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Please see Prescribing Information for RADICAVA®, also available at radicava.com.
INITIATING TREATMENT Getting your patient started with RADICAVA® (edaravone)
Actor portrayals.
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Following diagnosis of amyotrophic lateral sclerosis (ALS) and discussion with patient about their diagnosis…
Potential Pathways* to Treatment for Appropriate Patients
Prescriber faxes completed Benefit Investigation and Enrollment Form to Searchlight Support®
Fax: 1-888-782-6157 (Prescriber and patient signature required)
Searchlight Support® faxes Benefit Summary to the prescriber within 1-2 business days
Prescriber directs referral to treating Site of Care
For example: Fax orders, IV access/line information, and notes as requested by Site of Care
Prescriber directs referral to treating Site of Care
For example: Fax orders, IV access/line information, and notes as requested by Site of Care
Commercial Coverage including Medicare Advantage (Part C) and Medicare Part D Plans:
Prior Authorization is typically required
Prescriber and patient select appropriate Site of Care
• Home infusion • Infusion Center• Doctor’s office • Hospital
Prescriber office works with treating Site of Care to complete the Prior Authorization
Searchlight Support® may provide limited Prior Authorization assistance and status monitoring†
Call 1-844-772-4548
If Prior Authorization denied by health plan
Searchlight Support® may be able to provide
limited assistance†
Call 1-844-772-4548
Medicare Part B:
Prior Authorization is not required
Prescriber and patient select appropriate Site of Care
• Infusion Center • Doctor’s office • Hospital • Home infusion is an option but is not covered
“Incident to”/Physician oversight applies
Site of Care schedules infusion with patientIf Prior
Authorization approved by health plan
Action taken by:
Prescriber
Searchlight Support®
Health Plan
* This information is provided for illustrative purposes only to represent the typical processes for initiation of treatment. Neither RxC Acquisition Company d.b.a. RxCrossroads by McKesson, nor Mitsubishi Tanabe Pharma America, Inc. select or refer to Sites of Care, complete paperwork for Sites of Care, or provide infusion services. Mitsubishi Tanabe Pharma America, Inc., as well as its employees or agents, shall not be held liable for any damages or harm resulting from any use or reliance on information contained in this document, and may modify, amend, remove, or cancel this information at any time without notice.
† 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.
Please see full Indication and Important Safety Information and Prescribing Information for RADICAVA®, also available at radicava.com.
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Access to Treatment Considerations
Completing the Benefit Investigation and Enrollment Form
• A signature is required from the patient or a legally authorized patient representative in Section 3(A completed Patient Authorization Form can serve as a substitute for the patient signature on the Benefit Investigation and Enrollment Form. Both forms are available at radicava.com/hcp)
• A Prescriber signature is required in Section 5
• A Benefit Summary will be faxed to any Site of Care identified in Section 6
• The Benefit Summary will identify eligible patients with commercial insurance coverage and automatically enroll them in the Out-of-Pocket Assistance Program—see additional information on page 4
Prior Authorization Requirements
• May include Study Inclusion Criteria such as duration of disease (from diagnosis), Functional Rating Scale scores, and Forced Vital Capacity (%FVC)
• May require a Letter of Medical Necessity, a Peer-to-Peer conference, an Exception Request, and/or Appeal
Modes of InfusionPLEASE NOTE: Prescriber will generally be required to order a peripheral or central line.
Benefit Investigation and Enrollment FormFax this completed form to 1-888-782-6157 or mail to Searchlight Support®, P.O. Box 2930, Phoenix, AZ 85062
For assistance or additional information, call 1-844-SRCHLGT (1-844-772-4548), Monday–Friday, 8:00am–8:00pm ET
Page 1 of 4
NAME (First, MI, Last, Suffix)
ADDRESS
CITY STATE ZIP
EMAIL DOB (MM/DD/YYYY)
HOME PHONE CELL PHONE
PREFERRED NUMBER TO CALL q Home Phone q Cell Phone
1. PATIENT INFORMATION (REQUIRED)
By signing below, I certify and acknowledge that I have read, understand, and agree to the Patient Authorization on page 3 of this form, to participate in the Searchlight Support® Program and to release my Protected Health Information to Mitsubishi Tanabe Pharma America, Inc. (as defined on page 3 of this form), supporting the access program as indicated on the Patient Authorization.
PATIENT SIGNATURE DATE If patient cannot sign, patient’s legally authorized representative must sign below.
PATIENT NAME (Please Print)
AUTHORIZED REPRESENTATIVE BY (Please Print) (Signature of authorized representative)
RELATIONSHIP TO PATIENT DATE
3. PATIENT AUTHORIZATION (Patient must read the Patient Authorization on the Patient Copy and sign below.)
Please see accompanying Prescribing Information, including Patient Information, for RADICAVA®, also available at radicava.com.
PLEASE COMPLETE ALL THAT APPLY AND INCLUDE A FRONT AND BACK COPY OF INSURANCE CARD FOR EACH TYPE OF INSURANCE.
Please investigate benefits for: q SPECIALTY DISTRIBUTOR–BUY & BILL q SPECIALTY PHARMACY–PRESCRIPTION
q HOME INFUSION If applicable, please attach prescription.
Patients with no insurance will be contacted by Searchlight Support® for consideration in the Patient Assistance Program.
PRIMARY INSURANCE GROUP/PLAN NAME
CARDHOLDER NAME
RELATIONSHIP TO CARDHOLDER EMPLOYER
INS. CO. PHONE POLICY # GROUP #
SECONDARY INSURANCE GROUP/PLAN NAME
CARDHOLDER NAME
RELATIONSHIP TO CARDHOLDER EMPLOYER
INS. CO. PHONE POLICY # GROUP #
MEDICARE PART D q Yes q No SUPPLEMENTAL INSURANCE q Yes q No
q Is patient a dependent of the insured (child <18 yrs; student >18 yrs)? Check if yes.
2. INSURANCE INFORMATION (REQUIRED. Include alpha prefix and suffix with policy and group# when applicable)
5. PHYSICIAN SIGNATURE (REQUIRED) SPECIAL NOTE: If attaching a prescription, physician must comply with state-specific prescription requirements, such as e-prescribing, state-specific prescription form, fax language, etc. Non-compliance with state-specific requirements could result in follow-up and delayed processing.
RADICAVA® (edaravone) 30 mg/100 mL injection for infusion
ICD-10: G12.21 Amyotrophic lateral sclerosis
By signing this form, I certify and acknowledge that I have read, understand, and agree to the Healthcare Provider Disclaimer and the Healthcare Provider Attestation for Searchlight Support® Patient Assistance Program on page 2 of this form. I am also indicating a prescribing decision has been made. In addition, I am certifying treatment with RADICAVA® indicated above is medically necessary for this patient, and I have received authorization to release the medical and/or other patient information relating to this therapy to Mitsubishi Tanabe Pharma America, Inc., its affiliated companies, agents and representatives as specified in the Patient Authorization on page 3 of this form. I certify that, to the best of my knowledge, the patient and physician information in this form is complete, accurate, and consistent with applicable privacy regulations. If I am attaching a prescription, I certify that I have prescribed the product based on my professional judgment of medical necessity. I give Searchlight Support® permission to contact this patient to help obtain a signed Patient Authorization, if the patient has not provided their signature in Section 3 of this form.PHYSICIAN SIGNATURE REQUIRED TO PROCESS PATIENT ENROLLMENT: I have reviewed the current RADICAVA® Prescribing Information and I will be supervising the patient’s treatment. If I have attached a prescription, I authorize Searchlight Support® to act on my behalf to transmit the prescription to a contracted specialty pharmacy.
PHYSICIAN SIGNATURE DATE
q Please provide Infusion Site Location Assistance if Primary and/or Secondary location is unknown
If Primary Site of infusion is known, provide information below:
FACILITY NAME CONTACT
FACILITY PHONE FACILITY FAX
If Secondary Site of infusion is known, provide information below:
FACILITY NAME CONTACT
FACILITY PHONE FACILITY FAX
6. PREFERRED SITE OF INFUSION (OPTIONAL) (Do not complete fields below if information is the same as Prescriber Information)
PRESCRIBER CONTACT NAME (First, Last)
PRACTICE NAME
ADDRESS
CITY STATE ZIP
PHONE FAX
MEDICAID/MEDICARE PROVIDER # STATE LICENSE # UPIN/NPI #
PREFERRED OFFICE CONTACT (IF DIFFERENT THAN ABOVE)
PHONE FAX
4. PRESCRIBER OFFICE INFORMATION (REQUIRED)
Please see full Indication and Important Safety Information and Prescribing Information for RADICAVA®, also available at radicava.com.
Out-of-Pocket Cost Support Considerations
What eligible patients can expect
• Savings on their deductible, co-pay, and co-insurance costs for their medication and infusion costs for RADICAVA®
• Applicable out-of-pocket costs are covered—up to $20,000 per calendar year
- Persons residing in Massachusetts, Minnesota, Michigan, and Rhode Island are eligible for out-of-pocket assistance for the cost of the drug only and are not eligible for other types of cost support for administration of the medication
• Patients will be responsible for any out-of-pocket costs above the maximum annual program benefit
• Patients will be automatically re-enrolled for the next calendar year, if eligible
See full Eligibility Requirements & Terms and Conditions, also available at radicava.com/hcp.
Searchlight Support® Out-of-Pocket Assistance Program
* Restrictions apply. $20,000 maximum program benefit per calendar year per eligibility criteria. See full Eligibility Requirements & Terms and Conditions for details.
PER INFUSION*ELIGIBLE PATIENTS PAY AS LITTLE AS $0$0
Patients with commercial insurance coverage may be eligible for assistance with their out-of-pocket costs for treatment with RADICAVA® (edaravone)
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Please see full Indication and Important Safety Information and Prescribing Information for RADICAVA®, also available at radicava.com.
ALS Care Locator—available at radicava.com/carelocator
The ALS Care Locator was designed for the ALS community to help locate ALS care providers, specifically healthcare providers (HCPs) who treat ALS and infusion centers.
The ALS Care Locator can help you:
• Search for infusion providers capable of administering RADICAVA® (edaravone), including home infusion, based on your patient’s preferences:
- Type of Facility, Location, Insurance Accepted, including Medicare- Languages spoken, Hours of Operation, Amenities
• Find neurologists and other HCPs who treat ALS
How to enroll:
You can enroll your practice or infusion service in the ALS Care Locator. Visit ALSCareDirectory.com for more information.*
When you enroll, your site of care and profile information will be publicly available at radicava.com.
The ALS Care Locator is an informational resource only regarding available treatment providers. The providers listed in the directory are under no obligation to provide treatment.
Specialty Distributors for Buy & BillRADICAVA® can be obtained through the following specialty distributors. Use the Order Form for Buy & Bill, available at radicava.com/hcp.
ASD 1-800-746-6273 Metro Medical 1-800-768-2002
Besse 1-800-543-2111 McKesson Plasma and Biologics 1-877-625-2566
Oncology Supply 1-800-633-7555 RxCrossroads by McKesson 1-855-477-9800
BioCARE 1-800-304-3064 CuraScript SD 1-877-599-7748
Cardinal 1-800-926-3161
This list is subject to change without notice. Contact your Mitsubishi Tanabe Pharma America, Inc. representative for the most recent list or additional questions regarding specialty distributors.
All company names, trademarks or other trade names are the property of their respective owners.
Site of Care Considerations
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* The ALS Care Locator is a directory with a number of functions, including a directory of infusion centers that treat ALS and which have opted-in to participate in the directory. This submission information is updated on a monthly basis.
HCPs and infusion centers listed in the directory are not affiliated with Mitsubishi Tanabe Pharma America, Inc. and do not pay to be on this list. No fees or remuneration of any kind have been or will be exchanged for participation in the ALS Care Locator. Inclusion of an infusion center in the ALS Care Locator does not constitute a referral, recommendation, endorsement, or verification of credentials, qualifications, or abilities of the infusion center listed. Similarly, the absence of an infusion center's name and information should not be construed as a negative comment from Mitsubishi Tanabe Pharma America, Inc. about the infusion center's credentials, qualifications, or abilities.
Mitsubishi Tanabe Pharma America, Inc., as well as its employees or agents, shall not be held liable for any damages or harm resulting from any use or reliance on information contained in the ALS Care Locator; and may modify, amend, remove, or cancel the ALS Care Locator at any time without notice.
Please see full Indication and Important Safety Information and Prescribing Information for RADICAVA®, also available at radicava.com.
Administering RADICAVA® (edaravone)
Reference: 1. RADICAVA® Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; August 2018.
First Cycle
consecutive days on
out of 14 days on
consecutive days off
consecutive days off
Subsequent Cycles
RADICAVA® should be administered under the guidance of a healthcare provider. It may be received at:
Home Infusion center Doctor’s office Hospital
Consult with your patient to determine which option is right for them.
How to administer1
Administer each 60 mg dose of RADICAVA® as 2 consecutive 30 mg IV infusion bags over a total of 60 minutes (infusion rate ~1 mg per minute).
• Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction
• Other medications should not be injected into the infusion bag or mixed with RADICAVA®
• 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
• Advise patients to seek immediate medical care if they experience signs or symptoms of a hypersensitivity reaction or a sulfite allergic reaction
Infusion schedule
RADICAVA® is an ongoing treatment for ALS. For the first cycle, RADICAVA® is infused for 14 days, followed by a 14-day drug-free period. Subsequent cycles are infused for 10 days within a 14-day period, followed by a 14-day drug-free period.1
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Please see full Indication and Important Safety Information and Prescribing Information for RADICAVA®, also available at radicava.com.
Preparing the Infusion Bag
Following these instructions can help prevent damage to the stopper and avoid medication leakage
Handle the bag gently. Hold the bag with the rubber stopper facing upward. If the bag is already hanging, remove it from the IV pole. Align the spike to the center of the stopper without twisting.
DO NOT spike upward. It is important NOT to insert the spike at an angle.
Very gently and carefully insert the spike straight into the center of the stopper.
It is important not to twist the spike when inserting it into the IV bag. Be sure to only spike once. DO NOT spike multiple times.
Be careful NOT to insert the spike at an angle. Doing so may damage the IV bag and cause medication leakage.
NEVER INFUSE A BAG IF THE SPIKE HAS BEEN IMPROPERLY INSERTED INTO THE RUBBER STOPPER, CAUSING MEDICATION LEAKAGE.
To learn how to infuse RADICAVA®, see the Administration Video at radicava.com.
STEP 1 STEP 2
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Please see full Indication and Important Safety Information and Prescribing Information for RADICAVA®, also available at radicava.com.
INDICATION
Radicava® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Hypersensitivity ReactionsRadicava® 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 ReactionsRadicava® 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 ReactionsMost common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache.
PregnancyBased on animal data, Radicava® may cause fetal harm.
Geriatric UseNo 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.
Please see Prescribing Information for RADICAVA®, also available at radicava.com.
RADICAVA, the RADICAVA logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks of Mitsubishi Tanabe Pharma Corporation. Searchlight Support is a registered trademark of Mitsubishi Tanabe Pharma America, Inc.For US audiences only.Mitsubishi Tanabe Pharma America, Inc.525 Washington Boulevard, Suite 400Jersey City, NJ 07310© 2019 Mitsubishi Tanabe Pharma America, Inc. All rights reserved. CP-RC-US-1207 11/19
If you have any questions,
please contact your Mitsubishi Tanabe Pharma America, Inc. MPA
Call Searchlight Support® for more information or visit radicava.com
Eligibility Requirements & Terms and Conditions for the Out-of-Pocket Assistance Program• This offer may not be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.• Patient must be a citizen or a permanent resident of the US or its territories, and reside in the US or its territories where co-pay assistance
is not prohibited. Offer good only in the US and its territories.• Patient must be 18 to 64 years of age and not enrolled in Medicare.• Patient must not be enrolled in government health insurance, (i.e., Medicare, Medicaid, VA, DoD, or other federal or state assistance
programs). If patient moves or switches from commercial insurance to any government health insurance, patient will no longer be eligible. • This program is not valid in states where prohibited by law, taxed, or otherwise restricted.• Persons residing in Massachusetts, Minnesota, Michigan, and Rhode Island are eligible for out-of-pocket assistance for the cost of the drug
only and are not eligible for other types of cost support for administration of the medication. • Patient is being treated as an outpatient by a licensed healthcare provider in the US and has been prescribed RADICAVA® (edaravone) by
a licensed healthcare provider.• Patient currently has private, commercial health insurance with prescription coverage for RADICAVA® medication, and patient’s insurance
does not cover the entire cost of RADICAVA®.• There is no income requirement.• Patient will be automatically re-enrolled on December 31st in subsequent calendar years after the initial enrollment period ends as long
as patient continues to meet the eligibility requirements for participation in the Program.• Patient is responsible for reporting receipt of co-pay assistance to any insurer, health plan, or other third party who pays for or reimburses
any part of the medication or treatment cost using the Searchlight Support® Out-of-Pocket Assistance Program, as may be required.• Patient must not seek reimbursement or compensation, in whole or in part, from government health insurance (including Medicare,
Medicaid, VA, DoD, or other federal or state assistance programs), a Flexible Spending Account (FSA), a Health Savings Account (HSA), or a Health Reimbursement Account (HRA).
• Patient will not in any way report or count the value of the product provided under this Program as true out-of-pocket spending (TrOOP) under a Medicare Part D prescription drug benefit.
• Claims must be submitted in a timely manner. An EOB from patient’s private, commercial health insurance must be submitted within 365 days of the date of service on the EOB for patient to receive out-of-pocket assistance benefit. No EOB may be submitted more than 90 days after the expiration date of the Out-of-Pocket Assistance Program, and the date of service on the EOB must be prior to the program expiration date. The EOB must reflect the patient’s out-of-pocket cost for RADICAVA® medication and infusion services and submission of the claim by the patient’s physician for the cost of the medication and infusion services.
• This Out-of-Pocket Assistance Program is not health insurance.• This offer is limited to one (1) per person during this offering period and is not transferable.• No membership fees.• This offer is not conditioned on any past, present or future purchase, including refills.• Offer expires December 31, 2020. Mitsubishi Tanabe Pharma America, Inc. has the right to modify, alter, or cancel the Searchlight Support®
Out-of-Pocket Assistance Program at any time without prior notification.
RADICAVA, the RADICAVA logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks of Mitsubishi Tanabe Pharma Corporation.Searchlight Support is a registered trademark of Mitsubishi Tanabe Pharma America, Inc. For US audiences only.Mitsubishi Tanabe Pharma America, Inc.525 Washington Boulevard, Suite 400Jersey City, NJ 07310© 2019 Mitsubishi Tanabe Pharma America, Inc. All rights reserved. CP-RC-US-1207 11/19
Please see full Indication and Important Safety Information and Prescribing Information for RADICAVA®, also available at radicava.com.