Find policies, billing codes, payers, states, and providers
Tysabri (natalizumab) and Tyruko (natalizumab‑sztn) — Precertification Request Form Coverage Criteria
Customize your policy alerts
Sign up for all Aetna policy alerts
Know when Aetna releases new policies or updates existing guidance.
Monitor payer policy activity
Precertification and authorization information and required clinical data for Aetna coverage review of natalizumab products (Tysabri and biosimilar Tyruko) for initiation and continuation of therapy; intended for prescribers and administrative staff submitting requests.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initiation and Continuation Clinical Criteria
Covered when ALL of the following initiation or continuation documentation requirements are provided on the precertification request form:
See clinical initiation questions on the form
Continuation documentation must list which signs/symptoms improved for Crohn's disease when applicable (e.g., abdominal pain, weight, endoscopic appearance, CDAI score).
See safety and site‑of‑care questions on the form
The precertification form requires disclosure if the requested natalizumab product will be co-administered with other disease‑modifying multiple sclerosis agents, immunosuppressants, or tumor necrosis factor (TNF) inhibitors (for example, adalimumab or infliximab). The form clarifies that Ampyra and Nuedexta are not disease‑modifying agents and must not be considered disease‑modifying for this question.
The form states that required clinical information must be completed in its entirety for all precertification requests and includes specific items—such as adverse events during or immediately after infusion, presence of natalizumab antibodies, medical instability, severe venous access issues, and gaps in therapy—that must be documented. Failure to provide these required responses or supporting details may render the request incomplete and could lead to requests for additional information or delays in adjudication.
Coding
| Z79.899 | Other long term (current) drug therapy |
| R51 | Headache |
| M54.5 | Low back pain |
Provider Actions and Required Submission Data
Precertification required
Precertification is required for requests. Submit the completed Aetna Precertification Notification form via phone or fax to Aetna Precertification Notification: Phone: 1-866-752-7021 (TTY: 711); FAX: 1-888-267-3277. For Medicare Advantage Part B requests, use the Medicare Request Form.
- Aetna Precertification Notification — Phone: 1-866-752-7021 (TTY: 711); FAX: 1-888-267-3277
- Medicare Advantage Part B — Use Medicare Request Form
Indication-specific documentation
Indication-specific fields must be completed when applicable. For Crohn's disease, indicate diagnosis of moderately to severely active Crohn's disease, confirm prescriber specialty or consultation with a gastroenterologist, document anti-JCV antibody testing, and answer whether the patient has ever received or is currently receiving a biologic for Crohn's disease (excluding samples or manufacturer's patient assistance). For multiple sclerosis indications, indicate prescriber specialty (neurologist) and anti-JCV antibody testing as applicable. For continuation requests, provide documentation of clinical response or maintenance of remission and whether the patient is receiving the drug via samples or assistance programs.
- Crohn's disease: diagnosis confirmation, gastroenterology involvement, anti-JCV antibody test, prior biologic use (ever/current; exclude samples/PAP)
- Multiple sclerosis indications: neurologist involvement and anti-JCV antibody test
- Continuation requests: evidence of remission or positive clinical response; status of samples/manufacturer assistance
Required form fields and clinical documentation
The precertification form must be fully completed and legible. Required form fields and clinical documentation include patient demographics and contact information, insurance, prescriber and dispensing provider details (including specialty, NPI, state license), product selection and dosing (Tysabri or Tyruko, dose, frequency), primary and other ICD-10 diagnosis codes, and the required clinical questions in the clinical information section.
- Patient: name, DOB, weight, height, contact information
- Insurance: payer details and precertification requested by contact
- Prescriber: name, specialty, phone, fax, NPI, state license, DEA as applicable
- Dispensing provider: (if required) contact and licensure
- Product and dosing: select Tysabri (natalizumab) or Tyruko (natalizumab-sztn), list dose and frequency
- Diagnosis codes: primary ICD code and any secondary/other ICD codes
- Clinical information: outpatient setting, infusion adverse events, natalizumab antibodies, venous access, behavioral or cognitive issues, medical instability, gaps in therapy, combination therapy use
Prior biologic therapy documentation
Document whether the patient has ever received or is currently receiving a biologic indicated for the condition (for Crohn's disease questions explicitly ask about prior biologic therapy, excluding samples or manufacturer's patient assistance program). For continuation requests, document whether the patient is currently receiving the drug through samples or assistance and provide evidence of maintained benefit.
- Prior biologic therapy: Has the patient ever received or currently receiving a biologic for Crohn's disease? (exclude samples/PAP)
- Continuation: Is the patient receiving the drug via samples or manufacturer's assistance? Has the patient achieved/maintained remission or clinical response?
Incomplete documentation may prompt denial
Incomplete or missing required information may delay review or result in denial. The plan may request additional information or clarification; failure to provide complete and legible responses to required form fields or the clinical questions (including indication-specific items and prior biologic therapy answers) can prompt a request for more information or denial of the request.
- Missing or illegible patient, prescriber, product, dosing, or ICD code information may prompt denial
- Failure to complete indication-specific clinical questions (e.g., prior biologic use, anti-JCV testing, prescriber specialty) may prompt request for more information or denial
- Continuation requests missing documentation of clinical response or remission may be denied
Definitions and Testing
Background
Natalizumab (Tysabri) and its biosimilar Tyruko are monoclonal antibody therapies indicated for relapsing forms of multiple sclerosis and for moderately to severely active Crohn's disease. The precertification form queries anti‑JCV antibody status because of the association with progressive multifocal leukoencephalopathy (PML) risk and requires indication‑specific documentation for both initiation and continuation of therapy, including specialty consultation and evidence of clinical benefit for continuation requests.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.