By Counterforce Health Team in Ultomiris (ravulizumab) —

How to Get Ultomiris (Ravulizumab) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Coverage Guide

Answer Box: Getting Ultomiris Covered by Blue Cross Blue Shield in Pennsylvania

To get Ultomiris (ravulizumab) covered by Blue Cross Blue Shield in Pennsylvania: 1) Confirm your diagnosis meets FDA criteria (PNH, aHUS, gMG, or NMOSD) with required lab tests, 2) Complete meningococcal vaccination and REMS enrollment, 3) Submit prior authorization with complete clinical documentation through your BCBS plan's provider portal. If denied, Pennsylvania's new external review program overturns 50% of appeals. Start with your prescriber today to gather documentation and initiate the prior authorization process.

Table of Contents

Policy Overview: Pennsylvania BCBS Plans

Pennsylvania has two major Blue Cross Blue Shield plans: Highmark Blue Shield covering western Pennsylvania and Independence Blue Cross serving the Philadelphia region. Both require prior authorization for Ultomiris, but their specific criteria and processes differ.

Highmark Blue Shield provides initial authorization for 6 months, with reauthorization periods extending up to 12 months depending on clinical response. The plan requires provider attestation of clinical improvement for all continuation requests.

Independence Blue Cross classifies Ultomiris as a specialty medication requiring precertification through Carelon Medical Benefits Management. Effective January 2026, Ultomiris becomes a preferred product for Medicare Advantage members under IBX's step therapy protocol.

Both plans follow Pennsylvania's 180-day internal appeal window for commercial coverage, with access to the state's new external review program launched in January 2024.

Medical Necessity Requirements by Condition

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Diagnosis confirmation: Flow cytometry showing PNH type III red cells
  • Clinical evidence: History of at least one transfusion in 24 months OR documented active hemolysis
  • Age requirements: FDA-approved for adults and pediatric patients
  • Vaccination: Current meningococcal vaccination at least 2 weeks before treatment

Atypical Hemolytic Uremic Syndrome (aHUS)

  • Diagnostic criteria: Complement studies confirming aHUS with exclusion of STEC-HUS
  • Clinical documentation: Evidence of thrombotic microangiopathy with renal involvement
  • Age limits: Approved for patients 18 years and older (Highmark); pediatric use varies by plan
  • Exclusions: No evidence of active meningococcal infection

Generalized Myasthenia Gravis (gMG)

  • Antibody testing: Positive anti-acetylcholine receptor (AChR) antibody
  • Clinical classification: MGFA Class II-IV symptoms
  • Age requirement: 18 years or older
  • Prior therapy: Documentation of previous treatment attempts and outcomes

Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • Diagnostic confirmation: Positive AQP4-antibody testing and clinical criteria
  • Disease pattern: Documented relapsing course
  • Age considerations: Adult indication (18+); pediatric coverage varies
  • Treatment history: Prior immunosuppressive therapy attempts
Clinician Corner: Your medical necessity letter should include: confirmed diagnosis with specific lab values, prior treatment history with dates and outcomes, current clinical status, treatment goals, and citations to FDA labeling or specialty guidelines.

Step Therapy and Exception Pathways

Some Pennsylvania BCBS plans may require step therapy, particularly for PNH where less expensive alternatives exist. Medical exceptions are available when you can document:

  • Contraindications to preferred agents (e.g., allergic reactions, specific medical conditions)
  • Treatment failures with required prior therapies
  • Intolerance causing discontinuation of step therapy drugs

Independence Blue Cross specifically notes that certain plans may prefer biosimilar eculizumab before approving Ultomiris. Document any clinical reasons why the extended dosing interval of Ultomiris (every 8 weeks vs. every 2 weeks) is medically necessary.

Required Documentation Checklist

Essential Clinical Records

  • Complete diagnostic workup confirming FDA-approved indication
  • Laboratory results supporting diagnosis (flow cytometry, complement studies, antibody tests)
  • Prior treatment history with dates, doses, and outcomes
  • Current clinical status and symptom severity
  • Meningococcal vaccination records (within 3 years)
  • REMS program enrollment confirmation

Supporting Evidence

  • Specialist consultation notes (hematologist, neurologist)
  • Hospital records if applicable (transfusions, relapses)
  • Quality of life assessments or functional scales
  • Insurance card and member ID information

Counterforce Health helps patients and clinicians streamline this documentation process by automatically identifying the specific evidence requirements for each payer and organizing clinical information into targeted, evidence-backed appeals that align with Blue Cross Blue Shield's own coverage criteria.

Site of Care and Specialty Pharmacy Requirements

Ultomiris requires administration through specialty pharmacy networks and approved infusion centers. Both Highmark and Independence Blue Cross maintain preferred provider networks for complement inhibitor therapies.

Infusion requirements:

  • Initial loading dose followed by maintenance every 8 weeks
  • Administered by qualified healthcare professionals
  • Pre-medication and monitoring protocols per REMS requirements
  • On-body subcutaneous option available for some adult PNH/aHUS patients

Contact your plan's specialty pharmacy team to confirm network providers and prior authorization for the administration site.

Step-by-Step: Fastest Path to Approval

  1. Confirm diagnosis and indication (Patient + Prescriber)
    • Obtain required lab tests confirming FDA-approved indication
    • Timeline: 1-2 weeks for test results
  2. Complete REMS enrollment (Prescriber)
  3. Gather clinical documentation (Clinic staff)
    • Compile prior treatment records, lab results, specialist notes
    • Use checklist above for complete submission
    • Timeline: 3-5 business days
  4. Submit prior authorization (Prescriber)
    • File through BCBS provider portal or specialty pharmacy
    • Include all required clinical documentation
    • Timeline: Submit within 1 week of gathering documents
  5. Track authorization status (Patient + Clinic)
    • Follow up within 5-7 business days if no response
    • Request expedited review if clinically urgent
    • Timeline: Standard PA decisions within 15 business days
  6. Coordinate infusion scheduling (Patient + Specialty pharmacy)
    • Confirm network provider and schedule loading dose
    • Arrange transportation and pre-medications
    • Timeline: 1-2 weeks after approval
  7. Monitor for reauthorization (Prescriber)
    • Document clinical response for continuation requests
    • Submit reauthorization 30 days before expiration
    • Timeline: Ongoing every 6-12 months

Appeals Process for Pennsylvania

Pennsylvania launched a new Independent External Review Program in January 2024, which has overturned 50% of appealed denials in its first year. Here's your pathway if Ultomiris is initially denied:

Internal Appeal (Required First Step)

  • Timeline: Must file within 180 days of denial notice
  • Process: Submit through BCBS member portal or written request
  • Decision timeframe: 30 days for standard; 72 hours for expedited
  • Required: Include all clinical documentation and prescriber letter

External Review (State-Supervised)

  • Eligibility: After receiving Final Adverse Benefit Determination
  • Timeline: Request within 4 months of final internal denial
  • Cost: Free to patients
  • Process: Submit online at pa.gov/reviewmyclaim
  • Decision timeframe: 45 days for standard; 72 hours for expedited
  • Success rate: 50% overturn rate in 2024
From our advocates: We've seen patients succeed in external review by submitting additional peer-reviewed studies supporting off-label use and detailed letters from specialists explaining why alternative treatments failed. The independent review organizations often have more flexibility than internal reviewers when evaluating complex rare disease cases.

For assistance with appeals, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388 or the Pennsylvania Health Law Project for free advocacy support.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
"Not medically necessary" Submit specialist letter with clinical justification Neurologist/hematologist consultation, symptom severity scores
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA label, peer-reviewed studies
"Step therapy not completed" Request medical exception with contraindication Prior treatment records showing failure/intolerance
"Insufficient documentation" Resubmit with complete clinical records All items from documentation checklist above
"REMS requirements not met" Complete vaccination and enrollment Current vaccination record, REMS confirmation

Coverage at a Glance

Requirement Highmark Blue Shield Independence Blue Cross Where to Verify
Prior Authorization Required Required Provider portals
Initial Coverage Period 6 months Varies by indication Plan-specific policies
Reauthorization Up to 12 months Based on clinical response Medical necessity criteria
Step Therapy May apply Preferred product 2026+ Formulary documents
Specialty Pharmacy Required Required Network directories
REMS Enrollment Mandatory Mandatory Alexion Access Navigator

FAQ: Pennsylvania BCBS Ultomiris Coverage

How long does BCBS prior authorization take in Pennsylvania? Standard prior authorization decisions are made within 15 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Ultomiris is not on my formulary? Request a formulary exception with clinical justification. Both Highmark and Independence Blue Cross have processes for non-formulary drug coverage when medically necessary.

Can I request an expedited appeal? Yes, if your condition poses an imminent threat to your health. Submit expedited appeal requests with documentation of clinical urgency.

Does step therapy apply if I've failed treatments outside Pennsylvania? Treatment failures from other states count toward step therapy requirements. Include complete records from previous providers.

What's the cost difference between Ultomiris and alternatives? Ultomiris costs approximately $474,000-$569,000 annually. Biosimilar eculizumab may be preferred by some plans as a cost-effective alternative.

How do I find an in-network infusion center? Contact your BCBS plan's specialty pharmacy team or search the provider directory for complement inhibitor-approved facilities.

What happens if my external review is successful? The insurer must immediately provide coverage, including retroactive coverage if you paid out-of-pocket during the appeal process.

Can I get help with the appeals process? Yes, contact the Pennsylvania Health Law Project for free advocacy assistance or the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

This article provides educational information and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions. For official coverage information, contact your Blue Cross Blue Shield plan directly.

Sources & Further Reading

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