manifestations

Documentation must show at least one qualifying condition per FDA labeling:

  • Anemia
  • Thrombocytopenia
  • Bone disease (osteopenia, fractures, bone pain)
  • Hepatomegaly or splenomegaly

Age Requirements

FDA-approved for patients 2 years and older with Type 1 Gaucher disease.

Step Therapy and Exceptions

Required First-Line Therapies

Humana's 2025 step therapy policy mandates trials of preferred agents before Cerezyme:

  1. Elelyso (taliglucerase alfa, J7192)
  2. Vpriv (velaglucerase alfa, J7207)

Exception Pathways

You can bypass step therapy if you document:

Medical Contraindications:

  • Allergy or hypersensitivity to preferred agents
  • Drug interactions with current medications
  • Comorbidities making preferred agents inappropriate

Clinical Failure:

  • Inadequate response after appropriate trial duration
  • Intolerable side effects from preferred agents
  • Disease progression despite preferred therapy

Prior Authorization Override:

  • Previous successful treatment with Cerezyme
  • Specialist recommendation with clinical justification

Prior Authorization Process

Submission Requirements

Provider Responsibilities: Submit PA request via:

  • Fax: 1-877-486-2621 (Mon-Fri, 8 a.m.-8 p.m.)
  • Online: Humana provider portal
  • Phone: CenterWell Specialty at 1-800-486-2668

Required Documentation:

  • Complete diagnosis workup (enzyme assay, genetics)
  • Clinical notes documenting qualifying manifestations
  • Step therapy trial documentation or exception rationale
  • Dosing within FDA range: 2.5-60 units/kg per dose
  • Treatment goals and monitoring plan

Timeline Expectations

Review Type Standard Timeline Expedited Timeline
Initial PA ≤30 calendar days ≤72 hours
PA renewal ≤15 business days ≤24 hours
Appeal review ≤60 calendar days ≤72 hours
Tip: Request expedited review if delay would seriously jeopardize health or life.

Appeals Process in Pennsylvania

Internal Appeals (Required First Step)

For Medicare Advantage:

  • Deadline: 60 days from denial notice
  • Method: Call Humana customer service or submit via member portal
  • Timeline: Standard 30 days, expedited 72 hours
  • Required: Final Adverse Benefit Determination letter

Pennsylvania External Review (Commercial Plans Only)

Pennsylvania's Independent External Review program launched in 2024 with impressive results:

Success Rate: ~50% of appeals overturned in first year

Eligibility:

  • Commercial insurance plans (not Medicare or self-funded employer plans)
  • Completed internal appeal process
  • Received Final Adverse Benefit Determination

How to Submit:

  1. Go to pa.gov/reviewmyclaim
  2. Complete online form (free to submit)
  3. Submit within 4 months of final denial
  4. Include supporting medical evidence

Timeline:

  • Standard: ≤45 days from assignment to independent reviewer
  • Expedited: ≤72 hours for urgent health threats
  • Decision binding on insurer
Important: Medicare members cannot use Pennsylvania's external review. Use federal Medicare appeal rights instead.

Specialty Pharmacy Requirements

Network Restrictions

Humana routes Cerezyme through CenterWell Specialty Pharmacy, its owned network provider. This means:

  • Mandatory dispensing through designated specialty pharmacies
  • No retail pharmacy options for Cerezyme
  • Prior coordination required between prescriber and CenterWell

Prescription Submission

Prescriber Options:

  • E-prescribe (preferred method)
  • Fax: 1-877-405-7940
  • Phone: 1-800-486-2668

Delivery Timeline:

  • Initial fills: 7-10 business days after PA approval
  • Refills: 5-7 business days

Common Denial Reasons & Solutions

Denial Reason Required Fix Supporting Documents
Insufficient diagnosis Submit complete workup Enzyme assay, genetic testing, clinical notes
Step therapy not completed Document preferred agent trials Treatment records, side effect documentation
Dosing outside guidelines Adjust to FDA-approved range Specialist justification for specific dosing
Lack of specialist involvement Obtain specialist consultation Referral, specialist treatment plan
Missing clinical manifestations Document qualifying symptoms Lab values, imaging, physical exam findings

Cost Assistance Programs

Manufacturer Support

Cerezyme offers patient assistance including:

  • Insurance coverage support
  • Copay assistance programs
  • Patient education resources

Foundation Grants

  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation
  • Patient Advocate Foundation

Contact these organizations directly to verify current program availability and eligibility.

Clinician Corner: Medical Necessity Letter

When submitting PA requests, include these key elements:

Essential Components:

  1. Clear diagnosis: "Patient has confirmed Type 1 Gaucher disease via [specific test] showing [specific result]"
  2. Clinical manifestations: Document specific qualifying conditions with objective measures
  3. Step therapy rationale: Detail preferred agent trials or contraindications
  4. Treatment goals: Specify measurable outcomes (hemoglobin targets, spleen size reduction)
  5. Monitoring plan: Outline follow-up schedule and assessment methods

Helpful Citations:

When dealing with complex prior authorization requirements and appeals, Counterforce Health helps patients and clinicians navigate insurance denials by creating targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals that align with each payer's specific requirements, potentially improving approval rates for specialty medications like Cerezyme.

FAQ

How long does Humana prior authorization take for Cerezyme in Pennsylvania? Standard PA requests take up to 30 calendar days. Request expedited review (≤72 hours) if delay would seriously jeopardize health.

What if Cerezyme is non-formulary on my plan? Submit a formulary exception request with your PA. Include medical necessity documentation and step therapy rationale.

Can I get temporary coverage while PA is pending? New Humana members may qualify for a 30-day temporary supply during their first 90 days of coverage under Medicare transition policies.

Does Pennsylvania's external review apply to Medicare plans? No. Pennsylvania's external review only covers commercial insurance plans. Medicare members use federal appeal rights through CMS.

What happens if my appeal is approved? If Pennsylvania's external review overturns a denial, the insurer must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal.

How do I find a Gaucher disease specialist in Pennsylvania? Contact the National Gaucher Foundation or ask your primary care doctor for referrals to hematologists or genetic specialists experienced with lysosomal storage disorders.

From our advocates: We've seen cases where initial denials were overturned simply by including more detailed step therapy documentation. One effective approach is creating a timeline showing specific dates, dosages, and documented side effects or lack of efficacy for each preferred agent tried. This concrete evidence often satisfies reviewers who need clear proof that alternatives were genuinely attempted.

Sources & Further Reading

For complex cases requiring detailed appeal strategies, Counterforce Health provides specialized support in turning insurance denials into successful approvals through evidence-based appeal letters tailored to specific payer requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria change frequently. Always verify current requirements with your specific plan and consult healthcare professionals for medical decisions. For additional assistance with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

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