ModifiedCountycarePolicy 5035.CC

Natalizumab Products

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This guideline governs prior authorization for Tysabri (natalizumab) and Tyruko (natalizumab-sztn) under the Health Plan's medical benefit. It applies to practitioners requesting these products for adult Medicaid members with Crohn's disease or relapsing multiple sclerosis.

Policy Summary

PayerCountycare

PolicyNatalizumab Products

Policy CodePolicy 5035.CC

Change TypeModified

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required for Tysabri and Tyruko before coverage can be approved.

SourceLink

POLICY UPDATE CHANGES

Tyruko was added to the natalizumab product guideline.

Initial and reauthorization criteria were updated for multiple sclerosis and Crohn's disease.

2Natalizumab products covered

18+Minimum age for initial therapy

AnnualReauthorization review frequency

1 yearInitial authorization duration

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ModifiedCountycarePolicy 5035.CC

Natalizumab Products

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Policy Summary

PayerCountycare

PolicyNatalizumab Products

Policy CodePolicy 5035.CC

Change TypeModified

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required for Tysabri and Tyruko before coverage can be approved.

SourceLink

POLICY UPDATE CHANGES

Tyruko was added to the natalizumab product guideline.

Initial and reauthorization criteria were updated for multiple sclerosis and Crohn's disease.

2Natalizumab products covered

18+Minimum age for initial therapy

AnnualReauthorization review frequency

1 yearInitial authorization duration

Applicable billing codes

Coverage Criteria Overview

Initial Therapy - Crohn's Disease

Covered when all of the following criteria are met:

Crohn's disease initial therapy

Prescriber and age
- Prescribed by a gastroenterologist registered with the TOUCH Prescribing program.
- Member is age 18 years or older.18 years or older
Diagnosis and severity
- Diagnosis of moderately to severely active Crohn's disease or fistulizing Crohn's disease, as described in the 2018 ACG guidelines.Moderate-to-severe disease includes CDAI 220-450; severe-fulminant disease includes CDAI >450
At least one required prior therapy
- Adequate trial of an adalimumab product for at least 3 months, with failure, inadequate response, significant side effects or toxicities, or a contraindication.At least 3 months
- Adequate trial of Cimzia for at least 3 months, with failure, inadequate response, significant side effects or toxicities, or a contraindication.At least 3 months
Safety and dosing
- No current or historical progressive multifocal leukoencephalopathy (PML).
- Not receiving chronic immunosuppressant or immunomodulatory therapy, and no systemic medical condition resulting in significant compromised immune system function.
- Documentation of testing for anti-JCV antibodies.
- Prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.FDA-labeled dosing

Initial Therapy - Multiple Sclerosis

Covered when all of the following criteria are met:

Multiple sclerosis initial therapy

Prescriber, diagnosis, and age
- Prescribed by a neurologist registered with the TOUCH Prescribing program.
- Diagnosis of a relapsing form of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease.
- Member is age 18 years or older.18 years or older
At least one preferred MS therapy
- Inadequate response or intolerance to Betaseron (interferon beta-1b).

Continuation Therapy - Crohn's Disease

Covered when all of the following criteria are met. Renewals are reviewed annually:

Crohn's disease continuation therapy

Prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.FDA-labeled dosing
Clinical response
- Recent chart-note documentation shows achievement or maintenance of a positive clinical response evidenced by low disease activity.
- Recent chart-note documentation shows improvement from baseline in at least one measure: abdominal pain or tenderness; diarrhea; body weight; abdominal mass; hematocrit; mucosal appearance on endoscopy, CTE, MRE, or intestinal ultrasound; or a disease activity score such as CDAI.At least 1 measure

Continuation Therapy - Multiple Sclerosis

Covered when all of the following criteria are met. Renewals are reviewed annually:

Multiple sclerosis continuation therapy

Prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.FDA-labeled dosing
Recent provider chart documentation shows that the member's condition has stabilized or improved based on the prescriber's assessment while on therapy.Stabilized or improved
Documentation or provider attestation confirms no evidence of progressive multifocal leukoencephalopathy (PML).No evidence of PML

Progressive multifocal leukoencephalopathy (PML) is an exclusion to initial therapy when present currently or historically. For continuation therapy, any evidence of PML prevents reauthorization. Provider documentation or attestation must address this safety requirement.

Initial therapy is excluded when the member is receiving chronic immunosuppressant or immunomodulatory therapy or has a systemic medical condition causing significant immune system compromise. Examples identified in the policy include 6-mercaptopurine, azathioprine, cyclosporine, methotrexate, TNF-alpha inhibitors, and—under the multiple sclerosis criteria—interferon beta-1a, interferon beta-1b, glatiramer acetate, or fingolimod.

Applicable Codes and Clinical Definitions

Applicable CodesHCPCSCovered

J2323

Tysabri Injection, Natalizumab, 1mg

Applicable CodesHCPCSCovered

Q5134

Tyruko Injection, Natalizumab-sztn (Tyruko), biosimilar, 1mg

Crohn's Disease Activity Index for Moderate-to-Severe Disease

CDAI range220-450

Disease classificationModerate-to-severe Crohn's disease

Clinical contextClassification includes failure of treatment for mild to moderate disease and prominent symptoms such as fever, weight loss, abdominal pain or tenderness, intermittent nausea or vomiting, or anemia.

Crohn's Disease Activity Index for Severe-Fulminant Disease

CDAI thresholdGreater than 450

Disease classificationSevere-fulminant Crohn's disease

Authorization, Documentation, and Decision Outcomes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tysabri® (natalizumab) and Tyruko® (natalizumab-sztn) under the Health Plan’s medical benefit. Requests are reviewed against FDA criteria to determine medical necessity and are subject to Medical Policy Committee approval.

Applies to practitioners involved in providing the requested drug.

Note

Authorization Duration

Approval is granted for up to 1 year initially. Reauthorization is approved for the same duration as the initial authorization, up to 1 year.

Initial authorization: up to 1 year
Reauthorization: same as initial authorization

Natalizumab Background

Natalizumab is used as monotherapy for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is also used to induce and maintain clinical response and remission in adults with moderately to severely active Crohn's disease with evidence of inflammation, including patients with inadequate response to or inability to tolerate conventional Crohn's disease therapies and tumor necrosis factor-alpha inhibitors.

Clinical and Program Definitions

Relapsing Forms of Multiple Sclerosis

Clinically isolated syndromeIncluded as a relapsing form of multiple sclerosis.

Relapsing-remitting diseaseIncluded as a relapsing form of multiple sclerosis.

Active secondary progressive diseaseIncluded as a relapsing form of multiple sclerosis.

Moderate-to-Severe Crohn's Disease

CDAI range220-450

Prior disease-course characteristicFailure of treatment for mild to moderate disease.

Prominent symptoms

Initial Therapy by Disease

Crohn's Disease Initial Therapy

Covered when all diagnosis-specific, prior-treatment, safety, and dosing criteria are met:

Crohn's disease initial therapy

Prescribed by a gastroenterologist registered with the TOUCH Prescribing program.
Member is age 18 years or older.18 years or older
Diagnosis of moderately to severely active Crohn's disease or fistulizing Crohn's disease, as described in the 2018 ACG guidelines.Moderate-to-severe disease includes CDAI 220-450; severe-fulminant disease includes CDAI >450
At least one prior therapy

Reauthorization by Disease

Crohn's Disease Reauthorization

Covered when all continuation criteria are met. Reauthorization is reviewed annually:

Crohn's disease reauthorization

Prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.FDA-labeled dosing
Documented clinical response
- Recent chart-note documentation shows achievement or maintenance of a positive clinical response evidenced by low disease activity.
- Recent chart-note documentation shows improvement from baseline in at least one of the following: abdominal pain or tenderness; diarrhea; body weight; abdominal mass; hematocrit; mucosal appearance on endoscopy, CTE, MRE, or intestinal ultrasound; or a disease activity score such as CDAI.

Prerequisite Therapy

Step	Required prior therapy	Trial and outcome
1	At least one adalimumab product or Cimzia	Adequate trial of at least 3 months with failure, inadequate response, significant side effects or toxicities, or contraindication before natalizumab

Step	Preferred prior therapy	Additional requirement for highly active MS
1	At least one of: Betaseron, Copaxone, Gilenya, Rebif, or Tecfidera; inadequate response or intolerance is required	Gilenya is required for highly active MS or prognostic factors of a poorer clinical course

Policy Summary

PayerCountycare

PolicyNatalizumab Products

Policy CodePolicy 5035.CC

Change TypeModified

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required for Tysabri and Tyruko before coverage can be approved.

SourceLink

On This Page

Inadequate response or intolerance to Copaxone (glatiramer acetate).

Inadequate response or intolerance to Gilenya (fingolimod).Required for highly active MS or prognostic factors of poorer clinical course

Inadequate response or intolerance to Rebif (interferon beta-1a).

Inadequate response or intolerance to Tecfidera (dimethyl fumarate).

Safety and dosing

No current or historical progressive multifocal leukoencephalopathy (PML).
Not receiving chronic immunosuppressant or immunomodulatory therapy, and no systemic medical condition resulting in significant compromised immune system function.
Documentation of testing for anti-JCV antibodies.
Prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.FDA-labeled dosing

Documentation or provider attestation confirms no evidence of progressive multifocal leukoencephalopathy (PML).No evidence of PML

Clinical contextPersistent symptoms despite glucocorticoids or biologic agents, or high fever, persistent vomiting, intestinal obstruction, peritoneal signs, cachexia, or evidence of an abscess.

Step Therapy

Crohn’s Disease Prerequisite Therapy

For Crohn’s disease, document an adequate trial of at least 3 months and failure of at least one preferred therapy, demonstrated by inadequate response or significant side effects/toxicities, unless the therapy is contraindicated.

Adalimumab product
Cimzia

Step Therapy

Multiple Sclerosis Prerequisite Therapy

For multiple sclerosis, document a previous inadequate response or intolerance to at least one preferred MS therapy. Members with highly active MS or prognostic factors for a poorer clinical course are required to have tried Gilenya (fingolimod).

Betaseron (interferon beta-1b)
Copaxone (glatiramer acetate)
Gilenya (fingolimod)
Rebif (interferon beta-1a)
Tecfidera (dimethyl fumarate)

Documentation Required

Initial Safety Documentation

Include chart-note documentation or a provider attestation addressing all initial safety requirements for the applicable diagnosis.

No current or historical progressive multifocal leukoencephalopathy (PML).
No chronic immunosuppressant or immunomodulatory therapy, and no systemic medical condition causing significant immune-system compromise.
Documentation of anti-JCV antibody testing.
Dose must be within the manufacturer’s FDA-approved labeling guidelines, based on diagnosis, weight, and other applicable factors.

Documentation Required

Crohn’s Disease Documentation

For Crohn’s disease, document all diagnosis-specific initial requirements, including TOUCH registration, age, disease severity, and prior-treatment history.

Prescriber is a gastroenterologist registered with the TOUCH Prescribing Program.
Member is age 18 years or older.
Diagnosis is moderately to severely active Crohn’s disease or fistulizing Crohn’s disease as described in the 2018 ACG guidelines.
Documentation supports the required adequate trial and failure of adalimumab or Cimzia, including inadequate response, significant side effects/toxicities, or contraindication.

Documentation Required

Multiple Sclerosis Documentation

For multiple sclerosis, document all diagnosis-specific initial requirements, including TOUCH registration, relapsing MS diagnosis, age, and prior-treatment history.

Prescriber is a neurologist registered with the TOUCH Prescribing Program.
Diagnosis is a relapsing form of MS, including clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease.
Member is age 18 years or older.
Documentation supports inadequate response or intolerance to the required preferred MS therapy.

Documentation Required

Renewal Documentation

Reauthorization requires recent clinical documentation demonstrating continued benefit and safe continuation of therapy for the applicable diagnosis.

Crohn’s disease: positive clinical response shown by low disease activity or improvement from baseline in at least one relevant clinical, laboratory, imaging, endoscopic, or disease-activity measure.
Multiple sclerosis: the prescriber documents that the condition has stabilized or improved while on therapy.
For either diagnosis: dose remains within manufacturer’s FDA-approved dosing guidelines and documentation or attestation confirms no evidence of PML.

Denial Risk

Criteria Not Met

If established criteria are not met, refer the request to a Medical Director for review when required by the plan and the level of request.

Apply the applicable Medical Director review pathway before issuing a final decision.

Denial Risk

Initial Criteria Failure

The initial request is subject to denial when the applicable diagnosis-specific requirements are not met or adequately documented.

Crohn’s disease: diagnosis is not moderately to severely active or fistulizing, the member is under age 18, or the prescriber is not a TOUCH-registered gastroenterologist.
Multiple sclerosis: the diagnosis is not a relapsing form of MS, the member is under age 18, or the prescriber is not a TOUCH-registered neurologist.
Required prior therapy, including the applicable trial, failure, inadequate response, intolerance, side effects/toxicities, or contraindication, is not established.
Required safety documentation is absent or shows PML, prohibited chronic immunosuppressant/immunomodulatory therapy, significant immune compromise, or missing anti-JCV antibody testing.
Prescribed dose is outside the manufacturer’s FDA-approved dosing guidelines.

Denial Risk

Reauthorization Criteria Failure

Reauthorization is subject to denial when continued therapy requirements are not met or documented.

No recent evidence of positive clinical response, low disease activity, improvement, stabilization, or other applicable disease control.
Required Crohn’s disease improvement measures or MS prescriber assessment are absent or do not support continued benefit.
Dose is outside the manufacturer’s FDA-approved dosing guidelines.
Required continuation documentation or attestation is missing, including confirmation that there is no evidence of PML.

Fever, weight loss, abdominal pain and tenderness, intermittent nausea or vomiting, or anemia.

Endoscopic findingModerate to severely active endoscopic mucosal disease.

Severe-Fulminant Crohn's Disease

CDAI thresholdGreater than 450

Treatment-resistant symptomsPersistent symptoms despite glucocorticoids or biologic agents.

Severe clinical findingsHigh fever, persistent vomiting, intestinal obstruction, peritoneal signs, cachexia, or evidence of an abscess.

Kurtzke Expanded Disability Status Scale (EDSS)

PurposeA method of quantifying disability in multiple sclerosis.

Fully ambulatory rangeEDSS steps 1.0 to 4.5 refer to patients who are fully ambulatory.

Ambulation-impairment rangeEDSS steps 5.0 to 9.5 are defined by impairment in ambulation.

Tysabri Outreach Unified: Commitment to Health (TOUCH)

Program typeA restricted distribution program focused on safety.

DevelopmentDeveloped with the help of the FDA.

Authorized accessOnly Tysabri (natalizumab) and only certain pharmacies and infusion sites authorized by the program may prescribe, dispense, and infuse Tysabri for prescribers and patients enrolled in the program.

Adequate trial of an adalimumab product for at least 3 months, with failure, inadequate response, significant side effects or toxicities, or a contraindication.At least 3 months

Adequate trial of Cimzia for at least 3 months, with failure, inadequate response, significant side effects or toxicities, or a contraindication.At least 3 months

Safety and dosing documentation

No current or historical progressive multifocal leukoencephalopathy (PML).
Not receiving chronic immunosuppressant or immunomodulatory therapy, and no systemic medical condition resulting in significant compromised immune system function.
Documentation of testing for anti-JCV antibodies.
Prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.FDA-labeled dosing

Documentation or provider attestation confirms no evidence of progressive multifocal leukoencephalopathy (PML).No evidence of PML

Multiple Sclerosis Reauthorization

Covered when all continuation criteria are met. Reauthorization is reviewed annually:

Multiple sclerosis reauthorization

Prescribed at a dose within the manufacturer's dosing guidelines listed in the FDA-approved labeling.FDA-labeled dosing
Recent provider chart documentation shows that the member's condition has stabilized or improved based on the prescriber's assessment while on therapy.Stabilized or improved
Documentation or provider attestation confirms no evidence of progressive multifocal leukoencephalopathy (PML).No evidence of PML