CurrentAvMedPolicy N/A

Tysabri (natalizumab) IV prior authorization

Defines AvMed medical prior authorization and step-edit requirements for Tysabri (natalizumab) IV for members with multiple sclerosis or Crohn's disease, and the provider documentation and registration expectations.

Policy Summary

PayerAvMed

PolicyTysabri (natalizumab) IV prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and fax the medical prior authorization/step-edit request and include supporting documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mgrecommended IV dose every 4 weeks

300billable units per 300 mg vial/infusion

1minimum prior relapse for MS

≥1failed DMTs required for MS

moderate–severeCrohn's disease activity

Coverage Criteria for Tysabri (natalizumab) IV

Multiple Sclerosis - Initial Authorization

Covered when ALL of the following are met

MS initial therapy criteria

ONE of: Member has tried and failed at least ONE of the following agents (verified by chart notes or pharmacy paid claims): dimethyl fumarate (Tecfidera), glatiramer acetate (Glatopa or Copaxone), fingolimod (Gilenya), teriflunomide (Aubagio).
OR: Member's current or potential disease progression warrants the use of Tysabri.

Crohn's Disease - Initial Authorization

Covered when ALL of the following are met

Crohn's disease initial therapy criteria

Policy Summary

PayerAvMed

PolicyTysabri (natalizumab) IV prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and fax the medical prior authorization/step-edit request and include supporting documentation.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

ONE of: Member has tried and failed budesonide or high-dose steroids (40-60 mg prednisone).

OR: Member has tried and failed Renflexis AND Humira.

The policy does not accept initiation of Tysabri therapy based solely on manufacturer or clinic samples. Use of samples to initiate therapy does not meet step edit/ preauthorization criteria. Providers must document prior medication trials and any required step-therapy failures with chart notes or pharmacy paid-claim history as specified in the authorization requirements.

Coding and Dosing Information

Covered HCPCS CodesHCPCSCovered

J2323

Tysabri (natalizumab) IV

inv-05: Dose per infusion — 300 mg every 28 days

Dose per infusion300 mg infused over 1 hour every 28 days (recommended) — corresponds to one 300 mg/15 mL vial = 300 billable units

Billing units300 billable units per 300 mg vial/infusion

Infusion frequencyEvery 4 weeks (every 28 days)

Infusion durationInfused over 1 hour

Provider Authorization & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — prior authorization is required for Tysabri (natalizumab) IV (J2323). Prescriber must complete and sign the medical prior authorization/step-edit request and fax to 1-877-535-1391. If information provided is incomplete, incorrect, or illegible, authorization can be delayed or denied.

Drug requested: Tysabri (natalizumab) IV (J2323)
Fax number for prior authorization: 1-877-535-1391

Step Therapy

Step Therapy / Prior Medication Trials

Step therapy / prior medication trials — For MS indications, member must have tried and failed at least one specified disease-modifying therapy. Documentation (chart notes or pharmacy/medical paid claims) verifying prior therapies tried must be submitted; check each agent that was tried.

Required prior agents (verify with chart notes or paid claims): dimethyl fumarate (Tecfidera)
glatiramer acetate (Glatopa or Copaxone)
fingolimod (Gilenya)
teriflunomide (Aubagio)
Alternatively, member's current or potential disease progression may warrant use of Tysabri

Documentation Required

Required Submission Information

Required submission information — the prescriber signature (no preprinted stamps), prescriber and member details, diagnosis with ICD code, and supporting documentation (chart notes, labs, diagnostics, and pharmacy/medical paid claims) must be provided. For MS, include confirmation of relapsing‑remitting MS, documentation of at least one clinical relapse in the prior 12 months, neurologist prescriber status, and TOUCH enrollment. For Crohn's disease, include gastroenterologist prescriber status, evidence of moderate to severe active disease with inflammation, registration in CD TOUCH, and documentation of prior failed therapies.

Required: prescriber signature (hand-signed), prescriber name and specialty, member name and identifiers, diagnosis with ICD code
For MS: confirm relapsing‑remitting MS; neurologist prescriber; ≥1 documented clinical relapse in past 12 months; member registered in TOUCH
For Crohn's Disease: gastroenterologist prescriber; moderate to severe active Crohn's with inflammation; registered in CD TOUCH; documentation of prior failed budesonide/high-dose steroids or failed Renflexis AND Humira

Denial Risk

Incomplete or Illegible Request

Incomplete or illegible requests — authorization can be delayed or denied if the request form or supporting information is incomplete, incorrect, or illegible.

Ensure all fields are complete and legible; handwritten prescriber signature required
Include phone and fax numbers on the form to avoid follow-up delays

Denial Risk

Insufficient Supporting Documentation

Insufficient supporting documentation — requests may be denied if documentation does not support each checked clinical criterion. Provide chart notes, lab results, diagnostics, and pharmacy/medical paid claims to verify prior therapies and clinical history.

Documentation must substantiate each criterion checked (e.g., prior therapy trials, relapses, specialty provider, TOUCH/CD TOUCH enrollment)
Failure to submit supporting records may result in denial

Background

Tysabri (natalizumab) is an intravenous monoclonal antibody indicated for certain patients with relapsing-remitting multiple sclerosis and for selected cases of moderate to severe Crohn's disease. Under this policy, prior authorization is required for Tysabri IV (HCPCS code J2323), and prescribers must provide supporting documentation including diagnosis, prior therapy trials, and registration in the applicable risk management program (TOUCH for MS or the CD program for Crohn's disease). For urgent reviews, contact AvMed Pre-Authorization if a standard review would seriously jeopardize the member's health.

Risk-Management Program Definitions

inv-12: TOUCH program / CD TOUC — Risk management programs; member registration required

Program namesTOUCH (for Multiple Sclerosis) and CD TOUC (for Crohn's Disease)

Member requirementMember registration with the appropriate risk management program is required

MS requirement detailFor MS approvals, member must be registered with the Tysabri TOUCH program

CD requirement detailFor Crohn's disease approvals, member must be registered with the Tysabri CD TOUC program

DocumentationRegistration status must be documented as part of the authorization request (supporting documentation required)