Answer Box: Getting HAE Treatment When Berinert Is Denied

If UnitedHealthcare denies Berinert (C1-esterase inhibitor, IV) in Ohio, you have three main options: try preferred formulary alternatives like Orladeyo (oral prophylaxis) or Ekterly (oral on-demand), request a drug list exception with strong medical necessity documentation, or appeal the denial through Ohio's external review process. Start by checking your plan's specific formulary at UHCprovider.com and discussing alternatives with your HAE specialist. Most denials stem from step therapy requirements favoring newer oral agents over IV treatments.

Table of Contents

1. When Alternatives Make Sense
2. UnitedHealthcare's Preferred HAE Alternatives
3. Pros and Cons Overview
4. Exception Strategy for Berinert
5. Switching Logistics
6. Re-trying for Berinert Later
7. Appeals Playbook for Ohio
8. Cost Assistance Programs

When Alternatives Make Sense

UnitedHealthcare's 2026 formulary updates prioritize oral HAE treatments over traditional IV C1 inhibitors like Berinert. This shift reflects both cost considerations and clinical convenience, but alternatives aren't always appropriate for every patient.

Consider alternatives when:

• You're newly diagnosed and haven't tried oral options
• Current attacks are manageable and not life-threatening
• You prefer self-administered oral medications
• Your insurance has significant cost differences between tiers

Stick with Berinert exception requests when:

• You have severe laryngeal attacks requiring rapid IV treatment
• Oral alternatives have failed or caused intolerable side effects
• You have contraindications to preferred formulary options
• Your HAE specialist specifically recommends IV therapy

Note: According to UnitedHealthcare's prior authorization criteria, Berinert is only approved for acute HAE attacks, not prophylaxis, and requires prescribing by an immunologist or allergist.

UnitedHealthcare's Preferred HAE Alternatives

UnitedHealthcare's 2026 formulary changes significantly impact HAE treatment coverage. Here's what's preferred:

Prophylactic Options (Preventing Attacks)

Drug	Type	Coverage Notes	Typical Requirements
Orladeyo (berotralstat)	Oral daily	Requires trial/failure of Andembry	Step therapy documentation
Andembry (garadacimab-gxii)	Subcutaneous	New preferred preventive (1/1/2026)	Medical necessity review
Haegarda	Subcutaneous	Traditional C1-INH option	Prior authorization

Acute Treatment Options (On-Demand)

Drug	Type	Coverage Notes	Key Advantages
Ekterly (sebetralstat)	Oral	New option (2/1/2026)	Self-administered, rapid onset
Firazyr (icatibant)	Subcutaneous injection	Established formulary option	Home administration possible
Ruconest	IV infusion	Recombinant alternative to Berinert	No plasma-derived risks

From our advocates: "Many patients successfully transition from IV treatments to oral options like Orladeyo for prevention, keeping injectable rescue therapy for breakthrough attacks. The key is working with your HAE specialist to create a comprehensive plan that addresses both routine prevention and emergency situations."

Pros and Cons Overview

Oral Alternatives (Orladeyo, Ekterly)

Pros:

• Daily convenience without injections
• Lower insurance tier placement
• No refrigeration requirements
• Suitable for travel

Cons:

• May take weeks to reach full effectiveness
• Potential GI side effects
• Drug interactions possible
• Less rapid onset for acute attacks

Injectable Alternatives (Firazyr, Ruconest)

Pros:

• Rapid symptom relief
• Established efficacy data
• Self-administration possible
• Suitable for severe attacks

Cons:

• Injection site reactions
• Refrigeration requirements
• Higher cost tier
• Need for proper injection training

Monitoring considerations: All HAE treatments require regular follow-up with your specialist to track attack frequency, severity, and side effects. Laboratory testing frequency varies by medication but typically includes liver function tests for oral agents and general safety monitoring for all options.

Exception Strategy for Berinert

When formulary alternatives aren't appropriate, requesting a drug list exception can provide access to Berinert at a covered tier.

Required Documentation

Submit through UHCprovider.com or OptumRx with:

1. HAE diagnosis confirmation:
   • C1-INH antigenic or functional levels below normal
   • Low C4 supporting evidence
   • Genetic testing results (if applicable)
2. Medical necessity letter addressing:
   • Specific attack patterns (frequency, location, severity)
   • Why preferred alternatives are inappropriate
   • Previous treatment failures with documentation
   • Contraindications to formulary options
3. Clinical documentation:
   • Recent attack history with dates and treatments used
   • Emergency room visits or hospitalizations
   • Response to previous C1-INH therapy
   • Prescriber specialty credentials (immunology/allergy required)

Strengthening Your Exception Request

Include specific clinical scenarios:

• "Patient experienced laryngeal attacks requiring emergency IV treatment"
• "Oral prophylaxis failed to prevent breakthrough attacks despite compliance"
• "Previous adverse reactions to preferred formulary agents documented"

Reference established guidelines:

• FDA labeling for Berinert's approved indications
• International HAE management guidelines
• Specialty society treatment recommendations

Tip: Exception requests are most successful when they demonstrate that formulary alternatives pose clinical risks or have already failed. Generic statements about "patient preference" typically aren't sufficient.

Switching Logistics

Coordinating with Your Healthcare Team

Before switching:

1. Schedule appointment with HAE specialist
2. Review current attack patterns and triggers
3. Discuss emergency action plan during transition
4. Ensure rescue medications are available

During transition:

• Monitor attack frequency closely for first 4-6 weeks
• Keep detailed symptom diary
• Maintain direct contact with specialist's office
• Have emergency treatment plan readily accessible

Pharmacy Coordination

When switching between treatments:

• Verify new medication is in stock at specialty pharmacy
• Understand refrigeration and storage requirements
• Review administration techniques with pharmacist
• Confirm insurance coverage before first fill

Timeline expectations: Clinical studies suggest most patients transition smoothly between HAE treatments, but individual responses vary. Allow 30-60 days to assess effectiveness of new therapy.

Re-trying for Berinert Later

If you initially try alternatives, you can request Berinert coverage later with proper documentation.

What to Document During Alternative Trials

Track systematically:

• Attack frequency and severity (use standardized scales if available)
• Time to symptom resolution
• Side effects and tolerability issues
• Impact on quality of life measures
• Emergency department visits or hospitalizations

Maintain records of:

• Medication compliance and adherence
• Dose adjustments attempted
• Duration of adequate trial (typically 3-6 months)
• Specialist recommendations and observations

Building Your Case for Berinert

After documented failure of alternatives:

1. Compile comprehensive treatment history
2. Obtain specialist letter detailing inadequate response
3. Include objective measures (attack logs, ER visits)
4. Submit new prior authorization with failure documentation

Counterforce Health specializes in helping patients and clinicians navigate complex prior authorization denials like these. Their platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific insurer requirements and increase approval rates for specialty medications.

Appeals Playbook for Ohio

If exception requests are denied, Ohio provides robust appeal rights through multiple levels.

Internal Appeals with UnitedHealthcare

Level	Timeline	Process	Key Actions
Peer-to-Peer	24 hours post-denial	5-10 minute call with medical director	Focus on clinical necessity, attack severity
Level 1 Internal	≤180 days from denial	10-15 business days	Submit denial letter, medical records, necessity documentation
Level 2 Internal	≤60 days post-Level 1	15-20 business days	Include new evidence, specialist consultations

Ohio External Review

After exhausting internal appeals, Ohio residents can request binding external review:

Timeline: 180 days from final internal denial
Cost: Free to patients
Process: File with Ohio Department of Insurance
Decision timeline: 30 days standard, 72 hours expedited
Contact: 1-800-686-1526

Required documents:

• All denial letters from UnitedHealthcare
• Complete medical records
• External review request form
• Clinical justification for Berinert

Important: External review decisions are binding on UnitedHealthcare. If overturned, they must cover the treatment as requested.

Cost Assistance Programs

Manufacturer Support

CSL Behring Patient Services:

• Copay assistance programs
• Prior authorization support
• Injection training resources
• Financial hardship programs

Foundation Assistance

• Patient Advocate Foundation
• National Organization for Rare Disorders (NORD)
• HAE Association patient assistance programs

State Programs

Ohio residents may qualify for additional support through state pharmaceutical assistance programs. Contact the Ohio Department of Insurance for current program availability.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in Ohio?
Standard prior authorization decisions take 72 hours; urgent cases (like HAE treatments) can be expedited to 24-48 hours. Use OptumRx portal for fastest processing.

What if Berinert is non-formulary on my plan?
Request a drug list exception with medical necessity documentation. Include specific clinical reasons why formulary alternatives aren't appropriate for your HAE management.

Can I request expedited appeal for HAE denials?
Yes, HAE attacks can be life-threatening, particularly laryngeal attacks. Request expedited review citing urgent medical necessity and potential for serious harm.

Does step therapy apply if I've used Berinert successfully outside Ohio?
Previous successful treatment can support exception requests, but UnitedHealthcare may still require documentation of why current formulary options aren't suitable.

What happens if my HAE specialist isn't an immunologist or allergist?
UnitedHealthcare requires prescribing by immunology or allergy specialists. You may need referral to appropriate specialist or have current provider work with qualified specialist.

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This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. For additional help with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

Sources & Further Reading

• UnitedHealthcare Berinert Prior Authorization Criteria (PDF)
• UnitedHealthcare 2026 Pharmacy Updates (PDF)
• Ohio External Review Process - Department of Insurance
• HAE Treatment Guidelines - EMJ Reviews
• Berinert FDA Prescribing Information

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