Treating Patients

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Prepare Patients for SPRAVATO® Treatment

Treating Patients

Before starting patients on SPRAVATO®, you must provide a thorough consultation to discuss the potential benefits, risks and side effects, and process of SPRAVATO® treatment. This includes going over the patient’s health history, explaining the reason for the monitoring (eg, checking blood pressure levels, sedation, and dissociation), reviewing the Boxed WARNINGS, and discussing the process and determination for release.1

Patients will need to know ahead of time that1:

they should avoid food for 2 hours and no liquids for 30 minutes prior to their visit

each appointment will last at least 2 hours, including monitoring

they will self-administer SPRAVATO®

they will not be permitted to drive themselves home, so they must arrange transportation after every treatment session

they cannot engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day after a restful sleep

Patients must also be informed that SPRAVATO® treatment requires a series of frequent appointments that take place on a twice-weekly schedule for the first 4 weeks, once weekly for weeks 5 to 8, then once every week or 2 weeks thereafter.1 It’s a good idea to set up these appointments at the outset to help ensure the proper timing is followed.

Once your patient has agreed to start SPRAVATO® treatment, you will need to enroll him or her in the program by submitting a SPRAVATO® REMS Patient Enrollment Form. Then set up an intake appointment to get started.

REMS=Risk Evaluation and Mitigation Strategy.

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

Patient Support

Before starting a patient on SPRAVATO®, you will need to investigate his or her insurance benefits and obtain prior authorization, if needed.

We can help make it simple for you to help your patients. Janssen CarePath is your one source for access, affordability, and treatment support for your patients.

Janssen CarePath helps verify insurance coverage for your patients, provides reimbursement information, helps find financial assistance options for eligible patients, and provides ongoing support to help patients start and stay on the SPRAVATO® treatment that you prescribed.

Call a Janssen CarePath Care Coordinator at 844-777-2828, Monday – Friday, 8:00 AM to 8:00 PM ET.

Visit JanssenCarePath.com.

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Treat, Monitor, and Assess Patients

TREAT PATIENTS WITH SPRAVATO® 
AND FOLLOW UP

Remember to remind patients that they cannot have food for 2 hours or liquids for 30 minutes prior to their visit. After a patient self-administers the SPRAVATO® dose, he or she must then be monitored for a minimum of 2 hours, followed by an assessment to determine whether the patient is clinically stable and ready to leave the healthcare setting. Staff must also ensure that patients have someone to take them home as they cannot drive themselves.1

REVIEW THE RECOMMENDED DOSING AS NEEDED

Any time you want to review dosing for SPRAVATO®, visit the SPRAVATO® website for US healthcare providers by clicking here.

SUBMIT THE APPROPRIATE FORMS FOR REIMBURSEMENT

In order to avoid delays in being reimbursed for the SPRAVATO® treatment, you should submit the appropriate forms as soon as possible. It may also be useful to click here to review the Access & Reimbursement Guide.

If you are using a specialty pharmacy, you need only submit a claim for healthcare provider services

If you are using the Buy-and-Bill process, you will need to submit a claim for both the medication and healthcare provider services

This is the point where you should also start planning for the next appointment.

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

Manage Used and Unused Product

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USED DEVICES Once the SPRAVATO® device has been used by the patient, it should be disposed of as medical waste according to local, state, and federal regulations for controlled substances.

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UNUSED DEVICES If the patient hasn’t been treated with SPRAVATO® within 14 days of receipt of the patient-labeled product dispensed from a pharmacy, then the product must be disposed of.

Turn to the SPRAVATO® Safe Returns Program to dispose of unused or partially used devices if your healthcare setting is not equipped to do so. Simply call Stericycle® at 888-912-7348.

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PARTIALLY USED DEVICES If the patient received 1 spray and then either the patient or the healthcare provider decided not to continue with treatment, then the partially used product must be disposed of.

Turn to the SPRAVATO® Safe Returns Program to dispose of unused or partially used devices if your healthcare setting is not equipped to do so. Simply call Stericycle® at 888-912-7348.

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EXPIRED PRODUCT If the product is past the expiration date printed on the box and blister pack, then coordinate with the pharmacy that sent you the expired product to exchange it for new product.

If you purchased the product from a distributor or wholesaler, you can learn about the returns process and eligibility criteria by calling INMAR® at 800-967-5952, or click here to review Janssen’s Returns Policy.

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HANDLING DEVICE MALFUNCTIONS If the device has prematurely expelled medication—or won’t expel medication—then a healthcare provider should call Janssen Medical Information at 800-JANSSEN to report a product quality complaint.

The Medical Information team will assist in taking complaint submission. Your staff must then determine how to obtain more product to prevent the patient from missing doses (if possible), and follow the process for returning the device.

Reference:

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

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Next:

Education and Resources

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