Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®.
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 (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:
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.
Once a prescribing decision has been made can help navigate access and affordability processes efficiently so you can focus on your patients
SPRAVATO withMe Case Managers provide you with educational support to help your patients start and stay on track.
SPRAVATO withMe SAVINGS PROGRAM
Eligible patients with commercial insurance pay as little as $10 per treatment for their SPRAVATO® medication. There are quantity limits and savings limits each year. Program does not cover the cost of treatment observation. Patients may participate without sharing their income information. See program requirements
SPRAVATO withMe is limited to education for patients about SPRAVATO®, its administration, and/or their disease, and is not intended to provide medical advice, replace a treatment plan from the patient's doctor or nurse, or provide case management services.
Learn more about how SPRAVATO withMe can help your patients at www.spravatohcp.com/spravato-with-me
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.
SPRAVATO® is available in the following presentations:
Within each kit, each 28-mg device is individually packaged in a sealed blister (NDC 50458-028-00).
DISPOSAL
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.
WHAT IS IT?
WHEN TO USE IT?
HOW TO USE IT?
WHAT TO EXPECT?
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.
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.
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. July 2020.