Consideration

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.

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:

1. SPRAVATO® REMS Outpatient Healthcare Setting Enrollment Form

2. SPRAVATO® REMS Inpatient Healthcare Setting Enrollment Form

3. SPRAVATO® REMS Patient Enrollment Form

4. SPRAVATO® REMS
Patient Monitoring Form
FOR PHARMACIES:

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:

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

2. How and when will you educate appropriate staff?

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:

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

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

3. What is your timeline for these preparations?

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®?
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 payer processes.
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:

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

2. Who on your staff will perform these activities?

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. July 2020.