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

How to Get Haegarda Approved by UnitedHealthcare in Pennsylvania: A Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Haegarda Covered by UnitedHealthcare in Pennsylvania

UnitedHealthcare requires prior authorization for Haegarda (C1-esterase inhibitor, SC) in Pennsylvania. To get approval: (1) Ensure your allergist/immunologist documents confirmed HAE diagnosis with low C4 and C1-INH levels, (2) Submit PA through UHC Provider Portal with complete lab results and treatment history, (3) If denied, file internal appeal within 60 days, then external review with Pennsylvania Insurance Department within 4 months. Start today: Contact your prescriber to gather HAE diagnostic labs and prior therapy records for the PA submission.

Table of Contents

  1. Understanding UnitedHealthcare's Haegarda Requirements
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process in Pennsylvania
  5. Medical Necessity Documentation
  6. Cost and Support Options
  7. When to Escalate
  8. Frequently Asked Questions

Understanding UnitedHealthcare's Haegarda Requirements

UnitedHealthcare and OptumRx maintain specific prior authorization criteria for Haegarda that must be met for coverage approval.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all plans UHC PA Requirements
Confirmed HAE Diagnosis Type I, II, or normal C1-INH HAE Lab reports with C4, C1-INH levels
Prescriber Specialty Allergist or immunologist only Provider credentials
Prophylaxis Use Not for acute treatment Treatment plan documentation
No Combination Therapy Can't use with Cinryze, Takhzyro, or Orladeyo Current medication list
12-Month Approval Standard authorization period PA approval letter

Key Diagnostic Requirements

For Type I or II HAE (most common), you need documented evidence of:

  • C1-esterase inhibitor antigenic level below normal (Type I) or normal/elevated (Type II)
  • C1-esterase inhibitor functional level below normal (both types)
  • C4 complement level below 30% of normal

For HAE with normal C1-INH (rare), documentation must show:

  • Confirmed genetic variants in F12, ANGPT1, PLG, KNG1, MYOF, or HS3ST6 genes, OR
  • Recurring attacks unresponsive to high-dose antihistamines with clinical benefit from prophylaxis

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient + Clinic)

Timeline: 1-2 days

You'll need:

  • Complete HAE diagnostic labs (C4, C1-INH antigenic and functional levels)
  • Genetic testing results (if applicable)
  • Records of prior HAE therapies and outcomes
  • Current attack frequency and severity documentation
  • Insurance card and member ID
Tip: Request lab reports directly from the testing facility if your clinic doesn't have copies. Most labs can email results within 24 hours.

2. Confirm Prescriber Eligibility (Clinic)

Timeline: Same day

UnitedHealthcare requires Haegarda to be prescribed by a board-certified allergist or immunologist. If your current prescriber isn't qualified, you'll need a referral.

3. Submit Prior Authorization (Clinic)

Timeline: 30 minutes to complete

Submit through the UnitedHealthcare Provider Portal with:

  • Completed PA form with diagnosis codes
  • Lab results showing HAE confirmation
  • Treatment history and rationale
  • Dosing plan (60 IU/kg every 3-4 days)

4. Track Decision (Patient + Clinic)

Timeline: Up to 15 business days

UnitedHealthcare typically responds within 72 hours for urgent cases, up to 15 days for standard reviews. Check status through the provider portal or member services.

5. If Approved: Coordinate Specialty Pharmacy

Timeline: 2-3 days

UnitedHealthcare typically requires use of Optum Specialty Pharmacy or another network specialty pharmacy for Haegarda distribution and patient training.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"HAE diagnosis not confirmed" Submit complete diagnostic labs C4, C1-INH antigenic/functional levels, genetic testing if applicable
"Prescriber not qualified" Get referral to allergist/immunologist Board certification documentation
"Step therapy not met" Document failure of preferred agents Prior therapy records, intolerance/contraindication notes
"Not medically necessary" Strengthen clinical rationale Attack frequency, impact on quality of life, treatment goals
"Quantity/dosing inappropriate" Clarify weight-based dosing Patient weight, dosing calculation, administration plan

Most Effective Appeal Strategies

Based on successful Pennsylvania appeals, the strongest documentation includes:

  • Objective HAE confirmation: Lab reports with specific values and reference ranges
  • Treatment history timeline: Dates, doses, outcomes, and reasons for discontinuation of prior therapies
  • Clinical impact statement: How HAE affects daily life, work, and emergency department visits
  • Specialist support: Letter from HAE specialist explaining medical necessity

Appeals Process in Pennsylvania

Pennsylvania offers one of the strongest patient protection systems in the country for insurance appeals, with a state-run external review program that overturns about 50% of denials.

Internal Appeal (Required First Step)

Timeline: File within 60 days of denial Decision deadline: 30 days (pre-service), 60 days (post-service), 72 hours (urgent) How to submit: UnitedHealthcare Provider Portal or written appeal

Include in your internal appeal:

  • Copy of original denial letter
  • Additional medical records
  • Updated clinical rationale
  • Peer-reviewed literature supporting Haegarda use

Peer-to-Peer Review (Optional)

Before filing a formal appeal, request a peer-to-peer discussion with a UnitedHealthcare medical director. This must be requested within 24 hours of denial for most cases.

To schedule: Use the peer-to-peer request form in your denial letter or contact the number provided.

Pennsylvania External Review

If UnitedHealthcare upholds the denial, you can request an external review through the Pennsylvania Insurance Department.

Key details:

  • Deadline: Within 4 months of Final Adverse Benefit Determination
  • Cost: Free to you
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Success rate: Approximately 50% of appeals are overturned
  • How to submit: Online portal (preferred), fax, or mail

Required documents:

  • Final denial letter from UnitedHealthcare
  • Insurance ID card
  • Supporting medical records
  • Physician certification form (for expedited reviews)

Medical Necessity Documentation

Essential Elements for Your Medical Necessity Letter

1. HAE Diagnosis Confirmation

  • Specific lab values with reference ranges
  • Date of diagnosis
  • Type of HAE (I, II, or normal C1-INH)

2. Treatment History

  • Previous prophylactic therapies tried
  • Duration of each treatment
  • Reasons for discontinuation (efficacy, side effects, contraindications)
  • On-demand therapy usage and effectiveness

3. Current Clinical Status

  • Attack frequency and severity
  • Impact on quality of life
  • Emergency department visits
  • Work/school absences

4. Rationale for Haegarda

  • Why subcutaneous prophylaxis is appropriate
  • Expected clinical benefits
  • Monitoring plan
From our advocates: We've seen the strongest approvals when clinics include a detailed timeline showing at least 6 months of documented HAE management, including specific dates of attacks, treatments used, and outcomes. This concrete evidence helps medical reviewers understand the patient's journey and need for prophylactic therapy.

Cost and Support Options

Manufacturer Support Programs

CSL Behring Starting HAEGARDA Program

  • Patient access support
  • Insurance verification assistance
  • Copay assistance (for eligible patients)
  • Training and education resources

Contact: haegarda.com or through your prescriber

Additional Financial Resources

For Pennsylvania residents:

  • Pennsylvania Insurance Department consumer assistance: Call for help navigating appeals
  • Patient advocacy organizations: US Hereditary Angioedema Association (HAEA.org)
  • Foundation grants: Check HealthWell Foundation and other rare disease foundations

When to Escalate

Contact the Pennsylvania Insurance Department if:

  • UnitedHealthcare misses appeal deadlines
  • You suspect the denial violates Pennsylvania insurance law
  • You need help understanding your rights

Pennsylvania Insurance Department
Consumer Services
Phone: Available on pa.gov
Online complaint portal available

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in Pennsylvania? A: Standard PA decisions are made within 15 business days. Urgent requests are typically processed within 72 hours.

Q: What if Haegarda isn't on my formulary? A: You can request a formulary exception through the same PA process. Document why formulary alternatives aren't appropriate for your specific case.

Q: Can I get expedited review if I'm having frequent attacks? A: Yes. If delay would seriously jeopardize your health, request expedited review at both the PA and appeal levels.

Q: Does step therapy apply if I failed treatments in another state? A: Yes, treatment history from any location counts. Make sure all prior therapy records are included in your PA submission.

Q: What happens if I start Haegarda while my appeal is pending? A: You may need to pay out-of-pocket initially. If your appeal succeeds, UnitedHealthcare must provide retroactive coverage.

Q: How do I find an allergist or immunologist for my prescription? A: Use UnitedHealthcare's provider directory online or call member services. Look for providers who specialize in hereditary angioedema.

Getting Haegarda approved by UnitedHealthcare in Pennsylvania requires thorough preparation and persistence, but the state's strong patient protection laws provide multiple pathways to coverage. The key is assembling complete diagnostic documentation and working with a qualified specialist who understands both HAE management and insurance requirements.

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeals processes like this one. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals tailored to each payer's requirements. By turning insurance denials into targeted, documentation-rich appeals, we help ensure patients get access to the medications they need. Learn more about our services at counterforcehealth.org.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with UnitedHealthcare and Pennsylvania regulators.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.