Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. The REMS goal is to ensure that health care settings and pharmacies are certified and only dispense Sublocade directly to a health care provider for administration by a health care provider. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Targeted Alignment of Communication Can Improve Uptake of Men's Cancer Screenings in Marginalized Populations, FDA Issues EUA for COVID-19 Diagnostic Test to Confirm Recent or Prior COVID-19 Infection, New Technique for Cancer Cells Discovered to Evade Immunotherapies. A REMS must include a timetable for submission of assessments and can have several features, including elements to assure safe use (ETASU). The National Institute for Health and Care Excellence (NICE) has chosen not to recommend Janssen’s Spravato (esketamine) in a draft guidance due to uncertainties over its clinical and cost effectiveness. All rights reserved. Spravato is available only through a restricted program known as the Spravato REMS (Risk Evaluation and Mitigation Strategy) because of serious adverse outcomes that can be associated with the use of the medication including sedation, dissociation, abuse, misuse, and elevated blood pressure. By clicking "Continue" you will exit the SPRAVATO® REMS website. Spravato rejected by NICE. SPRAVATO ® can only be administered at healthcare settings certified in the SPRAVATO ® REMS Program. 4377 Bronx Blvd. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Treatment-resistant depression (TRD) in adults. This site is published by Janssen Pharmaceuticals Inc., which is solely responsible for its contents. SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the … Medical Buy & Bill Undecided Complete this section if you have checked REMS-certified Retail Pharmacy or if your patient has a preferred Specialty Pharmacy. REMS programs can be designed for a specific drug or a drug class, Ready said, adding that they are unique. SPRAVATO® REMS Resources PHARMACY • Inpatient Healthcare Setting Enrollment Form • REMS Program Overview • Prescribing Information • Pharmacy Enrollment Form • REMS Program Overview • Prescribing Information OUTPATIENT HEALTHCARE SETTING 8 Contact the SPRAVATO® REMS Phone: 1-855-382-6022 Fax: 1-877-778-0091 Hours of Operation: Monday- Friday 8:00 AM - 8:00 PM ET Visit … SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. Pharmacy … Spravato Nasal Spray Pharmacy Prior Authorization Request Form Do not copy for future use. 1. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program. REMS-certified Retail Pharmacy (If checked, please complete section below.) A REMS is a strategy to manage known or potential risks associated with a drug and is required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. You will need someone to drive you home after using Spravato. Inpatient Healthcare Settings must be certified, Outpatient Healthcare Settings must be certified, Patients must be enrolled in the SPRAVATO, Inpatient Healthcare Setting Certification, Outpatient Healthcare Setting Certification. Call … Specialty Pharmacy Support (We will provide information associated with REMS-certified Specialty Pharmacies that are covered under this patient’s plan.) 28th January 2020 . Ready, commander in the US Public Health Service and a risk management analyst at the FDA, first went over the basics of REMS, saying that the agency’s label is the official description of the drug product. “The communication plan is not intended for patients but health care providers.”. Further information, including a list of certified pharmacies is available at www.SPRAVATOrems.com or 1-855- 382-6022. Ready S, Dunn S. New drug approvals with REMS: the pharmacist’s role in supporting safe use. Health care setting requirements include completing, signing, and submitting the health care setting enrollment form to the REMS program, as well as having a prescriber during administration and for monitoring. Where to Find YESCARTA and TECARTUS REMS Program Information and Resources. SPRAVATO® must never be dispensed directly to a patient for home use. A presentation at the ASHP 54th Midyear Clinical Meeting and Exhibition in Las Vegas, Nevada, touched on how pharmacists can help manage risk evaluation and mitigation strategies (REMS). This site is intended for use by healthcare professionals in the United States and Puerto Rico. © 2021 MJH Life Sciences and Pharmacy Times. HEALTHCARE SETTINGS: A REMS-certified healthcare setting has 2 options for acquiring SPRAVATO®. Third party trademarks used herein are trademarks of their respective owners. All healthcare settings and pharmacies are required to enroll in the SPRAVATO™ REMS via a designated authorized representative before they can purchase product from a distributor, dispense, or supervise administration of SPRAVATO™ . SPRAVATO ® can only be administered at healthcare settings certified in the SPRAVATO ® REMS Program. Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. We are a REMs-certified pharmacy and currently dispense SPRAVATO to several pharmacies across New York State. A presentation at the ASHP (American Society of Health-System Pharmacists) 54th Midyear Clinical Meeting & Exhibition in Las Vegas, touched on how pharmacists can help manage risk evaluation and mitigation strategies (REMS). Spravato Pharmacy Prior Authorization Request Form Do not copy for future use. The REMS goals included ensuring that Spravato is only dispensed and administered to patients in a medically supervised health care setting that monitors these patients. The role of the pharmacist includes serving as the authorized representative for REMS enrollment, training staff members about REMS requirements and setting up policies and procedures to ensure safe use, and ensuring that the health care setting submits a patient-monitoring form documenting the outcome of the dose, as well as a separate adverse event form, if excessive sedation or loss of consciousness occur. Patient requirements include enrolling in the patient registry by completing the enrollment form with a health care provider and receiving counseling about the risks. For more information about the YESCARTA and TECARTUS REMS Program, see the Program Resources or call 1-844-454-KITE (5483). © 2021 MJH Life Sciences™ and Pharmacy Times. by. If you are an Inpatient Pharmacy (support inpatient units, emergency department, etc.) Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO ® is only available through a restricted program called the SPRAVATO ® Risk Evaluation and Mitigation Strategy (REMS) Program. T: (866)293-1559 Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Some people have thoughts about suicide while taking Spravato. Stay alert to changes in your mood or symptoms. Clinical Pharmacy Program Guidelines for Spravato- ARIZONA . Note that each patient's unique insurance benefit design may dictate … Please call to confirm. These may include that prescribers have special certifications or specific experience or training, that pharmacists or other dispensers be specially certified, and that the drug can be dispensed only in certain health care settings. “If you’ve seen 1 REMS, you’ve seen 1 REMS, she said. Forms are updated frequently. The REMS goals for Zulresso include that it must be administered only to patients in a medically supervised setting that provides monitoring while the drug is administered, ensuring that health care settings and pharmacies that dispense it are certified, ensuring that patients are informed of the risk of excessive sedation and loss of consciousness, and need for monitoring while it is administered. The pharmacy should be able to process the patient’s prescription under the patient’s medical benefit, pharmacy benefit, or both. Spravato is used only in a healthcare setting where you can be watched closely for at least 2 hours after each dose. Health care setting requirements include completing, signing, and submitting the health care setting enrollment form to the REMS program, as well as having a prescriber during administration and for monitoring. obtain the product from a REMS-certified pharmacy covered under the patient’s plan. Program does not cover costs to give you your treatment. • Pharmacies must be certified in the REMS and must only dispense Spravato to healthcare settings that are certified in the program. The safety concern for Sublocade that resulted in a REMS is the risk of death or serious harm that could result if the drug is self-administered intravenously. and operate under the same DEA license and physical location with your Inpatient Healthcare Setting, your pharmacy will be … The second drug approval is buprenorphine extended-release injection (Sublocade), which is intended to treat moderate to severe opioid use disorder. Inpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®, Outpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®, Pharmacies must be certified in the SPRAVATO® REMS in order to dispense SPRAVATO®, Patients must be enrolled in the SPRAVATO® REMS in order to receive SPRAVATO® treatment in an Outpatient Healthcare Setting, If you have any questions about the SPRAVATO® REMS or need help with certification or enrollment, call 1-855-382-6022Monday - Friday 8AM - 8PM ET, For SPRAVATO® REMS Program information contact: Pharmacy Claims BIN: 10020 GROP: 4002 Member: Medical Claims Payer I: 155 36 Member: Get savings on your out-of-pocket medication costs for SPRAVATO®. Pharmacy requirements include completing, signing, and submitting the pharmacy enrollment form to the REMS program. The third drug approval, esketamine nasal spray (Spravato), is used in conjunction with an oral antidepressant to treat treatment-resistant depression in adults. Pharmacies must be certified in the SPRAVATO ® REMS to be able to receive and dispense SPRAVATO ®.. SPRAVATO® is intended for use only in a certified Healthcare Setting. The risks for Spravato that led to REMS that were observed in clinical trials were dissociation, increased blood pressure, and sedation. Your healthcare provider will help you complete this form and provide you with a copy. You must be enrolled in the Savings Program before receiving your Janssen … If you have any questions about the SPRAVATO ® REMS or need help with certification or enrollment, call 1-855-382-6022 Monday - Friday 8AM - 8PM ET For SPRAVATO ® REMS Program information contact: Phone: 1-855-382-6022 Fax: 1-877-778-0091 In the presentation titled “New Drug Approvals With REMS: the Pharmacist’s Role in Supporting Safe Use,” 2 FDA analysts, Selena Ready, PharmD, and Somya Dunn, MD, discussed the role of REMS in new drug approvals and post-marketing safety, the safety concerns that required a REMS for certain new drug approvals, and resources for practitioners to use products safely. For more information, please reach out to us: Allure Specialty Pharmacy. Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). o SPRAVATO™ REMS Pharmacy Enrollment Form o SPRAVATO™ REMS Patient Enrollment Form o SPRAVATO™ REMS Patient Monitoring Form o SPRAVATO™ REMS Letter for Healthcare Providers o SPRAVATO™ Prescribing Information o SPRAVATO™ Medication Guide o SPRAVATO™ Instructions for Use For additional information or questions about the SPRAVATO™ REMS, call 1-855-382-6022. SPRAVATO ® Risk Evaluation and Mitigation Strategy (REMS). 1. The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. (Risk Evaluation and Mitigation Strategy). The first, brexanolone (Zulresso), is the first FDA-approved treatment for postpartum depression. REQUIRED: Office notes, labs and medical testing relevant to request showing medical justification are required to support diagnosis . • ®Enroll in the SPRAVATO REMS by completing this Pharmacy Enrollment Form and submitting this form to the SPRAVATO® REMS. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and Spravato dosing is in accordance with the United States Food and Drug Administration approved labeling; and Initial authorization will be for no longer than 12 weeks. Forms are updated frequently. Spravato 56 mg dose kit^ 56 mg/14 days _____ 2 units/14 days 0.15 units Spravato 84 mg dose kit* 84 mg/14 days _____ 3 units/14 days 0.22 units Suicidal Ideation Pharmacy Billing Weeks 1-4 Day Supply Weekly Daily Spravato 84 mg dose kit* 84 mg (twice a week) _____ 6 units/7days 0.86 units All rights reserved. Spravato. Fax: 1-877-778-0091, Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO® to Janssen at 1-800-JANSSEN (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch. SPRAVATO® (esketamine) nasal spray CIII is available only through a restricted distribution program called the SPRAVATO® REMS because of the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO. A certified SPRAVATO® treatment center designated as "Now Treating Patients" is defined as having submitted evidence of completed patient monitoring as part of the SPRAVATO® REMS patient registry. SPRAVATO® will not be delivered directly to patients. Program Prior Authorization Medication Spravato™ (esketamine) Markets in Scope Arizona . Continuation of Therapy . • ®Establish processes and procedures and train all relevant staff involved in dispensing SPRAVATO on the following: - SPRAVATO® can only be dispensed to a certified healthcare setting. Increased risk of suicidal thoughts and actions. “If we determine that labeling can’t mitigate a safety issue, we require a REMS,” she said. Report any new or worsening symptoms to your doctor. ©Janssen Pharmaceuticals, Inc. 2020 08/2020. REQUIRED: Office notes, labs and medical testing relevant to request showing medical justification to support diagnosis . This webpage does not constitute a replacement, modification, or revision of the approved REMS … Background: Quantity Limits and Exclusions: • Maximum dose of Spravato is 84 mg intranasally twice per week during the induction phase, (weeks 1-4); 84 mg intranasally once per week during the maintenance phase, weeks 5-8. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Ready and Dunn discussed 3 new drug approvals with REMS. Anna Smith. Health care settings and pharmacies must complete, sign, and submit an enrollment form to the REMS program, train all relevant staff members about REMS requirements, verify that Sublocade is dispensed directly to a health care provider, and notify health care providers that Sublocade must not be dispensed directly to patients. Safety concerns reported post-marketing were abuse and misuse, liver function and long-term cognitive impairment, and interstitial or ulcerative cystitis. Pharmacies must verify that the health care setting is certified prior to dispensing and not distribute, transfer, loan, or sell Zulresso. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Your facility or pharmacy must be SPRAVATO® REMS certified prior to acquiring SPRAVATO®. Our pharmacists will work with you to ensure that the medication is delivered in a safe and timely manner. SPRAVATO™ is available only through the SPRAVATO™ REMS, a restricted distribution program. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. *SPRAVATO™ is available only through a limited distribution program that is part of the SPRAVATO™ REMS. Drug Availa bility Only healthcare settings, pharmacies, and patients enrolled in the program can prescribe, dispense, and receive SPRAVATO™. Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico. Ketamine Therapeutics has been Certified as a Health Care Center and a Pharmacy by the SPRAVATO™ REMS program. Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. The REMS goals included ensuring that Spravato is only dispensed and administered to patients in a medically supervised health care setting that monitors these patients. The role of the pharmacist includes serving as the authorized representative for REMS enrollment, training staff members about REMS requirements and setting up policies and procedures to ensure safe use, and ensuring that the health care setting submits a post-infusion form documenting the outcome of the infusion, as well as a separate adverse event form, if excessive sedation or loss of consciousness occur. The role of the pharmacist includes serving as the authorized representative for REMS enrollment, training staff members about REMS requirements and setting up policies and procedures to ensure safe use. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Distributed by: Janssen Pharmaceuticals, Inc, Titusville, NJ 08560 Select either BUY-AND-BILL or PHARMACY to learn more about each option. Bronx, NY 10466. The safety concern for Zulresso that resulted in a REMS is the risk of excessive sedation or sudden loss of consciousness during infusion. Presented at: American Society of Health-System Pharmacists 54th Midyear Clinical Meeting and Exhibition; Las Vegas, Nevada: December 9, 2019. Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. Phone: 1-855-382-6022 Janssen Pharmaceuticals, Inc. recognizes that the internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. Sites that are "Now Treating Patients" may not be accepting new patients. SPRAVATO ® REMS Pharmacy Enrollment - for Outpatient Dispensing Only.