tysabri (natalizumab) · 2020. 5. 1. · tysabri® (natalizumab) increases the risk of pml, an...

Please see full Prescribing Information, including BOXED WARNING, as well as Important Safety Information about TYSABRI on pages 51-54.

TYSABRI® (natalizumab) ACCESS AND REIMBURSEMENT GUIDE

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https://www.tysabrihcp.com/content/dam/commercial/multiple-sclerosis/tysabri/hcp/en_us/PDFs/tysabri_prescribing_information.pdf?chromeless=true

2Please see full Prescribing Information, including BOXED WARNING, as well as Important Safety Information about TYSABRI on pages 51-54.

IndicationTYSABRI® (natalizumab) is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TYSABRI increases the risk of PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.

IMPORTANT SAFETY INFORMATIONWARNING: Progressive Multifocal Leukoencephalopathy (PML)

TYSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. 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 TYSABRI.

Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program.

Please see pages 51-54 for additional Important Safety Information.

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As you know, helping patients doesn’t have to end when their appointments are finished. That’s why Biogen Support Services is here to help you and your practice support your patients.

FOR YOUR PRACTICE:

• Benefits Investigation to help determine the best coverage options for patients

• Insurance counseling for the uninsured and underinsured

• Coverage and reimbursement support

• Free JCV testing

FOR YOUR PATIENTS:• A variety of financial and insurance

support services• 24/7 phone assistance from Nurse

Educators. Support is available in Spanish• Support finding assistance from

charitable organizations• Information about Biogen’s relapsing MS

(RMS) treatment options• Disease-state education

ABOUT THIS GUIDEBiogen is committed to providing coverage and reimbursement support to patients, physician offices, and infusion centers that administer TYSABRI® (natalizumab). As part of this commitment, we have developed this guide to provide information to help you understand the administrative aspects of the TYSABRI access and reimbursement process: the TOUCH® Prescribing Program; Benefits Investigation (BI); navigating payer restrictions; ordering; billing and claims filing; the appeals process; and patient support.

• The TYSABRI Access and Reimbursement Guide is intended for informational purposes only and does not represent legal or billing advice

• Consult a legal/billing advisor or billing/coding specialist for specific guidance in this area; it is the responsibility of the office to ensure the accuracy of all claims that are submitted for reimbursement

• The content in the TYSABRI Access and Reimbursement Guide is based on information current as of July 2020

• Any product, ancillary supplies, or services received free of charge cannot be billed to third-party payers. Doing so could be a violation of federal and/or state laws and/or third-party–payer requirements

JCV=John Cunningham virus; MS=multiple sclerosis.

Biogen Support Serviceswww.BiogenOptions.com 1-800-456-2255Monday through Friday, 8:30 am to 8:00 pm ET

www.TYSABRIHCP.com

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https://www.tysabrihcp.com/content/dam/commercial/multiple-sclerosis/tysabri/hcp/en_us/PDFs/tysabri_prescribing_information.pdf?chromeless=truehttp://www.BiogenOptions.comhttps://www.tysabrihcp.com/


STEPS TO HELP YOUR PATIENTS ACCESS TYSABRI® (natalizumab)

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ONCE TYSABRI® (natalizumab) IS PRESCRIBED

BEFORE INFUSION AFTER INFUSION

TOUCH On-Line

Benefits Investigation Worksheet (TYS-US-0549)

TOUCH On-Line

TOUCH On-Line

TOUCH Prescribing Program eLearning Module (located on TOUCH On-Line)

(TYS-US-0967)

TYSABRI Access and Reimbursement Guide (TYS-US-2481)

TYSABRI Copay Assistance Roadmap (TYS-US-1826)

TYSABRI Specialty Pharmacy Network Flashcard (TYS-US-0931)

Management of the Buy-and-Bill Process for Infusible Therapies (TYS-US-0933)

Enroll the patient in the TOUCH® Prescribing Program

• Complete, sign, and fax all pages of the “MS TOUCH Prescriber/Patient Enrollment Form” to the TOUCH Prescribing Program

• If you are referring the patient to a nonaffiliated infusion center, locate the nearest TOUCH-certified infusion center by visiting the “Infusion Center Locator” at TYSABRIHCP.com

• Review the “Pre-infusion Patient Checklist” with the patient

• TOUCH Case Manager confirms that paperwork is completed and patient status is updated in system to “Authorized” or sends a “Notice of Patient Authorization” and a copy of the “MS TOUCH Prescriber/Patient Enrollment Form” to the authorized infusion center

Complete a BI to determine if a Prior Authorization (PA) is required• Determine the patient’s insurance coverage for both

TYSABRI and infusion administration• Identify whether a PA, precertification, or referral

is necessary• Submit PA and other required documentation directly

to the payer• Request processing time frame and monitor progress.

Be sure to confirm that the PA is approved before infusing the patient

Determine if the patient is eligible for financial assistance programs and confirm the out-of-pocket (OOP) costs• Check TOUCH On-Line to confirm

that the patient is eligible to receive Biogen Support Services

• Determine if patient is commercially insureda and meets eligibility requirements for the Copay Program or the $250 per Infusion Copay Assistance Program. Please note that the programs are separately managed and eligibility criteria are different for each

• Make patient aware of the OOP cost amount

Schedule the patient’s infusion appointment

Acquire TYSABRI via Buy-and-Bill or specialty pharmacy (SP)• Check the BI to determine if the patient’s

payer requires use of Buy-and-Bill or SP to acquire TYSABRI

• If you are purchasing TYSABRI via Buy-and-Bill, determine if you would like to purchase through your current wholesaler or directly from Biogen

• If you are purchasing TYSABRI through one of the TOUCH-certified SPs, be sure to review the BI and determine if the patient’s payer requires you to order TYSABRI from a specific SP. To check on the status of a shipment or reorder, you can call the SP directly or check TOUCH On-Line

Please see additional Important Safety Information on the following pages and enclosed full Prescribing Information, including Boxed Warning.

$250 per Infusion Copay Assistance Program Up to $250 for the cost of infusion administration

for eligible patients receiving TYSABRI.b

THE TYSABRI® (natalizumab) $0 COPAY PROGRAM AND INFUSION COPAY ASSISTANCE PROGRAM

a Depending on income or, in some cases, if the medication is obtained from an out-of-network provider, there may be an annual cap that limits the amount of assistance that patients can receive over 1 year. Federal and state laws and other factors may prevent or otherwise restrict eligibility. People covered by Medicare, Medicaid, the VA/DoD, or any other federal plans are not eligible to enroll.

b Patients will be responsible for any costs associated with an infusion above the $250 per infusion assistance provided by the program. In order to participate in the program and get assistance, patients must meet the following requirements:

• They have a financial responsibility or copay for their infusion • They are not a resident of Massachusetts, Michigan, Minnesota, or Rhode Island • They are not covered by any federal healthcare program, like Medicare, Medicaid, the VA/DoD, or TRICARE®, and/or state medical or pharmaceutical assistance

programs. They agree to tell Biogen immediately if they obtain coverage through programs listed above • They are using TYSABRI as described in the FDA-approved label

TRICARE is a registered trademark of the Department of Defense, Defense Health Agency. All rights reserved.

Biogen is committed to helping make infusion therapy with TYSABRI affordable for your patients.

Financial and Insurance Support to help patients try to identify the best solutions in terms of benefits investigation, navigation of the Prior Authorization process, and our $0 Copay Program (if they’re eligible).

INDICATIONTYSABRI® (natalizumab) is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TYSABRI increases the risk of PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.

IMPORTANT SAFETY INFORMATIONWARNING: Progressive Multifocal Leukoencephalopathy (PML) TYSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI. Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended. Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program.

PLEASE SHARE WITH ACCOUNTS PAYABLE

$0 Copay Program No income requirements and no enrollment

time limit for eligible patients receiving TYSABRI.a

Please have your patient contact a Support Coordinator at Above MSTM at 1-800-456-2255 Monday through Friday, 8:30 am to 8 pm ET, or visit AboveMS.com to learn more and determine if they are eligible.

The TYSABRI $0 Copay Program and Infusion Copay Assistance Programare separately managed and eligibility criteria are different for each.

The TYSABRI® (natalizumab) Specialty Pharmacy NetworkPROVIDING YOU AND YOUR PATIENTS WITH A CONSISTENT LEVEL OF SERVICE

Why is there a specialty pharmacy network for TYSABRI?Biogen uses a qualified distribution model for TYSABRI to help ensure that pharmacy services are consistently delivered. The TYSABRI Specialty Pharmacy

Network is a network of preferred specialty pharmacy providers (SPPs) that dispense TYSABRI.

Contact information for pharmacies in the TYSABRI Specialty Pharmacy Network• If you need to check on the status of your TYSABRI shipments, or to follow up on TYSABRI reorders, you can call the specialty pharmacy directly• The SPPs provided here have been authorized by Biogen to supply TYSABRI under the special distribution requirements of the TOUCH® Prescribing Program• When calling an SPP, ask to speak with a member of the TYSABRI team

DECISIVE ACTIONMATTERSPlease see Important Safety Information on the following page

and full Prescribing Information, including Boxed Warning.

The TYSABRI Specialty Pharmacy Network

Specialty Pharmacy Name Phone Number Fax Number

AcariaHealth 1-877-928-5120 1-877-928-5121

Accredo 1-866-898-0034 1-877-201-4499

Aetna 1-866-782-2779 1-860-907-3866

AllianceRx Walgreens/Prime 1-888-884-8714 1-866-889-1510

BioScrip 1-877-517-9299 1-952-516-8805

BriovaRx 1-855-312-9074 1-866-876-8966

Cigna Tel-Drug 1-800-351-3606 1-800-351-3616

Caremark (CVS Health) 1-800-237-2767 1-800-323-2445



TYSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI.

Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program.

• Infection by the JC Virus (JCV) is required for the development of PML• There are no known interventions that can reliably prevent PML or that can adequately treat PML if it occurs• Postmarketing data suggest that the risk of developing PML may be associated with relative levels of serum anti-JCV antibody compared to a calibrator as

measured by ELISA (often described as an anti-JCV antibody index value)• MRI findings may be apparent before clinical signs or symptoms suggestive of PML. Monitoring with MRI for

signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Consider monitoring patients at high risk for PML more frequently. Lower PML-related mortality and morbidity have been reported following TYSABRI discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis

• PML has been reported after discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation. Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for at least 6 months after discontinuation of TYSABRI

a Patients covered by Medicare, Medicaid, the Veterans Administration/Department of Defense (VA/DoD), or any other federal plans are not eligible to enroll. There may be other programs for which they are eligible.

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MANAGEMENT OF THE BUY-AND-BILL PROCESSInsights and Resources

2. Conduct Benefits Investigation

Thoroughly investigate specific payer requirements regarding

• Coverage and documentation • Site of care

• Product acquisition • Coding and billing

• Patient cost-sharing

Payer Summary Reference Guide: You may use the template to track payer data, such as key contact information, billing codes, reimbursement rates, processes, and appeal information.

Benefits Investigation Worksheet: When conducting a Benefits Investigation, you can populate this worksheet with patient-specific payer information, such as claims address, referral requirements, policy effective date, deductible, copay, patient financial notification, and explanation of primary and secondary coverage.

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In this guide, you will find 2 templates that can assist you in gathering key payer information:

• The Payer Contact Information Template, which you can use to document important payer contacts. When creating this list, consider inputting the most frequently contacted payers first

• The Coverage & Reimbursement Summary Template, which you can use to capture payer requirements and processes related to the coverage, billing, and reimbursement of a specific drug therapy

Information that you should consider capturing in the templates includes relevant websites; medical utilization/pharmacy management; claims submission and processing; dispute resolution; coverage restrictions; process for prior authorizations (PAs), precertifications, and/or medical exceptions; coding and billing requirements; contracted rates; and appeals process.

The Payer Summary Reference Guide is designed to serve as a starting point for a thorough benefit investigation process. It also can provide useful information in case any coverage, billing, or reimbursement issues need to be resolved directly with a payer.

PAYER SUMMARY REFERENCE GUIDE: Introduction

The Payer Summary Reference Guide can serve as an important resource for documenting up-to-date information for the payers

you most frequently contact. Each payer may have different requirements for coverage and reimbursement. This Payer Summary

Reference Guide can help your infusion center create a single summary resource that captures key contact information, drug coverage

conditions, billing guidelines, reimbursement rates, and related processes for these payers.

As you conduct the benefit investigation, this guide can assist you in information gathering while engaging a patient’s payer. In this guide, you will find:

• A Benefit Investigation Worksheet with instructions, which explains the type of information that needs to be captured in each field

• An editable Benefit Investigation Worksheet. This form has editable fields that you can type in and then print to keep in the patient’s file. If you choose, you can print the form first and write in the information

It is important to determine each patient’s level of coverage before each administration since health plan coverage can vary and change over time.

BENEFIT INVESTIGATION WORKSHEET—GUIDE

Benefit investigation is a process that enables a provider to determine benefit design,

coverage requirements, coding guidance, and drug acquisition options for a specific patient

before administering treatment. For drug therapies that require provider administration, a patient

will need to know how his/her health plan covers the drug component and the administration

component (eg, infusion or injection procedure). It is important to recognize that the drug

component might be covered under the payer’s medical benefit and/or pharmacy benefit.

Biogen Access Toolkit: Refer to this comprehensive toolkit that includes the steps to product access, tips for completing a Biogen product Start Form, medical and pharmacy benefit information, a guide to submitting prior authorizations, a guide to requesting a medical exception, sample letters of medical necessity, and a digital storage device for electronic versions of the toolkit components.

Biogen Access Toolkit: Table of Contents

Steps to Product Access .................................................................................Inside front cover This foldout resource provides an overview of each step in the product access process, as well as resources provided by Biogen to help with the process of obtaining insurance approval.

Biogen Contacts ............................................................................................................ Page 1This is the contact information for your office’s Biogen representatives.

Tips to Successfully Completing a Biogen Product Start Form .......................................... Page 3 This guide explains the Biogen product Start Form and provides tips on how to complete each section.

Medical and Pharmacy Benefit Card Information ............................................................ Page 15This section includes information to help your office understand the differences for the commercial, Medicare, and Medicaid medical and pharmacy benefit cards for your patients.

Guide to Prior Authorization Submissions....................................................................... Page 23 This guide provides steps and tips when submitting a prior authorization.

Guide to Requesting a Medical Exception ...................................................................... Page 37This guide provides templates and tips for submitting a medical exception.

Sample Letter Templates .............................................................................................. Page 45There are 5 different sample letter templates, each based on a different patient insurance coverage situation. Each letter includes a list of the documentation that can accompany the request, if necessary.

Biogen Product Clinical Cards ....................................................................................... Page 52These individual cards provide key efficacy and safety information for the Biogen relapsing multiple sclerosis products.

Additional Resources ............................................................................................. Back pocket

Patient Benefit and Insurance Tracker ..................................................... Available on flash driveThis Excel tracker enables your office to capture information during the benefit investigation and log updates.

Welcome to the Biogen Access Toolkit!

a This resource focuses on specialty pharmacy and does not address the buy-and-bill process for infusible products. The focus is on self-administered drugs, such as orals and injectables, covered under the pharmacy benefit. Contact your Biogen representative for more information on the buy-and-bill process for infused products.

For more information about insurance coverage for Biogen products, contact Above MS at 1-800-456-2255, Monday through Friday, 8:30 am to 8 p m ET, or at AboveMS.com.

Obtaining approval for your patient’s medication for relapsing multiple sclerosis (RMS) often requires your office to complete several steps, such as gaining approval of a prior authorization (PA), also known as a precertification, or requesting a medical exception (ME).a In addition, your office may need to coordinate with a specialty pharmacy to ensure all payer approvals are obtained and the medication is shipped.

The Biogen Access Toolkit provides a comprehensive resource to assist your office in navigating the process to gain access and approval of your patient’s RMS treatment once prescribed. This toolkit provides various resources to help you with the following along the way:

Understanding the steps to product access. Open this page to see these steps. The action item for each step in the process is included, as well as tips and resources provided in this toolkit.

Completing the Biogen product Start Form.

Submitting PAs and MEs.

Tracking patient benefit and insurance information.

Explaining the differences between medical and pharmacy benefit card information.

Above MS Can Help

The Above MS™ program can assist your office in navigating the process of obtaining coverage for a patient’s prescribed Biogen product for RMS. The program can also help your patients with support along their journey. Here are some of the benefits that Above MS offers:

Above MS can conduct a patient’s benefits investigation and initiate the PA process. This support from Above MS are automatic when your patient signs Sections A and B of the Biogen product Start Form.

If you are concerned with how long the insurance approval process is taking, contact Above MS.

Ask your Biogen representative about the Access Toolkit flash drive containing the

Patient Benefit and Insurance Tracker and additional resources listed above.

Biogen Access Toolkit

Ensure appropriate payment by

• Monitoring payer remittance

• Appealing if needed

Claim Submission Checklist: Consult this checklist for claim submission considerations, such as

• Confirmation of different payer requirements

• Review of key information for accuracy and completeness

• Compliance with claim submission rules

Reimbursement Tracking Log: You can use this template to track payer remittance so that your office can

• Monitor payer contract compliance

• Review payer explanation of benefits against contracted fee schedules

• Evaluate payer responsiveness in addressing reimbursement issues

• Establish procedure for addressing claims denial and submitting appeals

4. Submit Claim

Successful Completion of Reimbursement Process

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Establish an efficient claim submission process that includes

• Appropriate documentation

• Accurate coding

• Timely submissions

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Completing timely and accurate claims can help facilitate prompt payment. In order to help proactively prevent denials and underpayment, it is important to review claims before submitting them to a payer.

The following claim submission checklist can help you review relevant considerations.

CLAIM SUBMISSION CHECKLIST

During the benefit investigation process, ensure that you have identified the following:

Coverage and prior authorization restrictions

Coding and billing guidelines

Required medical documentation

When filling out the claim form, please double-check the following:

Patient information (eg, patient name, insurer, subscriber name, date of birth, member ID)

Provider information (eg, NPI number, name, address, place of service)

Coding (eg, ICD, CPT, and/or HCPCS codes, along with appropriate modifiers)

Billing units (consistent with the descriptors for the reported CPT and/or HCPCS codes)

Additional information required by the payer (eg, PA number, NDC, discarded drug amount)

When submitting the claim, be mindful of the following:

Required standards for electronic claims

Punctuation and character limit requirements

Time frame for submitting claims

Confirm payer requirements

Check claim for accuracy and completeness

Ensure compliance with claim submission rules

© 2015 Biogen. All rights reserved. 11/15 FCH-US-1218

Please see reverse side for additional resources offered by Biogen.

3. Is Prior Authorization and/or Medical Exception Required?

This process may not apply to every patient. Some steps are dependent on whether you are infusing the patient at your office or referring him or her to a nonaffiliated infusion center. Please be sure to confirm your patient’s insurance coverage prior to each infusion, as some patients may have lost coverage or changed providers.

Infusion Center Locator at TYSABRIHCP.com

oror or ororororor or

Claims Submission Checklist (FCH-US-1218)

Reimbursement Tracking Log

(FCH-US-1225)

Submit a claim for reimbursement and track progress• Determine any payer-specific requirements for the

claims submission• Submit the claim in a timely fashion and double-check

to ensure that codes are accurate and appropriate documentation is included

• Track payer remittance and evaluate the payer’s responsiveness in addressing reimbursement issues

• Review payer Summary of Benefits against contracted fee schedules

• If claim is denied, determine how to go about submitting an appeal

Schedule the patient’s next infusion appointment• Ensure that your patient’s

benefits have not changed before scheduling the next infusion

• Communicate with the patient and infusion center (if applicable) to schedule the next infusion. As per the TYSABRI Prescribing Information, the recommended dosing schedule is every 28 days

TYSABRI Coding Reference Guide for Hospital Outpatient

(TYS-US-0966)

PRODUCT CODING—TYSABRIa

Coding System

Code (Description)

Location on CMS-1500 Payer Form (Electronic Equivalent)1

Comments

HCPCS2 J2323 (Injection, natalizumab, 1 mg)

Field 24D(Loop: 2400; Segment: SV101)

To report the use of an entire vial of TYSABRI (300 mg), 300 units must be reported in Field 24G (Electronic equivalent—Loop: 2400; Segment: SV104).

NDC364406-0008-01 (TYSABRI injection, 300 mg/15 mL)[11-digit format]

Per payer requirements

Although the FDA uses a 10-digit format when registering NDCs, payers often require an 11-digit NDC format on claim forms for billing purposes.It is important to confirm with your payer which NDC format they require. Guidelines for reporting the NDC in the appropriate format, quantity, and unit of measure vary by state and by payer and should be reviewed prior to submitting a claim.

a Providers accessing TYSABRI through the specialty pharmacy will not need to submit a claim for reimbursement; however, providers will have to submit a claim for reimbursement for administration services associated with TYSABRI.

CMS=Centers for Medicare and Medicaid Services; FDA=US Food and Drug Administration; HCPCS=Healthcare Common Procedure Coding System; NDC=National Drug Code.

Please see Important Safety Information on the following pages and full Prescribing Information, including Boxed Warning.

TYSABRI® (natalizumab) CODING REFERENCE GUIDEPHYSICIAN OFFICE BILLING


IMPORTANT SAFETY INFORMATIONWARNING: Progressive Multifocal Leukoencephalopathy (PML) TYSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI. Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended. Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program.

• Infection by the JC Virus (JCV) is required for the development of PML• There are no known interventions that can reliably prevent PML or that can adequately treat PML if it occurs• Postmarketing data suggest that the risk of developing PML may be associated with relative levels of serum anti-JCV antibody

compared to a calibrator as measured by ELISA (often described as an anti-JCV antibody index value) • MRI findings may be apparent before clinical signs or symptoms suggestive of PML. Monitoring with

MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Consider monitoring patients at high risk for PML more frequently. Lower PML-related mortality and morbidity have been reported following TYSABRI discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis

DECISIVE ACTIONMATTERS

Completing timely and accurate claims can help facilitate prompt payment. In order to help proactively prevent denials and underpayment, it is important to review claims before submitting them to a payer.

The following claim submission checklist can help you review relevant considerations.

CLAIM SUBMISSION CHECKLIST

During the benefit investigation process, ensure that you have identified the following:

Coverage and prior authorization restrictions

Coding and billing guidelines

Required medical documentation

When filling out the claim form, please double-check the following:

Patient information (eg, patient name, insurer, subscriber name, date of birth, member ID)

Provider information (eg, NPI number, name, address, place of service)

Coding

Billing units (consistent with the descriptors for the reported CPT and/or HCPCS codes)

Additional information required by the payer (eg, PA number, NDC, discarded drug amount)

When submitting the claim, be mindful of the following:

Required standards for electronic claims

Punctuation and character limit requirements

Time frame for submitting claims

Confirm payer requirements

Check claim for accuracy and completeness

Ensure compliance with claim submission rules

© 2015 Biogen. All rights reserved. 11/15 FCH-US-1218

Please see additional Important Safety Information on the following pages and full Prescribing Information, including Boxed Warning.

PRODUCT CODING—TYSABRIa



TYSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI. Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended. Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH® Prescribing Program.

• Infection by the JC Virus (JCV) is required for the development of PML• There are no known interventions that can reliably prevent PML or that can adequately

treat PML if it occurs• Postmarketing data suggest that the risk of developing PML may be associated with

relative levels of serum anti-JCV antibody compared to a calibrator as measured by ELISA (often described as an anti-JCV antibody index value)

Coding System

Code (Description)

Location on CMS-1450 Payer Form (Electronic Equivalent)1

Comments

HCPCS2 J2323 (Injection, natalizumab, 1 mg)

Field 44(Loop: 2400; Segment: SV202-2)

To report the use of an entire vial of TYSABRI (300 mg), 300 units must be reported in Field 46 (Electronic equivalent—Loop: 2400; Segment: SV205).

NDC364406-0008-01 (TYSABRI injection, 300 mg/15 mL)[11-digit format]

Per payer requirements

Although the FDA uses a 10-digit format when registering NDCs, payers often require an 11-digit NDC format on claim forms for billing purposes.It is important to confirm with your payer which NDC format they require. Guidelines for reporting the NDC in the appropriate format, quantity, and unit of measure vary by state and by payer and should be reviewed prior to submitting a claim.

AHARevenue Code4

Per payer requirements, an appropriate revenue code may include0250 (Pharmacy general classification) OR 0636 (Drug requiring detailed coding)

Field 42(Loop: 2400; Segment: SV201)

For Medicare, claims with HCPCS codes for drugs and biologics should be billed under the revenue code 0636.4 Private payers may also require revenue code 0636 for TYSABRI.

a Providers accessing TYSABRI through the specialty pharmacy will not need to submit a claim for reimbursement; however, providers will have to submit a claim for reimbursement for administration services associated with TYSABRI.

AHA=American Hospital Association; CMS=Centers for Medicare and Medicaid Services; FDA=US Food and Drug Administration; HCPCS=Healthcare Common Procedure Coding System; NDC=National Drug Code.

HOSPITAL OUTPATIENT BILLING

DECISIVE ACTIONMATTERS

TYSABRI® (natalizumab) CODING REFERENCE GUIDE

TYSABRI Coding Reference Guide for Physician Offices

(TYS-US-0930)

6 7

KEY

Please see full Prescribing Information, including BOXED WARNING, as well as Important Safety Information about TYSABRI on pages 51-54.5

Prescriber’s office

Specialty pharmacy

Infusion center

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THE TOUCH® PRESCRIBING PROGRAM

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Inform Warn Promote

TOUCH® PRESCRIBING PROGRAM

As part of Biogen’s commitment to patient safety, TYSABRI® (natalizumab) is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TYSABRI Outreach: Unified Commitment to Health (TOUCH) Prescribing Program. Designed with the help of the US Food and Drug Administration (FDA), the TOUCH Prescribing Program facilitates appropriate use of TYSABRI due to the risk of progressive multifocal leukoencephalopathy (PML).

prescribers, infusion centers, and patients about the risk of PML associated with TYSABRI, including the increased risk of PML with longer treatment duration, prior immunosuppressant use, and the presence of anti-JCV antibodies

against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised

appropriate monitoring practices for early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML

The TOUCH Prescribing Program is designed to

Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI, respectively

Only certain pharmacies and infusion centers authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI

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THE TOUCH® PRESCRIBING PROGRAM PROCESS

TYS-US-0495 v4

Phone: 1 800 456 2255 | Fax: 1 800 840 1278

By Facsimile Notice of Patient Authorization

This TOUCH Prescribing Program authorization is valid from through .

This notice is regarding only the patient’s enrollment period in the TOUCH Prescribing Program and does not refer to the patient’s insurance status or coverage.

Patient: Indication: Patient Enrollment Number: Patient DOB:

Account: Site Authorization Number: , Account Phone: Account Fax:

Prescriber: () Prescriber Phone: Prescriber Fax:

Our records indicate that will receive TYSABRI® (natalizumab) infusions for at and is authorized through . Every six (6) months, a patient must be reauthorized in the TOUCH® Prescribing Program in order to continue enrollment and remain authorized to receive TYSABRI for . If you are unable to verify current authorization status through TOUCH On-Line® (www.touchprogram.com), have received a Notice of Patient Discontinuation, or have not received an updated Notice of Patient Authorization, do not infuse, and contact Biogen Patient Services.

Per the requirements of the TOUCH Prescribing Program, authorized infusion sites must: Ø Verify that the patient is currently authorized to receive TYSABRI prior to each infusion Ø Provide the patient with a copy of the Patient Medication Guide prior to each infusion Ø Administer and Submit the Pre-infusion Patient Checklist, whether the patient is infused or not, to Biogen®

(www.touchprogram.com or fax to 1-800-840-1278) within one (1) business day of a patient visit.

If you become aware that a patient is discontinuing or switching administration sites, please let us know. Similarly, if Biogen learns of changes in patient treatment, we will bring it to your attention. If you have additional questions, please call Biogen Patient Services at 1-800-456-2255. We are available Monday through Friday, 8:30 AM to 8:00 PM (ET).

Please see the Prescribing Information, including BOXED WARNING, for more information.

Please retain a copy of this notice in the patient’s medical record.

Sincerely, TOUCH Prescribing Program

TYSABRI Notice of Patient Authorization (TYS-US-0495)

STEP 4: Record Prescriber Authorization (if required):

If the patient answered YES to question 1, 2 or 3, DO NOT INFUSE. Contact the healthcare provider who prescribedTYSABRI or a prescriber representative and review the patient’s answers.

After discussing the patient’s answers, did the prescriber authorize the patient to be infused?

Check here if you were unable to contact the prescriber. (See next page for further instructions.)

DETACH HERE

PRESCRIBING PROGRAMTYSABRI Outreach: Unified Commitment to Health

TYSABRI Pre-infusion Patient Checklist

Please submit this form to:Biogenwww.touchprogram.com Fax: 1-800-840-1278

Patient name:

Phone: 1-800-456-2255

Patient Enrollment Number:

As a condition of your site’s authorization to infuse TYSABRI® (natalizumab), this Pre-infusion Patient Checklist must be completed for each patient prior toeach infusion. This page must be submitted on-line (www.touchprogram.com) OR faxed to Biogen (1-800-840-1278) within 1 day of the patient’s visit and acopy retained in the patient’s record whether the patient has been infused or not.

STEP 1: Ensure that the patient is currently authorized to receive TYSABRI for MS or Crohn’s disease.

You must refer to the patient’s record prior to every infusion.

Ifthepatientdidnotreceivehisorherpreviousinfusion,andphysicianclearancewasrequired,youmustconfirm authorization from the prescriber before providing the current infusion

Confirmthepatientstatusislistedas“Authorized”onTOUCH®On-Line(www.touchprogram.com)OR ConfirmthatthereisacurrentNotice of Patient AuthorizationonfileandthatyouhavenotreceivedaNotice of Patient Discontinuation (paper-based process)

Is the patient currently authorized to receive TYSABRI? Yes NoYes Continue to next question.No STOP—DO NOT INFUSE.Ifauthorizationcannotbeverifiedon-lineatwww.touchprogram.comOR by calling 1-800-456-2255, the patient must be referred back to the healthcare provider who prescribed TYSABRI.

Site Authorization Number:Site name:

First MIMI Last (Issued by Biogen. Call 1-800-456-2255 or log on to www.touchprogram.comifnumberisnotonfile.)

STEP 2: Confirm that the patient has read and understood the Patient Medication Guide.

The patient must read the Patient Medication Guide prior to every infusion. Has the patient received and read the Patient Medication Guide,including the section “What should I tell my doctor and nurse before each infusion of TYSABRI?” Yes NoYes Continue to next question. No STOP—provide the Patient Medication Guide. Proceed to the next question after the patient has read it.

STEP 3: Read aloud and mark “Yes” or “No” for the patient’s answers to the following questions:

1. Overthepastmonth,haveyouhadanyneworworseningmedicalproblems(suchasaneworsuddenchangeinyourthinking, Yes No eyesight, balance, strength, or other problems) that have persisted over several days?

2. Do you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia or lymphoma, or anorgantransplant,thatmaysuggestthatyourbodyisnotabletofightinfectionswell?

3. In the past month have you taken, or are you currently on, any medicines other than steroid medicines to treat cancer or Crohn’s disease or any other medicines that weaken your immune system? (Review the list on the next page with the patient.)

3. In the past month, have you taken medicines to treat cancer or MS or any other medicines that weaken your immune system? (Review the list on the next page with the patient.)

Crohn’s disease ONLY MS ONLYYes NoYes No

Name and signature of staff completing checklist: Date

STEP 6: Submit the Pre-infusion Patient Checklist to Biogen on-line at www.touchprogram.com OR fax to 1-800-840-1278.

TYS-US-0487V4

STEP 5: Record infusion information

Date infused (MM/DD/YYYY): Not infused

If the next infusion has been scheduled, please enter date (MM/DD/YYYY):

/ /

/ /

Yes No

TYSABRI Pre-infusion Patient Checklist (TYS-US-0487)

Since starting TYSABRI therapy has the patient been diagnosed with any of the following that you have not reported to Biogen:

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Yes No or Under investigation OPPORTUNISTIC INFECTION* for which they have

been hospitalized Yes No or Under investigation MALIGNANCY Yes No or Under investigation Since , has the patient been tested

for the presence of anti-JCV antibodies? Yes Not performed If performed, since , test result: Positive Negative Pending If an anti-JCV antibody index value is available, please record it here: .

Is the patient currently receiving or has the patient received intermittent courses of steroids for the treatment of MS relapse in the previous 6 months?

Yes No If Yes, please circle the number of months of use: 1 2 3 4 5 6 >6

Is the patient still under ’s care? Yes No/I don’t knowIf No, please provide name and phone number for new prescriber, if available

Is the patient alive? Yes No

Is the patient currently receiving or has the patient received any IMMUNOMODULATORY or IMMUNOSUPPRESSANT THERAPIES in the previous 6 months? Yes NoIf Yes, please indicate the type of therapy.

Aubagio®

AVONEX®

Betaseron®

Copaxone®

Extavia®

Gilenya®

Lemtrada®

Mavenclad®

Mayzent®

Ocrevus®

PLEGRIDY®

Rebif®

TECFIDERA®

Azathioprine

Chronic systemic steroids

Cyclophosphamide

Methotrexate

Mitoxantrone

Mycophenolate

Other immunomodulatory or immunosuppressant therapy

Dear ,Our records indicate that ’s authorization to receive TYSABRI will expire on and he/she will no longer be able to receive TYSABRI. Please submit the completed form to Biogen via TOUCH On-Line (www.touchprogram.com) OR fax (1-800-840-1278) on and place a copy in the patient’s record.

*OPPORTUNISTIC INFECTION is defined as an infection due to an organism that generally does not cause disease, or causes only mild or self-limited disease in people with normally functioning immune systems, but causes more significant disease in people with impaired immunity. These infections are frequently severe, prolonged, or disseminated. Examples include esophageal candidiasis, systemic fungal infections, pneumocystis carinii pneumonia, mycobacterial infections (including pulmonary and extra-pulmonary tuberculosis), chronic intestinal cryptosporidiosis, and disseminated viral infections (such as disseminated herpes or cytomegalovirus infections).

Phone: 1-800-456-2255

Re: Patient Enrollment Number: Patient date of birth: Authorization expiration date:

Please submit this form to: Biogen www.touchprogram.comFax: 1-800-840-1278

TYS-US-0479 V506/2020© 2006-2020 BiogenAll other trademarks are the marks of their respective owners.

TYSABRI Patient Status Report and Reauthorization Questionnaire–MS

A

B

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D

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TOUCH Certified Prescriber or Delegate Signature: Date:(If applicable) Print TOUCH Certified Prescriber or Delegate Name:Please Note: A TOUCH certified prescriber or delegate may complete and submit this form on behalf of the certified Prescriber of record. The certified TOUCH Prescriber of record is responsible for compliance with the TOUCH Prescribing Program requirements, including monitoring, evaluation, and management of each patient under his/her care. This questionnaire will be used consistent with the TOUCH Prescriber/Patient Enrollment Form signed by you and your patient with HIPAA and applicable privacy rules. If you have questions, or if you need additional information, please call 1-800-456-2255.

Please see the Prescribing Information, including BOXED WARNING, for more information

If the patient is still under ’s care DO YOU AUTHORIZE the continuation of TYSABRI treatment for the next 6 months for the patient? Yes NoIf you answer No, Biogen will contact the patient and the infusion site to STOP TYSABRI TREATMENT. The patient will not be eligible to receive TYSABRI treatment, and you will receive a final questionnaire for this patient in 6 months.

I

TYSABRI Patient Status Report and Reauthorization Questionnaire (TYS-US-0479)


PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Yes No or Under investigation

OPPORTUNISTIC INFECTION* for which they have been hospitalized


MALIGNANCY


Since , has the patient been tested for the presence of anti-JCV antibodies?

Yes Not performed If performed, since , test result:

Positive Negative Pending If an anti-JCV antibody index value is available, please record it here: .

Is the patient still under ’s care?

Yes No/I don’t knowIf No, please provide name and phone number for new prescriber, if available

Is the patient alive?

Yes No

Phone: 1-800-456-2255


TYS-US-0478 V506/2020©2006-2020 Biogen

TYSABRI Initial Discontinuation Questionnaire–MS

ThisTYSABRIPatientDiscontinuationQuestionnaireisnecessarytofulfillthetrackingrequirementsoftheTOUCH® Prescribing Program for all patients treated with TYSABRI. You may also be contacted for additional information in response to answers provided on this form.

SubmitthecompletedTYSABRIPatientDiscontinuationQuestionnairetoBiogenviaTOUCHOn-Line(www.touchprogram.com) ORfax(1-800-840-1278)andplaceonecopyinthepatient’srecord.

This form is mandatory for all discontinued patients.

A

B

C

D

E

F

TOUCH Certified Prescriber or Delegate Signature: Date:(If applicable) Print TOUCH Certified Prescriber or Delegate Name:Please Note: ATOUCHcertifiedprescriberordelegatemaycompleteandsubmitthisformonbehalfofthecertifiedPrescriberofrecord.ThecertifiedTOUCHPrescriberofrecordisresponsibleforcompliancewiththeTOUCHPrescribingProgramrequirements,includingmonitoring,evaluation,andmanagementofeachpatientunderhis/hercare.ThisquestionnairewillbeusedconsistentwiththeTOUCHPrescriber/PatientEnrollmentFormsignedbyyouandyourpatientwithHIPAAandapplicableprivacyrules.Ifyouhavequestions,orifyouneedadditionalinformation,pleasecall1-800-456-2255.


Prescriber name:

Prescriber address:

Patient: Patient enrollment number:

Patientdateofbirth(MM/DD/YYYY)://

First

First

MI

MI

City State ZIP

Last

Last

Street

*OPPORTUNISTIC INFECTIONisdefinedasaninfectionduetoanorganism that generally does not cause disease, or causes only mild or self-limiteddisease in people with normally functioning immune systems, but causes more significantdiseaseinpeoplewithimpairedimmunity.Theseinfectionsarefrequentlysevere,prolonged,ordisseminated.Examplesincludeesophageal candidiasis, systemic fungal infections, pneumocystis carinii pneumonia,mycobacterialinfections(includingpulmonaryandextra-pulmonarytuberculosis), chronicintestinalcryptosporidiosis,anddisseminatedviralinfections(suchas disseminatedherpesorcytomegalovirusinfections).


PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)


OPPORTUNISTIC INFECTION* for which they have been hospitalized


MALIGNANCY


Since , has the patient been tested for the presence of anti-JCV antibodies?

Yes Not performed If performed, since , test result:

Positive Negative Pending If an anti-JCV antibody index value is available, please record it here: .

Is the patient still under ’s care?

Yes No/I don’t knowIf No, please provide name and phone number for new prescriber, if available

Is the patient alive?

Yes No

Phone: 1-800-456-2255


TYS-US-0477 V506/2020©2013-2020 Biogen

TYSABRI 6-Month Discontinuation Questionnaire–MS

ThisTYSABRIPatientDiscontinuationQuestionnaireisnecessarytofulfillthetrackingrequirementsoftheTOUCH® Prescribing Program for all patients treated with TYSABRI. You may also be contacted for additional information in response to answers provided on this form.

SubmitthecompletedTYSABRIPatientDiscontinuationQuestionnairetoBiogenviaTOUCHOn-Line(www.touchprogram.com) ORfax(1-800-840-1278)andplaceonecopyinthepatient’srecord.

This form is mandatory for all discontinued patients.

A

B

C

D

E

F

TOUCH Certified Prescriber or Delegate Signature: Date:(If applicable) Print TOUCH Certified Prescriber or Delegate Name:Please Note: ATOUCHcertifiedprescriberordelegatemaycompleteandsubmitthisformonbehalfofthecertifiedPrescriberofrecord.ThecertifiedTOUCHPrescriber ofrecordisresponsibleforcompliancewiththeTOUCHPrescribingProgramrequirements,includingmonitoring,evaluation,andmanagementofeachpatientunderhis/hercare. ThisquestionnairewillbeusedconsistentwiththeTOUCHPrescriber/PatientEnrollmentFormsignedbyyouandyourpatientwithHIPAAandapplicableprivacyrules. Ifyouhavequestions,orifyouneedadditionalinformation,pleasecall1-800-456-2255.


Prescriber name:

Prescriber address:

Patient: Patient enrollment number:

Patientdateofbirth(MM/DD/YYYY)://

First

First

MI

MI

City State ZIP

Last

Last

*OPPORTUNISTIC INFECTIONisdefinedasaninfectionduetoan organism that generally does not cause disease, or causes only mild or self-limited disease in people with normally functioning immune systems,butcausesmoresignificantdiseaseinpeoplewithimpaired immunity.Theseinfectionsarefrequentlysevere,prolonged,or disseminated.Examplesincludeesophagealcandidiasis,systemic fungal infections, pneumocystis carinii pneumonia, mycobacterial infections(includingpulmonaryandextra-pulmonarytuberculosis), chronic intestinal cryptosporidiosis, and disseminated viral infections (suchasdisseminatedherpesorcytomegalovirusinfections).

Street

TYSABRI Patient Initial Discontinuation Questionnaire (TYS-US-0478)

TYSABRI Patient 6-Month Discontinuation Questionnaire (TYS-US-0477)


06/2020©2006-2020 BiogenAll other trademarks are the marks of their respective owners.

Patient Information

Infusion Site Information*

OR

Date of birth: Patient name:

In addition, I allow the sharing of my health information to the person or people I name below. Biogen may contact the people named below to discuss my enrollment in the TOUCH Program.

Designated Individual (print name): Relationship:

First MI Last(MM/DD/YYYY)/ /

Prescriber will administer TYSABRI and request the following services (check only one): No services required Forward this prescription to a specialty pharmacy provider Please conduct insurance OR to investigate pharmacy coverage and coordinate delivery OR research and procurement to prescriber’s office options for TYSABRI

Prescriber will refer TYSABRI treatment to another site (check only one): I require assistance in locating an infusion site OR I am referring the patient to the following infusion site or healthcare provider:

1

2

Name of infusion site

Name of healthcare provider (First, Last)

Street address or site Authorization Number

City State ZIP

Office contact

Telephone

Fax

*Note: TYSABRI can only be infused at authorized infusion sites. Biogen will contact you if the infusion site you have indicated is not authorized to infuse TYSABRI.

-

-

-

-

TYS-US-0481 V5 5 of 5

Phone: 1-800-456-2255


Prescriber/Patient Enrollment Form–MS

Completion of all pages required.

Prescriber Acknowledgment

I have read and understand the Prescribing Information for TYSABRI

I understand that TYSABRI is indicated as monotherapy for relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

I understand that this patient has a relapsing form of MS based on clinical and radiological evidence

I understand that TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. When initiating and continuing treatment with TYSABRI, I should consider whether the expected benefit of TYSABRI is sufficient to offset the risk

I am aware that cases of PML have been reported in patients taking TYSABRI who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving TYSABRI monotherapy

I understand that three risk factors identified thus far that increase the risk of PML in TYSABRI-treated patients are: -The presence of anti-JCV antibodies -Longer treatment duration, especially beyond 2 years -Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil)

These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI

I understand that TYSABRI is not ordinarily recommended for patients who are receiving chronic immunosuppressant or immunomodulatory therapy, or who are significantly immunocompromised from any other cause

To my knowledge, this patient has no known contraindications to TYSABRI treatment, including PML

I understand that an MRI should be performed prior to initiating therapy with TYSABRI in MS patients

I understand that MRI findings may be apparent before clinical signs or symptoms. Periodic monitoring for radiographic signs consistent with PML should be considered to allow for an early diagnosis of PML. Lower PML-related mortality and morbidity have been reported following TYSABRI discontinuation in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis

I have instructed this patient to promptly report to me any continuously worsening symptoms that persist over several days, especially nervous system symptoms

I understand that this patient should be seen and evaluated 3 months after the first infusion, 6 months after the first infusion, every 6 months thereafter, and for at least 6 months after TYSABRI has been discontinued

I will determine every 6 months whether this patient should continue on TYSABRI and if so, authorize treatment for another 6 months. I understand that I am required to submit an “Initial Discontinuation Questionnaire” when TYSABRI is discontinued and a “6-Month Discontinuation Questionnaire” following discontinuation of TYSABRI

I should report, as soon as possible, cases of PML, hospitalizations due to opportunistic infection, or deaths to Biogen

I understand that data concerning this patient and me will be entered into the mandatory TOUCH Prescribing Program. Biogen requires my cooperation with periodic data collection. Failure to provide the requested information or otherwise comply with the requirements of the TOUCH Prescribing Program may result in discontinuation of TYSABRI treatment for this patient and termination of my authorization to prescribe TYSABRI

I have received educational materials regarding the benefits and risks of TYSABRI treatment

I have, or another healthcare provider under my direction has, educated this patient on the benefits and risks of treatment with TYSABRI, provided him or her with the Patient Medication Guide and Enrollment Form, instructed him or her to read these materials, and encouraged him or her to ask questions when considering TYSABRI

Patient name: Date of birth:

Prescriber signature: Date:

First MI Last (MM/DD/YYYY)/ /

TYS-US-0481 V5 4 of 5

Phone: 1-800-456-2255




Please indicate the patient’s MOST RECENT therapy for MS (if patient was most recently on combination therapy, check all that apply). None

Patient History

Prescription for TYSABRI

Prescriber

Patient name: DOB:

Date of first MS symptoms:

Dose: TYSABRI® (natalizumab) 300 mg Dispense: 1 vial Refills: 12 Directions: IV infusion per Prescribing Information every 4 weeksI authorize Biogen as my designated agent and on behalf of my patient to (1) use the information on this form to enroll the above-named patient in the TOUCH Prescribing Program, (2) furnish any information on this form to the insurer of the above-named patient, (3) forward the information on this form to the prescriber or infusion site administering TYSABRI, if applicable, (4) forward the above prescription by fax or by another mode of delivery to a pharmacy, if applicable, and (5) coordinate delivery of TYSABRI on behalf of the above-named patient.

Prescriber signature (stamps not acceptable): Date:

Please indicate the start and stop dates of most recent therapy: Start date / Stop date /

Has the patient ever received TYSABRI before? Yes No

Aubagio® AVONEX® Copaxone® Lemtrada®

Mavenclad® Mayzent®

Cyclophosphamide Methotrexate Mitoxantrone

Betaseron® Gilenya®

TECFIDERA®

Azathioprine

Has the patient EVER been tested for the presence of anti-JCV antibodies? Yes No Unknown

If yes, has the patient EVER tested POSITIVE for the presence of anti-JCV antibodies? Yes No Pending

If an anti-JCV antibody index value is available, please record it here: .

Has the patient EVER been prescribed an immunosuppressant or an antineoplastic therapy for any condition? Yes No

If yes, please check all of the following that apply:

Azathioprine Cyclophosphamide Methotrexate Mitoxantrone Mycophenolate Other

First MI Last (MM/DD/YYYY)

(MM/DD/YYYY)

/ /

Extavia®

Rebif®

Mycophenolate

Prescriber name:

Street address

City State ZIP

Telephone

Fax

Office contact

Tax ID #

DEA #

NPI/UPIN/provider ID # with patient’s insurer(s)--

--

First MI Last

TYS-US-0481 V5 3 of 5

Continued on next page

/ /

M MM MY YY YY YY Y

PLEGRIDY® Ocrevus®

Phone: 1-800-456-2255




TYSABRI®

Other

Patient Acknowledgment

Biogen considers patient safety a priority. Read each section below and initial in the space provided if you understand the information. Do not sign this form if there is anything you do not understand about all the information you have received. Ask your doctor about anything you do not understand before you initial and sign this form.

I understand that TYSABRI increases my chance of getting a rare brain infection that usually leads to death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). PML usually happens in people with

weakened immune systems There is no known treatment, prevention, or cure for PML My chance for getting PML may be higher if I am also being treated with other medicines that can weaken my

immune system, including other MS treatments. Even if I use TYSABRI alone to treat my MS, I can still get PML My chance for getting PML increases if I: - Have been exposed to John Cunningham Virus (JCV). JCV is a common virus that is harmless in most people but

can cause PML in people who have weakened immune systems, such as people taking TYSABRI. Most people who are exposed to JCV do not know it or have any symptoms. This exposure usually happens in childhood. My doctor may do a blood test to check if I have been exposed to JCV before I start receiving TYSABRI or during my treatment

- Have received TYSABRI for a long time, especially longer than 2 years - Have received certain medicines that can weaken my immune system before I start receiving TYSABRI My risk of getting PML is greatest if I have all 3 risk factors listed above. There may be other risk factors for getting

PML during TYSABRI treatment that we do not know about yet. My doctor should discuss the risks and benefits of TYSABRI treatment with me before I decide to receive TYSABRI

I should call my doctor right away if I get any new or worsening symptoms that last several days, especially nervous systom syptoms, while I am taking TYSABRI, and for at least 6 months after I stop taking TYSABRI. Some of these symptoms include a new or sudden change in my thinking, eyesight, balance, or strength, but I should also report other new or worsening symptoms

To receive TYSABRI, all patients must be enrolled in a restricted program called the TOUCH® Prescribing Program. The TOUCH Prescribing Program is run by the company that makes TYSABRI. Under this program, the

company is required to collect information about my health at regular time periods. I cannot receive TYSABRI if I do not agree to follow the requirements of the TOUCH Prescribing Program. I understand that the TOUCH Prescribing Program does not require me to sign the Authorization included on page 1 of this form

The company may use my information to meet the requirements of the TOUCH Prescribing Program, including helping me locate an authorized infusion site

I must notify the TOUCH Prescribing Program if I switch physicians or infusion sites I have received, read, and understand the Patient Medication Guide I will bring to each TYSABRI infusion a list of all medicines and treatments that I have

taken during the past month Initials:

Initials:

I understand that TYSABRI is a medicine approved to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. I have talked to my doctor and understand the benefits and risks of TYSABRI treatment TYSABRI increases the risk of PML. I understand that when starting and continuing

treatment with TYSABRI, I should talk to my doctor about whether the expected benefit of TYSABRI is enough to outweigh the risk (see important safety information about PML below) Initials:

Patient name: Date of birth:

Patient signature (or personal representative): Date:

Authority of personal representative (if applicable):

First MI Last (MM/DD/YYYY)/ /

TYS-US-0481 V5 2 of 5

Phone: 1-800-456-2255




TYS-US-0481 V5 1 of 5

Phone: 1-800-456-2255




Patient Information

Patient Authorization to Use/Disclose Health Information

Insurance Information

I understand that I have certain rights related to the collection, use, and disclosure of my medical and health information. This information is called “protected health information” (PHI) and includes demographic information (such as sex, race, date of birth, etc.), the results of physical examinations, clinical tests, blood tests, X-rays, and other diagnostic and medical procedures that may be included in my medical records. Biogen will not use my PHI without my consent.This Authorization form applies to PHI created or obtained by my prescriber, my infusion site, my pharmacy, and my health insurance company. I understand that by signing this Authorization, I authorize my prescriber, infusion site, pharmacy, and/or health insurance company to disclose the PHI in my medical records to Biogen and its representatives or agents, including information related to my medical condition, treatment, and health insurance, as well as all information provided on any prescription. I also authorize Biogen to use this information to provide TYSABRI support services, such as investigating insurance coverage for TYSABRI and coordinating delivery of TYSABRI to the prescriber or infusion site administering TYSABRI (which may include forwarding my health information to a pharmacy).I agree to allow Biogen to ask me about and provide me with these support services, educational kits, and other information related to TYSABRI and/or my medical condition. I understand that, once my PHI has been disclosed to Biogen, federal privacy laws may no longer protect the information. However, Biogen agrees to protect my PHI by using it only for the purposes authorized in this Authorization or as required by law.I understand that I may refuse to sign this Authorization, and refusing to do so will affect my eligibility to receive these additional services but will not affect my ability to receive TYSABRI. I understand that signing this Authorization will not change how my healthcare providers, health insurance plan, and pharmacies provide my medical treatment or payment for treatment or insurance benefits.I understand that I may cancel all or a part of this Authorization at any time by mailing a letter requesting such cancellation to TYSABRI Support Services, 5000 Davis Drive, PO Box 13919, Research Triangle Park, NC 27709. If I cancel this Authorization, Biogen will end further use and disclosure of my PHI as soon as possible. This will not affect health information that has already been used or disclosed in reliance upon this Authorization.I will receive a copy of this signed Authorization. This Authorization expires ten (10) years from the date this Authorization is signed.Patient signature (or personal representative): Date:Authority of personal representative (if applicable):

Date of birth:

Patient name:

Street address

City State ZIP

Work telephone

Home telephone

Patient may be contacted at Home Work Best time:

Female Male

Patient SSN

Please attach copies of both sides of patient’s insurance and pharmacy card(s).

Check if no insurance Medicare Medicaid

Policyholder’s name:

Primary insurance Insurance company telephone

Policy number Group number

Pharmacy benefit manager

(MM/DD/YYYY)/

--

-

--

-/

First

First

E-mail address

Medicaid Plan Type

MI

MI

Last

Last

TYSABRI HCP MS TOUCH Prescriber/Patient Enrollment Form (TYS-US-0481)

PRESCRIBER/PATIENTThe prescriber and patient review, complete, and sign the MS TOUCH Prescriber/Patient Enrollment Form

PRESCRIBER/PATIENTThe prescriber evaluates patient at 3 and 6 months after the first infusion, every 6 months thereafter, and for at least 6 months after discontinuing TYSABRIThe prescriber completes the Patient Status Report and Reauthorization Questionnaire every 6 months

BIOGEN The TOUCH Prescribing Program assigns patient to an authorized infusion center, changes patient status to “Authorized” in TOUCH On-Line and provides a Notice of Patient Authorization

BIOGEN Tracking begins for the 6-month authorization period and Pre-infusion Patient Checklist

INFUSION CENTER The infusion center confirms that patient is currently authorized to receive TYSABRI® (natalizumab)The patient receives TYSABRI infusion based on answers to the Pre-infusion Patient ChecklistThe Pre-infusion Patient Checklist is submitted by the infusion center via TOUCH On-Line or faxed within 1 day of the patient’s infusion

2

1

3

4

5

TYS-US-0481 V5 1 of 5

Phone: 1-800-456-2255




Patient Information

Patient Authorization to Use/Disclose Health Information

Insurance Information

I understand that I have certain rights related to the collection, use, and disclosure of my medical and health information. This information is called “protected health information” (PHI) and includes demographic information (such as sex, race, date of birth, etc.), the results of physical examinations, clinical tests, blood tests, X-rays, and other diagnostic and medical procedures that may be included in my medical records. Biogen will not use my PHI without my consent.This Authorization form applies to PHI created or obtained by my prescriber, my infusion site, my pharmacy, and my health insurance company. I understand that by signing this Authorization, I authorize my prescriber, infusion site, pharmacy, and/or health insurance company to disclose the PHI in my medical records to Biogen and its representatives or agents, including information related to my medical condition, treatment, and health insurance, as well as all information provided on any prescription. I also authorize Biogen to use this information to provide TYSABRI support services, such as investigating insurance coverage for TYSABRI and coordinating delivery of TYSABRI to the prescriber or infusion site administering TYSABRI (which may include forwarding my health information to a pharmacy).I agree to allow Biogen to ask me about and provide me with these support services, educational kits, and other information related to TYSABRI and/or my medical condition. I understand that, once my PHI has been disclosed to Biogen, federal privacy laws may no longer protect the information. However, Biogen agrees to protect my PHI by using it only for the purposes authorized in this Authorization or as required by law.I understand that I may refuse to sign this Authorization, and refusing to do so will affect my eligibility to receive these additional services but will not affect my ability to receive TYSABRI. I understand that signing this Authorization will not change how my healthcare providers, health insurance plan, and pharmacies provide my medical treatment or payment for treatment or insurance benefits.I understand that I may cancel all or a part of this Authorization at any time by mailing a letter requesting such cancellation to TYSABRI Support Services, 5000 Davis Drive, PO Box 13919, Research Triangle Park, NC 27709. If I cancel this Authorization, Biogen will end further use and disclosure of my PHI as soon as possible. This will not affect health information that has already been used or disclosed in reliance upon this Authorization.I will receive a copy of this signed Authorization. This Authorization expires ten (10) years from the date this Authorization is signed.Patient signature (or personal representative): Date:Authority of personal representative (if applicable):

Date of birth:

Patient name:

Street address

City State ZIP

Work telephone

Home telephone

Patient may be contacted at Home Work Best time:

Female Male

Patient SSN

Please attach copies of both sides of patient’s insurance and pharmacy card(s).

Check if no insurance Medicare Medicaid

Policyholder’s name:

Primary insurance Insurance company telephone

Policy number Group number

Pharmacy benefit manager

(MM/DD/YYYY)/

--

-

--

-/

First

First

E-mail address

Medicaid Plan Type

MI

MI

Last

Last

STEPS TO

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Provides real-time access to TYSABRI® (natalizumab) patient data

Helps maintain compliance with the TOUCH Prescribing Program

Streamlines communication to and from prescribers and infusion centers

If you are interested in more information about the TOUCH Prescribing Program or TOUCH On-Line, please reach out to your center’s administrator (if TOUCH On-Line is already within your center), your Biogen Access and Reimbursement Manager, or Biogen Support Services.

Biogen Support Serviceswww.BiogenOptions.com 1-800-456-2255Monday through Friday, 8:30 am to 8:00 pm ET

www.TYSABRIHCP.com

TOUCH® ON-LINETOUCH On-Line is a web-based tool designed to assist TOUCH Prescribing Program participants in fulfilling their TOUCH Prescribing Program requirements. TOUCH On-Line enables your office to

• Receive notifications for missing information, action items, and updates• Verify a patient’s authorization status (Notice of Patient Authorization) and authorization dates• View a patient’s Summary of Benefits and financial assistance information• Access and print TOUCH Prescribing Program information, including the most

current Medication Guide• Export a full list of patients to Microsoft Excel® to view patients who are scheduled for an infusion, without a

scheduled infusion, overdue for an infusion, or enrolled in Biogen Support Services and receiving financial assistance• Save data to a patient’s electronic medical records• Receive Notice of Patient Authorization and/or Discontinuation Questionnaires

If you do not have a TOUCH On-Line user name and password, your Biogen Access and Reimbursement Manager can help, as well as provide training materials and support. If you forget your TOUCH On-Line user name or password, Patient Services can get you back online.

STEPS TO

PATIENT AC

CESS

THE TO

UC

H®

PRESCRIBIN

G PRO

GRAM

BENEFITS

INVESTIG

ATION

NAVIG

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PAYER RESTRIC

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tysabri (natalizumab) · 2020. 5. 1. · tysabri® (natalizumab) increases the risk of pml, an...

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