By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (Berotralstat) Covered by UnitedHealthcare in New Jersey: Complete Guide with Forms and Appeal Templates

Answer Box: Getting Orladeyo Covered by UnitedHealthcare in New Jersey

Orladeyo (berotralstat) requires prior authorization from UnitedHealthcare in New Jersey. To get approved:

  1. Visit an HAE specialist (allergist/immunologist) who can document your hereditary angioedema diagnosis with C1-INH testing and attack frequency
  2. Submit prior authorization through the UnitedHealthcare Provider Portal with medical necessity documentation
  3. If denied, file internal appeals (up to 180 days), then external review through New Jersey's IHCAP program via Maximus Federal Services

First step today: Call UnitedHealthcare member services at the number on your insurance card to confirm your plan's prior authorization requirements and formulary status for Orladeyo.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for Orladeyo under OptumRx UnitedHealthcare Provider Portal UHC PA Requirements
Age Restriction Must be ≥12 years old FDA labeling, payer policies Premera Policy
Diagnosis Confirmed HAE with C1-INH testing Lab results, specialist evaluation UHC Medical Necessity Form
Step Therapy May require trial/failure of other HAE prophylaxis Treatment history documentation UHC Step Therapy Updates
Attack Frequency ≥2 attacks in 8 weeks or ≥1/month for 6 months Attack logs, medical records Cigna Coverage Policy

Step-by-Step: Fastest Path to Approval

1. Confirm Your HAE Diagnosis (Patient + Doctor)

  • Who does it: HAE specialist (allergist/immunologist)
  • Documents needed: C1-INH function/antigen tests, C4 levels, genetic testing if applicable
  • Timeline: 1-2 weeks for lab results
  • Submit via: Specialist's office coordinates testing

2. Document Attack History (Patient + Doctor)

  • Who does it: Patient tracks attacks, doctor reviews records
  • Documents needed: Attack frequency log, emergency room visits, medication use
  • Timeline: Ongoing documentation, minimum 2-3 months of data
  • Submit via: Include in medical necessity letter

3. Submit Prior Authorization (Doctor's Office)

  • Who does it: Prescribing physician or office staff
  • Documents needed: UHC Medical Necessity Form, clinical notes, lab results
  • Timeline: Submit within 30 days of prescription
  • Submit via: UnitedHealthcare Provider Portal or fax (verify current number)

4. Follow Up on Decision (Patient + Doctor)

  • Who does it: Both patient and provider monitor status
  • Documents needed: Approval/denial letter, EOB if applicable
  • Timeline: UnitedHealthcare responds within 15 business days (standard) or 72 hours (urgent)
  • Submit via: Check status through member/provider portals

5. Appeal if Denied (Patient + Doctor)

  • Who does it: Patient files appeal with doctor's support
  • Documents needed: Denial letter, additional clinical evidence, peer-reviewed studies
  • Timeline: File within 180 days of denial
  • Submit via: UnitedHealthcare appeals department (address on denial letter)

Working with Your Doctor

Visit Preparation Checklist

Before your HAE specialist appointment, gather:

  • Insurance card and policy details
  • Complete attack history (dates, severity, treatments used, hospital visits)
  • Previous medication trials and outcomes (including side effects or failures)
  • Family history of HAE or unexplained swelling episodes
  • Current medications and dosages
  • Lab results from other providers (if available)
Tip: Keep an attack diary using your phone's notes app. Record date, location of swelling, severity (1-10), triggers if known, and treatment used.

Questions to Ask Your Specialist

  1. "Do my symptoms and test results confirm HAE Type I or II?"
  2. "What's my attack frequency, and does it meet criteria for prophylaxis?"
  3. "Have I tried enough first-line treatments to justify Orladeyo?"
  4. "Can you help with the prior authorization paperwork?"
  5. "What documentation will strengthen my case if we need to appeal?"

Medical Necessity Letter Essentials

Your doctor's medical necessity letter should include these key elements:

Required Clinical Information

  • Patient demographics: Full name, DOB, insurance ID, ICD-10 code (D84.1 for HAE)
  • Confirmed diagnosis: HAE Type I or II with supporting lab values (C4 level, C1-INH antigen/function)
  • Attack history: Specific frequency, severity, and impact on daily activities
  • Prior treatments: Medications tried, duration, outcomes, reasons for discontinuation
  • Clinical rationale: Why Orladeyo is medically necessary for this patient

Supporting Evidence to Include

  • FDA approval status for HAE prophylaxis in patients ≥12 years
  • Clinical trial data showing attack reduction (reference pivotal studies)
  • Guideline support from World Allergy Organization or American Academy of Allergy, Asthma & Immunology
  • Patient-specific factors (injection intolerance, compliance issues, quality of life impact)
From our advocates: We've seen stronger approvals when specialists include a brief statement about why oral therapy specifically benefits the patient—whether it's needle phobia, frequent travel, or difficulty with injection schedules. These personal factors help reviewers understand the individual medical need.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Provide detailed attack logs and functional impact Attack frequency data, work/school absences, ER visits
"Step therapy not met" Document failure/intolerance to Takhzyro, Haegarda, or Cinryze Treatment history with dates, adverse events, efficacy data
"Age restriction" Confirm patient is ≥12 years old Birth certificate or government ID
"Concurrent prophylaxis" Verify no other long-term HAE medications prescribed Current medication list, pharmacy records
"Insufficient diagnosis" Strengthen HAE confirmation Additional C1-INH testing, genetic counseling, specialist consultation

Appeals Process in New Jersey

Internal Appeals with UnitedHealthcare

Level 1 Internal Appeal

  • Timeline: File within 180 days of denial
  • Decision timeframe: 30 days (standard), 72 hours (urgent)
  • Submit to: Address provided in denial letter
  • Required documents: Denial letter, additional clinical evidence, physician statement

Level 2 Internal Appeal (if Level 1 denied)

  • Timeline: File within 60 days of Level 1 denial
  • Decision timeframe: 30 days (standard), 72 hours (urgent)
  • Submit to: Same process as Level 1
  • Required documents: Previous denial letters, new supporting evidence

External Review Through New Jersey IHCAP

After completing internal appeals, you can request external review through New Jersey's Independent Health Care Appeals Program (IHCAP), administered by Maximus Federal Services.

Eligibility Requirements:

  • Completed UnitedHealthcare's internal appeal process
  • Denial based on medical necessity or experimental/investigational status
  • Fully-insured New Jersey health plan (not self-funded employer plans)
  • Appeal filed within 4 months of final internal denial

Process:

  1. Submit application directly to Maximus (not NJ DOBI)
  2. Preliminary review within 5 business days to confirm eligibility
  3. Full medical review by specialty-matched physicians
  4. Final decision within 45 days (standard) or 48 hours (expedited)

Cost: Free to patients; insurers pay all review costs

Note: If IHCAP overturns the denial, UnitedHealthcare must comply and cover Orladeyo. This decision is legally binding under New Jersey statute.

Cost Assistance Options

Manufacturer Support

  • BioCryst Patient Assistance Program: Income-based financial assistance for eligible patients
  • Copay savings: May reduce out-of-pocket costs for commercially insured patients
  • Contact: Visit BioCryst's website or call their patient support line (verify current contact information)

Foundation Grants

  • Patient Advocate Foundation: Provides copay assistance for chronic disease medications
  • HAE-specific organizations: Hereditary Angioedema Association may offer resources
  • State programs: New Jersey may have additional pharmaceutical assistance programs

Specialty Pharmacy Options

  • OptumRx specialty pharmacy: Required for many UnitedHealthcare plans
  • Alternative specialty pharmacies: May be available with prior authorization
  • Patient support services: Many specialty pharmacies offer injection training, refill reminders, and insurance assistance

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in New Jersey? Standard prior authorization decisions are made within 15 business days. Urgent requests (when delay could seriously jeopardize health) are processed within 72 hours.

What if Orladeyo isn't on my UnitedHealthcare formulary? Non-formulary medications can still be covered with prior authorization and medical necessity documentation. Your doctor may need to request a formulary exception.

Can I request an expedited appeal if I'm having frequent HAE attacks? Yes. If delaying Orladeyo could seriously jeopardize your health, request expedited review at each appeal level. Document the urgency with recent attack history and specialist assessment.

Does step therapy apply if I tried other HAE medications outside New Jersey? Treatment history from any licensed U.S. provider should count toward step therapy requirements. Include complete medical records and prescription history from previous states.

What happens if UnitedHealthcare denies my peer-to-peer review request? Peer-to-peer reviews are typically offered after initial denials. If denied or if the reviewer upholds the denial, proceed immediately to formal internal appeals.

How do I find an HAE specialist in New Jersey? Search for board-certified allergists/immunologists with HAE experience. The Hereditary Angioedema Association maintains a provider directory, or ask for referrals through your primary care doctor.

Can my doctor appeal on my behalf? Yes. Providers can file appeals with patient consent. Many specialists have staff experienced in insurance appeals who can help navigate the process.

What if my employer's health plan is self-funded? Self-funded employer plans aren't subject to New Jersey's external review process. These plans follow federal ERISA rules and may have different appeal procedures outlined in your plan documents.

Counterforce Health helps patients and healthcare providers navigate complex insurance approval processes for specialty medications like Orladeyo. Our platform analyzes denial letters, identifies specific appeal strategies, and drafts evidence-backed responses tailored to each payer's requirements. By turning insurance denials into targeted appeals with the right clinical documentation and regulatory compliance, we help ensure patients get access to the treatments they need. Visit www.counterforcehealth.org to learn more about our coverage advocacy services.

When working with your healthcare team on Orladeyo approval, remember that persistence and thorough documentation are key. Many initial denials can be overturned with the right clinical evidence and appeal strategy. Counterforce Health specializes in helping patients and providers build stronger cases for specialty medication approvals, reducing the time and effort required to navigate insurance barriers.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently, and individual circumstances vary. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider about the most appropriate treatment for your condition. For questions about New Jersey's external appeal process, contact the NJ Department of Banking and Insurance at 1-800-446-7467.

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