By Counterforce Health Team in Ultomiris (ravulizumab) —

How Long Does It Take to Get Ultomiris (ravulizumab) Approved by Humana in North Carolina? Complete Timeline Guide

Quick Answer: Humana typically approves complete Ultomiris prior authorizations within 1 business day for electronic submissions, but missing REMS enrollment or vaccination records can delay approval by weeks. Start by ensuring your prescriber is enrolled in the UltSolREMS program and you've received both MenACWY and MenB vaccines at least 2 weeks before treatment. If denied, you have 65 days to appeal internally, then can request external review through North Carolina's Smart NC program.

Table of Contents

What Affects Ultomiris Approval Timing

Getting Ultomiris (ravulizumab) approved by Humana in North Carolina depends on several key factors that can either streamline or significantly delay the process.

Benefit Type Matters Humana processes Ultomiris differently depending on whether you have Medicare Advantage, Medicare Part D, or a commercial plan. Medicare Advantage prior authorizations must be decided within 7 calendar days starting in 2026 (currently 14 days), while expedited requests get 48-hour turnaround. Part D drug exceptions have faster timelines: 72 hours for standard requests and 24 hours for expedited.

REMS Compliance is Critical Ultomiris requires enrollment in a shared Risk Evaluation and Mitigation Strategy (REMS) program with Soliris. This isn't optional—it's an FDA mandate that Humana strictly enforces. Your prescriber must be enrolled at UltSolREMS.com or by calling 1-888-765-4747 before any approval can proceed.

Documentation Completeness Humana reports that 95% of complete electronic prior authorizations receive decisions within 1 business day. However, missing vaccination records, incomplete diagnostic documentation, or REMS enrollment gaps can extend this to weeks.

Pre-Submission Preparation (0-2 Days)

Before your doctor submits the prior authorization, gather these essential documents to avoid delays:

Required Documentation Checklist

Medical Records:

  • Confirmed diagnosis with supporting lab results (flow cytometry for PNH, complement studies for aHUS)
  • Previous treatment history and outcomes
  • Current clinical status and treatment goals
  • Baseline laboratory values

REMS and Safety Requirements:

  • Prescriber REMS enrollment confirmation
  • Patient counseling documentation
  • Meningococcal vaccination records (both MenACWY and MenB, given at least 2 weeks prior)
  • If urgent treatment needed: documented antibiotic prophylaxis plan

Insurance Information:

  • Current Humana member ID and plan details
  • Verification that Ultomiris requires prior authorization on your specific formulary
Tip: Contact CenterWell Specialty Pharmacy at 1-800-486-2668 early in the process. They can help coordinate with your prescriber and verify coverage requirements specific to your Humana plan.

Submission to Initial Review (1-5 Days)

Electronic vs. Paper Submission Humana strongly recommends electronic submission through their provider portal for fastest processing. Electronic submissions typically receive decisions within 1 business day, while fax or mail submissions can take up to 30 days.

What Reviewers Check First Humana's initial review focuses on:

  1. REMS program enrollment verification
  2. Vaccination requirement compliance
  3. Diagnosis confirmation with appropriate lab values
  4. Step therapy requirements (if applicable to your plan)
  5. Formulary status and any quantity limits

Expedited Review Options If your health could be seriously jeopardized by waiting, request expedited review. Include clinical documentation supporting urgency. Humana processes expedited requests within 48 hours for standard urgent cases, or 24 hours for life-threatening situations.

Common Delays and Information Requests

Most Frequent Delay Causes:

Issue Solution Timeline Impact
Missing vaccination records Submit both MenACWY and MenB vaccination dates +3-7 days
REMS non-enrollment Prescriber must complete UltSolREMS.com registration +5-10 days
Incomplete diagnostic documentation Provide flow cytometry results, complement studies, or relevant labs +3-5 days
Step therapy requirements Document failure/intolerance of required alternatives +7-14 days

Responding to Information Requests When Humana requests additional information, you typically have 14 days to respond before the request is considered abandoned. Submit responses electronically when possible and include a cover letter referencing the original prior authorization number.

Decision Window and Outcomes

Typical Decision Timeline:

  • Electronic submissions: 1 business day for 95% of complete requests
  • Paper/fax submissions: Up to 30 days
  • Expedited requests: 24-48 hours depending on urgency level

Reading Approval Letters Approvals will specify:

  • Approved indication and dosing
  • Duration of approval (typically 6-12 months)
  • Any ongoing requirements (lab monitoring, REMS compliance)
  • Preferred specialty pharmacy for dispensing

Partial Approvals Sometimes Humana approves a modified version of the request (different dosing interval, quantity limits, or duration). Review approval letters carefully and discuss any limitations with your prescriber.

If Denied: Appeals Timeline

Internal Appeals Process If your initial request is denied, you have 65 days from the denial notice to file an internal appeal (redetermination). Humana must respond within:

  • 7 calendar days for standard appeals
  • 72 hours for expedited appeals

Required Appeal Documentation:

  • Original denial letter
  • Additional clinical evidence addressing denial reasons
  • Updated prescriber letter explaining medical necessity
  • Any new supporting studies or guidelines

External Review Through Smart NC If Humana denies your internal appeal, you can request external review through North Carolina's Smart NC program. This independent review is binding on Humana if they overturn the denial.

Smart NC Process:

  • File within 120 days of final internal denial
  • Standard external review: decision within 45 days
  • Expedited external review: decision within 72 hours
  • Contact Smart NC at 1-855-408-1212 for assistance
Note: Smart NC provides free advocacy and can help you gather supporting documentation for your external review request.

Renewal Cycles and Re-Authorization

When to Re-Authorize Most Ultomiris approvals are valid for 6-12 months. Start the renewal process 30-60 days before expiration to avoid treatment interruptions.

Renewal Documentation

  • Updated clinical status and response to treatment
  • Current laboratory values showing treatment effectiveness
  • Continued REMS compliance
  • Any changes in diagnosis or treatment goals

What Speeds Renewals Renewals typically process faster than initial approvals if you can demonstrate:

  • Stable clinical response (improved LDH levels for PNH, reduced hemolysis markers)
  • Good medication adherence
  • Continued medical necessity
  • No safety concerns

Timeline Overview Table

Milestone Standard Timeline Expedited Timeline Key Requirements
Pre-submission prep 0-2 days Same REMS enrollment, vaccinations, documentation
Electronic submission to decision 1 business day 24-48 hours Complete documentation package
Paper/fax submission to decision Up to 30 days 24-48 hours All required forms and attachments
Internal appeal response 7 calendar days 72 hours Address specific denial reasons
External review (Smart NC) 45 days 72 hours Exhaust internal appeals first

Time-Saving Tips

Portal Usage Always submit through Humana's electronic portal when possible. Electronic submissions are processed significantly faster and provide real-time status updates.

Bundled Evidence Strategy Submit all supporting documentation with the initial request rather than waiting for information requests. Include:

  • Complete diagnostic workup
  • Treatment history with outcomes
  • Current clinical status
  • REMS and vaccination compliance proof

Direct Specialty Routing Work with CenterWell Specialty Pharmacy from the beginning. They can coordinate directly with Humana's specialty drug review team and often identify potential issues before formal submission.

Peer-to-Peer Reviews For complex cases or denials, request a peer-to-peer review where your prescriber can discuss the case directly with a Humana medical director. This can resolve clinical questions more efficiently than written appeals.

At Counterforce Health, we help patients and clinicians navigate these complex prior authorization processes by analyzing denial letters and crafting targeted appeals that address payers' specific requirements. Our platform identifies exactly why medications like Ultomiris get denied and provides evidence-backed strategies to overcome common approval barriers. Whether you're dealing with REMS compliance issues, step therapy requirements, or medical necessity questions, having the right documentation and approach can significantly reduce approval timelines.

FAQ

How long does Humana take to approve Ultomiris in North Carolina? For complete electronic submissions, Humana typically provides decisions within 1 business day. Paper submissions can take up to 30 days. Missing REMS enrollment or vaccination records are the most common causes of delays.

What if Ultomiris is non-formulary on my Humana plan? You can request a formulary exception through Humana's drug exception process. Include clinical documentation showing why formulary alternatives are inappropriate for your condition.

Can I get an expedited appeal if Humana denies Ultomiris? Yes, if the delay could seriously jeopardize your health. Expedited appeals must be decided within 72 hours. Your prescriber should provide clinical documentation supporting the urgent need.

Does step therapy apply if I've already tried alternatives outside North Carolina? Documentation of prior treatment failures from any location should satisfy step therapy requirements. Ensure your prescriber includes detailed records of previous therapies and outcomes.

What happens if I miss the 65-day appeal deadline? You may lose the right to internal appeal, but you might still have options through Smart NC's external review process. Contact Smart NC at 1-855-408-1212 to discuss your specific situation.

How do I know if my prescriber is enrolled in the REMS program? Your prescriber can verify enrollment status at UltSolREMS.com or by calling 1-888-765-4747. REMS enrollment is required before any Ultomiris prescription can be processed.

Can Smart NC help with the appeals process? Yes, Smart NC provides free advocacy and can help you gather documentation, complete forms, and navigate the external review process. Call 1-855-408-1212 for assistance.

Sources & Further Reading:

This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For additional help with insurance appeals in North Carolina, contact Smart NC at 1-855-408-1212 or visit the North Carolina Department of Insurance website.

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