Denied Tysabri? You Still Have Options.
Tysabri (natalizumab) is used to treat relapsing forms of multiple sclerosis and moderately to severely active Crohn's disease, and because of its specific risk profile and cost, it faces significant prior authorization scrutiny. Many insurers require step therapy — proof that other MS or Crohn's therapies have been tried and found insufficient before Tysabri is approved. Some plans also require specific risk stratification testing (like JC virus antibody testing for MS patients) as part of the prior authorization process, and any gap in that documentation can trigger a denial.
Option 1: Appeal Your Denial
If your neurologist or gastroenterologist prescribed Tysabri for a specific clinical reason — such as rapidly evolving MS or refractory Crohn's — that reasoning belongs front and center in your appeal. Documenting your prior treatment history and any contraindications to alternative therapies strengthens your case significantly. Ellen can help you draft your appeal letter.
Option 2: Explore Clinical Trials
Natalizumab and related integrin inhibitor therapies continue to be studied in both neurology and gastroenterology. Clinical trials may offer access to Tysabri, biosimilars in development, or next-generation therapies with a similar mechanism. Participants in qualifying trials typically receive the study medication at no charge. Search ClinicalTrials.gov for "natalizumab," "multiple sclerosis," or "Crohn's disease" to see current opportunities.
Option 3: Patient Assistance Programs
Biogen, Tysabri's manufacturer, offers financial assistance and support through Biogen's patient support programs for eligible individuals. The National MS Society (nationalmssociety.org) provides navigators, financial assistance, and access support specifically for people living with MS. The Crohn's and Colitis Foundation (crohnscolitisfoundation.org) offers similar resources for IBD patients.
For a complete guide to Tysabri financial assistance — including copay cards, free drug programs, and independent foundations — see our financial assistance page for Tysabri.
Ellen can help you figure out your next step. Start with Ellen →
Frequently Asked Questions
Why was Tysabri denied?
Tysabri is most often denied because of step therapy requirements — insurers typically want evidence that first- or second-line therapies have been tried and failed before approving Tysabri. For MS patients, some plans also require JC virus antibody test results as part of the prior authorization. Missing documentation, incomplete authorization filings, or requests for an indication that falls outside the plan's criteria are other common causes. Your denial letter will point to the specific reason.
Can I get Tysabri through a clinical trial?
Clinical trials studying natalizumab or related alpha-4 integrin inhibitors for MS and Crohn's disease do exist. Eligible participants typically receive the study medication at no cost. For MS patients, there are also trials studying next-generation therapies in the same class, as well as combination approaches. Your neurologist or gastroenterologist is the right person to evaluate whether a trial matches your situation. Browse ClinicalTrials.gov for current options.
How long does a Tysabri appeal take?
For non-urgent standard appeals, you can generally expect a decision within 30 days. Expedited appeals, when medical urgency is documented, must be resolved within 72 hours. If your internal appeal is denied, an independent external review typically takes up to 45 days. For relapsing MS especially, the urgency of staying on a consistent treatment regimen is worth articulating clearly in your appeal and in any urgency documentation. Talk to your doctor before making any decisions about your treatment.