By Counterforce Health Team in Haegarda (C1-esterase inhibitor, SC) —

Blue Cross Blue Shield Michigan Haegarda Coverage: Prior Authorization Requirements and Appeal Guide

Answer Box: Getting Haegarda Covered by Blue Cross Blue Shield of Michigan

Blue Cross Blue Shield of Michigan (BCBSM) requires prior authorization for Haegarda (C1-esterase inhibitor, subcutaneous) for hereditary angioedema prophylaxis. To get approved: (1) Confirm HAE diagnosis with low C4 and C1-INH functional testing, (2) Submit PA request through your allergist/immunologist with attack frequency documentation, and (3) Use BCBSM's specialty pharmacy network for home administration. If denied, you have 180 days to file an internal appeal, then 127 days for external review through Michigan DIFS.

Start today: Contact your prescribing specialist to initiate the prior authorization process via BCBSM's provider portal.

Table of Contents

  1. BCBSM Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Site of Care and Specialty Pharmacy
  5. Required Documentation
  6. Appeals Process in Michigan
  7. Common Denial Reasons and Solutions
  8. FAQ

BCBSM Policy Overview

Blue Cross Blue Shield of Michigan covers approximately 67% of commercial plan members in the state and treats Haegarda as a specialty medication requiring prior authorization. The drug appears on BCBSM's Preferred Drug List with specific coverage criteria that must be met before approval.

Plan Types Affected:

  • Commercial HMO and PPO plans
  • Blue Care Network (BCN) members
  • Medicare Advantage (separate criteria may apply)

BCBSM's pharmacy and therapeutics committee has established Haegarda as a preferred first-line option for HAE prophylaxis, which means it's favored over newer alternatives like Andembry but still requires documentation of medical necessity.

Note: Medicaid members should check with their managed care plan, as criteria may differ from commercial coverage.

Medical Necessity Requirements

Core Eligibility Criteria

To qualify for Haegarda coverage under BCBSM, patients must meet these fundamental requirements:

Confirmed HAE Diagnosis:

  • Type I or Type II hereditary angioedema confirmed by laboratory testing
  • Low serum C4 levels (typically <50% of normal)
  • Abnormal C1-INH functional assay results
  • Testing performed during remission for accuracy

Clinical Need for Prophylaxis:

  • History of at least 2 HAE attacks per month, OR
  • Severe attacks involving laryngeal, facial, or gastrointestinal swelling
  • Documentation that attacks significantly impact quality of life

Prescriber Requirements:

  • Must be prescribed by an immunologist, allergist, or hematologist
  • Provider must submit clinical rationale supporting prophylactic therapy

FDA-Approved Indication

Haegarda is FDA-approved for routine prophylaxis to prevent HAE attacks in patients 6 years of age and older. BCBSM generally covers FDA-approved indications when medical necessity criteria are met.

Step Therapy and Exceptions

BCBSM's step therapy requirements for HAE medications position Haegarda as a preferred option, but certain protocols must be followed:

Current Step Therapy Protocol

Based on BCBSM's formulary guidelines, Haegarda is considered a first-line prophylactic option. However, for coverage of newer HAE treatments like Andembry, patients must demonstrate:

  • Trial and treatment failure of Haegarda, Takhzyro, and Orladeyo
  • Documented intolerance or contraindications to preferred agents

Medical Exception Pathways

Patients can bypass step therapy requirements if they have:

  • Contraindications: Documented allergies or medical conditions preventing use of preferred drugs
  • Previous failures: Prior unsuccessful trials with required medications (from any insurer)
  • Clinical urgency: Severe HAE requiring immediate prophylaxis

To request a medical exception, submit documentation of:

  • Specific contraindication with supporting medical records
  • Previous trial outcomes with dates and clinical response
  • Allergist/immunologist's clinical justification

Site of Care and Specialty Pharmacy

Preferred Coverage Location

BCBSM primarily covers Haegarda under the outpatient pharmacy benefit for self-administration at home. This approach:

  • Reduces patient cost-sharing compared to medical benefit coverage
  • Allows for convenient twice-weekly subcutaneous injections
  • Requires access through BCBSM's designated specialty pharmacy network

Specialty Pharmacy Network

Haegarda must be obtained through BCBSM's retail specialty pharmacy partners. Contact your plan's pharmacy benefit manager to identify in-network specialty pharmacies in your area.

Medical Benefit Coverage

Coverage under the medical benefit (physician's office, infusion center) is only approved when:

  • Patient cannot safely self-administer at home
  • Clinical documentation supports need for supervised administration
  • Provider submits prior authorization with specific rationale
Tip: Home administration is strongly preferred and typically results in lower out-of-pocket costs for patients.

Required Documentation

Laboratory Evidence

Submit recent laboratory results confirming HAE diagnosis:

  • C4 complement level (must be low, typically <50% normal)
  • C1-INH antigenic level (protein measurement)
  • C1-INH functional assay (activity measurement)
  • C1q level (to rule out acquired angioedema)

Clinical Documentation

Your healthcare provider must include:

  • Attack history: Frequency, severity, and anatomical locations affected
  • Treatment goals: Reduction in attack frequency and severity
  • Dosing rationale: 60 IU/kg twice weekly based on patient weight
  • Monitoring plan: Follow-up schedule to assess treatment response

Prior Therapy Records

If applicable, document:

  • Previous HAE treatments attempted
  • Clinical response or reasons for discontinuation
  • Dates of treatment trials
  • Adverse events or contraindications experienced

Appeals Process in Michigan

Internal Appeals with BCBSM

If your initial prior authorization is denied:

Timeline: File within 180 days of denial notice Process: Submit through BCBSM member portal or provider portal Decision timeframe: BCBSM has 30 calendar days to respond Required documents: Original denial letter, additional clinical documentation, prescriber letter

External Review Through Michigan DIFS

After exhausting BCBSM's internal appeals:

Timeline: File within 127 days of BCBSM's final adverse determination Process: Submit request to Michigan Department of Insurance and Financial Services (DIFS) Decision timeframe: 45-60 days for standard review Cost: Free to patients Success rate: Approximately 38-45% of external reviews overturn BCBSM denials

Expedited Appeals

For urgent medical situations:

  • DIFS expedited external appeal: Decision within 72 hours
  • Requires physician letter documenting medical urgency
  • Only available for pre-service denials (prior authorization requests)

Contact DIFS at (877) 999-6442 for assistance with the external review process.

Common Denial Reasons and Solutions

Denial Reason Solution
Insufficient HAE documentation Submit complete lab panel (C4, C1-INH antigenic/functional, C1q)
Attack frequency not documented Provide detailed attack logs with dates, severity, anatomical locations
Wrong prescriber specialty Ensure prescription from allergist, immunologist, or hematologist
Missing prior therapy trials Document previous treatments attempted (if applicable)
Quantity/dosing concerns Justify 60 IU/kg twice weekly with weight-based calculations
Site of care issues Request home administration through specialty pharmacy

Clinician Corner: Medical Necessity Letter

When submitting a prior authorization for Haegarda, include these key elements:

Patient Problem:

  • Confirmed HAE Type I or II diagnosis
  • Specific attack frequency and severity
  • Impact on patient's quality of life and daily functioning

Clinical Rationale:

  • FDA-approved indication for HAE prophylaxis in patients ≥6 years
  • Evidence-based dosing at 60 IU/kg subcutaneously twice weekly
  • Expected reduction in attack frequency based on clinical trial data

Supporting Evidence:

  • Reference FDA prescribing information
  • Cite relevant guidelines from World Allergy Organization (WAO)
  • Include laboratory confirmation of C1-INH deficiency

FAQ

How long does BCBSM prior authorization take for Haegarda? Standard prior authorization decisions are made within 72 hours for urgent requests and 14 days for routine requests. Complex cases may take up to 30 days.

What if Haegarda is non-formulary on my plan? Haegarda appears on BCBSM's Preferred Drug List. If it's not covered under your specific plan, request a formulary exception with clinical justification.

Can I request an expedited appeal if my HAE is severe? Yes, if your physician documents that delayed treatment would seriously jeopardize your health, you can request expedited review through both BCBSM and Michigan DIFS.

Does step therapy apply if I've tried other HAE medications outside Michigan? Previous treatment trials from any location count toward step therapy requirements. Submit documentation of prior therapies and outcomes.

What are my options if BCBSM denies coverage entirely? After internal appeals, file for external review with Michigan DIFS. You can also explore manufacturer patient assistance programs and copay support.

How much does Haegarda cost without insurance? Retail cash prices per vial typically reach high four- to five-figure amounts. Monthly costs vary based on patient weight and dosing requirements.

Patient Support Resources

Manufacturer Support

CSL Behring offers patient assistance through their Haegarda support program. Eligible patients may receive:

  • Copay assistance for commercially insured patients
  • Patient assistance program for uninsured/underinsured individuals
  • Injection training and ongoing support

Michigan-Specific Resources

Michigan Department of Insurance and Financial Services (DIFS)

  • Phone: (877) 999-6442
  • External review forms and guidance
  • Consumer assistance with insurance disputes

Counterforce Health helps patients navigate complex prior authorization requirements and turn insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters and plan policies, then drafts point-by-point rebuttals aligned to each insurer's specific rules while pulling appropriate clinical evidence and documentation requirements.

For patients facing repeated denials or complex coverage challenges, Counterforce Health provides specialized support for HAE medications and other specialty therapies, helping ensure that clinical documentation meets payer-specific criteria and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by individual plan and circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For official appeals procedures and forms, contact Michigan DIFS or your insurance carrier directly.

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