Consideration

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What to Consider Before Becoming a REMS-Certified
 Treatment Center

What to Know About Becoming a REMS-Certified SPRAVATO® Treatment Center

For an overview of setting up a REMS-certified SPRAVATO® treatment center, watch the video below.

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REMS=Risk Evaluation and Mitigation Strategy.

Understanding How to Enroll

You should become familiar with the SPRAVATO® REMS requirements before beginning the certification process.

For healthcare settings, there will be forms that need to be completed depending on your setting’s designation as inpatient or outpatient.

For pharmacies, only the REMS enrollment form is required.

FOR HEALTHCARE SETTINGS:

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1. SPRAVATO® REMS Outpatient Healthcare Setting Enrollment Form

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2. SPRAVATO® REMS Inpatient Healthcare Setting Enrollment Form

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3. SPRAVATO® REMS Patient Enrollment Form

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4. SPRAVATO® REMS 
Patient Monitoring Form

FOR PHARMACIES:

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1. SPRAVATO® REMS 
Pharmacy Enrollment Form

LEARN MORE ABOUT THE SPRAVATO® REMS CERTIFICATION PROCESS ON THE REMS WEBSITE.

Complying With 
Controlled Substance Requirements

As SPRAVATO® is a Schedule III controlled substance, your REMS-certified SPRAVATO® treatment center will require appropriate storage of SPRAVATO®.1

Staff protocols will need to be established for handling and disposal as well, in accordance with federal and state regulations and laws.1

THINGS TO CONSIDER:

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1. Which space will you designate as your secure storage area?

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2. How and when will you educate appropriate staff?

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3. What is your timeline for these preparations?

 

Considerations for 
SPRAVATO® Treatment

Your REMS-certified SPRAVATO® treatment center will require a space with seating in which patients can self-administer SPRAVATO® under the supervision of a trained healthcare provider. The patient must then be monitored post-administration for a minimum of 2 hours.1

It’s important to note that once a patient starts SPRAVATO®, multiple appointments will be needed as part of the patient's treatment plan.1

THINGS TO CONSIDER:

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1. Which location within the treatment center will be used for SPRAVATO® treatment administration, observation and monitoring?

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2. How will you educate existing or new staff to handle patient visits?

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3. What is your timeline for these preparations?

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4. Does your practice have the capacity to accept referrals, and schedule and accommodate the series and frequency of appointments required for patients requiring treatment with SPRAVATO®?

If yes, let HCPs in your community know you're accepting new SPRAVATO® patients. And ensure your practice's information is up to date at spravatohcp.com/find-a-center

Understanding the 
Access and 
Reimbursement Process

Treatment centers should have the ability to conduct benefits investigations and understand reimbursement requirements for patient access to SPRAVATO® or they may partner with SPRAVATO withMe for support.

Once a prescribing decision has been made Spravato WithMe  logo can help navigate access and affordability processes efficiently so you can focus on your patients

Learn how to minimize delays in the access process with the help of Case Managers. They will provide you with educational support to help your patients navigate the process and get them started on treatment quickly.

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Benefits investigations for medical and pharmacy coverage

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Real-time notifications via a custom portal view with updates on your individual patients and accounts

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Prior authorization and appeals support

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A progress tracker that provides visibility to your patients' access status

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Coding and reimbursement support

affordability

Patient affordability support

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Confirmation on which pharmacies accept your patients' insurance

THINGS TO CONSIDER:

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1. Does your treatment center have the ability to manage benefits investigations and their reimbursement process for patients?

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2. Who on your staff will perform these activities?

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3. Do you need support from Janssen CarePath to help conduct your patients' benefits investigations and provide information on the prior authorization process and reimbursement?

Learn more about how SPRAVATO withMe can help your patients at www.spravatohcp.com/spravato-with-me

To find out more about SPRAVATO withMe or to enroll your patients, give us a call at 1-844-4S-WITHME (1-844-479-4846), Monday through Friday, from 8:00 AM to 8:00 PM ET.

SPRAVATO withMe Care Navigators: dedicated support for your patients at every step of their treatment journey. Your adult patients prescribed SPRAVATO®, regardless of their insurance, will have access to SPRAVATO withMe Care Navigators, mental health professionals* who can offer supplemental one-to-one support.

Reference:

1. SPRAVATO® [Prescribing Information]. 
Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

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Next:

Certify and Establish a 
Treatment Center