Tysabri denied by insurance? Appeal and win.
A denial of Tysabri (natalizumab) is the start of a process, not the end of it. This drug is frequently denied because it is a high-cost specialty infusion with strict prior authorization rules, and plans often require documented failure of preferred therapies and proof of TOUCH program enrollment before they will pay. Appeals usually succeed when the file clearly maps the patient's diagnosis, prior treatment history, and required JCV antibody testing to the plan's own written coverage criteria.
Reviewed by the Apellica Appeals Team · Updated June 2026
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Tysabri is FDA approved as a single-agent (monotherapy) treatment for relapsing forms of multiple sclerosis in adults, which includes clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease. It is also approved for adults with moderately to severely active Crohn's disease who have evidence of inflammation and have not responded to, or cannot tolerate, conventional Crohn's therapies and TNF-alpha inhibitor (anti-TNF) drugs. It is given as a 300 mg intravenous infusion once every four weeks, and because of the risk of a rare brain infection called PML, it is only available through the restricted REMS program known as TOUCH.
Why Tysabri gets denied
- Step therapy not satisfied: the plan requires documented trial and failure, intolerance, or contraindication to one or more preferred MS therapies (or, for Crohn's, conventional agents and an anti-TNF) before it will cover natalizumab.
- Non-formulary or non-preferred status: many plans now prefer the biosimilar natalizumab-sztn (Tyruko) or other agents, so brand Tysabri is denied as non-preferred unless a formulary or tier exception is filed.
- Prior authorization criteria not documented: missing or incomplete records, such as no JCV (anti-John Cunningham virus) antibody test result, no recent MRI, or no confirmation of TOUCH program enrollment for the patient, prescriber, and infusion site.
- Site-of-care policy: the plan steers infusions away from a hospital outpatient setting to a lower-cost site such as an infusion center or home infusion, and denies the requested location.
What a winning appeal includes
- A confirmed diagnosis with the correct ICD-10 code (for example G35 for multiple sclerosis or a K50.xx code for Crohn's disease), supported by neurology or gastroenterology notes and imaging.
- A clear prior-therapy history listing each preferred or conventional drug tried, the dates, and the specific reason it failed, was not tolerated, or is contraindicated, which directly answers a step therapy denial.
- A point-by-point letter of medical necessity that maps the patient's situation to the plan's own published coverage criteria and quotes that language back to the reviewer.
- Drug-specific documentation: a recent anti-JCV antibody test result, a current MRI, and proof that the patient, prescriber, and infusion site are all enrolled in the TOUCH REMS program.
How we approach the appeal
First identify which kind of denial you received, because the path differs. If Tysabri was denied as non-formulary or non-preferred, file a formulary or tier exception arguing the preferred alternative is medically inappropriate; if it was denied on prior authorization or medical necessity grounds, file an internal appeal that quotes the plan's own criteria, for example its requirement that the member have "an inadequate response to or contraindication to one or more conventional therapies" or, for Crohn's, that the member "tested negative for anti-JCV antibodies in the past 6 months." Attach the letter of medical necessity, prior-therapy records, JCV test, MRI, and TOUCH enrollment, and if the internal appeal is upheld, request an external (independent) review within your state's deadline.
Tysabri appeal letter template
Copy this Tysabri appeal letter, fill in the brackets, and send it within your deadline. It is built on what overturns Alpha-4 integrin receptor antagonist (monoclonal antibody) denials.
[Date] [Your name] · Member ID [ID] · Rx claim # [#] [Insurer or PBM] - Appeals Department Re: Appeal of Tysabri denial I am appealing the denial of Tysabri (natalizumab). I request that the denial be overturned and Tysabri approved. 1. The denial. [Insurer] denied Tysabri stating, verbatim: "[paste the exact denial reason from your letter]." 2. Medical necessity. Tysabri is medically necessary for my condition. First identify which kind of denial you received, because the path differs. If Tysabri was denied as non-formulary or non-preferred, file a formulary or tier exception arguing the preferred alternative is medically inappropriate; if it was denied on prior authorization or medical necessity grounds, file an internal appeal that quotes the plan's own criteria, for example its requirement that the member have "an inadequate response to or contraindication to one or more conventional therapies" or, for Crohn's, that the member "tested negative for anti-JCV antibodies in the past 6 months." Attach the letter of medical necessity, prior-therapy records, JCV test, MRI, and TOUCH enrollment, and if the internal appeal is upheld, request an external (independent) review within your state's deadline. 3. Step-therapy or formulary exception (if that was the reason): I have tried and failed [preferred drug(s)], with pharmacy records attached, or the preferred alternative is contraindicated because [reason]. I request a formulary or step-therapy exception. 4. My request. Approve Tysabri within the timeframe required by law. If the denial is upheld, please provide the specific criteria used, the reviewing clinician's credentials, and external-review instructions. Attached: prescriber letter of medical necessity, pharmacy and prior-trial records, and supporting clinical notes. Sincerely, [Your name]
Want it built and filed for you? Use the free generator, or have Apellica do it.
Internal appeals: 30 days pre-service, 60 days post-service, 72 hours urgent. File within 180 days of the denial.
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- · The denial letter and your Explanation of Benefits (EOB)
- · Insurance ID, plan name, and the claim or prior-authorization number
- · Diagnosis with ICD-10 code and the prescriber's clinical notes
- · A record of treatments already tried and how they worked
Appealing a Tysabri denial by insurer
The path depends on who manages your benefit. The most common:
Coverage runs through the pharmacy benefit. Appeal the coverage determination and, when the drug is non-formulary, file a formulary or tier exception with a provider attestation that covered alternatives are unsuitable.
Publishes detailed prior-authorization criteria. A denial usually means a criterion was not documented. Appeal through a coverage review, with a formulary exception for excluded drugs.
Administers many UnitedHealthcare and employer plans. Appeals and exceptions follow the plan's published PA criteria; expedited review exists for urgent cases.
Internal appeal first, then independent external review. Pre-service decisions are generally made within 30 days, urgent within 72 hours.
Internal appeals and external review; pharmacy denials often route through OptumRx criteria.
Independent state plans, so criteria vary. Match the appeal to your specific BCBS plan, internal appeal first, then external review.
Frequently asked questions
Why does my plan want me to try a different MS drug before approving Tysabri?
This is called step therapy, and most plans use it because they consider other MS therapies or the natalizumab biosimilar (Tyruko) preferred. You can satisfy or appeal it by documenting each drug you have already tried with the dates and the reason it failed, was not tolerated, or is medically contraindicated for you. If a required drug would be unsafe given your history, your prescriber can request a step therapy exception instead of having you try it.
My plan now prefers the biosimilar Tyruko instead of Tysabri. Can I still get Tysabri covered?
Often yes, but you will likely need a formulary or tier exception rather than a standard prior authorization. The appeal should explain a clinical reason the specific brand is needed, for example an established stable response on Tysabri or a documented reaction. If there is no specific clinical reason and the products are interchangeable for you, the plan may still require the preferred biosimilar, so it helps to confirm with your prescriber before appealing.
Does insurance require JCV antibody testing and TOUCH enrollment before covering Tysabri?
Yes. Because Tysabri carries a risk of PML, it is only available through the TOUCH REMS program, and the patient, prescriber, and infusion site must all be enrolled. Most plans also require a recent anti-JCV antibody test result as part of prior authorization. Including the current JCV result and proof of TOUCH enrollment in your submission removes two of the most common reasons these requests are denied or delayed.
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Start Your AppealThis page provides general information about appeal strategy. It is not legal or medical advice. Apellica is not a law firm. Outcomes depend on documentation, plan terms, and timing.