By Counterforce Health Team in Kanuma (sebelipase alfa) —

Getting Kanuma (Sebelipase Alfa) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Cost-Saving Guide

Answer Box: Getting Kanuma Covered in Pennsylvania

Kanuma (sebelipase alfa) is typically covered by Blue Cross Blue Shield plans in Pennsylvania as a specialty drug requiring prior authorization. To get coverage:

  1. Submit PA request with LAL-D diagnosis confirmation (enzyme activity test + LIPA genetic testing)
  2. Use specialty pharmacy (required for all PA Blue Cross plans)
  3. Apply for Alexion OneSource copay assistance if you have commercial insurance (can reduce costs to $0)

First step today: Contact your prescriber to initiate the prior authorization process and enroll in OneSource patient support at 1-888-765-4747. If denied, Pennsylvania's external review program has a 50% success rate for overturning rare disease drug denials.

Table of Contents

  1. What Drives Kanuma Costs
  2. Investigating Your Benefits
  3. Financial Assistance Options
  4. Requesting Tier Exceptions
  5. Specialty Pharmacy Requirements
  6. Appeals Process in Pennsylvania
  7. Annual Renewal Planning
  8. Conversation Scripts

What Drives Kanuma Costs

Kanuma carries an annual cost ranging from $890,000 to $4.9 million depending on patient weight and dosing, making it one of the most expensive medications in the U.S. Your out-of-pocket costs depend on several benefit design factors:

Formulary Tier Placement

Highmark Blue Cross Blue Shield: Places Kanuma on Tier 5 (specialty drugs) with the highest cost-sharing requirements.

Independence Blue Cross: Lists Kanuma on Tier 3 with specialty pharmacy requirements and quantity limits.

Coverage Controls

Control Type What It Means Impact on You
Prior Authorization (PA) Insurer review before coverage Must prove medical necessity
Specialty Pharmacy (SP) Must use approved pharmacy Limited to network providers
Quantity Limits (QL) Dosing restrictions Must align with FDA labeling
Note: Both major Pennsylvania Blues require all three controls for Kanuma coverage.

Investigating Your Benefits

Before starting treatment, gather this information from your Blue Cross Blue Shield plan:

Essential Questions to Ask

Call member services and ask:

  • "What's my specialty drug coinsurance percentage?"
  • "What's my annual out-of-pocket maximum?"
  • "Which specialty pharmacies are in-network for Kanuma?"
  • "Is prior authorization required, and what documentation is needed?"

Information to Record

  • Plan type: HMO, PPO, or POS
  • Deductible: Medical vs. prescription
  • Specialty tier cost-sharing: Percentage or fixed copay
  • Out-of-pocket maximum: Individual vs. family
Tip: Request this information in writing via your member portal to avoid confusion later.

Financial Assistance Options

Manufacturer Copay Program

Alexion OneSource CoPay Assistance can reduce your costs to as little as $0 for eligible patients with commercial insurance.

Eligibility Requirements:

  • Commercial insurance (not Medicare, Medicaid, or VA)
  • U.S. residency
  • Prescribed for FDA-approved indication
  • Enrolled in OneSource patient support

How to Apply:

  1. Call OneSource at 1-888-765-4747 (Monday-Friday, 8:30am-8:00pm ET)
  2. Complete enrollment with your case manager
  3. Provide insurance information and prescription details
Important: Government insurance beneficiaries cannot use manufacturer copay assistance but may qualify for other support programs through OneSource.

Foundation Grants

Several patient assistance foundations provide grants for rare disease medications:

  • HealthWell Foundation
  • Patient Access Network (PAN) Foundation
  • Patient Advocate Foundation

Contact OneSource for current foundation partnerships and application assistance.

Requesting Tier Exceptions

If your plan places Kanuma on a high-cost tier, you can request a formulary exception to reduce your cost-sharing.

When to Request an Exception

  • Step therapy required: When you've failed or can't tolerate required first-line treatments
  • High cost-sharing: When specialty tier costs are unaffordable
  • Non-formulary status: When Kanuma isn't covered at all

Required Documentation

Medical Necessity Letter must include:

  • LAL-D diagnosis with enzyme activity results
  • LIPA genetic testing confirmation
  • Clinical rationale for Kanuma specifically
  • Documentation of disease severity
  • Treatment goals and monitoring plan

Submission Process

Highmark: Submit via provider portal or fax to utilization management department (verify current fax number with customer service).

Independence Blue Cross: Use the formulary exception request form available on the provider portal.

Clinician Corner: Include specific enzyme activity levels (typically <1% of normal) and cite the 2015 consensus recommendations for LAL-D diagnosis and treatment when drafting medical necessity letters.

Specialty Pharmacy Requirements

Both Highmark and Independence Blue Cross require Kanuma to be dispensed through approved specialty pharmacies.

Approved Specialty Pharmacy Networks

Common in-network options:

  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Walgreens Specialty Pharmacy
  • Express Scripts Specialty

Coordination Tips

  1. Verify network status before transferring prescriptions
  2. Confirm shipping capabilities to your location
  3. Establish infusion site coordination if receiving treatment at a clinic
  4. Set up automatic refills to avoid treatment delays

Counterforce Health helps patients navigate these complex specialty pharmacy requirements by identifying the right network providers and coordinating with both the pharmacy and infusion site to ensure seamless treatment delivery.

Appeals Process in Pennsylvania

Pennsylvania offers one of the most patient-friendly appeals processes in the nation, with over 50% of rare disease drug denials overturned through external review.

Internal Appeals (First Step)

Timeline: 30 days from denial notice Process: Submit appeal with additional clinical documentation Decision: Within 30 days (expedited: 72 hours for urgent cases)

Pennsylvania External Review

When to use: After exhausting internal appeals Timeline: Must request within 4 months of final denial Cost: Free to patients Success rate: Over 50% of denials overturned

Required Documents for External Review

  • Insurance card and member ID
  • Final adverse benefit determination letter
  • Supporting medical records
  • Signed physician certification form

Submit online: Pennsylvania Insurance Department External Review Portal

External Review Timeline

Review Type Decision Timeline When to Use
Standard 45 days from IRO assignment Most cases
Expedited 72 hours from IRO assignment Life-threatening situations

Annual Renewal Planning

Plan benefits can change annually, affecting your Kanuma coverage and costs.

What Can Change

  • Formulary tier placement
  • Prior authorization requirements
  • Specialty pharmacy network
  • Cost-sharing amounts

Renewal Checklist

October-November:

  • Review next year's formulary
  • Check specialty pharmacy network changes
  • Confirm prior authorization requirements

December:

  • Re-enroll in copay assistance programs
  • Update specialty pharmacy information
  • Schedule provider appointments for new PAs if needed

Budget Planning

  • Track annual out-of-pocket spending to understand deductible timing
  • Plan infusion scheduling around benefit year resets
  • Coordinate with OneSource for assistance program renewals

Conversation Scripts

Calling Blue Cross Blue Shield Member Services

"Hi, I'm calling about coverage for Kanuma, spelled K-A-N-U-M-A, generic name sebelipase alfa. My member ID is [X]. I need to understand:

  • Is prior authorization required?
  • What formulary tier is it on?
  • What's my cost-sharing for specialty drugs?
  • Which specialty pharmacies are in-network? Can you also send me this information through my member portal?"

Requesting Peer-to-Peer Review

"I'm calling to request a peer-to-peer review for my patient's Kanuma prior authorization denial. The case number is [X]. My patient has confirmed LAL-D with enzyme deficiency and genetic testing. When can I speak with the medical director?"

Specialty Pharmacy Coordination

"I need to transfer a prescription for Kanuma to your specialty pharmacy. The patient has [Insurance Name] and needs coordination with [Infusion Site]. What's your process for insurance verification and delivery scheduling?"

FAQ

How long does Blue Cross Blue Shield PA take in Pennsylvania? Standard PA decisions are made within 72 hours of receiving complete documentation. Expedited requests (for urgent medical situations) are decided within 24 hours.

What if Kanuma is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. If denied, appeal through Pennsylvania's external review program, which has a 50% success rate for rare disease medications.

Can I request an expedited appeal? Yes, if waiting for coverage could seriously harm your health. Your physician must complete a certification form documenting the urgent medical need.

Does step therapy apply to Kanuma? Generally no, since there are no approved alternative enzyme replacement therapies for LAL-D. However, plans may require documentation of failed supportive treatments.

What happens if I move to another state? Coverage may change if you switch to a different Blue Cross Blue Shield plan. Contact member services immediately to understand new requirements and transfer care.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Insufficient diagnosis documentation Submit enzyme activity test results and LIPA genetic testing
Not medically necessary Provide clinical evidence of disease severity and treatment response
Dosing not per FDA label Confirm weight-based dosing calculations with prescriber
Lack of specialist involvement Include metabolic specialist or hepatologist consultation notes

When navigating these complex appeals, Counterforce Health specializes in turning insurance denials into successful approvals by crafting evidence-backed appeals that address each plan's specific denial reasons with targeted clinical documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For personalized assistance with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department's consumer services line.

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