FDA recognizes RADICAVA ORS® as MAJOR CONTRIBUTION TO PATIENT CARE Call a JourneyMate Resource Specialist at 1-855-457-6968.
FDA recognizes RADICAVA ORS® as MAJOR CONTRIBUTION TO PATIENT CARE Call a JourneyMate Resource Specialist at 1-855-457-6968.
Get answers about starting RADICAVA® and how the JourneyMate Support Program™ can help you.
Still have questions about starting RADICAVA®?
Call a JourneyMate Resource Specialist at 1-855-457-6968 between 9 AM and 9 PM ET, Monday through Friday.
Learn more
Q: For RADICAVA®, what clinical studies were done? How many people have used it?
RADICAVA® has been on the market for 7+ years since its FDA approval in 2017. The safety and tolerability of RADICAVA® have been studied in 500+ people across multiple clinical studies since 2017. RADICAVA® has been evaluated in over 2 decades of clinical research, with efficacy demonstrated in a pivotal phase 3 clinical trial.
As for real-world experience, 16,400+ people have been treated with RADICAVA since 2017 for 2.0 million+ days of therapy.a,b (see footnote)
Learn more about the RADICAVA® history of clinical and real-world experience.
Q: Why was RADICAVA ORS® recognized by the FDA in 2024 for its major contribution to patient care?
The FDA says RADICAVA ORS® provides a clinically superior option for patients due to its oral suspension route of administration. RADICAVA ORS® provides a less burdensome option vs the intravenous administration of previously approved RADICAVA®. Learn more about the RADICAVA® history of clinical and real-world experience.
Q: What if I want to switch from RADICAVA® IV to RADICAVA ORS® (edaravone)?
Please talk with your doctor about RADICAVA ORS® to see if it's right for you.
Q: How can I get help accessing RADICAVA ORS® or RADICAVA® IV?
Once your doctor has prescribed RADICAVA® and submitted a Benefit Investigation and Enrollment Form (BIF) to check how your health insurance covers RADICAVA®, an Insurance & Access Specialist will reach out to help you understand the insurance and infusion site-of-care selection process (if you’ll receive IV treatment), if applicable.
An Insurance & Access Specialist will:
Help to investigate your health insurance coverage and health plan benefits, as well as the RADICAVA® financial support options which may be available to you
Answer your questions and let you know what is needed next at each step in the process as you pursue treatment
Help you understand how to access your prescribed medication, whether it is:
RADICAVA ORS® from a specialty pharmacy; or
RADICAVA® IV from an infusion therapy provider
Q: How do I enroll in the JourneyMate Support Program™?
To be enrolled in the JourneyMate Support Program™, your doctor must submit a completed and signed Benefit Investigation and Enrollment Form (BIF), which includes a prescription for RADICAVA ORS® or RADICAVA® IV, to the JourneyMate Support Program™. You will also need to authorize your enrollment in the program. You may do so by signing the BIF or the Patient Authorization Form.
If you're unable to provide your signature on the form—for whatever reason—a JourneyMate Support Program™ Insurance & Access Specialist will contact you to obtain your authorization.
Q: Can I get help paying for RADICAVA ORS® or RADICAVA® IV?
The JourneyMate Support Program™ Insurance & Access Specialist can give you information about financial support options and other sources of financial assistance that may be available to you if you meet all eligibility criteria.
If you meet the eligibility requirements and are otherwise eligible for treatment with RADICAVA ORS® or RADICAVA® IV, you may be enrolled when your healthcare provider submits a Benefit Investigation and Enrollment Form for RADICAVA ORS® and RADICAVA® IV which you have signed. If you are in financial need and have no insurance, you may qualify for the Patient Assistance Program.
For questions about financial support options, call the JourneyMate Support Program™ Insurance & Access Specialist at 1-844-772-4548.
Q: What can I do if my insurance company denies coverage for RADICAVA ORS® or RADICAVA® IV?
Your insurance company may initially deny your treatment with RADICAVA ORS® or RADICAVA® IV. If this happens, you may be able to do something about it. Here are some ideas you may find helpful:
Talk to your doctor and call your health plan to request an exception for coverage of your medication
If you have been notified that your medication is not covered by your health plan or that you need to meet other requirements before obtaining it, you can call your health plan and request an exception for coverage of your medication.
Review this guide for some helpful steps you may follow: Requesting an Exception from Your Health Plan.
Talk to your doctor to see if it may be possible to file an appeal
If your request for an exception is denied you may be able to appeal the decision.
Having your doctor file an appeal may help give your insurance provider more details about why you should receive treatment.
If the appeal does not work, your doctor may request a next-level appeal. Some of the people that may be involved include a panel of doctors, an administrative judge, or a local state representative.
Consider other insurance plan options
If you or or your loved one has been diagnosed with ALS, there may be government health plan options to consider. Regardless of age, people diagnosed with ALS can apply for Social Security Disability Insurance (SSDI) benefits, and subsequently, can apply for Medicare and/or Medicaid coverage.
For questions about appeals or insurance coverage, call the JourneyMate Support Program™ Insurance & Access Specialist at 1-844-772-4548 to learn more.
Q: What is the re-enrollment process for the Out-of-Pocket Assistance Program?
You will be re-enrolled and remain in the Out-of-Pocket Assistance Program in 2024 so long as reverification of your insurance benefits confirms that you continue to meet the eligibility requirements for participation in the Out-of-Pocket Assistance Program. You will receive a letter notifying you of this information at the end of each calendar year.
Please be sure to notify the JourneyMate Support Program™ Insurance & Access Specialist at any time during the 2024 calendar year if you have any change in your status, which affects your ability to meet the eligibility requirements for the Out-of-Pocket Assistance Program. If you are no longer eligible, you will be unable to continue participation in the Out-of-Pocket Assistance Program, and your personalized information will no longer be active for out-of-pocket assistance.
Q: What is eSign and how do I use it with the JourneyMate Support Program™?
eSign provides electronic signature technology to facilitate electronic exchange of signed documents. You may request the JourneyMate Support Program™ Insurance & Access Specialist to send a link to eSign and submit a Patient Authorization Form.a (see footnote)
Q: Who can sign the Patient Authorization Form?
Either you or your Legal Representative can sign the eSign Patient Authorization Form. If a Legal Representative is signing on your behalf, the Legal Representative completes the required fields on the form identifying the Legal Representative and their relationship to you.
aBased on RADICAVA ORS® and RADICAVA® IV prescriptions submitted in the US as of August 2024. Not independently verified. Return to content
bDays of therapy based on number of RADICAVA ORS® and RADICAVA® IV cartons sold as of August 2024. Each carton of RADICAVA® IV includes 1 day of therapy. For RADICAVA ORS®, each Starter Kit includes 14 days of therapy, and each Maintenance Kit includes 10 days of therapy. Return to content
c 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. Return to content
Do not receive RADICAVA (edaravone) or RADICAVA ORS (edaravone) if you are allergic to edaravone or any of the ingredients in RADICAVA and RADICAVA ORS.
Before you take RADICAVA or RADICAVA ORS, tell your healthcare provider about all of your medical conditions, including if you:
have asthma.
are allergic to other medicines.
are pregnant or plan to become pregnant. It is not known if RADICAVA or RADICAVA ORS will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if RADICAVA or RADICAVA ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA or RADICAVA ORS or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of RADICAVA and RADICAVA ORS?
RADICAVA and RADICAVA ORS may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Hypersensitivity reactions have happened in people receiving RADICAVA or taking RADICAVA ORS and can happen after your medicine has been given.
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions.
The most common side effects include bruising (contusion), problems walking (gait disturbance) and headache.
These are not all the possible side effects of RADICAVA or RADICAVA ORS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch or Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058.
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information and Patient Information.
Do not receive RADICAVA (edaravone) or RADICAVA ORS (edaravone) if you are allergic to edaravone or any of the ingredients in RADICAVA and RADICAVA ORS.
Before you take RADICAVA or RADICAVA ORS, tell your healthcare provider about all of your medical conditions, including if you:
have asthma.
are allergic to other medicines.
are pregnant or plan to become pregnant. It is not known if RADICAVA or RADICAVA ORS will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if RADICAVA or RADICAVA ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA or RADICAVA ORS or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of RADICAVA and RADICAVA ORS?
RADICAVA and RADICAVA ORS may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Hypersensitivity reactions have happened in people receiving RADICAVA or taking RADICAVA ORS and can happen after your medicine has been given.
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions.
The most common side effects include bruising (contusion), problems walking (gait disturbance) and headache.
These are not all the possible side effects of RADICAVA or RADICAVA ORS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch or Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058.
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information and Patient Information.
RADICAVA, RADICAVA ORS, the RADICAVA logo, the RADICAVA ORS logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks of Mitsubishi Tanabe Pharma Corporation.
JourneyMate Support Program is a trademark of Mitsubishi Tanabe Pharma America, Inc.
All other company names, product names, trade/service marks or other trade names are the property of their respective owners.
For US audiences only.
© 2024 Mitsubishi Tanabe Pharma America, Inc. All rights reserved. CP-OE-US-0850 12/24
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