By Counterforce Health Team in Ultomiris (ravulizumab) —

Myths vs. Facts: Getting Ultomiris (ravulizumab) Covered by Blue Cross Blue Shield in Ohio - Appeals Process and Requirements

Answer Box: Getting Ultomiris Covered by BCBS in Ohio

Fastest Path to Approval: Blue Cross Blue Shield in Ohio requires prior authorization for Ultomiris (ravulizumab) with new step therapy requirements effective July 2024—patients must try Empaveli (pegcetacoplan) first unless contraindicated. Submit PA requests through NovoLogix online tool with complete documentation. If denied, file internal appeals within 180 days, then request external review through Ohio Department of Insurance within 30 days for binding IRO decision.

First Step Today: Contact your prescriber to confirm step therapy documentation and gather diagnosis proof, prior therapy records, and vaccination status for your PA submission.

Table of Contents

Why Ultomiris Coverage Myths Persist

Ultomiris (ravulizumab) coverage denials create confusion because patients and families often receive conflicting information about what's really required. At around $474,000-$569,000 annually, this complement inhibitor faces rigorous insurance scrutiny—especially with Blue Cross Blue Shield plans in Ohio.

The complexity stems from evolving policies. As of July 2024, most BCBS commercial members face new step therapy requirements that weren't in place previously. Meanwhile, patients hear outdated advice or assume rare disease drugs get automatic approval.

At Counterforce Health, we help patients and clinicians navigate these exact scenarios—turning insurance denials into targeted, evidence-backed appeals by understanding what payers actually require versus what people think they require.

Common Myths vs. Facts

Myth 1: "If my doctor prescribes Ultomiris, BCBS has to cover it"

Fact: Prior authorization is mandatory for all BCBS plans in Ohio. Even FDA-approved medications require meeting specific coverage criteria, step therapy protocols, and documentation requirements before approval.

Myth 2: "Rare disease drugs don't have step therapy requirements"

Fact: BCBS now requires patients to try Empaveli (pegcetacoplan) first before Ultomiris approval, effective July 22, 2024, unless you have documented contraindications or intolerance.

Myth 3: "Internal appeals are just a formality—they always deny them"

Fact: Well-documented internal appeals addressing specific denial reasons can succeed. However, external reviews through Ohio's Independent Review Organizations show substantially higher overturn rates (30-65%) for medically necessary rare disease medications.

Myth 4: "I can't appeal if I haven't tried the drug yet"

Fact: You can appeal prospective denials (before treatment starts) and retrospective denials (after treatment). Ohio law provides external review rights for both scenarios.

Myth 5: "Appeals take months and aren't worth it"

Fact: Ohio's external review process provides decisions within 30 days for standard cases and 72 hours for urgent medical situations.

Myth 6: "Biosimilar eculizumab is exactly the same as Ultomiris"

Fact: While both are C5 complement inhibitors, Ultomiris offers extended dosing intervals (every 8 weeks vs. every 2 weeks) and may have different side effect profiles. Document medical necessity for the specific drug.

Myth 7: "Patient assistance programs replace insurance coverage"

Fact: Alexion's OneSource program provides valuable support, but securing insurance coverage remains essential for long-term access and avoiding coverage gaps.

What Actually Influences BCBS Approval

Primary Approval Factors:

  • Confirmed FDA-indicated diagnosis with supporting lab work (flow cytometry for PNH, complement studies for aHUS, antibody testing for myasthenia gravis/NMOSD)
  • Step therapy compliance or documented contraindication/intolerance to Empaveli
  • REMS program enrollment and meningococcal vaccination records
  • Complete prior authorization submission through NovoLogix platform
  • Medical necessity documentation from qualified specialists

Documentation That Matters:

Your appeal success depends on addressing BCBS's specific criteria. Coverage policies require:

  • Diagnosis confirmation with ICD-10 codes
  • Prior therapy trials and outcomes
  • Absence of active meningococcal infection
  • Prescriber specialty credentials
  • Treatment goals and monitoring plans

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Mandatory pre-approval NovoLogix online tool
Step Therapy Try Empaveli first BCBS medical policy
REMS Enrollment Safety monitoring program Ultomiris REMS website
Specialist Prescriber Hematologist, neurologist, etc. Plan provider directory
Vaccination Records Meningococcal vaccines current CDC vaccination guidelines
Appeals Deadline 180 days from denial Ohio Department of Insurance

Avoid These Critical Mistakes

1. Skipping Step Therapy Documentation

Don't assume your doctor knows about the new Empaveli requirement. Explicitly discuss and document why Empaveli isn't appropriate or hasn't worked.

2. Incomplete Prior Authorization Submissions

Missing documentation is a leading denial reason. Submit all required forms, lab results, and clinical notes together.

3. Waiting Too Long to Appeal

Ohio's 180-day appeal deadline is firm. Start your internal appeal immediately after receiving a denial letter.

4. Generic Appeal Letters

Address each specific denial reason individually. Cookie-cutter appeals that don't respond to BCBS's stated concerns typically fail.

5. Not Requesting Expedited Review When Appropriate

If treatment delays could cause serious harm, request expedited processing. Document medical urgency clearly.

Quick Action Plan

Step 1: Gather Essential Documents Today

  • Insurance card and policy details
  • Complete medical records for your condition
  • Documentation of prior therapies tried/failed
  • Current vaccination records
  • Any previous denial letters

Step 2: Confirm Your BCBS Plan's Specific Requirements

Not all BCBS plans follow identical policies. Contact member services to verify your plan's current Ultomiris coverage criteria and step therapy requirements.

Step 3: Work with Your Provider on Strategy

Schedule a focused appointment to review:

  • Step therapy documentation needs
  • Prior authorization submission timeline
  • Backup appeal strategy if initially denied
From our advocates: We've seen patients succeed by proactively gathering step therapy documentation before their first PA submission. One patient's neurologist documented specific contraindications to Empaveli based on the patient's cardiac history, leading to direct Ultomiris approval without delays. While outcomes vary, thorough preparation consistently improves approval odds.

Appeals Process for Ohio

Internal Appeals (Required First Step)

  1. File within 180 days of denial date
  2. Submit through BCBS member portal or written request
  3. Include new clinical information addressing denial reasons
  4. Request peer-to-peer review if available
  5. Expect decision within 30 days (15 days for urgent cases)

External Review Through Ohio Department of Insurance

If internal appeals fail:

  1. Request Ohio External Review Form from BCBS or ODI website
  2. Submit within 4 months of final internal denial
  3. Include all medical records and provider recommendations
  4. Independent Review Organization decides within 30 days (72 hours if urgent)
  5. Decision is binding on BCBS

Contact Information:

  • Ohio Department of Insurance Consumer Services: 1-800-686-1526
  • BCBS Member Services: Number on your insurance card
  • Alexion OneSource Support: 1-888-765-4747

FAQ

Q: How long does BCBS prior authorization take in Ohio? A: Standard PA decisions are typically made within 15 business days. Urgent requests may be processed within 72 hours if medical necessity is documented.

Q: What if Ultomiris isn't on my plan's formulary? A: You can request a formulary exception by demonstrating medical necessity and that preferred alternatives aren't appropriate for your condition.

Q: Can I get Ultomiris covered if I live in Ohio but have coverage from another state's BCBS plan? A: Yes, but you'll follow that state's specific BCBS policies and appeal rights. Ohio's external review may not apply to out-of-state plans.

Q: Does the step therapy requirement apply if I've already been on Soliris? A: Step therapy requirements may be waived if you've previously tried eculizumab (Soliris) or have documented contraindications to Empaveli.

Q: What happens if my appeal is successful? A: BCBS must provide coverage as specified in the approval decision. Retroactive coverage for the appeal period may also be required.

Q: Can I continue treatment while appealing? A: This depends on your specific situation. Discuss interim coverage options with your provider and consider Alexion's patient assistance programs.

Resources and Support

Official Sources:

Additional Help:

  • UHCAN Ohio (Consumer advocacy): Provides assistance with insurance appeals
  • Ohio Department of Insurance Consumer Hotline: 1-800-686-1526
  • Counterforce Health: Specialized support for prescription drug appeals and denials

Financial Assistance:

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and requirements change frequently. Always verify current requirements with your specific BCBS plan and consult healthcare providers for medical decisions. For official appeals guidance, contact the Ohio Department of Insurance or your plan's member services directly.

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