Prepare Patients for SPRAVATO® Treatment
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 observation period (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®; a healthcare provider will show them how to use the nasal spray device
- 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
- they will still be able to reach out to their referring HCP with any questions or to address concerns
Stay up-to-date with your patients’ treatment. Get started using the Patient Treatment Progress form.
Patients must also be informed that SPRAVATO® treatment requires a series of frequent appointments.
For patients with treatment-resistant depression (TRD), these appointments will take place on a twice-weekly schedule for the first 4 weeks (the induction phase). Evidence of therapeutic benefit should be evaluated at the end of the induction phase to determine the need for continued treatment. If treatment continues, appointments will be once weekly for weeks 5 to 8, then once every week or 2 weeks thereafter.*1
For depressive symptoms in adult patients with major depressive disorder (MDD) with acute suicidal ideation or behavior, these appointments will take place twice weekly for 4 weeks. After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment.*
It’s a good idea to set up these appointments at the outset to help ensure the proper timing is followed.
Patient REMS enrollment will differ in an inpatient vs outpatient setting. In an outpatient setting, 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.
* Treatment beyond 4 weeks has not been systematically evaluated.
LEARN MORE ABOUT THE SPRAVATO® REMS CERTIFICATION PROCESS ON THE REMS WEBSITE.
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 877-CarePath (877-227-3728), Monday – Friday, 8:00 AM to 8:00 PM ET.
Sign up or log in to the Provider Portal at JanssenCarePathPortal.com where you can request and review benefits investigations, enroll eligible patients in the Janssen CarePath Savings Program and view Savings Program transactions as requested by the patient.
Treat, Monitor, and Assess Patients
TREAT PATIENTS WITH SPRAVATO®
AND FOLLOW UP
Reach out to the referring HCP before the first SPRAVATO® treatment session.
Once the patient has begun their treatment, keep an open line of communication with the referring HCP about their progress.
Remember to remind patients that they should not have food for 2 hours or liquids for 30 minutes prior to their visit. After a patient self-administers the SPRAVATO® dose under the supervision of a healthcare provider, 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® – either for patients with TRD or for depressive symptoms in adult patients with MDD with acute suicidal ideation or behavior – 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.
Supply and Storage of Product
SPRAVATO® is available in the following presentations:
- 56-mg dose kit: Unit-dose carton containing two 28-mg nasal spray devices (56-mg total dose) (NDC 50458-028-02)
- 84-mg dose kit: Unit-dose carton containing three 28-mg nasal spray devices (84-mg total dose) (NDC 50458-028-03)
Within each kit, each 28-mg device is individually packaged in a sealed blister (NDC 50458-028-00).
- Once SPRAVATO® is delivered for a named-patient or is obtained for a healthcare setting’s bulk supply, it must be kept in a secure place per state and federal regulations
- Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F)
- Product dispensed for a specific, named-patient must be administered within 14 days after receipt by the healthcare setting
- After 14 days, unused named-patient products must be appropriately disposed of as per state and federal regulations and may not be returned to the general inventory of the healthcare setting or pharmacy
SPRAVATO® nasal spray devices must be handled with adequate security, accountability, and proper disposal, per facility procedure for a Schedule III drug product, and per applicable federal, state, and local regulations.
PLEASE REFER TO THE FULL PRESCRIBING INFORMATION AND INSTRUCTIONS FOR USE FOR MORE INFORMATION.
Manage Used and Unused Product
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.
SPRAVATO® Disposal Program
WHAT IS IT?
- Janssen has partnered with the SPRAVATO® Disposal Program, a reverse distribution company to support the safe return and destruction of partially used or unused dispensed patient-labeled product at no cost to the healthcare provider
WHEN TO USE IT?
- If you have partially used devices – meaning the patient received one spray and then either the patient or the healthcare provider decided not to continue with treatment
- If a pharmacy dispensed patient-labeled product to your healthcare setting and the patient was not treated with SPRAVATO® within 14 days of receipt
HOW TO USE IT?
- You can utilize the SPRAVATO® Disposal Program by calling 888-912-7348
WHAT TO EXPECT?
- When you call the SPRAVATO® Disposal Program, they will capture your name, practice name, address, DEA#, reason for disposal, # of units, NDC and description, lot #, and expiration date and send you a pre-populated packing slip (shipping label)
- Package the device and send via UPS Ground Transportation using the packing slip provided by the SPRAVATO® Disposal Program
PARTIALLY USED DEVICES
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® Disposal Program to dispose of unused or partially used devices if your healthcare setting is not equipped to do so. Simply call 888-912-7348.
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.
HANDLING DEVICE MALFUNCTIONS
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.
1. SPRAVATO® [Prescribing Information].
Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.
Education and Resources
Need Access and Reimbursement Support?
Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728),
Monday – Friday, 8:00 AM to 8:00 PM ET.
Multilingual phone support available.
Sign Up or Log In to the Provider Portal at JanssenCarePathPortal.com