Consideration

considerations-banner

What to Consider Before Becoming a REMS-certified
 Treatment Center

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

consideration-videocover
play-button

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, this includes 3 forms that will need to be completed in order to certify your healthcare setting, as well as to enroll and treat patients.

For pharmacy settings, only the REMS enrollment form is required.

FOR HEALTHCARE SETTINGS:

requirements-icon

1. SPRAVATO® REMS Healthcare Setting Enrollment Form

requirements-icon

2. SPRAVATO® REMS Patient Enrollment Form

requirements-icon

3. SPRAVATO® REMS 
Patient Monitoring Form

FOR PHARMACY SETTINGS:

enrollmentform

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:

consider1-red

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

managing2

2. How and when will you educate appropriate staff?

consider3-red

3. What is your timeline for these preparations?

consideration-breakimage

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 for the induction and maintenance visits as part of the patient’s treatment plan.1

THINGS TO CONSIDER:

consider1

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

consider2

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

consider3

3. What is your timeline for these preparations?

consider4

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

Understanding the 
Access & 
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 Janssen CarePath for support.

Janssen CarePath provides access, affordability, and treatment support for your patients.

Access support to help navigate the payer process.
Janssen CarePath helps verify insurance coverage for your patients prescribed SPRAVATO®, and provides reimbursement information.

Affordability support to help your patients start and stay on the treatment you prescribe.
Janssen CarePath can help you find out what affordability assistance may be available for your patients taking SPRAVATO®.

Treatment support to help your patients get informed and stay on SPRAVATO®.
Janssen CarePath provides additional support to your patients, including patient education, web-based resources, and assistance finding a location that offers SPRAVATO® treatment.

THINGS TO CONSIDER:

under-desk

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

managing2

2. Who on your staff will perform these activities?

managing1

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?

Or call Janssen CarePath at 844-777-2828
Monday – Friday, 8:00 AM to 8:00 PM ET.

Reference:

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

next-background

Next:

Certify and Establish a 
Treatment Center

Need a SPRAVATO® REMS-certified pharmacy? 
Call 855-382-6022

Need Access and Reimbursement Support?
Call a Janssen CarePath Care Coordinator at 844-777-2828,
 Monday – Friday, 8:00 AM to 8:00 PM ET
or visit JanssenCarePath.com