Natalizumab (ARCHIVED)

Policy ID: I-9085-008

Section: Injections

Effective Date: April 01, 2021

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-9085-008

Section: Injections

Effective Date: April 01, 2021

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Natalizumab (Tysabri) is a recombinant humanized IgG4k monoclonal antibody produced in murine myeloma cells. Natalizumab (Tysabri) contains human framework regions and the complementarity determining regions of a murine antibody that binds to a 4-integrin.

Natalizumab-sztn (Tyruko®) is the biosimilar to natalizumab (Tysabri).

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

*Preferred Crohn's Disease agents
adalimumab/adalimumab biosimilar
infliximab/infliximab biosimilar
Skyrizi (risankizumab-rzaa)
Stelara (ustekinumab)

Natalizumab may be considered medically necessary when the following criteria are met:

ONE of the following:
- Information has been provided that the individual has been treated with natalizumab within the past 90 days; or
- The prescriber states the individual has been treated with natalizumab within the past 90 days AND is at risk if therapy is changed; or
- The individual has a diagnosis of moderately to severely active Crohn's Disease (CD) AND ALL of the following:
  1. Natalizumab will NOT be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate); and
  2. ONE of the following:
    1. The individual has tried and had an inadequate response to ONE conventional agent [i.e., 6-mercaptopurine, azathioprine, corticosteroids (e.g., prednisone, budesonide EC capsule), methotrexate] used in the treatment of CD for at least three (3) months; or
    2. The individual has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of CD; or
    3. The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD; or
    4. The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or NCCN compendium recommended use 1 or 2a for the treatment of CD; and
  3. ONE of the following:
    1. The individual has tried and had an inadequate response to at least ONE preferred biologic agent* for the treatment of CD used for at least three (3) months; or
    2. The individual has an intolerance or hypersensitivity to ONE preferred biologic agent for the treatment of CD; or
    3. The individual has an FDA labeled contraindication to ALL preferred biologic agents for the treatment of CD; and
  4. The individual will NOT be using natalizumab in combination with an immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) for the requested indication; or
- The individual has a diagnosis of a relapsing form of MS AND the individual will NOT be using natalizumab in combination with an additional disease modifying agent (DMA) for the requested indication; or
- The individual has another FDA approved indication for natalizumab and the route of administration; and
If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for natalizumab; or
- The prescriber has provided information in support of using natalizumab for the individual's age for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., gastroenterologist for the diagnosis of Crohn's Disease or neurologist for the diagnosis of MS) or the prescriber has consulted with a specialist in the area of the individual's diagnosis.

The use of natalizumab for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J2323

Q5134

Reauthorization Criteria

Natalizumab may be considered medically necessary when the following criteria are met:

The individual has been previously approved for natalizumab through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit from treatment with natalizumab; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., gastroenterologist for the diagnosis of Crohn's Disease or neurologist for the diagnosis of MS) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
If the individual has a diagnosis of MS, the individual will NOT be using natalizumab in combination with another disease modifying agent (DMA) for the requested indication; and
If the individual has a diagnosis of CD, the individual will NOT be using natalizumab in combination with an immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) for the requested indication.

Procedure Codes

J2323

Q5134

Natalizumab is not indicated for the treatment of chronic progressive multiple sclerosis.

Note: Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

G35

K50.00

K50.10

K50.80

K50.90

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K50.911

K50.912

K50.913

K50.914

K50.918

K50.919

Professional Statements and Societal Positions Guidelines

MS Disease Modifying Agents

Aubagio (teriflunomide)
Avonex (interferon b-1a)
Bafiertam (monomethyl fumarate)
Betaseron (interferon b-1b)
Briumvi (ublituximab-xiiy)
Copaxone (glatiramer)
Dimethyl fumarate
Extavia (interferon b-1b)
fingolimod
Gilenya (fingolimod)
Glatopa (glatiramer)
Glatiramer
Kesimpta (ofatumumab)
Mavenclad (cladribine)
Mayzent (siponimod)
Plegridy (peginterferon b-1a)
Ponvory (ponesimod)
Rebif (interferon b-1a)
Tascenso ODT (fingolimod)
Tecfidera (dimethyl fumarate)a
Vumerity (diroximel fumarate)
Zeposia (ozanimod)

Immunomodulatory Agents NOT to be used concomitantly

Actemra (tocilizumab)
Adalimumab
Adbry (tralokinumab-ldrm)
Amjevita (adalimumab-atto)
Arcalyst (rilonacept)
Avsola (infliximab-axxq)
Benlysta (belimumab)
Bimzelx (bimekizumab-bkzx)
Cibinqo (abrocitinib)
Cimzia (certolizumab)
Cinqair (reslizumab)
Cosentyx (secukinumab)
Cyltezo (adalimumab-adbm)
Dupixent (dupilumab)
Enbrel (etanercept)
Entyvio (vedolizumab)
Fasenra (benralizumab)
Hadlima (adalimumab-bwwd)
Hulio (adalimumab-fkjp)
Humira (adalimumab)
Hyrimoz (adalimumab-adaz)
Idacio (adalimumab-aacf)
Ilaris (canakinumab)
Ilumya (tildrakizumab-asmn)
Inflectra (infliximab-dyyb)
Infliximab
Kevzara (sarilumab)
Kineret (anakinra)
Litfulo (ritlecitinib)
Nucala (mepolizumab)
Olumiant (baricitinib)
Omvoh (mirikizumab-mrkz)
Opzelura (ruxolitinib)
Orencia (abatacept)
Otezla (apremilast)
Remicade (infliximab)
Renflexis (infliximab-abda)
Riabni (rituximab-arrx)
Rinvoq (upadacitinib)
Rituxan (rituximab)
Rituxan Hycela (rituximab/hyaluronidase human)
Ruxience (rituximab-pvvr)
Siliq (brodalumab)
Simlandi (adalimumab-ryvk)
Simponi (golimumab)
Simponi ARIA (golimumab)
Skyrizi (risankizumab-rzaa)
Sotyktu (deucravacitinib)
Spevigo (spesolimab-sbzo)
Stelara (ustekinumab)
Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tofidence (tocilizumab-bavi)
Tremfya (guselkumab)
Truxima (rituximab-abbs)
Tyenne (tocilizumab-aazg)
Tysabri (natalizumab)
Velsipity (etrasimod)
Wezlana (ustekinumab-auub)
Xeljanz (tofacitinib)
Xeljanz XR (tofacitinib extended release)
Xolair (omalizumab)
Yuflyma (adalimumab-aaty)
Yusimry (adalimumab-aqvh)
Zeposia (ozanimod)
Zymfentra (infliximab-dyyb)

Class

Class Drug Agents

CD20 monoclonal antibody

CD20 monoclonal antibody

BRIUMVI*ublituximab-xiiy soln for iv infusion

CD20 monoclonal antibody

KESIMPTA*Ofatumumab Soln Auto-Injector

CD20 monoclonal antibody

OCREVUS*Ocrelizumab Soln For IV Infusion

CD52 monoclonal antibody

CD52 monoclonal antibody

LEMTRADA*Alemtuzumab IV Inj

Fumarates

Fumarates

BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release

Fumarates

TECFIDERA*Dimethyl Fumarate Capsule Delayed Release

Fumarates

VUMERITY*Diroximel Fumarate Capsule Delayed Release

Glatiramer

Glatiramer

COPAXONE*Glatiramer Acetate Soln Prefilled Syringe

Glatiramer

GLATOPA*Glatiramer Acetate Soln Prefilled Syringe

IgG4k monoclonal antibody

IgG4k monoclonal antibody

TYSABRI*Natalizumab for IV Inj Conc

Interferons

Interferons

AVONEX*Interferon beta-1a injection

Interferons

BETASERON*Interferon beta-1b injection

Interferons

EXTAVIA*Interferon beta-1b injection

Interferons

PLEGRIDY*Peginterferon beta-1a injection

Interferons

REBIF*Interferon beta-1a injection

Purine antimetabolite

Purine antimetabolite

MAVENCLAD*Cladribine Tab Therapy Pack

Pyrimidine synthesis inhibitor

Pyrimidine synthesis inhibitor

AUBAGIO*Teriflunomide Tab

Sphingosine 1-phosphate (SIP) receptor modulator