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Getting Started

Here we will review how to get your patient started on treatment with RADICAVA® (edaravone), as well as information on ordering RADICAVA®. For additional assistance or to learn more, call the JourneyMate Support Program Insurance & Access Specialist at 1-844-772-4548.

Process Overview

Below are the steps to get your patients started, including benefit investigation, insurance approval, selecting a site of care, and scheduling infusions. Learn more about Step 1: Begin With the BIF; Step 2: Insurance Approval and Selecting a Site of Care; and Step 3: Schedule Infusions.

 
Step 1 of 3

Begin With the Benefit Investigation and Enrollment Form

If you are considering starting a patient on RADICAVA® it is important to begin with the Benefit Investigation and Enrollment Form (BIF) as soon as possible, as it lets your patients know their insurance coverage. Once you know the insurance coverage you and your patient can make a final decision on whether RADICAVA® is right for them. Completing the BIF also enrolls your patient in the JourneyMate Support Program.a

 

The BIF can be completed 2 waysb:

Online via eSign
You may complete, sign, and submit the enrollment form online to the JourneyMate Support Program.

  1. Access the BIF at RadicavaOnlineEnrollmentForm.com
  2. Follow instructions for completing, signing, and submitting the online form.

By Mail, Fax, or Electronic Fax
If you have access to a printer, you may submit a completed and signed BIF to the JourneyMate Support Program via mail, fax, or electronic fax.

  1. Download and save the editable BIF
  2. Print, sign, scan or photograph, and submit the completed form using:
blue envelope with piece of paper with green lines Mail:
JourneyMate Support Program
Insurance & Access Specialist

680 Century Point
Lake Mary, FL 32746
blue and green fax machine Fax or Electronic Fax: 1-888-782-6157

Patient authorization is required to complete a BIF. Patients can provide this authorization online via eSign or via mail, fax, or electronic fax. Learn more about the Patient Authorization Form.

NOTE: As a reminder, all covered entities are obligated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to have a business associate agreement (BAA) in place with any service provider that handles protected health information (PHI) on their behalf. This includes, among others, electronic data transmission services such as eSign and electronic fax services. Please refer to each service provider’s website for more information regarding BAAs and PHI.

Restrictions apply. See .

When completing the BIF, be sure to provide:

  • Patient and your office information, and the preferred infusion site
  • Proper insurance information or a copy of your patient's insurance card(s)
  • Patient authorization, signature of the patient or their Legal Representative
  • Your signature

Patients May Start With the Patient Authorization Form

If a patient or their Legal Representative is not available to sign a Benefit Investigation and Enrollment Form, the patient or their Legal Representative has options for submitting a signed Patient Authorization Form:

  • The JourneyMate Support Program can email the patient or their Legal Representative a link to the eSign Patient Authorization Form to complete and submit.
  • The patient or their Legal Representative can download, complete, and sign the Patient Authorization Form available at radicava.com and submit by electronic fax, conventional fax, or USPS mail. Learn more.
  • The JourneyMate Support Program can mail the patient or their Legal Representative a copy of the Patient Authorization Form to return by electronic fax, conventional fax, or USPS mail.

Patient Authorization Form

Restrictions apply. See .

Final Benefit Summary

After the BIF is submitted, the JourneyMate Support Program will provide your office with a Final Benefit Summary within 2 business days. Information included in the Final Benefit Summary includes:

 
clipboard with green cross in blue circle
  • Medical Coverage Detail
    • Primary/Secondary/Tertiary plan coverage information
    • Prior authorization requirements
    • Deductible, out-of-pocket maximum, and patient co-pay/co-insurance
    • Supporting documentation requirements
    • Medication procurement options
    • Coding requirements
clipboard with green Rx symbol
  • Pharmacy Coverage Detail
    • Primary/Secondary plan coverage information, as applicable (the information above plus pharmacy-specific benefits verification)
clipboard with green cross in shield symbol
  • Medicare Part D Pharmacy Coverage Detail
    • Payer/plan name information
    • Year-to-date out-of-pocket phase status; deductible, initial coverage limit, coverage gap, catastrophic
 

Let your patients know

After the enrollment process is complete, an Insurance & Access Specialist from the JourneyMate Support Program will be assigned and may call your patients to help with:

aA patient cannot be enrolled in the JourneyMate Support Program without patient authorization, which can be found on the Benefit Investigation and Enrollment Form, or a separate signed Patient Authorization Form for RADICAVA® on file. In addition, a Benefit Investigation and Enrollment Form must be submitted for each patient for whom treatment with RADICAVA® is requested.

bMitsubishi Tanabe Pharma America, Inc. (“MTPA”) is not affiliated with any electronic fax service providers (collectively, “service providers”). No fees or remuneration of any kind have been or will be exchanged with any healthcare provider for use of these service providers. Mention of these service providers does not constitute a referral, recommendation, endorsement of a particular service provider, and similarly, the absence of a service provider’s name should not be construed as a negative comment from MTPA about that service provider. MTPA, as well as its employees or agents, shall not be held liable for any damages or harm resulting from any use or reliance on these service providers, and MTPA may modify its policy regarding these service providers at any time without notice.

Restrictions apply. See .

 
 
Step 2 of 3

Insurance Approval and Selecting a Site of Care

Please select the appropriate insurance coverage for your patient based on their Final Benefit Summary.

Commercial Insurance Medicare Advantage (Part C) Medicare Part D Medicare Part B

Actor portrayal.

 

For patients with commercial coverage, including Medicare Advantage (Part C), or Medicare Part D

Prior authorization is typically required.

Work with your patient and their insurance company to select an appropriate site of care for them to receive their RADICAVA® infusions. These include:

  • Home infusion
  • Infusion center
  • Doctor's office
  • Hospital
green circle with blue building with green cross

Use our ALS Care Locator to help find sites of care that are convenient for them.

You will send a referral to the treating site of care, including fax orders, IV access/line information, and notes as requested by the site of care.

If required, work with the site of care to complete the prior authorization.

The JourneyMate Support Program™ Insurance & Access Specialist can assist with limited support for the Prior Authorization and exceptions and appeals processes by:

  • Researching patient's health plan for Prior Authorization requirements and forms
  • Monitoring the status of Prior Authorization submission
  • Notifying your office within 3 weeks prior to Prior Authorization expiration

Limited exceptions and appeals assistancec

If the Prior Authorization is denied by the health plan, the JourneyMate Support Program Insurance & Access Specialist may be able to provide limited assistance.

Sample Letter of Medical Necessity

Download

This letter provides rationale for treatment with RADICAVA®. It can help when filing appeals.

Sample Appeal Letter

Download

This letter may be considered if your patient’s coverage is denied because their condition did not meet the plan’s criteria for treatment with RADICAVA®.

Sample Exceptions Letter

Download

This letter may be considered if your patient’s coverage is denied because RADICAVA® is not on your patient’s health plan formulary, or for another reason.

cThe JourneyMate Support Program does not fill out any information that requires the medical judgment of the prescriber, and only the prescriber can determine whether to pursue a Prior Authorization. Determination of Prior Authorization is at the sole discretion of the health plan.The JourneyMate Support Program and Mitsubishi Tanabe Pharma America, Inc. do not assume responsibility for, nor do they guarantee the approval of a Prior Authorization request.

Restrictions apply. See .

Continue to Step 3

 

 

For patients with Medicare Part B Plans

Prior authorization is not required.

Discuss with your patient and select an appropriate site of care for them to receive their RADICAVA® infusions. Possible sites of care include:

  • Infusion center
  • Doctor's office
  • Hospital
  • Home infusion
  • (this is an option but it is not covered)

green circle with blue building with green cross

Use our ALS Care Locator to help find sites of care that are convenient for them.

You will direct a referral to the treating site of care, including fax orders, IV access/line information, and notes as requested by the site of care.

 
 
 
Step 3 of 3

Schedule Infusions

The chosen site of care schedules the infusion with your patient.

Remind your patients of the importance of staying on therapy and continuing to receive their infusions as prescribed.

 

Financial Support Options Flashcard

Use with your patients to help them navigate options that may be available to them to help cover applicable out-of-pocket costs associated with RADICAVA®.

Download

Treatment Initiation Checklist

Use this checklist to facilitate a common understanding of the steps involved in coordinating treatment initiation between the prescribing physician and the infusion site of care. Also includes an insert outlining relevant information typically required for a valid prescription, as well as the 2 ways to submit a prescription with a BIF.

Download

Ordering RADICAVA®

After you have completed the BIF, your patient will be enrolled in the JourneyMate Support Program and a Patient ID will be assigned.

You may place all subsequent orders for RADICAVA® using their Patient ID to complete the Buy and Bill Order Form.


Order Form for Buy and Bill

Download

You can submit your signed form by:


Fax or Electronic Fax: 1-888-782-6157
Mail:
JourneyMate Support Program
Insurance & Access Specialist

680 Century Point
Lake Mary, FL 32746

For questions about ordering RADICAVA®, call the JourneyMate Support Program™ Insurance & Access Specialist at 1-844-772-4548.

JourneyMate Support Program FAQs

Who can use the JourneyMate Support Program?

To help navigate access to treatment with RADICAVA®, the JourneyMate Support Program offers product access services for people who receive RADICAVA®. Caregivers may also seek support on behalf of a loved one who receives RADICAVA®. Resources for healthcare providers are also available.

For questions about the resources available for your patients and your practice, call the JourneyMate Support Program Insurance & Access Specialist at 1-844-772-4548.

Does the JourneyMate Support Program offer product access support options for RADICAVA® for veterans with ALS?

No. However, the Department of Veterans Affairs (VA) provides assistance and access to treatment options for veterans with ALS. This includes treatment with RADICAVA®, which is on the VA National Formulary subject to National Prior Authorization criteria. You can learn more about these services and accessing RADICAVA® for veterans here.

Can you send a representative to my office?

Yes. To arrange for a Rep to come to your office, sign up to request a visit.

How can I start ordering RADICAVA®?

The JourneyMate Support Program offers tools and resources to help you navigate access to treatment for your patients.

Is product training available?

Yes. A representative from the JourneyMate Support Program can visit your practice to show you how to properly store and administer RADICAVA®.

To request a visit, you can sign up or call the JourneyMate Support Program Insurance & Access Specialist at 1-844-772-4548.

These topics are also discussed in the Administration Guide Video.

How can I tell if product has been exposed to oxygen and is unusable?

When you remove RADICAVA® from the carton, you will notice that the IV bags are protected by a secondary overwrap packaging that contains an oxygen absorber and an oxygen indicator. You should only use RADICAVA® if the indicator is pink prior to opening the overwrap packaging. This reflects appropriate oxygen levels.

However, if the indicator is blue or purple before the overwrap is opened, it means that the product was exposed to oxygen and should not be used.

For more information, watch the Administration Guide Video or call the JourneyMate Support Program Insurance & Access Specialist at 1-844-772-4548.

How do I return damaged or unused product?

To return damaged or unused product, contact MTPA's Order/Returns Service at 1-844-529-8990.

Potential Adverse Event: Contact MTPA Medical Information at 1-888-292-0058 no later than one (1) business day of receipt of the information.

Review the Return Goods Policy

What is eSign?

eSign provides electronic signature technology facilitating electronic exchange of signed documents.

The JourneyMate Support Program utilizes two eSign processes for completion of the Benefit Investigation and Enrollment Form:

  • An online prescriber form for completion and capture of the prescriber’s signature.
  • The ability for the JourneyMate Support Program Insurance & Access Specialist to send an eSign link to the patient to eSign and submit a Patient Authorization Form.

Prescribers may use a web-enabled form available at radicavahcp.com to complete, sign, and submit a Benefit Investigation and Enrollment Form to the JourneyMate Support Program.

As a reminder, all covered entities are obligated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to have a business associate agreement (BAA) in place with any service provider that handles protected health information (PHI) on their behalf. This includes, among others, electronic data transmission services such as eSign and electronic fax services. Please refer to each service provider’s website for more information regarding BAAs and PHI.

Mitsubishi Tanabe Pharma America, Inc. (“MTPA”) is not affiliated with any electronic fax service providers (collectively, “service providers”). No fees or remuneration of any kind have been or will be exchanged with any healthcare provider for use of these service providers. Mention of these service providers does not constitute a referral, recommendation, endorsement of a particular service provider, and similarly, the absence of a service provider’s name should not be construed as a negative comment from MTPA about that service provider. MTPA, as well as its employees or agents, shall not be held liable for any damages or harm resulting from any use or reliance on these service providers, and MTPA may modify its policy regarding these service providers at any time without notice.

If a patient or their Legal Representative is not available to sign a Benefit Investigation and Enrollment Form, the JourneyMate Support Program Insurance & Access Specialist can email the patient or their Legal Representative a link to the eSign Patient Authorization Form to complete and submit.

As a reminder, all covered entities are obligated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to have a business associate agreement (BAA) in place with any service provider that handles protected health information (PHI) on their behalf. This includes, among others, electronic data transmission services such as eSign and electronic fax services. Please refer to each service provider’s website for more information regarding BAAs and PHI.

Mitsubishi Tanabe Pharma America, Inc. (“MTPA”) is not affiliated with any electronic fax service providers (collectively, “service providers”). No fees or remuneration of any kind have been or will be exchanged with any healthcare provider for use of these service providers. Mention of these service providers does not constitute a referral, recommendation, endorsement of a particular service provider, and similarly, the absence of a service provider’s name should not be construed as a negative comment from MTPA about that service provider. MTPA, as well as its employees or agents, shall not be held liable for any damages or harm resulting from any use or reliance on these service providers, and MTPA may modify its policy regarding these service providers at any time without notice.

Who can eSign the Patient Authorization Form?

Either a patient or Legal Representative can sign the eSign Patient Authorization Form. If a Legal Representative is signing on behalf of the patient, the Legal Representative completes the required fields on the form identifying the Legal Representative and their relationship to the patient.

To learn more, call the Insurance & Access Specialist at 1-844-772-4548

▲ EXPAND▼ COLLAPSE

Important Safety Information

Hypersensitivity Reactions

Radicava® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in Radicava®. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported. Patients should be monitored carefully for hypersensitivity reactions, and if they occur, discontinue Radicava®, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions

Radicava® contains sodium bisulfite, and may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown, but occurs more frequently in asthmatic people.

Most Common Adverse Reactions

Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache.

Pregnancy

Based on animal data, Radicava® may cause fetal harm.

Geriatric Use

No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Please see full Prescribing Information.

For more information about RADICAVA®, call 1-888-292-0058.