Some patients taking SPRAVATO® may experience nausea or vomiting. No adverse effects of SPRAVATO® nasal spray on cognitive functioning were observed in a one-year open-label safety study; however, the long-term cognitive effects of SPRAVATO® have not been evaluated beyond one year. Treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior: dissociation, dizziness, sedation, blood pressure increased, hypoesthesia, vomiting, euphoric mood, and vertigo. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Diagnosis/ICD Code Approximate date of patient’s diagnosis (mm/dd/yyyy) Treatment Information for SPRAVATO™ Dose Strengths to Investigate: 84 mg 56 mg Clinical Information (Required) The information requested here is needed to investigate benefits. Spravato is approved by the Food and Drug Administration (FDA) to treat a form of depression called treatment-resistant depression (TRD). SPRAVATO® is not approved in pediatric (<18 years of age) patients. In patients whose BP is elevated prior to SPRAVATO® administration (as a general guide: >140/90 mmHg), a decision to delay SPRAVATO® therapy should take into account the balance of benefit and risk in individual patients. Only dispensed and administered in healthcare settings. Abuse and Misuse: SPRAVATO® contains esketamine, a Schedule III controlled substance (CIII), and may be subject to abuse and diversion. SPRAVATO® may cause fetal harm when administered to pregnant women. Closely monitor for sedation with concomitant use of CNS depressants. Administered by patients under the direct observation of a healthcare provider and that patients are monitored by a healthcare provider for at least 2 hours after administration of SPRAVATO, Pharmacies must be certified in the REMS and must only dispense SPRAVATO. Patient insurance benefits investigation and other Janssen CarePath program offerings are provided by third-party service providers for Janssen CarePath, under contract with Johnson & Johnson Health Care Systems Inc. on behalf of Actelion Pharmaceuticals US, Inc., Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc., and Janssen Products, LP (Janssen). The medicine, which is used in conjunction with an antidepressant administered orally, is designed for adults who suffer from treatment-resistant depression (TRD). Benefits Investigation Form Complete and fax this form to Janssen CarePath at 833-777-7282. Program limits apply. Benefits Investigation via CarePath Program. Closely monitor blood pressure with concomitant use of psychostimulants. Diagnosis/ICD Code Approximate date of patient’s diagnosis (mm/dd/yyyy) Treatment Information for SPRAVATO™ Dose Strengths to Investigate: 84 mg 56 mg Each HCP and patient is responsible for verifying or confirming any information provided. Benefits Investigation Form Complete and fax this form to Janssen CarePath at 833-777-7282. If BP remains high, promptly seek assistance from practitioners experienced in BP management. Healthcare settings must be certified in the SPRAVATO ® REMS in order to prescribe product. 1 People who are currently struggling with major depressive disorder (MDD) may have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode. Release Form . Closely monitor for sedation with concomitant use of SPRAVATO® with CNS depressants [see Drug Interaction (7.1)]. Patients will need to arrange transportation home following treatment with SPRAVATO®. SPRAVATO® is contraindicated in patients for whom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage). If a woman becomes pregnant while being treated with SPRAVATO®, treatment with SPRAVATO® should be discontinued and the patient should be counseled about the potential risk to the fetus. 1. SPRAVATO ® is only available through a restricted program called the SPRAVATO ® REMS (5.4). SPRAVATO® has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Capitalized product names are trademarks of Johnson & Johnson or its affiliated companies. Spravato™ Nasal Spray. Benefits Investigation Form - Tips for Completing, Savings Program – Submitting Medical Claims. Clinical Information (Required) The information requested here is needed to investigate benefits. The impact is even greater for individuals who do not benefit from standard treatments. The efficacy of SPRAVATO ® for the treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO ® plus a newly initiated oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 years of age. 1. 2. Benefits Investigation Form 3 of 5 6. Impaired Ability to Drive and Operate Machinery: Before SPRAVATO® administration, instruct patients not to 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 following a restful sleep. Assess blood pressure prior to dosing with SPRAVATO [see Warnings and Precautions (5.6)]. The efficacy of SPRAVATO® for the treatment of TRD in geriatric patients was evaluated in a 4-week, randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO® plus a newly initiated oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 years of age. The use of the information on this site is subject to the terms of our Legal Notice and Privacy Policy. I understand that I am entitled to a signed copy of this authorization. 3 of 6 6. No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age. Janssen CarePath is not available to patients participating in the Patient Assistance Program offered by Johnson & Johnson Patient Assistance Foundation. You may want to bring a book, a relaxing playlist or another form of entertainment for the session because your healthcare provider will monitor you for at least two hours after treatment. Use in this population is not recommended. Note that each patient's unique insurance benefit design may dictate how you ultimately acquire SPRAVATO®. Given its potential to induce dissociative effects, carefully assess patients with psychosis before administering SPRAVATO®; treatment should be initiated only if the benefit outweighs the risk. It’s … It is to be used in conjunction with an oral antidepressant to help those who have failed to respond to at least 2 antidepressants. Approximately 8% to 19% of SPRAVATO®-treated patients experienced an increase of more than 40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the first 1.5 hours after administration at least once during the first 4 weeks of treatment. Please switch auto forms mode to off. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. Embryo-fetal Toxicity: SPRAVATO® may cause fetal harm when administered to pregnant women. Assess BP prior to administration of SPRAVATO®. Closely monitor blood pressure with concomitant use of MAOIs. This form does NOT serve as a valid prescription. Spravato is approved by the Food and Drug Administration (FDA) to treat a form of depression called treatment-resistant depression (TRD). Hepatic Impairment: SPRAVATO®-treated patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time. Please complete these forms if directed by our office staff, and then submit them to us. 1. The med, also known as esketamine, won FDA approval earlier this year in … ... (marketed as a nasal spray called Spravato). 3. Sleepiness was comparable after 4 hours post-dose. Controlled Substance: SPRAVATO® contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO®. New Orleans, LA, (May 21, 2019) — The Janssen Pharmaceutical Companies of Johnson & Johnson presented a new cost-efficiency analysis at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting (ISPOR 2019) that illustrates the value of SPRAVATO™ (esketamine) CIII nasal spray for treatment-resistant depression (TRD), for patients, U.S. payers, and … Pregnancy: SPRAVATO® is not recommended during pregnancy. | 877-524-3579877-CarePath (877-227-3728), Monday-Friday, 8:00 AM to 8:00 PM ET. Before prescribing SPRAVATO®, patients with other cardiovascular and cerebrovascular conditions should be carefully assessed to determine whether the potential benefits of SPRAVATO® outweigh its risk. Spravato Benefit Investigation Consent. The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. • Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. SPRAVATO has the potential to be abused and misused. Attention A T users. The mechanism by which esketamine exerts its antidepressant effect is unknown. Lactation: SPRAVATO® is present in human milk. The FDA has now approved the first drug that can relieve depression in hours instead of weeks. Consider the risks and benefits of prescribing esketamine prior to using in patients at higher risk of abuse. Spravato is an altered form of ketamine, which is used legally in anesthesia and illegally as a street drug. Spravato Forms. Adults with treatment-resistant depression (TRD) Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions Long-Term Cognitive Impairment:  Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. PDF Form. In patients with history of hypertensive encephalopathy, more intensive monitoring, including more frequent blood pressure and symptom assessment, is warranted because these patients are at increased risk for developing encephalopathy with even small increases in blood pressure. Since the FDA-approval of Spravato on March 5, 2019, we have received numerous questions about the drug from those suffering from depression who have not had success with conventional treatments.. Below is a list of the most commonly asked questions about Spravato from our readers, answered by our pharmacist. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. ; If baseline blood pressure is elevated (e.g., >140 mmHg systolic, >90 mmHg diastolic), consider the risks of short term increases in blood pressure and benefit of SPRAVATO treatment [see Warnings and Precautions (5.6)]. At the end of four weeks, there was no statistically significant difference between groups on the primary efficacy endpoint of change from baseline to Week 4 on the Montgomery-Åsberg Depression Rating Scale (MADRS). Janssen Pharmaceuticals, Inc. 221 1/21 cp-6844v5 Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. Janssen CarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the HCP under appropriate authorization following the provider's exclusive determination of medical necessity. Would you take a brief survey so we can improve your experience on our website ? Consider changing the therapeutic regimen, including possibly discontinuing SPRAVATO® and/or the concomitant oral antidepressant, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO® caused cognitive performance decline 40 minutes post-dose. This information and assistance are made available as a convenience to patients, and there is no requirement that patients or HCPs use any Janssen product in exchange for this information or assistance. If prior authorization is not obtained, Oxford will review for out-of-network benefits and medical necessity after the service is rendered. The availability of information and assistance may vary based on the Janssen medication, geography and other program differences. Privacy Policy | Legal Notice | Site MapSite Map | Contact UsContact Us, Indications and Important Safety Information, Prior Authorization, Exceptions, & Appeals, Indication & Important Safety Information. Once benefit coverage has been approved for Spravato under the pharmacy benefit, a prescription can be filled by the provider at any Spravato certified pharmacy within UnitedHealthcare’s retail pharmacy network which includes Genoa Healthcare pharmacies which are dedicated to individuals with behavioral health and complex, chronic conditions. Pediatric Use: The safety and effectiveness of SPRAVATO® in pediatric patients have not been established. These links should direct you to forms you may need if you are applying for esketamine (Spravato) treatment through our office. Janssen assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. ... Spravato Benefits Investigation Form. There are risks to the mother associated with untreated depression in pregnancy. Spravato is a prescription medication for the treatment of depression. In a recent article titled “ FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression, “ NPR stated: “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Dr. Tiffany Farchione, … No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. Created Date: This section is … SPRAVATO™ (esketamine) CIII, is a nasal spray approved for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). SPRAVATO® is available only through a restricted program under a REMS. Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO® and refer to an appropriate healthcare provider as clinically warranted. SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS): SPRAVATO® is available only through a restricted program called the SPRAVATO® REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse. Measure blood pressure around 40 minutes post-dose and subsequently as clinically warranted until values decline. Cognitive performance and mental effort were comparable between SPRAVATO® and placebo at 2 hours post-dose. Because of the possibility of delayed or prolonged sedation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Hypersensitivity to esketamine, ketamine, or any of the excipients. Hit enter to expand a main menu option (Health, Benefits, etc). PDF Form. SPRAVATO® may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment, and to be “spaced out.” Monitoring for signs of abuse and misuse is recommended. In 2019 Janssen’s product called Spravato, which contains ketamine molecules, officially became FDA approved. 2 If you don't find what you are looking for in this article, be sure to … 4 of 6 Janssen Pharmaceuticals, Inc. 2019 12/19 cp-68044v3 Please see the full Prescribing Information, including Boxed WARNINGS and Medication Guide, for SPRAVATO®. ... Spravato Benefits Investigation Form. Geriatric Use: Of the total number of patients in Phase 3 clinical studies exposed to SPRAVATO®, 12% were 65 years of age and older, and 2% were 75 years of age and older. INSTRUCTIONS: This form is intended only for use by outpatient medical offices or clinics, excluding emergency departments. This site is intended for use in the United States. at 1-877-778-0091. Abuse: Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of SPRAVATO®. ©  Johnson & Johnson Health Care Systems Inc. 2021. ;3û½.¹;×åh”éÑ¡kÁô }zĞâôdBhKH¢Çı…şj]ÖͲuurÌ\ IË÷g ©ÏRŸ%ÎtRZT‚‰Ç«mI+j[Ó‰J. J&J Financial Assistance Program: Insurance Coverage: Superbill submitted by patient for reimbursement of E&M. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Benefits investigations & prior authorizations, Enroll eligible patients in Savings Program. Select either BUY-AND-BILL or PHARMACY to learn more about each option. Closely monitor blood pressure with concomitant use of SPRAVATO® with psychostimulants or monoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)]. To enter and activate the submenu links, hit the down arrow. Registration Forms: Child/Adolescent Registration Forms (Under 18 years of age) Adult Registration Forms. The mean esketamine Cmax and AUC values were higher in elderly patients compared with younger adult patients. Dissociation: The most common psychological effects of SPRAVATO® were dissociative or perceptual changes (including distortion of time, space and illusions), derealization and depersonalization (61% to 84% of SPRAVATO®-treated patients developed dissociative or perceptual changes). Spravato Clinical Trials and Results. Spravato is a nasally administered form of esketamine that is FDA approved for the treatment of treatment resistant depression in adults over the age of 18. SPRAVATO ® REMS Healthcare Setting Enrollment. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. Spravato Forms. In clinical studies with SPRAVATO® nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO®-treated patients than in placebo-treated patients. All rights reserved. It’s approved for use in adults, in combination with at least one other antidepressant drug that’s taken by mouth. Increase in Blood Pressure: SPRAVATO® causes increases in systolic and/or diastolic blood pressure (BP) at all recommended doses. Treatment may include up to three devices administered on the same day. 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. SPRAVATO® will not be delivered directly to patients. At the end of four weeks, there was no statistically … A substantial increase in blood pressure could occur after any dose administered even if smaller blood pressure effects were observed with previous administrations. https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. ... for SPRAVATO™, and discuss any questions you have with your doctor. BP should be monitored for at least 2 hours after SPRAVATO® administration. Treatment-resistant depression (TRD) in adults. Blood Pressure Assessment Before and After Treatment. Benefits Investigation Form 3 of 5 6. SPRAVATO ® is a prescription medicine, used along with an antidepressant taken by mouth to treat: . The efficacy of two forms of ketamine treatments for depression is compared. Please complete these forms if directed by our office staff, and then submit them to us. Jansen Pharmaceuticals Pharmacy Benefit. Increases in BP peak approximately 40 minutes after SPRAVATO® administration and last approximately 4 hours. 1. SPRAVATO® is contraindicated in patients with: Sedation: In clinical trials, 48% to 61% of SPRAVATO®-treated patients developed sedation and 0.3% to 0.4% of SPRAVATO®-treated patients experienced loss of consciousness. PDF Form. Spravato (esketamine) is the S-enantiomer of racemic ketamine, and is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. Consider the risks and benefits of prescribing SPRAVATO prior to use in patients at higher risk of abuse. This site is published by Johnson & Johnson Health Care Systems Inc. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. This form does NOT serve as a valid prescription. Assess each patient’s risk for abuse or misuse prior to prescribing and monitor all patients for the development of these behaviors or conditions, including drug-seeking behavior, while on therapy. Third party trademarks used herein are trademarks of their respective owners. These links should direct you to forms you may need if you are applying for esketamine (Spravato) treatment through our office. Authorization Form, or cancel or revoke my authorization later, I understand that this means I will not be able to participate or receive assistance from Janssen CarePath. The most common adverse reactions with SPRAVATO® plus oral antidepressant (incidence ≥5% and at least twice that of placebo nasal spray plus oral antidepressant) were: TRD: dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk. Refer patients experiencing symptoms of a hypertensive crisis (e.g., chest pain, shortness of breath) or hypertensive encephalopathy (e.g., sudden severe headache, visual disturbances, seizures, diminished consciousness, or focal neurological deficits) immediately for emergency care. Females and Males of Reproductive Potential: SPRAVATO® may cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. All claims and other submissions to payers should be in compliance with all applicable requirements. This form is needed to authorize release of any of your records to another specified professional. Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included adult and pediatric patients, the incidence of suicidal thoughts and behaviors in patients age 24 years and younger was greater than in placebo-treated patients. CNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increase sedation. Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label use or misuse/abuse of ketamine. Careful consideration is advised prior to use of individuals with a history of substance use disorder, including alcohol. Patients treated in outpatient settings (e.g., medical offices and clinics) must be enrolled in the program. Spravato Registration Forms . Provide the Medication Guide to your patients and encourage discussion. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato … Potential for abuse and misuse. Consider the risks and benefits of using SPRAVATO ® prior to use in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse [see WARNINGS AND PRECAUTIONS]. Monitor for signs and symptoms of abuse and misuse (5.3). Spravato must be administered at a REMS certified treatment center. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®. To access the menus on this page please perform the following steps. Important requirements of the SPRAVATO® REMS include the following: Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. HEALTHCARE SETTINGS: A REMS-certified healthcare setting has 2 options for acquiring SPRAVATO®. PDF Form. Healthcare settings must be certified in the program and ensure that SPRAVATO. Spravato® (Esketamine) Page 1 of 9 UnitedHealthcare Oxford Clinical Policy Effective 02/01/2021 ©1996-2021, Oxford Health Plans, LLC . No insurance verification by KWC: CarePath performs benefits investigation. SPRAVATO® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of: WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS, See full prescribing information for complete boxed warning. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Provide the Medication Guide to your patients and encourage discussion. SPRAVATO® (esketamine) CIII nasal spray is indicated, in conjunction with an oral antidepressant (AD) for the treatment of: • Treatment-resistant depression (TRD) in adults. Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. Advise women of reproductive potential to consider pregnancy planning and prevention. Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure. 8. Individuals with a history of drug abuse or dependence are at greater risk; therefore, use careful consideration prior to treatment of individuals with a history of substance use disorder and monitor for signs of abuse or dependence. For most people, antidepressant drugs or psychotherapy sessions may help lessen the symptoms, but standard treatments are not sufficient for patients with TRD. Depending on how their insurance covers SPRAVATO®, there is a program benefit limit of list price of the medication and a quantity limit of three devices per day or up to 24 devices in the first 24-day period, and three devices per day or up to 23 devices in a 24-day period after the first 24-day period. The FDA Approval of Spravato was based on 3 short-term clinical trials contacted for 4 weeks and 1 long-term maintenance-of-effect trial, which involved assessing the … ®Complete this form online at www.SPRAVATOrems.com, or complete the paper form and fax to the SPRAVATO REMS. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO®, during pregnancy. SPRAVATO™ is an FDA approved prescription medicine, used with oral antidepressants, for treatment-resistant depression (TRD) and Major Depressive Disorder (MDD) with Suicidal Ideation in adults. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO®. SPRAVATO®-treated subjects required a greater effort to complete the cognitive tests at 40 minutes post-dose.
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