By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (berotralstat) Covered by UnitedHealthcare in Pennsylvania: Complete Guide to Prior Authorization, Appeals, and State Protections

Quick Answer: Getting Orladeyo Covered in Pennsylvania

Fast track to approval: Submit prior authorization through UnitedHealthcare's provider portal with complete HAE diagnosis documentation, C1-INH lab results, and evidence of failed/contraindicated injectable therapies. If denied, you have 180 days for internal appeals, then 4 months for Pennsylvania's Independent External Review Program, which overturns about 50% of denials. Start today: Contact your HAE specialist to request a medical necessity letter citing step therapy exceptions under Pennsylvania's 2024 utilization management reforms.

Table of Contents

  1. Why Pennsylvania State Rules Matter
  2. UnitedHealthcare Coverage Requirements
  3. Prior Authorization Timeline Standards
  4. Step Therapy Protections in Pennsylvania
  5. Continuity of Care Provisions
  6. Pennsylvania's External Review Process
  7. Appeals Playbook: Internal to External
  8. Practical Scripts and Documentation
  9. ERISA Plan Limitations
  10. Quick Reference Resources
  11. FAQ

Why Pennsylvania State Rules Matter

Pennsylvania's 2024 utilization management reforms significantly strengthen patient protections for specialty medications like Orladeyo. The state now operates its own Independent External Review Program, separate from federal oversight, with a 50% overturn rate for denied claims in its first year.

These state protections apply to plans purchased through Pennie (Pennsylvania's marketplace), direct-purchase individual plans, and most employer-sponsored plans. However, self-funded ERISA plans may have different rules (see limitations section below).

Key Pennsylvania advantages:

  • Enhanced step therapy override protections
  • Mandatory 4-month external review window
  • State-supervised independent review organizations
  • Strict insurer compliance with overturn decisions

UnitedHealthcare Coverage Requirements

Orladeyo requires prior authorization across all UnitedHealthcare plans, managed through OptumRx. The medication is typically excluded from standard formularies but can be covered through medical exception processes.

Coverage at a Glance

Requirement What it means Where to find it Source
Prior Authorization Required for all plans UHC Provider Portal UHC PA Requirements
Formulary Status Non-formulary/excluded Plan formulary documents OptumRx Formulary
Step Therapy Try injectables first (commercial) Medical necessity criteria UHC Policy Documents
Age Requirement ≥12 years FDA labeling requirement FDA Package Insert
Specialist Requirement Immunologist/allergist preferred Medical necessity guidelines UHC HAE Treatment Policy
Appeals Deadline 180 days from denial Member handbook UHC Appeals Process

Medical Necessity Documentation

UnitedHealthcare requires comprehensive documentation including:

  • HAE diagnosis confirmation: C4 levels, C1-INH quantitative and functional testing
  • Attack frequency and severity: Detailed history over 6-12 months
  • Prior therapy documentation: Specific outcomes with injectable prophylaxis (Takhzyro, Haegarda, Cinryze)
  • Clinical rationale: Why oral therapy is medically necessary over injectable options
  • Contraindications or intolerances: Documented adverse reactions to first-line therapies

Prior Authorization Timeline Standards

Standard Review Process

  • Initial determination: 15 business days from complete submission
  • Additional information requests: 5 business days to respond
  • Final determination: Within 30 days total

Expedited Review (Urgent Cases)

  • Qualification: Immediate threat to health or function
  • Timeline: 72 hours from complete submission
  • Documentation: Physician attestation of urgency required
Note: Pennsylvania law requires insurers to process urgent requests within 72 hours, with standard requests completed within 30 days for services not yet received.

Step Therapy Protections in Pennsylvania

Pennsylvania's 2024 utilization management reforms provide significant step therapy protections that benefit Orladeyo patients.

Automatic Override Situations

Under Pennsylvania's step therapy protections, insurers cannot require step therapy if:

  1. Prior use: You've already used the required step therapy drug under current or previous coverage
  2. FDA approval: The step therapy drug isn't FDA-approved for your specific condition
  3. Medical necessity: Your provider determines the step therapy would be ineffective or harmful

Documentation for Override Requests

When requesting step therapy exceptions, include:

  • Previous therapy history: Specific medications tried, duration, and outcomes
  • Clinical contraindications: Medical reasons why injectable therapies aren't appropriate
  • Guideline support: References to HAE treatment guidelines supporting oral therapy
  • Patient factors: Quality of life, adherence concerns, or injection site reactions

Continuity of Care Provisions

Pennsylvania protects patients transitioning between plans or experiencing coverage changes.

Transition Protections

  • Plan changes: New insurers cannot require repeating step therapy if you've already completed it
  • Provider networks: Temporary coverage for out-of-network specialists during transitions
  • Medication continuity: Short-term coverage for current medications while PA processes
Tip: Document your current Orladeyo therapy thoroughly before any plan changes to ensure continuity protections apply.

Pennsylvania's External Review Process

Pennsylvania's Independent External Review Program offers a powerful second chance after internal appeals fail.

Step-by-Step: External Review Process

  1. Complete internal appeals first - Required prerequisite
  2. Obtain Final Adverse Benefit Determination letter - Your insurer's final denial
  3. Submit within 4 months - Deadline from final denial date
  4. File online or by mail - Through PA Insurance Department portal
  5. Provide supporting documentation - 15 days after assignment to review organization
  6. Receive decision - Within 45 days (72 hours for urgent cases)
  7. Binding implementation - Insurer must comply immediately if overturned

Required Documentation for External Review

  • Copy of Final Adverse Benefit Determination letter
  • All internal appeal correspondence
  • Medical records supporting necessity
  • Provider statement explaining why Orladeyo is medically necessary
  • Any new evidence not previously submitted

Success Rates and Outcomes

In 2024, Pennsylvania's external review program received 517 appeals and overturned 259 denials (50% success rate), resulting in coverage for treatments initially denied by insurers.

Appeals Playbook: Internal to External

Internal Appeals with UnitedHealthcare

Level 1 Internal Appeal

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard review, 72 hours for urgent
  • Submission: UnitedHealthcare member portal, mail, or fax
  • Required: Completed appeal form, supporting documentation, provider letter

Level 2 Internal Appeal (if available)

  • Automatic: Some plans require second internal review
  • Timeline: Additional 30 days
  • New evidence: Can submit additional documentation

External Review Transition

After receiving your Final Adverse Benefit Determination:

  1. Immediate action: Note the 4-month deadline for external review
  2. Gather documents: Compile all appeal correspondence and medical records
  3. Contact PA Insurance Department: 1-877-881-6388 for guidance
  4. Submit complete application: Include all required forms and documentation

Practical Scripts and Documentation

Patient Phone Script for UnitedHealthcare

"I'm calling about prior authorization for Orladeyo for hereditary angioedema. I have a confirmed HAE diagnosis and have failed/cannot tolerate injectable prophylaxis. Under Pennsylvania's step therapy protections, I believe I qualify for an exception. Can you please connect me with a clinical reviewer to discuss my case?"

Medical Necessity Letter Template Elements

For clinicians writing support letters:

  1. Patient identification: Full name, DOB, member ID, diagnosis codes
  2. HAE confirmation: "Patient has confirmed hereditary angioedema with C1-INH deficiency based on [specific lab results]"
  3. Attack history: "Patient experiences [frequency] HAE attacks affecting [locations] with severity requiring [interventions]"
  4. Prior therapy failures: "Patient has trialed [specific medications] with outcomes of [specific results/intolerances]"
  5. Medical necessity: "Orladeyo is medically necessary because [clinical rationale]"
  6. Guidelines support: Reference to [HAE treatment guidelines] supporting oral prophylaxis option
  7. Monitoring plan: "Patient will be monitored via [specific parameters and timeline]"

Peer-to-Peer Review Request

"I'm requesting a peer-to-peer review for Orladeyo prior authorization. My patient has documented HAE with inadequate response to injectable prophylaxis. I can provide clinical details and discuss the medical necessity within 24 hours of your medical director's availability."

ERISA Plan Limitations

Important limitation: If your UnitedHealthcare plan is self-funded by your employer (ERISA plan), Pennsylvania state protections may not apply. ERISA plans follow federal regulations and the insurer's own policies.

How to Determine Plan Type

  • Check your Summary Plan Description (SPD)
  • Look for "self-funded" or "self-insured" language
  • Contact HR department for confirmation
  • ERISA plans typically have different appeal processes and timelines

ERISA Appeal Rights

  • Two levels of internal appeals required
  • 180 days for non-urgent appeals
  • Federal external review through independent review organization
  • Right to file federal lawsuit after exhausting internal appeals

Quick Reference Resources

Key Contacts

  • UnitedHealthcare Customer Service: 1-800-711-4555 (commercial), 1-800-711-0646 (Medicare Advantage)
  • OptumRx Prior Authorization: 1-800-711-4555
  • PA Insurance Department Consumer Services: 1-877-881-6388
  • PA External Review Portal: pa.gov/reviewmyclaim

Essential Forms and Portals

Financial Assistance

  • BioCryst Patient Assistance: 1-866-536-7693
  • Empower Patient Services: Commercial copay assistance program
  • NORD Patient Assistance: Grants for uninsured/underinsured patients
  • HealthWell Foundation: Disease-specific grants

FAQ

Q: How long does UnitedHealthcare prior authorization take in Pennsylvania? A: Standard PA decisions are made within 15 business days, with urgent cases decided within 72 hours. Pennsylvania law requires completion within 30 days for standard requests.

Q: What if Orladeyo is non-formulary on my UnitedHealthcare plan? A: Non-formulary medications can still be covered through medical exception processes. Submit comprehensive medical necessity documentation showing why formulary alternatives aren't appropriate.

Q: Can I request an expedited appeal if my PA is denied? A: Yes, if there's immediate threat to your health or function. Provide physician documentation of urgency. Expedited appeals are decided within 72 hours.

Q: Does step therapy apply if I've failed injectable HAE therapies outside Pennsylvania? A: Pennsylvania's protections recognize prior therapy under previous coverage. Document your previous treatment history thoroughly to support step therapy exceptions.

Q: What happens if Pennsylvania's external review overturns my denial? A: The decision is binding on UnitedHealthcare. They must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during appeals.

Q: Can I get help with the appeals process in Pennsylvania? A: Yes, contact the Pennsylvania Health Law Project for free assistance, especially for complex cases. The PA Insurance Department Consumer Services also provides guidance at 1-877-881-6388.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Orladeyo. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that speak directly to each payer's requirements. We help patients, clinicians, and specialty pharmacies navigate the prior authorization maze with targeted documentation that reduces approval timelines and increases success rates.

When facing UnitedHealthcare denials for specialty medications, having the right documentation strategy can make the difference between approval and prolonged appeals. Counterforce Health's approach combines payer-specific policy knowledge with clinical evidence to create compelling cases for coverage.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with complex appeals, consider consulting with patient advocacy organizations or legal professionals specializing in health insurance matters.

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