Denied Soliris? You Still Have Options.
Soliris (eculizumab) is one of the most expensive medications in the world, used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and certain other rare conditions. Because of its cost, it faces an exceptionally high prior authorization burden. Insurers often require extensive documentation, specialist confirmation, and specific lab evidence before approving Soliris — and any gap in that documentation can trigger a denial. The rarity of the conditions it treats also means insurance reviewers may not be familiar with the clinical picture.
Option 1: Appeal Your Denial
Appeals for Soliris require thorough, well-organized clinical documentation — lab values, specialist notes, diagnosis confirmation, and a clear explanation of why treatment cannot wait. Your hematologist or nephrologist is a critical partner in this process. Ellen can help you draft your appeal letter.
Option 2: Explore Clinical Trials
Research in complement inhibition — the mechanism that makes Soliris work — is ongoing and expanding. Trials may study eculizumab, next-generation complement inhibitors like ravulizumab (Ultomiris), or entirely new approaches for PNH, aHUS, and related conditions. Participants typically receive study medications at no cost. Search ClinicalTrials.gov for "eculizumab," "PNH," or "complement inhibitor" to see what's currently enrolling.
Option 3: Patient Assistance Programs
Alexion, the manufacturer of Soliris, has a dedicated patient assistance program called OneSource that helps eligible individuals navigate access and affordability. The Aplastic Anemia and MDS International Foundation (aamds.org) and the National Organization for Rare Disorders (rarediseases.org) also offer resources for people facing access challenges with rare disease medications.
For a complete guide to Soliris financial assistance — including copay cards, free drug programs, and independent foundations — see our financial assistance page for Soliris.
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Frequently Asked Questions
Why was Soliris denied?
Soliris denials most often happen because the prior authorization file was incomplete, because the insurer's reviewer required additional specialist documentation, or because the plan has specific criteria that must be met before approving such a high-cost therapy. Rare disease medications like Soliris sometimes face reviewers who are unfamiliar with the condition — making a detailed, well-documented appeal even more important. Your denial letter should specify what's missing or disputed.
Can I get Soliris through a clinical trial?
Possibly. Clinical research in complement inhibition is very active, and trials studying eculizumab or related next-generation inhibitors for PNH and aHUS do exist. Participants who qualify for these trials may receive the study drug at no cost. Your hematologist or nephrologist will have the most current information on what's available for your specific situation. You can also search ClinicalTrials.gov for currently enrolling studies.
How long does a Soliris appeal take?
Standard internal appeals generally resolve within 30 days. If your doctor documents medical urgency, the expedited timeline is 72 hours. After an internal denial, you can escalate to an independent external review, which typically resolves within 45 days. For rare disease situations where treatment delays can be medically serious, your specialist should clearly articulate urgency in every document submitted. Talk to your doctor before making any decisions about your treatment.