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. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO®. Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. Only dispensed and administered in healthcare settings. SPRAVATO (esketamine) MB1921 . No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. ���.�p�@?���9.06�L�K8�h�0�+P��00�}��@��>� ͌Z���8�;�`�c����D�;� .���956H�ﻸ�u^����ך�S�KgtJ�u+�u���pj�ف�:��Վ=w�e��|m7��q=�@�Jؼ0���Q����l�v@}&P��@����\�0 E �� The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. Spravato is a federally controlled substance because it can be abused or lead to dependence. Treatment-resistant depression (TRD) in adults. Females and Males of Reproductive Potential: SPRAVATO® may cause embryo-fetal harm when administered to a pregnant woman. Adults with treatment-resistant depression (TRD) Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions Sleepiness was comparable after 4 hours post-dose. All I needed to do at this point is find a physician participating in the program who accepts Medicare. This drug is likely to be covered under your medical benefit if you have insurance. 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. Medicaid Fee-for-Service is a state-specific program. Each device delivers 2 sprays containing a total of 28 mg of esketamine. Patients will need to arrange transportation home following treatment with SPRAVATO®. Closely monitor blood pressure with concomitant use of psychostimulants. 0 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. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. 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. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. UnitedHealthcare Medicare and Retirement plans. 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. If not currently enrolled, you can search for Medicare plans that cover Spravato. Since 2019, when it was approved for use by the FDA for treatment-resistant depression, people have been paying an average of $4,700.00 to … Coverage will be determined by the patient’s insurance plan and the plan’s specific benefit design. This shouldn’t be for the extremely wealthy only. Assess each patient’s risk for abuse or misuse prior to prescribing and monitor all patients for the development of these behaviors or conditions, including drug-seeking behavior, while on therapy. Drugs covered under Medicare Part D. Medicare Prescription Drug Plans and Medicare Advantage Prescription Drug plans cover all commercially available vaccine drugs when medically necessary to prevent illness. SPRAVATO® is available only through a restricted program under a REMS. No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. No . Costs for covered alternatives may vary. At the time of writing this, state and federal insurance plans such as Medicare, Medicaid, TriCare, and other Veteran Affairs-affiliated plans do not accept Ketamine Infusion Therapy as a covered treatment. | 877-524-3579877-CarePath (877-227-3728), Monday-Friday, 8:00 AM to 8:00 PM ET. %PDF-1.7 %���� SPRAVATO® is not approved in pediatric (<18 years of age) patients. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. h�b```f``:������� Ȁ �@16��| endstream endobj startxref You will not be able to use this medicine at home. ,l�eg�;������H3 T�[50�GX�8�8��=4 �#��!5��M��,N�P�+q���2��IgF�,f�T�!%�ۙ�drc�Ϧ��Z;ڬ�MC2�ey1�K�:�|���Ej��ӳV�6x[�ݴ�]I�n`�X�2�T )��]�6� ��Z`���~Z�N$���N_i4*���G��Ji��L �i6�U�=�F�`q �� �&ecӰ�(h`PN� 1��aeRR� Janssen assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. Part D Medicare coverage is an optional benefit that covers prescription drugs. 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. 2. Janssen CarePath does not endorse and is not responsible for the content on any of the websites listed below, or the services provided by these organizations. SPRAVATO™ treatment may be covered through the pharmacy benefit, medical benefit, or both. 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). Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. Lactation: SPRAVATO® is present in human milk. SPRAVATO® may cause fetal harm when administered to pregnant women. 4. BlueCHiP for Medicare Spravato™ (esketamine) is medically necessary when the criteria above have been met. This site is intended for use in the United States. COVERAGE Benefits may vary between groups and contracts. KanCare and Medicaid. 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. Spravato ™ requires … 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. Please file adjustments for claims that may have been incorrectly paid. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO®. 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. Member is at least 18 years old b. If you are uninsured or need help with your co-pay, the manufacturer may also offer assistance. Coverage for SPRAVATO® may depend on the indication as well as other factors. Closely monitor blood pressure with concomitant use of SPRAVATO® with psychostimulants or monoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)]. 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. Healthcare setting and dispensing pharmacy are certified in the Spravato REMS program. Program limits apply. Hepatic Impairment: SPRAVATO®-treated patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time. Dsuvia™ is covered only when administered in a hospital inpatient setting, and is not covered when administered in an outpatient setting. 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). Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO® and refer to an appropriate healthcare provider as clinically warranted. Both patient benefit design and location of certified SPRAVATO™ treatment centers will influence reimbursement for SPRAVATO™. 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. Hypersensitivity to esketamine, ketamine, or any of the excipients. Any word on whether Medicaid will cover Esketamine/Spravato? Controlled Substance: SPRAVATO® contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act. Use in this population is not recommended. All claims and other submissions to payers should be in compliance with all applicable requirements. Spravato is for use only in adults under a special program. 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. Janssen CarePath is not available to patients participating in the Patient Assistance Program offered by Johnson & Johnson Patient Assistance Foundation. I triple-questioned the customer service person to make sure there was no confusion. 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. Additional covered alternatives may be available. The Division of Health Care Finance (DHCF) is responsible for purchasing health services for children, pregnant women, people with disabilities, the aged, and the elderly through the Medicaid program, the Children’s Health Insurance Program (CHIP), and … Spravato nasal spray is supplied as an aqueous solution of esketamine hydrochloride in a vial with a nasal spray device. These eligibility standards include CHIP-funded Medicaid expansions. 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. Many major commercial and Medicare plans now cover SPRAVATO ® treatment for depression. ... 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. X\L��H��`�Lv�����`�)B��L����&�";@$w��\��"���"`�ȯ�[�$��E[*,�f�Q���g`�%,��8���L9 �� Spravato (esketamine) is a member of the miscellaneous antidepressants drug class and is commonly used for Depression, and Major Depressive Disorder. Embryo-fetal Toxicity: SPRAVATO® may cause fetal harm when administered to pregnant women. Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. 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.) 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. 276 0 obj <>stream SPRAVATO ® is a prescription medicine, used along with an antidepressant taken by mouth to treat: . 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. Medicaid Fee-for-Service is a state-specific program. 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. Healthcare settings must be certified in the program and ensure that SPRAVATO. CHIP covers birth through age 18 unless otherwise noted in parentheses. Patients treated in outpatient settings (e.g., medical offices and clinics) must be enrolled in the program. BP should be monitored for at least 2 hours after SPRAVATO® administration. ©  Johnson & Johnson Health Care Systems Inc. 2021. Otherwise, the plan decides which drugs to cover, which drugs not to cover, and under which tier to cover them. 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. States have the option to cover pregnant women under CHIP. 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. Closely monitor for sedation with concomitant use of CNS depressants. If BP remains high, promptly seek assistance from practitioners experienced in BP management. 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. No. Benefits investigations & prior authorizations, Enroll eligible patients in Savings Program. 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. For the record, my insurance provider at this time was Blue Cross Blue Shield (PPO plan). Spravato is also used to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. 5. Abuse and Misuse: SPRAVATO® contains esketamine, a Schedule III controlled substance (CIII), and may be subject to abuse and diversion. 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. 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). 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. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO®, during pregnancy. 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.

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