CurrentWashington State Health Care AuthorityPolicy 62.40.50.AA-1

Multiple Sclerosis Agents: natalizumab (Tysabri)

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Apple Health Medicaid fee-for-service prior authorization, medical-necessity review, dosing limits, and reauthorization for natalizumab (Tysabri) in eligible adults with multiple sclerosis, clinically isolated syndrome, or moderate-to-severe Crohn's disease.

Policy Summary

PayerWashington State Health Care Authority

PolicyMultiple Sclerosis Agents: natalizumab (Tysabri)

Policy CodePolicy 62.40.50.AA-1

Change TypePolicy split from broader class policy

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit a prior authorization request demonstrating that the applicable clinical-policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy was split from a broader class policy to create a separate policy for Tysabri.

2Covered therapeutic indications

2 agentsPreferred-agent trials before initial approval

6 monthsInitial Crohn's authorization

12 monthsMS initial and reauthorization period

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CurrentWashington State Health Care AuthorityPolicy 62.40.50.AA-1

Multiple Sclerosis Agents: natalizumab (Tysabri)

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 62.40.50.AA-1 alerts

Get alerted when Policy 62.40.50.AA-1 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerWashington State Health Care Authority

PolicyMultiple Sclerosis Agents: natalizumab (Tysabri)

Policy CodePolicy 62.40.50.AA-1

Change TypePolicy split from broader class policy

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit a prior authorization request demonstrating that the applicable clinical-policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy was split from a broader class policy to create a separate policy for Tysabri.

2Covered therapeutic indications

2 agentsPreferred-agent trials before initial approval

6 monthsInitial Crohn's authorization

12 monthsMS initial and reauthorization period

300 mg every 4 weeks

J2323Covered HCPCS code

Coverage Criteria

Initial therapy — Crohn's disease

Covered when all of the following documented criteria are met. Initial authorization is for 6 months.

Initial Crohn's disease criteria

Required clinical criteria
- The patient is 18 years of age or older; natalizumab is prescribed by, or in consultation with, a gastroenterologist; natalizumab is not used in combination with another Cytokine and CAM medication; and the patient has moderate-to-severe Crohn's disease.Age ≥ 18 years
- Disease-treatment pathway
  - Conventional-therapy pathway: Treatment with conventional therapy has been ineffective, unless all conventional options are contraindicated or not tolerated. Conventional therapy includes short-term oral corticosteroids to induce remission or alleviate signs and symptoms of a flare, plus at least one immunomodulatory agent such as methotrexate, azathioprine, or 6-mercaptopurine.Minimum 12-week trial for the immunomodulatory agent
  - High-risk disease pathway: The patient has documented high-risk Crohn's disease, such as symptoms despite conventional therapy, obstruction, abscess, stricture, phlegmon, fistulas, resection, extensive bowel involvement, early age of onset, growth retardation, Crohn's Disease Activity Index (CDAI) greater than 450, or Harvey-Bradshaw index greater than 7.CDAI > 450 or Harvey-Bradshaw index > 7 when applicable

Initial therapy — Crohn's preferred-agent step therapy

An additional requirement for initial Crohn's disease approval is that both preferred-agent trials meet the policy standard.

Preferred-agent requirement: The patient has received trials of two preferred Cytokine and CAM Apple Health Preferred Drug List (PDL) medications, and each medication was ineffective, unless all applicable medications are contraindicated or not tolerated.Minimum 12-week trial for each medication

Continuation therapy — Crohn's disease

Covered when all of the following documented criteria are met. Reauthorization is for 12 months.

Crohn's disease continuation criteria

Natalizumab is not used in combination with another Cytokine and CAM medication.
Documentation demonstrates disease stability or a positive clinical response.
Examples include improved endoscopic activity, tapering or discontinuation of corticosteroids, fewer liquid stools, reduced abdominal pain, or a decreased CDAI or Harvey-Bradshaw index.

Initial therapy — multiple sclerosis

Covered when all of the following documented criteria are met. Initial authorization is for 12 months.

Initial multiple sclerosis criteria

Required clinical criteria
- The patient is 18 years of age or older; natalizumab is prescribed by, or in consultation with, a neurologist; natalizumab is not used in combination with another disease-modifying therapy for multiple sclerosis; the diagnosis is confirmed and documented by a laboratory report such as an MRI; and the baseline number of relapses per year or Expanded Disability Status Scale (EDSS) score is documented.Age ≥ 18 years
- Covered multiple sclerosis diagnosis
  - Relapsing-remitting multiple sclerosis (RRMS).
  - Active secondary progressive multiple sclerosis (SPMS).

Continuation therapy — multiple sclerosis

Covered when all of the following documented criteria are met. Reauthorization is for 12 months.

Multiple sclerosis continuation criteria

Natalizumab is not used in combination with another disease-modifying therapy for multiple sclerosis.
Documentation demonstrates disease stability or a positive clinical response.
Examples include a decrease in the number of relapses per year or improvement in the EDSS score.

Combination therapy is not covered under this policy. For Crohn's disease, natalizumab must not be used with another Cytokine and CAM medication. For multiple sclerosis, natalizumab must not be used with another disease-modifying therapy (DMT). These restrictions apply to both initial approval and reauthorization.

Coding and Clinical Thresholds

Covered HCPCS CodeHCPCSCovered

J2323

Injection, natalizumab, 1 mg; 1 billable unit = 1 mg (Tysabri only)

Crohn’s disease immunomodulator trial

RequirementAt least one immunomodulatory agent must be tried for a minimum of 12 weeks.

ExamplesMethotrexate, azathioprine, or 6-mercaptopurine.

Crohn’s therapy contextThe immunomodulator is used with short-term oral corticosteroids to induce remission or relieve flare symptoms.

Preferred Cytokine and CAM medication trials

Required agentsTwo preferred Cytokine and CAM Apple Health Preferred Drug List medications.

Trial durationEach medication requires a minimum trial of 12 weeks.

Provider Requirements and Decision Points

Prior Authorization

Prior Authorization Required

Prior authorization is required for natalizumab (Tysabri). Requests are subject to the applicable clinical-policy review and must include documentation supporting medical necessity.

Note

New FDA Indication Review

If natalizumab receives a new FDA-approved indication, medical necessity for that indication is determined on a case-by-case basis following FDA labeling.

Denial Risk

Prohibited Combination Therapy

Policy Background

This policy covers natalizumab (Tysabri) for eligible adults with moderate-to-severe Crohn's disease or multiple sclerosis, including relapsing-remitting disease, active secondary progressive disease, and clinically isolated syndrome. Coverage requires prior authorization and fulfillment of the applicable clinical criteria. Initial Crohn's disease authorization may be approved for 6 months; initial multiple sclerosis authorization and reauthorization for either indication may be approved for 12 months.

Clinical Definitions

Relapsing-remitting multiple sclerosis (RRMS)

Dissemination in spaceDamage is present in at least two separate areas of the central nervous system.

Dissemination in timeThe areas of damage occurred at different points in time.

Clinical attacksThe course may be demonstrated by at least two clinical attacks, or by one clinical attack plus qualifying MRI or cerebrospinal-fluid findings.

MRIMRI should be obtained unless contraindicated.

Active secondary progressive multiple sclerosis (SPMS)

EDSSAt least 3.0.

Progression

Initial Therapy

Initial Crohn's disease therapy

Covered for initial Crohn's disease therapy when all clinical criteria and the preferred-agent requirement are met. Initial authorization is for 6 months.

Clinical criteria
- The patient is 18 years of age or older; natalizumab is prescribed by, or in consultation with, a gastroenterologist; natalizumab is not used in combination with another Cytokine and CAM medication; and the patient has moderate-to-severe Crohn's disease.Age ≥ 18 years
- Disease-treatment pathway
  - Conventional-therapy pathway: Treatment with conventional therapy has been ineffective, unless all conventional options are contraindicated or not tolerated. Conventional therapy includes short-term oral corticosteroids and at least one immunomodulatory agent such as methotrexate, azathioprine, or 6-mercaptopurine.Minimum 12-week trial for the immunomodulatory agent

Continuation and Reauthorization

Crohn's disease reauthorization

All of the following documented criteria must be met. Reauthorization is for 12 months.

Natalizumab is not used in combination with another Cytokine and CAM medication.
Documentation demonstrates disease stability or a positive clinical response.
Examples include improved endoscopic activity, tapering or discontinuation of corticosteroids, fewer liquid stools, reduced abdominal pain, or a decreased CDAI or Harvey-Bradshaw index.

Multiple sclerosis reauthorization

All of the following documented criteria must be met. Reauthorization is for 12 months.

Natalizumab is not used in combination with another disease-modifying therapy for multiple sclerosis.

Preferred-Agent Requirements

Step	Requirement	Duration	Coverage
1	Trial of two preferred Cytokine and CAM Apple Health Preferred Drug List (PDL) medications before initial Crohn's disease approval. Each medication must have been ineffective, unless all applicable medications are contraindicated or not tolerated.	Minimum 12 weeks for each trial	Required before approval

Step	Requirement	Duration	Coverage
1	Trial of two preferred Multiple Sclerosis Apple Health Preferred Drug List (PDL) medications before initial multiple sclerosis approval. Each medication must have been ineffective, unless all applicable medications are contraindicated or not tolerated.	Minimum 12 weeks where specified	Required before approval

Dosing and Quantity Limits

Tysabri 300 mg/15 mL vial

DrugTysabri (natalizumab).

Dosage form300 mg/15 mL vial.

Quantity limit300 billable units per 28 days.

Policy Summary

PayerWashington State Health Care Authority

PolicyMultiple Sclerosis Agents: natalizumab (Tysabri)

Policy CodePolicy 62.40.50.AA-1

Change TypePolicy split from broader class policy

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit a prior authorization request demonstrating that the applicable clinical-policy criteria are met.

SourceLink

On This Page

Active SPMS requires an EDSS score of at least 3.0, progression for at least 3 months following an initial relapsing-remitting course, and qualifying relapse or MRI activity.

Clinically isolated syndrome (CIS).

Response requirement

Each medication must have been ineffective, unless all are contraindicated or not tolerated.

Crohn’s Disease Activity Index

MeasureCrohn’s Disease Activity Index (CDAI).

ThresholdGreater than 450.

Clinical useA CDAI greater than 450 is listed as an example of high-risk Crohn’s disease.

Harvey-Bradshaw index

MeasureHarvey-Bradshaw index.

ThresholdGreater than 7.

Clinical useA Harvey-Bradshaw index greater than 7 is listed as an example of high-risk Crohn’s disease.

Active SPMS EDSS

MeasureExpanded Disability Status Scale (EDSS).

ThresholdAt least 3.0.

Additional requirementActive SPMS also requires documented progression and disease activity.

Active SPMS progression

Progression durationAt least 3 months following an initial relapsing-remitting course.

EDSS progressionAn EDSS increase of 1.0 applies when EDSS is 5.5 or less; an increase of 0.5 applies when EDSS is 6 or greater.

Disease activityAt least one relapse within the previous 2 years or MRI evidence of gadolinium-enhancing activity or new or unequivocally enlarging T2 lesions is also required.

For initial approval, natalizumab must not be used with prohibited concurrent therapies. For Crohn’s disease, do not combine it with another Cytokine and CAM medication; for multiple sclerosis, do not combine it with other disease-modifying therapies (DMTs).

The same combination-therapy restriction applies at reauthorization.

Unsupported block type: step_therapyอย่าง?

Documentation Required

Initial Clinical Documentation

Submit initial clinical documentation showing the patient’s age, the prescribing specialist or consultation, the diagnosis and disease severity, and compliance with applicable combination-therapy restrictions.

Crohn’s disease: document age 18 or older, gastroenterologist involvement, and moderate-to-severe disease or qualifying high-risk disease.
Multiple sclerosis: document age 18 or older, neurologist involvement, an eligible diagnosis, diagnostic confirmation, and baseline disease activity.

Step Therapy

Trial of Two Preferred Agents

Before initial approval, document trials of two preferred medications from the applicable Apple Health PDL class, each demonstrating inadequate response, unless the medications are contraindicated or not tolerated.

Crohn’s disease: two preferred Cytokine and CAM PDL medications, with a minimum trial of 12 weeks.
Multiple sclerosis: two preferred multiple sclerosis PDL medications.

Documentation Required

Crohn’s Conventional Therapy

For Crohn’s disease, document that conventional therapy was ineffective, unless all conventional options were contraindicated or not tolerated. Conventional therapy includes short-term oral corticosteroids to induce remission or relieve flare symptoms and at least one immunomodulatory agent, such as methotrexate, azathioprine, or 6-mercaptopurine, with a minimum 12-week trial.

Alternatively, document high-risk disease, such as symptoms despite conventional therapy, obstruction, abscess, stricture, phlegmon, fistulas, resection, extensive bowel involvement, early age of onset, growth retardation, CDAI greater than 450, or Harvey-Bradshaw index greater than 7.

Documentation Required

Initial Clinical Documentation

Submit the clinical records needed to establish eligibility and medical necessity at initial review, including age, specialist involvement, diagnosis, disease severity or activity, diagnostic confirmation, baseline status, and applicable prior-treatment history.

For multiple sclerosis, include laboratory or imaging confirmation such as MRI and the baseline number of relapses per year or Expanded Disability Status Scale (EDSS) score.
For Crohn’s disease, include documentation of moderate-to-severe or high-risk disease and the required conventional-therapy history.

Documentation Required

Multiple Sclerosis Documentation

For multiple sclerosis, submit records confirming the diagnosis and baseline disease activity before initial approval. Reauthorization requires documentation of disease stability or a positive clinical response.

Eligible diagnoses include relapsing-remitting disease, active secondary progressive disease, or clinically isolated syndrome.
Document the baseline number of relapses per year or EDSS score; for reauthorization, provide changes such as fewer relapses or improved EDSS score.

Denial Risk

Crohn’s Response and Criteria Review

For Crohn’s disease reauthorization, submit evidence of disease stability or a positive clinical response. Requests may be denied when required clinical criteria, prior-treatment history, or supporting documentation are absent or not met.

Examples include improved endoscopic activity, corticosteroid taper or discontinuation, fewer liquid stools, reduced abdominal pain, a decreased CDAI, or a decreased Harvey-Bradshaw index.
Initial approval is generally authorized for 6 months for Crohn’s disease and 12 months for multiple sclerosis; reauthorization is authorized for 12 months when all applicable criteria are met.

Disease is progressive for at least 3 months following an initial relapsing-remitting course.

Relapse activityAt least one relapse within the previous 2 years.

MRI activityGadolinium-enhancing activity or new or unequivocally enlarging T2 contrast-enhancing lesions shown by MRI.

Clinically isolated syndrome (CIS)

Clinical episodeA monophasic episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system.

Symptom durationNeurologic symptoms last at least 24 hours, with or without recovery.

ExclusionThere is no fever or infection.

Multiple sclerosis statusThe patient is not known to have multiple sclerosis.

Conventional Crohn’s disease therapy

Corticosteroid therapyShort-term oral corticosteroids, such as prednisone or methylprednisolone, used to induce remission or alleviate signs and symptoms of a disease flare.

Immunomodulatory therapyAt least one immunomodulatory agent, such as methotrexate, azathioprine, or 6-mercaptopurine.

Trial durationThe immunomodulator requires a minimum trial of 12 weeks.

High-risk disease pathway: The patient has documented high-risk Crohn's disease, including symptoms despite conventional therapy, obstruction, abscess, stricture, phlegmon, fistulas, resection, extensive bowel involvement, early age of onset, growth retardation, CDAI greater than 450, or Harvey-Bradshaw index greater than 7.CDAI > 450 or Harvey-Bradshaw index > 7 when applicable

Preferred-agent requirement: Two preferred Cytokine and CAM Apple Health PDL medications have each been ineffective, unless all applicable medications are contraindicated or not tolerated.Minimum 12-week trial for each medication

Initial multiple sclerosis therapy

Covered for initial multiple sclerosis therapy when all clinical criteria and the preferred-agent requirement are met. Initial authorization is for 12 months.

Clinical criteria
- The patient is 18 years of age or older; natalizumab is prescribed by, or in consultation with, a neurologist; natalizumab is not used in combination with another disease-modifying therapy for multiple sclerosis; the diagnosis is confirmed and documented by a laboratory report such as an MRI; and the baseline number of relapses per year or EDSS score is documented.Age ≥ 18 years
- Covered multiple sclerosis diagnosis
  - Relapsing-remitting multiple sclerosis (RRMS).
  - Active secondary progressive multiple sclerosis (SPMS).
  - Clinically isolated syndrome (CIS).
Preferred-agent requirement: Two preferred Multiple Sclerosis Apple Health PDL medications have each been ineffective, unless all applicable medications are contraindicated or not tolerated.Minimum 12-week trial where specified

Documentation demonstrates disease stability or a positive clinical response, such as a decrease in the number of relapses per year or improvement in the EDSS score.