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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 1-844-SRCHLGT (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 Searchlight Support®.a

 

The BIF can be completed 2 waysb:

Online via DocuSign® PowerForm
You may use a web-enabled DocuSign® PowerForm to complete, sign, and submit a BIF to Searchlight Support®.

  1. Access the BIF at DocuSign®
  2. Follow instructions for completing, signing, and submitting the DocuSign® PowerForm

By Mail, Fax, or Electronic Fax
If you have access to a printer, you may submit a completed and signed BIF to Searchlight Support® 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: PO Box 2930, Phoenix, AZ 85062 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 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 DocuSign® 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
patient authorization form for RADICAVA® (edaravone) Download

Patients May Start with the Patient Authorization Form

If a patient or their Legal Representative is not available to sign a BIF, they may authorize Searchlight Support® services by submitting a Patient Authorization Form instead. This form is also available to patients on the patient website, and they can also submit it electronically via DocuSign®. Learn more.

While patients may receive RADICAVA® without providing this authorization, they will not be able to participate in or receive assistance from Searchlight Support®.

Let patients know that this authorization can be cancelled at any time. It will remain in effect for 5 years from the date of signature, or until a patient is no longer participating in Searchlight Support® services, whichever is sooner. Refer patients to the Patient Authorization Form for full terms and conditions.

Restrictions apply. See

Final Benefit Summary

After the BIF is submitted, Searchlight Support® will provide your office with a comprehensive 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, a Case Manager from Searchlight Support® will be assigned and may call your patients to help with:

aSearchlight Support® cannot enroll a patient in Searchlight Support® services 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 Searchlight Support® 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 DocuSign® or 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.

Searchlight Support® 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, Searchlight Support® may be able to provide limited assistance.

Sample Letter of Medical Necessity

Download

This letter provides rationale for treatment with RADICAVA®. It can help you strengthen claims for treatment and 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.

cSearchlight Support® 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. Searchlight Support® 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.

Continue to Step 3

 
 
 
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.

 
Initiating Treatment Brochure that has steps for getting patients started on treatment with RADICAVA®

Initiating Treatment Brochure

Download the Initiating Treatment brochure to keep the steps of getting your patients started on treatment with RADICAVA® handy. It also contains information on completing the BIF, out-of-pocket cost support, finding a site of care, and administration of RADICAVA®.

Download
flashcard for the affordability options for RADICAVA® (edaravone) to help cover applicable out-of-pocket costs

Affordability Options Flashcard

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 insert outlining relevant information typically required for a valid patient prescription, as well as the 2 ways to submit a prescription with a BIF.

Download
Treatment Initiation Checklist to facilitate a common understanding of the steps involved in coordinating treatment initiation

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
badge with plus symbol over clipboard
Learn about the cost support options available for your patients

Ordering RADICAVA®

After you have completed the BIF, your patient will be enrolled in Searchlight Support® 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.


buy and bill order form to place orders for RADICAVA® (edaravone), an FDA approved treatment option for ALS

Order Form for Buy & Bill

Download

You can submit your signed form by:


Fax or Electronic Fax: 1-888-782-6157 Mail: PO Box 2930, Phoenix, AZ 85062

For questions about ordering RADICAVA®, call 1-844-SRCHLGT (1-844-772-4548).

Searchlight Support® FAQs

Who can use Searchlight Support®?

To help navigate access to treatment with RADICAVA®, Searchlight Support® offers product access programs for healthcare providers and people who receive RADICAVA®. Caregivers may also seek support on behalf of a loved one who receives RADICAVA®.

For questions about the services available for your patients and your practice, call Searchlight Support® at 1-844-SRCHLGT (1-844-772-4548).

Does Searchlight Support® 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®?

At Searchlight Support®, we offer tools and services to help you navigate access to treatment for your patients.

Is product training available?

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

To request a visit, you can sign up or call Searchlight Support® at 1-844-SRCHLGT (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 Searchlight Support® at 1-844-SRCHLGT (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 DocuSign®?

DocuSign® provides electronic signature technology and digital transaction management services to facilitate electronic exchange of contracts and signed documents.d,e

Searchlight Support® utilizes 2 options offered by DocuSign®:

  • DocuSign® envelope: a container used to send 1 document via email for signature using the DocuSign® system. The document can have multiple pages, such as the Patient Authorization Form
  • DocuSign® PowerForm is available to healthcare providers here in order to complete, sign, and submit required documents

Patients may use the web-enabled DocuSign® PowerForm available at RADICAVA.com, or the DocuSign® envelope sent to them by Searchlight Support® to complete, sign and submit a Patient Authorization Form to Searchlight Support®.

Prescribers may use a web-enabled DocuSign® PowerForm to complete, sign, and submit a Benefit Investigation and Enrollment Form to Searchlight Support®.

  1. Contact your Mitsubishi Tanabe Pharma America, Inc. representative to obtain a link to the Benefit Investigation and Enrollment Form at DocuSign®.
  2. Follow the instructions for completing, signing, and submitting the DocuSign® PowerForm.

dAs 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 DocuSign® and electronic fax services. Please refer to each service provider's website for more information regarding BAAs and PHI.

eMitsubishi Tanabe Pharma America, Inc. ("MTPA") is not affiliated with DocuSign® or 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, or 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.

Your patient or their Legal Representative have options for submitting a signed Patient Authorization Form to Searchlight Support®f:

  • A patient or their Legal Representative may access the DocuSign® PowerForm available at RADICAVA.com
  • You can advise your patient or their Legal Representative to download, complete, and sign the Patient Authorization Form available at RADICAVA.com and submit by electronic fax, conventional fax, or USPS

fMitsubishi Tanabe Pharma America, Inc. ("MTPA") is not affiliated with DocuSign® or 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 sign the Patient Authorization Form?

Either a patient or their Legal Representative can sign the DocuSign® 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.

The signer must identify themselves as either the "Patient" or "Legal Representative" and select the applicable checkbox on the DocuSign® form. DocuSign® will prompt the user to sign the applicable section based on how the user identifies themselves.

To learn more, call 1-844-SRCHLGT (1-844-772-4548)

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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.