CurrentCignaPolicy IP0690

Natalizumab Products Prior Authorization Policy

Defines prior authorization and coverage-related information for natalizumab IV products (Tysabri and biosimilars) and lists related multiple sclerosis disease‑modifying therapies included in appendices; affects providers requesting coverage from Cigna for these agents.

Policy Summary

PayerCigna

PolicyNatalizumab Products Prior Authorization Policy

Policy CodePolicy IP0690

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and specify the natalizumab intravenous product (Tysabri or biosimilar) listed in Appendix A when submitting requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Natalizumab in Appendix A

multipleOther DMTs in Appendix A

ExtensiveBiologic agents in Appendix B

Coverage Criteria

Product inclusion

Listing of included products (informational only).

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The provided appendix listings identify products that are included for reference; however, the source chunks do not state any explicit exclusions for natalizumab (Tysabri and biosimilars) or for other agents listed in the appendices. Appendix A enumerates multiple disease‑modifying therapies including Natalizumab Intravenous Products (Tysabri, biosimilar) as an item in the list, but no exclusion language or explicit limiting conditions are provided in these chunks.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required for natalizumab IV products (Tysabri and listed biosimilars). Providers must submit a prior authorization request for any natalizumab intravenous product as identified in Appendix A.

Affected products: natalizumab IV (Tysabri and biosimilars)
Operational note: include product identification (Tysabri or biosimilar name) on the PA request

Note

Policy Grouping Note

Policy groups natalizumab among multiple disease-modifying therapies (see Appendix A) and also lists it among biologic agents (Appendix B). This grouping has operational implications for formulary management and prior authorization workflows — ensure requests reference the appropriate appendix/product grouping.

Natalizumab appears in Appendix A with other MS disease-modifying therapies
Natalizumab is also listed among biologic agents in Appendix B

Prior Authorization

Prior Authorization Request Guidance

When submitting a prior authorization request for natalizumab IV, include explicit product identification indicating the natalizumab IV product (e.g., Tysabri or the specific biosimilar name) to avoid processing delays.

Include product name (Tysabri or biosimilar) on PA form
Provide administration route: intravenous infusion

Denial Risk

Denial risk is implied when natalizumab IV products are not appropriately identified or when prior authorization is not obtained as required. Failure to include the correct product identification (Tysabri or biosimilar) on the PA request may result in denial of coverage.

Risk of denial if PA not obtained for natalizumab IV products
Risk of denial if product identification (Tysabri or biosimilar) is omitted or incorrect on the PA request

Background

Appendix listings provide context on disease‑modifying and biologic therapies used for multiple sclerosis and other immune‑mediated conditions. Appendix A lists oral, injectable, and intravenous disease‑modifying therapies — for example, Aubagio (teriflunomide) — oral, interferons and glatiramer formulations — injectable — and Natalizumab Intravenous Products (Tysabri, biosimilar) — intravenous infusion. Appendix B catalogs a broad set of biologic agents grouped by mechanism and examples of indications (for example, TNF inhibitors and other targeted biologics), which helps situate natalizumab among alternative high‑efficacy biologic therapies.

Definitions

Natalizumab Intravenous Products (Tysabri and biosimilars) — key facts

Defined productsTysabri and biosimilar natalizumab products administered by intravenous infusion (listed in Appendix A)

Mode of administrationIntravenous infusion

Appendix locationListed in Appendix A among multiple disease‑modifying therapies for multiple sclerosis

Prior authorization notePrior authorization is required for natalizumab intravenous products per policy (see Appendix A listing)

Provider documentationWhen requesting prior authorization, include product identification indicating natalizumab IV product (Tysabri or biosimilar)