CurrentMolina HealthcarePolicy C10276-A

Tysabri (natalizumab) Coverage Criteria

Customize your policy alerts

Sign up for Molina Healthcare Policy C10276-A alerts

Get alerted when Policy C10276-A changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Coverage and prior authorization requirements for Tysabri in adults with relapsing forms of multiple sclerosis or moderately to severely active Crohn's disease, including initial and continuation criteria, documentation, safety, and authorization requirements.

Policy Summary

PayerMolina Healthcare

PolicyTysabri (natalizumab) Coverage Criteria

Policy CodePolicy C10276-A

Change TypeNo material change

Effective DateJun 28, 2025

Next Review DateApr 1, 2026

Key ActionSubmit documentation of the applicable diagnosis, prior treatment response or failure, safety screening, and required specialist or TOUCH program participation with each authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

12 monthsAuthorization duration

85%Continuation adherence

24 monthsPML counseling threshold

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentMolina HealthcarePolicy C10276-A

Tysabri (natalizumab) Coverage Criteria

Customize your policy alerts

Sign up for Molina Healthcare Policy C10276-A alerts

Get alerted when Policy C10276-A changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerMolina Healthcare

PolicyTysabri (natalizumab) Coverage Criteria

Policy CodePolicy C10276-A

Change TypeNo material change

Effective DateJun 28, 2025

Next Review DateApr 1, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

12 monthsAuthorization duration

85%Continuation adherence

24 monthsPML counseling threshold

3 monthsPrior therapy trial

300 mg every 4 weeksQuantity and frequency

Coverage Criteria and Exclusions

All indications

Required for all indications.

Safety eligibility: The prescriber attests, or clinical review finds, that the member has no FDA-labeled contraindication to Tysabri that remains unaddressed in the submitted documentation.

Contraindications include current or prior PML and a prior hypersensitivity reaction to Tysabri.

Initial therapy: moderately to severely active Crohn's disease

Covered for moderately to severely active Crohn's disease when all criteria are met.

Crohn's disease initial therapy

High-risk Crohn's feature: At least one high-risk feature is present.1 or more
Features include diagnosis before age 30, active or recent tobacco use, elevated C-reactive protein and/or fecal calprotectin, deep colonoscopic ulcers, long-segment small- or large-bowel involvement, perianal disease, extra-intestinal manifestations, or prior bowel resection.
Immunomodulator pathway: Either treatment failure, serious side effects, or clinical contraindication to an adequate trial of one immunomodulator, such as azathioprine, 6-mercaptopurine, or methotrexate, for more than 3 months at maximally indicated doses; or documented medical justification supporting inability to use immunomodulators.Trial longer than 3 months when applicable
The inability-to-use pathway includes inability to induce short-term symptomatic remission with a 3-month systemic glucocorticoid trial and relevant high-risk intestinal-complication or postoperative-recurrence factors.
Additional Crohn's requirements: Treatment failure, serious side effects, or clinical contraindication to one TNF inhibitor is documented; baseline disease activity and treatment goals are documented; and, for a non-formulary or non-preferred product, trial/failure or serious side effects to the required preferred alternatives are documented.
Preferred-alternative documentation must cover a majority, not more than three, of the preferred formulary or PDL alternatives.

Initial therapy: relapsing multiple sclerosis

Covered for relapsing forms of multiple sclerosis when all criteria are met.

Multiple sclerosis initial therapy

Prior therapy failure or highly active MS
- Inadequate response criteria: During treatment, at least two of the following are documented: clinical relapses, CNS lesion progression measured by MRI, or worsening disability.2 of 3
  Clinical relapse means at least two relapses within the past 12 months. Worsening disability may include sustained worsening of EDSS or neurologic findings, decreased mobility, decreased activities of daily living, or EDSS greater than 3.5.
- Highly active MS indicators: At least one indicator of a highly active course is documented.1 or more
  Indicators include age of onset over 40 years, male gender, African American race, motor, sphincter, or brainstem-cerebellar symptoms, brainstem or spinal cord MRI lesions, or more than two acute relapses in the first two years with significant sustained disability.

Continuation therapy: all indications

Required for continuation requests at 24 months or beyond, in addition to indication-specific renewal criteria.

Long-term continuation requirements: The member and/or caregiver has received counseling about the increased PML risk with longer treatment and has been re-instructed on early PML signs and symptoms; adherence is at least 85%, or lower adherence is attributable to surgery or infection requiring temporary discontinuation; and there is no evidence of intolerable adverse effects or drug toxicity.Adherence >=85% unless temporary interruption is due to surgery or infection

Examples of toxicity include hypersensitivity reactions, hepatotoxicity, PML signs or symptoms, and severe infections.

Continuation therapy: Crohn's disease

Continuation for Crohn's disease.

Crohn's continuation: Documentation shows positive clinical response demonstrated by low disease activity and/or improvement in signs and symptoms, and Tysabri is prescribed as monotherapy only rather than in combination with immunosuppressants or TNF-alpha inhibitors.

Continuation therapy: multiple sclerosis

Continuation for multiple sclerosis.

Multiple sclerosis continuation response: Documentation shows positive clinical response or stable disease based on one of the following: stable or decreased acute attacks within the last 6 months; lack of progression or sustained disability; or MRI within the last 6 months showing no new asymptomatic lesions.At least 1 of 3 response or stability measures

Multiple sclerosis — FDA-approved use

FDA-approved multiple sclerosis use.

Adult relapsing multiple sclerosis: The patient is an adult with a relapsing form of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease, and Tysabri is used as monotherapy.Age 18 years or older

Expected benefit should be weighed against the risk of PML.

Crohn's disease — FDA-approved use

FDA-approved Crohn's disease use.

Adult moderately to severely active Crohn's disease: The patient is an adult with moderately to severely active Crohn's disease with evidence of inflammation and an inadequate response to, or inability to tolerate, conventional Crohn's disease therapies and TNF-alpha inhibitors.Moderately to severely active disease with evidence of inflammation

Tysabri should not be used in combination with immunosuppressants or TNF-alpha inhibitors.

TOUCH program and safety requirements

Coverage and continued treatment require all applicable safety and program conditions to be met.

TOUCH and safety requirements

Program participation: The prescriber is certified, the patient is enrolled and has completed the required Patient-Prescriber Enrollment Form, and the dispensing pharmacy or infusion center is specially certified.
No prohibited concomitant therapy: The member is not receiving another disease-modifying MS agent, immunosuppressant, or TNF inhibitor.
Examples include adalimumab and infliximab.

Contraindications and investigational use

Tysabri is not covered for the following conditions or uses.

Contraindications or excluded use: The patient has or has had PML; the patient has had a hypersensitivity reaction to Tysabri; the member is receiving another disease-modifying MS agent, immunosuppressant, or TNF inhibitor; or the use is otherwise experimental or investigational.

Other experimental or investigational uses follow Molina's Off-Label policy.

Coverage requires documentation that the member does not have an unaddressed FDA-labeled contraindication to Tysabri, including current or prior progressive multifocal leukoencephalopathy (PML) or a prior hypersensitivity reaction to Tysabri.

Coverage is limited to members 18 years of age and older. Members younger than 18 years are excluded.

For Crohn's disease continuation, Tysabri must be prescribed as monotherapy. Combination use with immunosuppressants or TNF-alpha inhibitors is excluded.

The policy identifies no compendial approved off-label uses for Tysabri.

For Crohn's disease, Tysabri must not be used in combination with immunosuppressants or TNF-alpha inhibitors.

Patients who have or have had PML, or who have had a hypersensitivity reaction to Tysabri, are excluded unless the contraindication is addressed in the submitted documentation.

The member must not be receiving another disease-modifying MS agent, immunosuppressant, or TNF inhibitor, including adalimumab or infliximab.

Uses of Tysabri other than the policy-supported indications are considered experimental or investigational and are subject to Molina's Off-Label policy.

Initial Therapy Requirements

All-indication initial requirement

For all indications.

Safety eligibility: The prescriber attests, or clinical review finds, that the member has no FDA-labeled contraindication to Tysabri that remains unaddressed in the submitted documentation.

Contraindications include current or prior PML and a prior hypersensitivity reaction to Tysabri.

Crohn's disease initial therapy — moderately to severely active disease

For moderately to severely active Crohn's disease.

Crohn's initial eligibility

High-risk feature: At least one high-risk Crohn's feature is present.1 or more

Continuation and Renewal Requirements

Continuation therapy — all-indication requirements

For all indications, continuation requires all of the following, particularly for requests at 24 months or beyond.

All-indication continuation: At 24 months or beyond, member or caregiver counseling and PML re-instruction are documented; adherence is at least 85%, or lower adherence resulted from surgery or infection requiring temporary discontinuation; and there are no intolerable adverse effects or drug toxicity.Adherence >=85% unless temporary interruption is due to surgery or infection

Crohn's disease continuation — renewal criteria

For Crohn's disease continuation.

Crohn's continuation: Positive clinical response is documented through low disease activity and/or improvement in signs and symptoms, and Tysabri is used as monotherapy only.

Do not combine with immunosuppressants or TNF-alpha inhibitors.

Required Prior Therapy

Indication	Required prior therapy	Trial duration	Failure or exception criteria
Crohn's disease	One immunomodulator at maximally indicated doses and one TNF inhibitor	Immunomodulator: more than 3 months; TNF inhibitor: adequate trial	Treatment failure, serious side effects, or clinical contraindication to each therapy; medical justification may support inability to use an immunomodulator

Indication	Required prior therapy	Trial duration	Failure or exception criteria
Relapsing multiple sclerosis	One interferon, glatiramer, or formulary oral disease-modifying therapy	3 months	Inadequate response demonstrated by at least 2 of 3 criteria: at least 2 relapses within the prior 12 months, CNS lesion progression on MRI, or worsening disability; alternatively, document indicators of a highly active MS course

Product status	Required alternatives	Number of alternatives	Failure criteria
Non-formulary or non-preferred Tysabri	Preferred formulary or PDL alternatives for the diagnosis	A majority, not more than 3	Trial and failure or serious side effects; submit medications tried, trial dates, and reasons for failure

Indication	Required prior therapy	Requirement before Tysabri	Failure or tolerance criteria
Adult moderately to severely active Crohn's disease	Conventional Crohn's disease therapies and TNF-alpha inhibitors	Inadequate response to, or inability to tolerate, both categories of therapy	Evidence of inflammation and inadequate response or inability to tolerate prior treatment; Tysabri must not be combined with immunosuppressants or TNF-alpha inhibitors

Coding and Clinical Thresholds

HCPCS CodeHCPCS

J2323

Injection, natalizumab, 1mg

Crohn's immunomodulator trial

Required trial duration> 3 months

Prior therapyOne immunomodulator, such as azathioprine, 6-mercaptopurine, or methotrexate

Qualifying outcomeTreatment failure, serious side effects, or clinical contraindication at maximally indicated doses

Multiple sclerosis prior therapy trial

Required trial duration3 months

Qualifying prior therapyOne interferon, glatiramer, or formulary oral disease-modifying therapy

Required outcome

Prior Authorization and Documentation Checklist

Prior Authorization

Covered Indications and Safety Screening

Submit documentation supporting a covered indication: relapsing forms of multiple sclerosis, including clinically isolated syndrome, or moderately to severely active Crohn’s disease. The prescriber must attest that no unaddressed FDA-labeled contraindication is present.

Contraindications include current or prior PML and hypersensitivity to Tysabri.

Prior Authorization

MS Specialist Prescriber Required

For multiple sclerosis, Tysabri must be prescribed by or in consultation with a board-certified neurologist or multiple sclerosis specialist.

Note

Authorization Duration

Policy Background

Tysabri (natalizumab) is covered under this policy for adults with relapsing forms of multiple sclerosis and adults with moderately to severely active Crohn's disease. For multiple sclerosis, covered relapsing forms include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, with Tysabri used as monotherapy. For Crohn's disease, coverage applies when there is evidence of inflammation and an inadequate response to, or inability to tolerate, conventional Crohn's disease therapies and TNF-alpha inhibitors. Coverage also requires appropriate safety screening, including review of contraindications such as PML and hypersensitivity, and excludes other uses considered experimental or investigational.

Key Definitions

Inadequate response

Required number of criteriaAt least 2 of 3 criteria during treatment

Clinical relapsesAt least 2 relapses within the past 12 months

MRI evidenceCNS lesion progression as measured by MRI

Disability evidenceWorsening disability, such as sustained worsening of the EDSS score or neurological examination findings

Continuation adherence

Adherence thresholdAt least 85% of the time

VerificationVerified by the prescriber or member medication fill history

Dose and Frequency

Quantity limits

DrugTysabri (natalizumab)

Dose300 mg

FrequencyEvery 4 weeks

Administration Location

Billing Rule

Use a non-hospital facility-based infusion location

Administer infused Tysabri under the Molina Health Care Site of Care program in a non-hospital facility-based location. The Site of Care Utilization Management Policy applies.

Billing Rule

Use a TOUCH-certified infusion center

Tysabri may be infused only at an infusion center specially certified under the TOUCH Prescribing Program.

Policy Summary

PayerMolina Healthcare

PolicyTysabri (natalizumab) Coverage Criteria

Policy CodePolicy C10276-A

Change TypeNo material change

Effective DateJun 28, 2025

Next Review DateApr 1, 2026

SourceLink

On This Page

Non-preferred product alternatives: If the product is non-formulary or non-preferred, trial/failure or serious side effects to a majority, not more than three, of the preferred formulary or PDL alternatives for the diagnosis are documented.Majority; not more than 3 alternatives

Submit the medications tried, trial dates, and reasons for failure or serious side effects.

Immunomodulator pathway: Either treatment failure, serious side effects, or clinical contraindication to an adequate trial of one immunomodulator for more than 3 months at maximally indicated doses, or documented medical justification supporting inability to use immunomodulators.Trial longer than 3 months when applicable

Additional requirements: Failure, serious side effects, or clinical contraindication to one TNF inhibitor; baseline disease activity and treatment goals; and required preferred-alternative documentation for non-formulary or non-preferred products are documented.

Multiple sclerosis initial therapy — relapsing multiple sclerosis

For relapsing multiple sclerosis.

Multiple sclerosis initial eligibility

Prior therapy failure or highly active disease
- Inadequate response: At least two of the following are documented during treatment: at least two relapses within the past 12 months, CNS lesion progression on MRI, or worsening disability.2 of 3
- Highly active MS indicator: At least one indicator of a highly active MS course is documented.1 or more

Multiple sclerosis continuation — renewal criteria

For multiple sclerosis continuation.

Multiple sclerosis continuation: Positive clinical response or stable disease is documented by stable or decreased relapses within 6 months, lack of progression or sustained disability, or MRI within 6 months showing no new asymptomatic lesions.1 of 3 measures

Six-month continuation reassessment — TOUCH compliance and periodic reassessment

Continued treatment requires ongoing TOUCH program compliance and periodic clinical reassessment.

Six-month continuation reassessment: The prescriber evaluates the patient three months after the first infusion, six months after the first infusion, every six months thereafter, and for at least six months after discontinuation; every six months the prescriber determines whether treatment should continue and, if so, authorizes treatment for another six months.Every 6 months after the initial evaluations

A Tysabri Patient Status Report and Reauthorization Questionnaire is required six months after initiation and every six months thereafter.

Inadequate response during treatment

Multiple sclerosis relapse criterion

Relapse thresholdAt least 2 relapses within the past 12 months

Measurement periodDuring treatment

Criteria structureRelapses are 1 of 3 inadequate-response criteria; at least 2 of 3 criteria are required

Multiple sclerosis disability criterion

EDSS thresholdEDSS > 3.5

Alternative evidenceSustained worsening of the EDSS score or neurological examination findings

Functional effectsWorsening may include decreased mobility or decreased ability to perform activities of daily living due to disease progression

Multiple sclerosis continuation MRI

MRI timingWithin the last 6 months

Continuation findingNo development of new asymptomatic lesions

Response frameworkMRI stability is 1 of 3 acceptable measures of positive clinical response or stable disease

Request authorization for 12 months initially. Continuation authorizations are issued for 12 months.

Initial authorization: 12 months
Continuation authorization: 12 months

Documentation Required

Submit Member-Specific Dosing Data

When dosing depends on weight, body surface area, or another member-specific measurement, include the measurement supporting the requested dose with the medical-necessity submission.

Prior Authorization

Crohn’s Specialist Consultation Required

For Crohn’s disease, Tysabri must be prescribed by or in consultation with a board-certified gastroenterologist or colorectal surgeon.

Prior Authorization

Adult Patient Requirement

Coverage is limited to adult patients 18 years of age and older.

Submit the member’s age or date of birth when needed to establish eligibility.

Prior Authorization

TOUCH Certification and Enrollment

Enroll the prescriber and patient in the applicable MS TOUCH® or CD TOUCH® program before treatment and maintain compliance with program requirements.

Prescribers must be TOUCH-certified.
Prescribers must complete education, provide the Medication Guide, educate the patient on risks and benefits, and complete the Patient-Prescriber Enrollment Form.
Patients must read the Medication Guide, understand treatment risks, and complete and sign the enrollment form.

Denial Risk

No Prohibited Concomitant Therapy

Confirm and document that the member is not receiving prohibited concomitant therapy with Tysabri.

No other disease-modifying MS agent, immunosuppressant, or TNF inhibitor may be used concurrently.

Step Therapy

Crohn’s Prior Immunomodulator and TNF-Inhibitor Therapy

For Crohn’s disease, document failure, serious adverse effects, or a clinical contraindication to adequate prior therapy with both an immunomodulator and a TNF inhibitor.

Immunomodulator trial must exceed 3 months and use maximally indicated doses; examples include azathioprine, 6-mercaptopurine, and methotrexate.
Document an adequate trial of one TNF inhibitor and the reason it was unsuccessful, not tolerated, or contraindicated.

Step Therapy

Prior Conventional and TNF-Inhibitor Therapy

For Crohn’s disease, submit treatment history showing inadequate response, serious side effects, or contraindication to conventional Crohn’s therapies and a TNF inhibitor.

Tysabri is intended for adults with moderately to severely active Crohn’s disease with evidence of inflammation.
Document why conventional therapies and TNF-α inhibitors were inadequate or could not be tolerated.

Step Therapy

MS Prior Therapy or Highly Active Disease

For multiple sclerosis, document either an inadequate response to qualifying prior disease-modifying therapy or indicators of a highly active disease course.

An inadequate-response trial must last 3 months and meet at least two of: at least two relapses in 12 months, CNS lesion progression on MRI, or worsening disability.
Alternatively, document qualifying highly active disease indicators, including specified onset, demographic, symptom, MRI, relapse, or sustained-disability features.

Step Therapy

Non-Preferred Product Requirement

If Tysabri is non-formulary or non-preferred, document trials, failures, or serious side effects involving a majority of the preferred formulary or PDL alternatives for the diagnosis.

Do not document more than three preferred alternatives.
Include each medication tried, trial dates, and the reason for treatment failure or adverse effects.

Documentation Required

General Medical Records Required

Submit complete medical records and supporting information when requested for the coverage determination.

Records may include patient records, test results, and credentials of the ordering or performing provider.
Documentation must support medical necessity, non-investigational use, benefit coverage, and appropriate billing or practice.

Documentation Required

Crohn’s Baseline Assessment

For Crohn’s disease, establish and document baseline disease activity and treatment goals before starting therapy.

The baseline assessment will be used to evaluate efficacy at renewal.

Documentation Required

Preferred Alternative History

For preferred-alternative review, provide a complete medication history supporting the requested non-preferred product.

List medications tried and the dates of each trial.
State whether each trial failed or caused serious side effects, and provide the applicable reason.

Documentation Required

Long-Term Continuation Documentation

At 24 months or beyond, document that the member or caregiver was counseled on the increased risk of PML with longer treatment and was re-instructed on early PML signs and symptoms.

Include counseling and re-instruction documentation with the continuation request.

Documentation Required

Crohn’s Renewal Documentation

For Crohn’s renewal, document a positive clinical response demonstrated by low disease activity and/or improvement in signs and symptoms.

Also document that Tysabri is prescribed as monotherapy, not in combination with immunosuppressants or TNF-α inhibitors.

Documentation Required

MS Renewal Documentation

For multiple sclerosis renewal, document positive clinical response or stable disease using an accepted disease measure.

Stable or decreased relapses during the prior 6 months; lack of progression or sustained disability; or an MRI within the prior 6 months showing no new asymptomatic lesions.

Documentation Required

MS Consultation Notes

For MS requests, submit consultation notes when a neurologist or MS specialist is involved in prescribing.

Include the notes with the initial request and each reauthorization request.

Documentation Required

Crohn’s Consultation Notes

For Crohn’s requests, submit consultation notes when a gastroenterologist or colorectal surgeon is involved in prescribing.

Include the notes with the initial request and each reauthorization request.

Documentation Required

TOUCH Enrollment and Reauthorization Documentation

Maintain TOUCH® enrollment and submit the required reauthorization documentation throughout treatment.

Prescribers must evaluate the patient at 3 months, 6 months, every 6 months thereafter, and for at least 6 months after discontinuation.
Determine every 6 months whether treatment should continue and authorize another 6 months when appropriate.
Submit the Tysabri Patient Status Report and Reauthorization Questionnaire 6 months after initiation and every 6 months thereafter.

Documentation Required

Discontinuation Documentation

When Tysabri is discontinued, complete and submit the required TOUCH® discontinuation questionnaires.

Complete the Initial Discontinuation Questionnaire at discontinuation.
Complete the 6-Month Discontinuation Questionnaire after discontinuation.

Denial Risk

JCV and PML Monitoring

Monitor JCV and PML risk throughout treatment and act immediately when PML is suspected.

Patients with a negative anti-JCV antibody result remain at risk and should be retested periodically.
Withhold Tysabri immediately and perform an appropriate diagnostic evaluation at the first sign or symptom suggestive of PML.

Denial Risk

FDA-Labeled Contraindications

Do not administer Tysabri when the member has or has had PML or has had a hypersensitivity reaction to Tysabri, unless the issue has been appropriately addressed in submitted documentation.

These are FDA-labeled contraindications.

Denial Risk

Age Restriction

Coverage is limited to patients who are 18 years of age or older.

Denial Risk

Crohn’s Monotherapy Requirement

For Crohn’s disease continuation, prescribe Tysabri as monotherapy only.

Do not combine Tysabri with immunosuppressants or TNF-α inhibitors.

Denial Risk

Continuation Safety and Adherence

For continuation requests, verify adherence and confirm that treatment remains safe and tolerated.

Adherence must be at least 85% based on prescriber verification or medication fill history, unless lower adherence resulted from temporary discontinuation for surgery or infection.
The prescriber must attest that there are no intolerable adverse effects or drug toxicity, including hypersensitivity, hepatotoxicity, PML, or severe infection.

Denial Risk

Insufficient Supporting Documentation

Insufficient or unsupported documentation may result in denial of reimbursement or other appropriate action.

Molina may request additional records, test results, or provider credentials.
Documentation must support medical necessity, non-investigational use, benefit eligibility, and appropriate billing or practice.

Denial Risk

Age Restriction: Adults Only

Patients must be 18 years of age or older for coverage.

Denial Risk

Prohibited Crohn’s Disease Combinations

Do not use Tysabri for Crohn’s disease in combination with prohibited therapies.

Prohibited combinations include immunosuppressants and TNF-α inhibitors such as adalimumab or infliximab.

Denial Risk

Experimental or Investigational Use

Uses other than the covered FDA-approved indications are considered experimental or investigational and are reviewed under Molina’s Off-Label policy.

Denial Risk

Contraindications and Prohibited Concomitant Therapy

Do not initiate or continue Tysabri in the presence of contraindications or prohibited concomitant therapy.

Contraindications include current or prior PML and hypersensitivity to Tysabri.
The member must not receive another disease-modifying MS agent, immunosuppressant, or TNF inhibitor concurrently.

Denial Risk

TOUCH Program Compliance

Use only TOUCH®-certified pharmacies and infusion centers, and maintain all required prescriber and patient program compliance.

Tysabri is available only through the restricted TOUCH® REMS program.
Pharmacies and infusion centers must be specially certified to dispense or infuse Tysabri.

Allowed interruptionAdherence below 85% may be accepted when surgery or treatment of an infection requires temporary discontinuation

PML

AbbreviationPML

Full termProgressive multifocal leukoencephalopathy

Clinical significanceA serious neurologic infection risk associated with Tysabri, with risk increasing with longer treatment duration

TOUCH Prescribing Program

Program typeRestricted program under a Risk Evaluation and Mitigation Strategy (REMS)

PurposeRequired because of the risk of PML

Program componentsMS TOUCH for multiple sclerosis and CD TOUCH for Crohn's disease

Participation requirementsCertified prescribers, enrolled patients, and specially certified pharmacies or infusion centers

PML

Full termProgressive multifocal leukoencephalopathy

DefinitionAn opportunistic viral infection of the brain

Potential outcomesUsually leads to death or severe disability

Safety actionWithhold Tysabri immediately at the first sign or symptom suggestive of PML