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

Humana's Coverage Criteria for Haegarda (C1-esterase inhibitor, SC) in Pennsylvania: What Counts as "Medically Necessary"?

Answer Box: Getting Haegarda Covered by Humana in Pennsylvania

Humana requires prior authorization for Haegarda (C1-esterase inhibitor, SC) in Pennsylvania. Medical necessity requires confirmed HAE diagnosis with low C4 and abnormal C1-INH levels, documented attack frequency, and often step therapy through oral berotralstat (Orladeyo) or lanadelumab (Takhzyro) first.

Fastest path: Have your prescriber submit PA via Humana's provider portal with complete HAE labs, attack logs, and prior therapy documentation. For Medicare Advantage denials, use Medicare's appeal process, not Pennsylvania's external review.

Table of Contents

Policy Overview

Humana Medicare Advantage and Part D plans classify Haegarda as a high-cost specialty biologic requiring prior authorization across all plan types in Pennsylvania. The drug falls under Humana's Clinical Pharmacy Review (HCPR) process rather than standard medical service authorizations.

Plan Types and Coverage

  • Medicare Advantage (Part C): Covers Haegarda when billed as a Part B professionally administered drug or Part D specialty medication
  • Part D Stand-alone: Coverage through specialty pharmacy networks
  • Dual Eligible Special Needs Plans (D-SNP): Same PA requirements with potential state Medicaid coordination

Humana maintains separate prior authorization lists for medical services versus medications. Haegarda appears on the medication PA list, which you can verify using Humana's Prior Authorization Search Tool.

Note: Pennsylvania's new Independent External Review process does not apply to Medicare Advantage plans. Humana MA denials follow federal Medicare appeal rules, not state commercial insurance appeals.

Indication Requirements

FDA-Approved Use

Haegarda is approved for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years and older. Humana's medical necessity criteria align closely with the FDA label:

  • Confirmed HAE due to C1-esterase inhibitor deficiency (Types I or II)
  • Prophylactic use only (not for on-demand treatment of acute attacks)
  • Subcutaneous self-administration after proper training

Off-Label Considerations

Humana typically does not cover off-label uses of Haegarda. The policy focuses strictly on FDA-approved HAE prophylaxis. Requests for other angioedema conditions require extensive documentation and often face denial.

Step Therapy & Exceptions

Humana implements step therapy requirements for HAE prophylaxis, treating certain agents as preferred alternatives before approving Haegarda.

Typical Step Therapy Hierarchy

Based on Humana's 2025 formulary patterns, the common sequence is:

  1. Berotralstat (Orladeyo) - oral prophylaxis, often preferred first-line
  2. Lanadelumab (Takhzyro) - subcutaneous injection alternative
  3. Haegarda - after documented failure or contraindication to preferred options

Medical Exception Pathways

You can bypass step therapy by documenting:

  • Contraindications to preferred agents (e.g., hepatic disease limiting berotralstat use)
  • Prior treatment failures with specific reasons for discontinuation
  • Intolerance or adverse effects that prevent use of step therapy drugs
  • Clinical circumstances requiring C1-INH replacement specifically
Clinician Tip: Document not just that other drugs "didn't work," but provide specific details: duration tried, doses used, quantified outcomes, and adverse effects experienced.

Quantity and Frequency Limits

Standard Dosing Parameters

Humana approves Haegarda based on weight-based dosing at 60 IU/kg subcutaneously twice weekly (every 3-4 days). Coverage policies typically include:

  • Maximum dose: Generally aligned with clinical trial data (up to ~10,000 IU per dose for larger patients)
  • Frequency limits: Twice weekly administration; daily dosing requires special justification
  • Vial quantity: Calculated based on patient weight and vial strengths available

Renewal Requirements

Annual reauthorizations require documentation of:

  • Clinical benefit: ≥50% reduction in monthly attack frequency compared to baseline
  • Continued adherence: Pharmacy refill records showing consistent use
  • Ongoing medical necessity: Updated attack logs and specialist assessment

Required Diagnostics

Laboratory Confirmation

Humana requires confirmed HAE diagnosis with specific lab values documented on two separate occasions:

Test HAE Type I HAE Type II Normal Range
C4 Low (<30% normal) Low (<30% normal) Varies by lab
C1-INH Antigenic Low Normal/High Lab-specific
C1-INH Functional Low Low Lab-specific
C1q Normal Normal Lab-specific

Clinical Documentation

Beyond labs, medical records must include:

  • Attack history: Frequency, severity, location, and impact over 6-12 months
  • Emergency interventions: ER visits, hospitalizations, or urgent treatments
  • Family history: If available, genetic testing results or affected relatives
  • Physical examination findings during or between attacks

Site of Care & Administration

Self-Administration Requirement

Haegarda coverage specifically requires patient or caregiver self-administration at home after structured training. Humana policies typically exclude:

  • Routine provider office administration
  • Infusion center delivery
  • Hospital-based prophylaxis programs

Training Documentation

Prior authorization submissions must confirm:

  • Completed training by qualified healthcare professional or Haegarda Connect nurse
  • Demonstrated competency in reconstitution and injection technique
  • Emergency action plan including access to on-demand HAE treatments
  • Follow-up schedule for monitoring and technique assessment

Evidence to Support Necessity

Guideline Support

Strong medical necessity letters reference established guidelines:

  • US HAEA Treatment Guidelines: Support prophylaxis for patients with frequent/severe attacks
  • FDA Package Insert: Confirms approved indication and dosing
  • International HAE Guidelines: Provide additional clinical context for C1-INH prophylaxis

Peer-Reviewed Evidence

Key studies supporting Haegarda use include:

  • Phase III clinical trials demonstrating efficacy in attack reduction
  • Real-world evidence of improved quality of life
  • Safety data supporting long-term subcutaneous use

Compendium Listings

Haegarda appears in recognized drug compendia for HAE prophylaxis, supporting medical necessity determinations.

Sample Medical Necessity Narrative

Here's a template structure for documenting medical necessity:

Patient presents with confirmed hereditary angioedema Type [I/II] based on laboratory studies showing [specific C4, C1-INH values with dates and reference ranges]. Despite [previous treatments tried with specific durations and outcomes], patient continues to experience [frequency] attacks per month involving [locations: face, larynx, abdomen] requiring [emergency interventions]. Haegarda 60 IU/kg subcutaneously twice weekly is medically necessary for prophylaxis as [patient/caregiver] has completed injection training and demonstrated competency. Alternative prophylactic agents [berotralstat/lanadelumab] are not appropriate due to [specific contraindications/intolerances/failures]. Expected outcome is ≥50% reduction in attack frequency consistent with clinical trial data.

Edge Cases & Special Populations

Pediatric Considerations

  • FDA approval for ages ≥6 years
  • Weight-based dosing calculations critical
  • Enhanced training requirements for caregivers
  • School administration plans may be needed

Pregnancy and Reproductive Health

  • HAE attacks often worsen during pregnancy
  • Limited safety data requires risk-benefit analysis
  • Coordination with obstetric care team
  • Alternative prophylaxis options may be preferred

Comorbidity Considerations

  • Liver disease may affect drug metabolism
  • Bleeding disorders require careful monitoring
  • Immunocompromised patients need additional safety evaluation

Coverage at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans PA form via provider portal Humana PA Search
Diagnosis HAE Types I or II Labs on 2 occasions with ranges FDA Label
Step Therapy Often required Prior therapy documentation Plan-specific formulary
Dosing 60 IU/kg SC twice weekly Weight-based calculation FDA Label
Training Self-administration competency Training completion certificate Haegarda Connect
Appeals Deadline 65 days from denial Medicare appeal process CMS regulations

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documents Needed
"No confirmed HAE diagnosis" Submit complete lab panel C4, C1-INH antigenic/functional, C1q with reference ranges
"Step therapy not completed" Document prior failures Detailed treatment history with specific outcomes
"Not medically necessary" Strengthen clinical narrative Attack logs, ER records, specialist letters
"Experimental/investigational" Cite FDA approval Package insert, clinical guidelines
"Quantity exceeds limits" Justify weight-based dosing Current weight, dose calculation worksheet

Appeals Process in Pennsylvania

Medicare Advantage Appeal Levels

Level 1: Plan Reconsideration

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for standard, 72 hours for expedited
  • How to file: Online member portal, phone, or written request
  • Required: Denial letter, additional medical records, prescriber statement

Level 2: Independent Review Entity (IRE)

  • Automatic: If Level 1 denial, or can request directly
  • Timeline: 60 days for standard, 72 hours for expedited
  • Reviewer: Medicare contractor independent of Humana
  • Binding: Decision is final and enforceable
Important: Pennsylvania's state external review process does not apply to Medicare Advantage plans. Use Medicare's federal appeal system instead.

When to Request Expedited Review

  • Life-threatening HAE attacks (especially laryngeal)
  • Severe attack frequency causing disability
  • Current prophylaxis failing with breakthrough attacks
  • Prescriber attestation of serious health risk

Costs & Patient Support

Manufacturer Support Programs

  • Haegarda Connect: Free nursing support and training
  • CSL Behring Patient Support: Copay assistance and prior authorization help
  • Specialty pharmacy coordination: Often required for dispensing

Financial Assistance Options

  • Medicare Part D Low-Income Subsidy (Extra Help)
  • State pharmaceutical assistance programs
  • Patient advocacy organizations
  • Clinical trial opportunities through ClinicalTrials.gov

At Counterforce Health, we help patients and clinicians turn insurance denials into successful appeals by analyzing denial letters, identifying the specific coverage criteria, and drafting evidence-backed responses that align with each plan's requirements. Our platform streamlines the prior authorization process for complex specialty medications like Haegarda, reducing the administrative burden on healthcare providers while improving patient access to necessary treatments.

FAQ

How long does Humana prior authorization take for Haegarda in Pennsylvania? Standard PA decisions are typically completed within 72 hours of receiving complete documentation. Expedited requests for urgent medical situations are decided within 24 hours.

What if Haegarda is non-formulary on my Humana plan? You can request a formulary exception with medical necessity documentation. Focus on why formulary alternatives are inappropriate and provide strong clinical justification for Haegarda specifically.

Can I request an expedited appeal if my Haegarda is denied? Yes, if your prescriber can document that delay would seriously jeopardize your health or ability to regain maximum function. Frequent severe HAE attacks, especially involving the airway, often qualify.

Does step therapy apply if I've tried other HAE drugs outside Pennsylvania? Yes, document all prior HAE therapies regardless of where they were prescribed. Include medication names, doses, duration, outcomes, and reasons for discontinuation.

What's the success rate for HAE medication appeals with Humana? While Humana reports a relatively low overall PA denial rate (~3.5% for Medicare Advantage), specialty drug appeals with complete clinical documentation and specialist support have higher success rates, especially when medical necessity is clearly established.

Do I need a specialist to prescribe Haegarda? While not always required, having an allergist, immunologist, or hematologist involved strengthens your case. Many PA policies prefer specialist involvement for rare disease medications.

Can I get Haegarda covered for HAE with normal C1-INH levels? HAE with normal C1-INH (HAE-nC1INH or Type III) has limited diagnostic testing options. Coverage is more challenging and requires extensive family history documentation and clinical presentation consistent with HAE.

What happens if I move between Pennsylvania and another state with Humana? Your coverage should remain consistent within the same Humana plan type, but specific state regulations and formulary details may vary. Notify Humana of address changes promptly.

This article provides educational information about insurance coverage and is not medical advice. For specific medical questions, consult your healthcare provider. For insurance coverage questions, contact Humana member services or visit Medicare.gov for official Medicare appeal information.

Sources & Further Reading

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