By Counterforce Health Team in Hemlibra (emicizumab-kxwh) —

How to Get Hemlibra (Emicizumab) Covered by Blue Cross Blue Shield in New York: Complete Prior Authorization Guide

Answer Box: Getting Hemlibra Covered by BCBS New York

To get Hemlibra (emicizumab-kxwh) covered by Blue Cross Blue Shield in New York: Submit prior authorization through your hemophilia treatment center with diagnosis documentation (ICD-10: D66), Factor VIII levels <5%, inhibitor titer results, and evidence of inadequate prophylaxis with standard factor concentrates. BCBS NY requires specialty pharmacy dispensing and may mandate step therapy. If denied, file internal appeal within 180 days, then external review with NY Department of Financial Services within 4 months. Start by calling BCBS member services at the number on your insurance card to confirm current PA requirements and obtain forms.

Table of Contents

  1. BCBS New York Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Specialty Pharmacy and Site of Care
  5. Required Documentation
  6. Appeals Process in New York
  7. Common Denial Reasons and Solutions
  8. Cost Assistance Options
  9. FAQ
  10. Sources and Further Reading

BCBS New York Policy Overview

Blue Cross Blue Shield in New York operates through multiple affiliates including Anthem BCBS NY (Empire BlueCross BlueShield) and regional plans like Excellus BCBS. Each plan maintains its own formulary and prior authorization criteria, though they share common elements for specialty medications like Hemlibra.

Plan Types and Coverage:

  • Commercial Plans: HMO, PPO, and EPO plans typically require prior authorization for Hemlibra
  • Medicaid Managed Care: Covered under New York Medicaid with PA requirements
  • Medicare Advantage: Subject to Medicare Part D or medical benefit rules

Hemlibra (emicizumab-kxwh) is a subcutaneous prophylactic therapy for hemophilia A with or without Factor VIII inhibitors. It's manufactured by Genentech and available in multiple vial strengths (30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL) for weight-based dosing.

Tip: Contact your specific BCBS plan's member services using the phone number on your insurance card to confirm which formulary applies to your coverage and obtain current PA forms.

Medical Necessity Requirements

BCBS New York typically requires the following criteria to establish medical necessity for Hemlibra coverage:

Primary Requirements

  • Diagnosis: Congenital hemophilia A (ICD-10: D66)
  • Age: Generally ≥12 years old (verify with your plan)
  • Prescriber: Must be prescribed by a hematologist at a hemophilia treatment center
  • Factor VIII Level: Severe (<1%) or moderate (1-5%) deficiency documented

Clinical Documentation Needed

  1. Bleeding History: Documentation of bleeding episodes despite optimal factor prophylaxis
  2. Inhibitor Status: For patients with inhibitors, titer >5 Bethesda Units/mL
  3. Previous Therapies: Evidence of inadequate response to factor VIII concentrates or bypassing agents
  4. Weight-Based Dosing Plan: Appropriate dosing per FDA label (1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks)

Step Therapy and Exceptions

Many BCBS New York plans require step therapy, meaning you must try and fail standard treatments before Hemlibra is covered. However, medical exceptions are available.

Typical Step Therapy Sequence:

  1. Factor VIII prophylaxis (for patients without inhibitors)
  2. Bypassing agents (for patients with inhibitors)
  3. Hemlibra (after documented failure or intolerance)

Medical Exception Criteria

You can bypass step therapy if you have:

  • Documented allergic reaction to required first-line therapies
  • Contraindications that make standard treatments unsafe
  • Clinical evidence that standard therapies are inappropriate
  • Previous treatment failure documented in medical records
Note: Under New York Insurance Law, insurers must approve step therapy overrides within 72 hours for urgent requests.

Specialty Pharmacy and Site of Care

Hemlibra must be dispensed through BCBS-approved specialty pharmacies and is typically administered at home via subcutaneous injection.

Dispensing Requirements

  • Specialty Pharmacy Only: Cannot be filled at retail pharmacies
  • Network Restrictions: Must use BCBS-contracted specialty pharmacies (often CVS Specialty)
  • Prior Authorization: Required before first fill and for renewals

Administration Settings

Setting Coverage Notes
Home Administration Preferred Self-administered subcutaneous injection; requires training
Provider Office Covered Higher costs; typically unnecessary for subcutaneous therapy
Infusion Center Limited May require additional authorization; avoid hospital-based centers

Home administration is strongly preferred as it reduces costs significantly (approximately $10,104 annually vs. $18,819 for clinic administration) and improves patient independence.

Required Documentation

When submitting your prior authorization, ensure you include:

Clinical Documentation Checklist

  • Diagnosis confirmation with ICD-10 code D66
  • Factor VIII activity level (recent lab results)
  • Inhibitor titer (Bethesda assay results if applicable)
  • Bleeding diary or documentation of bleeding episodes
  • Previous treatment history including specific products tried and outcomes
  • Weight and dosing calculation per FDA-approved regimen
  • Prescriber attestation from hemophilia treatment center

Supporting Evidence

Include peer-reviewed literature and clinical guidelines that support Hemlibra use for your specific situation. Key references include:

  • FDA prescribing information
  • World Federation of Hemophilia treatment guidelines
  • National Hemophilia Foundation recommendations

Appeals Process in New York

New York has robust patient protection laws for insurance appeals, offering multiple levels of review.

Internal Appeal Process

  1. File within 180 days of denial notice
  2. Submit to BCBS using their reconsideration request form
  3. Include documentation addressing the specific denial reason
  4. Timeline: 30 days for standard appeals, 72 hours for expedited

External Appeal Through NY DFS

If your internal appeal is denied, you can request an external review:

  1. File within 4 months of final internal denial
  2. Submit online at DFS.ny.gov
  3. Independent review by medical experts
  4. Timeline: 30 days standard, 72 hours expedited (24 hours for drug denials)
  5. Binding decision on the insurance company
Important: External appeal decisions are binding on BCBS and cannot be overturned. The state charges a maximum $25 filing fee, waived for financial hardship.

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
Not medically necessary Submit bleeding diary, factor levels, treatment center letter documenting inadequate prophylaxis
Step therapy not completed Request medical exception with contraindication documentation or prior failure evidence
Off-label use Provide FDA labeling showing approved indication matches patient's condition
Quantity limits exceeded Submit weight-based dosing calculation and clinical justification for prescribed frequency
Non-preferred drug Document medical necessity and failure/intolerance of preferred alternatives

Clinician Corner: Medical Necessity Letter

Healthcare providers should structure medical necessity letters to include:

  • Patient demographics and hemophilia A diagnosis with severity
  • Clinical history including bleeding episodes and hospitalizations
  • Previous treatments tried with specific outcomes and reasons for discontinuation
  • Current clinical status and treatment goals
  • Evidence-based rationale citing relevant guidelines and literature
  • Monitoring plan and expected outcomes with Hemlibra therapy

Cost Assistance Options

Several programs can help reduce out-of-pocket costs for Hemlibra:

Manufacturer Support

  • Genentech Patient Foundation: Income-based assistance for eligible patients
  • Co-pay assistance programs: May reduce monthly costs for commercially insured patients

Additional Resources

  • National Bleeding Disorders Foundation: Patient assistance programs and grants
  • State pharmaceutical assistance programs: Check New York-specific options
  • Hospital charity care: For facility-administered doses

Contact Counterforce Health for assistance with navigating coverage denials and appeals. Their platform specializes in turning insurance denials into evidence-backed appeals for specialty medications like Hemlibra.

FAQ

Q: How long does BCBS New York prior authorization take for Hemlibra? A: Standard PA decisions are made within 15 days for pre-service requests. Expedited reviews are completed within 72 hours for urgent medical needs.

Q: What if Hemlibra is not on my BCBS formulary? A: Request a formulary exception by demonstrating medical necessity and providing clinical documentation. Your hemophilia treatment center can assist with this process.

Q: Can I get temporary coverage while my appeal is pending? A: Yes, you may request continuation of therapy during the appeal process, especially if discontinuation could cause serious harm.

Q: Do I need to use a specific specialty pharmacy? A: Yes, BCBS contracts with specific specialty pharmacies. Contact member services to identify approved providers in your network.

Q: What if I move to New York from another state while on Hemlibra? A: Contact BCBS member services immediately to ensure continuity of coverage. You may need to submit new prior authorization with your current clinical documentation.

Q: How often do I need to renew prior authorization? A: Typically annually, though some plans may require more frequent renewals. Your specialty pharmacy will notify you when renewal is needed.

From Our Advocates

We've seen many Hemlibra appeals succeed when families work closely with their hemophilia treatment center to document breakthrough bleeding episodes and previous treatment failures. The key is presenting a clear clinical picture that shows standard prophylaxis isn't adequately preventing bleeds, supported by objective data like joint assessments and bleeding diaries. While each case is unique, thorough documentation significantly improves approval chances.

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting targeted, evidence-backed appeals. Their platform ingests clinical documentation and payer policies to identify the strongest arguments for coverage approval.

Sources and 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 frequently. Always consult your insurance plan documents and healthcare providers for current requirements. For assistance with insurance appeals, contact the New York Department of Financial Services Consumer Assistance Unit at 1-800-342-3736.

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