Sleepiness was comparable after 4 hours post-dose. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. (NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance) 1. Embryo-fetal Toxicity: SPRAVATO® may cause fetal harm when administered to pregnant women. 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. 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. A substantial increase in blood pressure could occur after any dose administered even if smaller blood pressure effects were observed with previous administrations. If a retail pharmacy meets the REMS requirement and dispenses the drug directly to the administering provider, Spravato would be covered under the pharmacy benefit. ,l�eg�;������H3 T�[50�GX�8�8��=4 �#��!5��M��,N�P�+q���2��IgF�,f�T�!%�ۙ�drc�Ϧ��Z;ڬ�MC2�ey1�K�:�|���Ej��ӳV�6x[�ݴ�]I�n`�X�2�T )��]�6� ��Z`���~Z�N$���N_i4*���G��Ji��L �i6�U�=�F�`q �� �&ecӰ�(h`PN� 1��aeRR� Covered Service: Yes Prior Authorization Required: Yes Additional Information: Must be prescribed by, or in consultation with, a psychiatrist or psychiatric nurse practitioner with prior authorization through Navitus Medicare Policy: Prior authorization is dependent on the member’s Medicare coverage. Member is at least 18 years old b. 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. Pregnancy: SPRAVATO® is not recommended during pregnancy. 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 ® is a prescription medicine, used along with an antidepressant taken by mouth to treat: . Advise women of reproductive potential to consider pregnancy planning and prevention. Click on the state's name to access the state's Medicaid site. Adults with treatment-resistant depression (TRD) Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions Medicare Coverage for Spravato. At the time of writing this, state and federal insurance plans such as Medicare, Medicaid, TriCare, and other Veteran Affairs-affiliated plans do not accept Ketamine Infusion Therapy as a covered treatment. Lactation: SPRAVATO® is present in human milk. The team at your certified SPRAVATO® treatment center may be able to assist you in determining your specific insurance coverage for SPRAVATO® and potential out-of-pocket costs of treatment. Medicare Coverage for Esketamine Esketamine as a treatment for depression in adults is relatively new in the United States. Spravato (esketamine) is a member of the miscellaneous antidepressants drug class and is commonly used for Depression, and Major Depressive Disorder. No. Please refer to the applicable plan's website, or contact the plan for more information about coverage or any restrictions or prerequisites that may apply. The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. 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. Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO® caused cognitive performance decline 40 minutes post-dose. Use in this population is not recommended. Overview of Medicare. Long-Term Cognitive Impairment:  Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse. Pediatric Use: The safety and effectiveness of SPRAVATO® in pediatric patients have not been established. If you are uninsured or need help with your co-pay, the manufacturer may also offer assistance. Medicaid Fee-for-Service Medicaid Fee-for-Service. 276 0 obj <>stream This site is published by Johnson & Johnson Health Care Systems Inc. h�bbd```b``��M`v��h���� 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. Dsuvia™ is covered only when administered in a hospital inpatient setting, and is not covered when administered in an outpatient setting. Spravato must be administered in the presence of a certified healthcare provider and is covered under the medical benefit. h�b```f``:������� Ȁ �@16��| Medicare is a federal program that provides health insurance coverage to the following types of people: Individuals over age 65 with a work history Individuals with certain disabilities who have been disabled for at least 2 … 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. Member has a confirmed diagnosis of severe major depressive disorder (single or recurrent episode), documented by standardized rating scales that reliably measure depressive symptoms (e.g., Beck Depression Scale [BDI], Hamilton Depression Rating Scale [H… Yes. 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). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. For specific questions about your coverage, please call the number on your member ID card. Each HCP and patient is responsible for verifying or confirming any information provided. 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. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. Blank Entry: Not found in the public domainBrand: A patented drug listed in PDL or supporting documentsCovered: Drug is listed in PDL or supporting documentsPreferred: Refers to the coverage level of a drug. 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. Part D Medicare coverage is an optional benefit that covers prescription drugs. I know every state has its own list of covered meds, but just curious whether any Medicaid plans are going to be on board right away. 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. 3. Drugs covered under Medicare Part D. Medicare Prescription Drug Plans and Medicare Advantage Prescription Drug plans cover all commercially available vaccine drugs when medically necessary to prevent illness. Patients in need of this drug may find the cost paid by an insurance company, government, or non-profit organization. Please file adjustments for claims that may have been incorrectly paid. All claims and other submissions to payers should be in compliance with all applicable requirements. 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. SPRAVATO (esketamine) MB1921 . SPRAVATO® may cause fetal harm when administered to pregnant women. Assess BP prior to administration of SPRAVATO®. Capitalized product names are trademarks of Johnson & Johnson or its affiliated companies. Spravato nasal spray is used only in a healthcare setting. This site is intended for use in the United States. The use of the information on this site is subject to the terms of our Legal Notice and Privacy Policy. Closely monitor blood pressure with concomitant use of MAOIs. 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. 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. Only those products of the manufacturers which participate in the Federal Rebate Program will be covered by the Medicaid program. 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. Spravato is available as a nasal spray: 28 mg of esketamine per device. 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. Third party trademarks used herein are trademarks of their respective owners. Applicable Codes For the record, my insurance provider at this time was Blue Cross Blue Shield (PPO plan). There are risks to the mother associated with untreated depression in pregnancy. 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). 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. Medicaid Fee-for-Service is a state-specific program. Program limits apply. If not currently enrolled, you can search for Medicare plans that cover Spravato. I was told by United Healthcare, the insurance company providing Part D coverage, they cover Spravato with an $8.32 co-pay. SPRAVATO® is available only through a restricted program under a REMS. *The title for each state's Medicaid Fee-for-Service drug list may vary (eg, Prescription Drug List, Contract Drug List). Medicare beneficiaries may be able to get coverage for their depression medication and treatment – which could include esketamine or Spravato – if they have a Medicare Part D prescription drug plan or a Medicare Advantage Prescription Drug plan that offers coverage for the drug. 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. We encourage you to read the Privacy Policy of every website you visit. The mean esketamine Cmax and AUC values were higher in elderly patients compared with younger adult patients. Effective with date of service 3/8/2019, the North Carolina Medicaid and NC Health Choice programs cover esketamine nasal spray (Spravato™) for use in the Physician Administered Drug Program when billed with HCPCS code J3490 - Unclassified drugs. Benefits investigations & prior authorizations, Enroll eligible patients in Savings Program. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. 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. 0 Note: REQUIRES PRECERTIFICATIONFootnotes* Aetna considers esketamine (Spravato) nasal spray medically necessary for the treatment of treatment-resistant depression (TRD) in adults (18 years of age or older) when the following criteria are met: 1. Each device delivers 2 sprays containing a total of 28 mg of esketamine. Spravato is for use only in adults under a special program. ©  Johnson & Johnson Health Care Systems Inc. 2021. The availability of information and assistance may vary based on the Janssen medication, geography and other program differences. Treatment may include up to three devices administered on the same day. Treatment-resistant depression (TRD) in adults. Spravato administration, and advise no driving or use of heavy machinery for the remainder of the day. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO®. Patients will need to arrange transportation home following treatment with SPRAVATO®. Closely monitor blood pressure with concomitant use of psychostimulants. Instead, the patient must self-administer it under the supervision of a health care provider in a doctor’s office or clinic certified by the drug’s manufacturer — a distribution model that will further add to the cost of an already expensive treatment. Janssen CarePath is not available to patients participating in the Patient Assistance Program offered by Johnson & Johnson Patient Assistance Foundation. Spravato (esketamine) is considered medically necessary for the treatment of treatment-resistant depression (TRD) when ALL of the following are met: a. Coverage will be determined by the patient’s insurance plan and the plan’s specific benefit design. 242 0 obj <>/Filter/FlateDecode/ID[<5CB92A624344474C84E82901C2B5CAF7><7D936DF15153A643B2C0C396A729777C>]/Index[209 68]/Info 208 0 R/Length 139/Prev 263847/Root 210 0 R/Size 277/Type/XRef/W[1 3 1]>>stream Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®. Healthcare settings must be certified in the program and ensure that SPRAVATO. The Affordable Care Act provides a simplified method for calculating income eligibility for Health First Colorado and Child Health Plan Plus (CHP+) based on what is called Modified Adjusted Gross Income (MAGI). 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. Any word on whether Medicaid will cover Esketamine/Spravato? Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. Spravato Prices. | 877-524-3579877-CarePath (877-227-3728), Monday-Friday, 8:00 AM to 8:00 PM ET. Hypersensitivity to esketamine, ketamine, or any of the excipients. 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. Clicking on any of the links below will take you to a website to which our Privacy Policy does not apply. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice, nor does it promise or guarantee coverage, levels of reimbursement, payment, or charge. BlueCHiP for Medicare Spravato™ (esketamine) is medically necessary when the criteria above have been met. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. 209 0 obj <> endobj Coverage for SPRAVATO ® may depend on the indication as well as other factors. Only dispensed and administered in healthcare settings. %PDF-1.7 %���� 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). Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable physician administered drug benefits/coverage. Both patient benefit design and location of certified SPRAVATO™ treatment centers will influence reimbursement for SPRAVATO™. Females and Males of Reproductive Potential: SPRAVATO® may cause embryo-fetal harm when administered to a pregnant woman. SPRAVATO® is not approved in pediatric (<18 years of age) patients. Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. This drug is likely to be covered under your medical benefit if you have insurance. endstream endobj startxref Spravato ™ requires … You will not be able to use this medicine at home. 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/. Medicaid Fee-for-Service is a state-specific program. Closely monitor blood pressure with concomitant use of SPRAVATO® with psychostimulants or monoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)]. This table does not include notations of states that have elected to provide CHIP coverage of unborn children from conception to birth. All rights reserved. Closely monitor for sedation with concomitant use of CNS depressants. Please indicate length on Spravato (esketamine): Is this continuation request a result of the patient receiving samples of Spravato (esketamine)? Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO®, during pregnancy. SPRAVATO™ treatment may be covered through the pharmacy benefit, medical benefit, or both. These eligibility standards include CHIP-funded Medicaid expansions. This shouldn’t be for the extremely wealthy only. As with other medical treatments, contact your specific insurance provider to confirm whether SPRAVATO ® is covered for you. endstream endobj 210 0 obj <>>> endobj 211 0 obj <. Description. Member must meet the DSM-5 diagnostic criteria for 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. 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. The cost for Spravato nasal spray 28 mg is around $687 for a supply of 2 spray, depending on the pharmacy you visit. Cognitive performance and mental effort were comparable between SPRAVATO® and placebo at 2 hours post-dose. Costs for covered alternatives may vary. UnitedHealthcare Medicare and Retirement plans. 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. No . Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. 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. 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. SPRAVATO® has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Privacy Policy | Legal Notice | Site MapSite Map | Contact UsContact Us, Indications and Important Safety Information, Prior Authorization, Exceptions, & Appeals, Indication & Important Safety Information, Benefits Investigation Form - Tips for Completing, Savings Program – Submitting Medical Claims. Measure blood pressure around 40 minutes post-dose and subsequently as clinically warranted until values decline. Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities. Esketamine (Spravato TM) is the S-isomer of racemic ketamine and is an antidepressant which is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor (an ionotropic glutamate receptor).Due to adverse events (sedation, dissociation, etc.) 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 assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. CNS depressants (e.g., benzodiazepines, opioids, alcohol): Concomitant use may increase sedation. As this information varies by state, it is important to contact the state agency directly or consult its website to obtain product-specific coverage and other information. Coverage for SPRAVATO® may depend on the indication as well as other factors. 5. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. ... To access coverage for Spravato under the pharmacy benefit for a UnitedHealthcare member with pharmacy benefits managed by UnitedHealthcare and administered by OptumRx, a prior authorization should be requested through OptumRx. Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure. Abuse: Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of SPRAVATO®.