General information about the safe and effective use of SPRAVATO. The conclusion that a particular service or supply is medically necessary does not constitute a To make an appropriate determination, providing the most accurate diagnosis for the use of the SPRAVATO ® is intended for use only in a certified Healthcare Setting. If you are uninsured or need help with your co-pay, the manufacturer may also offer assistance. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0374-19 Spravato (esketamine) nasal spray Override(s) Approval Duration Prior Authorization Quantity Limit Initial approval: 3 months Maintenance approval: 12 months Medications Quantity Limit Spravato (esketamine) nasal spray 56 mg Treatment requires the patient to receive the medication from a provider at a medical facility. The recommended dosage of Spravato for the treatment of TRD in adults is shown in Table 1. Spravato side effects. Part D Medicare coverage is an optional benefit that covers prescription drugs. It comes as a nasal spray that's taken under medical … Some drugs can be used for indications other than those that are listed below. However, the effectiveness of Spravato in preventing suicide or reducing suicidal ideation or behaviour was not demonstrated. Spravato Prior Authorization Request CVS Caremark administers the prescription benefit plan for the patient identified. Ventegra: A New Class of Trade (Medical Benefit Manager) Ventegra is proud to be classified as the first of a new class-of-trade: Medical Benefit Manager (MBM). 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 ® must never be dispensed directly to a patient for home use. Innovative, Noninvasive Treatment. HEALTHCARE SETTINGS: A REMS-certified healthcare setting has 2 options for acquiring SPRAVATO®. Call your doctor for medical advice about side effects. Specialty medical benefit drug list Each specialty medical benefit drug below is categorized according to its most commonly recognized therapeutic indication or treatment class. These are not all the possible side effects of SPRAVATO. Medical Drug Benefit List This list is subject to change without notification. before starting treatment with Spravato. Do not administer if an increase in blood pressure or intracranial pressure poses a serious risk. Get emergency medical help if you have signs of an allergic reaction to Spravato: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Spravato™ (esketamine) will be approved when ALL of the following are met: 1) The patient has been previously approved for the requested agent through the Prime Therapeutics Medical Drug Review process AND 2) The patient has had clinical benefit with the requested agent as demonstrated by 50% improvement from The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit … These are not all the possible side effects of SPRAVATO ®. Spravato ™ (esketamine ... (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of ... Each benefit program defines which services are covered. (2.1) Evidence of therapeutic benefit should be evaluated at the end of the induction phase to determine need for continued treatment. Medical Necessity shall mean a service or benefit that is compensable under the Medical Assistance Program and if it meets any one of the following standards: (i) the service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. Specialty medical benefit drug list Each specialty medical benefit drug below is categorized according to its most commonly recognized therapeutic indication or treatment class. Note that each patient's unique insurance benefit design may dictate how you ultimately acquire SPRAVATO®. Legend: $ = under $100, $$ = $100-$250, $$$ = $251-$500, $$$$ = $501-$1,000, $$$$$ = over $1,000, A = drug not subject to medical deductible or member cost share, * = drug may require prior authorization in … Patients in need of this drug may find the cost paid by an insurance company, government, or non-profit organization. This patient’s benefit plan requires prior authorization for certain medications in order for the drug to be covered. 1. If not currently enrolled, you can search for Medicare plans that cover Spravato. SPRAVATO® will not be delivered directly to patients. Spravato (esketamine) when it is determined to be medically necessary ... • Standard medical management (pharmacotherapy, psychotherapy and/or somatic therapy) Relevant outcomes include: ... therapeutic benefit should be evaluated at the end of the induction phase to Call your doctor for medical advice about side effects. Treatment may include up to three devices administered on the same day. Spravato is a brand-name prescription drug that's prescribed for treatment-resistant depression in adults. Blood pressure should bemonitored after dose administration. FDA Approves Spravato For Suicidal Patients With Major Depression : Shots - Health News Doctors have a new option for suicidal patients. Administer SPRAVATO intranasally under the supervision of a healthcare provider. You may report side effects to FDA at 1-800-FDA-1088. Pharmacy Medical Necessity Guidelines: Spravato™ (esketamine) Nasal Spray Effective: October 19, 2020 Prior Authorization Required √ Type of Review – Care Management Not Covered Type of Review – Clinical Review √ Pharmacy (RX) or Medical (MED) Benefit MED Department to Review PRECERT /MM If you already enrolled in Part D prescription drug coverage, check your plan’s formulary, or list of covered drugs. Only initiate treatment with Spravato in patients with clinically significant or unstable cardiovascular or respiratory conditions if the benefit outweighs the risk. The policy is not medical advice. Dosage adjustments should be made based on efficacy and tolerability. Some drugs can be used for indications other than those that are listed below. Description. Esketamine is used as a nasal spray or by injection into a vein.. Esketamine acts primarily as a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Your blood pressure will need to be checked before and after you use Spravato. This drug is likely to be covered under your medical benefit if you have insurance. 6547219 2 Pharmacy Medical Necessity Guidelines: Spravato® (esketamine) Nasal Spray The plan may authorize coverage of Spravato® (esketamine) when ALL of the following criteria are met: 1. Select either BUY-AND-BILL or PHARMACY to learn more about each option. Providers/health care settings, pharmacies, and members must be certified and/or enrolled in the in the Spravato Risk and Evaluation Mitigation Strategy (REMS) program. 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 in … There is a quantity limit of 24 devices in a 24-day period for one use per lifetime. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Blood pressure should be … Spravato provides a new FDA-approved treatment for TRD that may be reimbursed, as it shows some clinical benefits for TRD patients; however, the high price of the therapy can limit its uptake as evidence showed non-significant benefit in terms of cost-effectiveness. Providers must submit claims for esketamine (Spravato) with unlisted procedure code J3490. Researchers observed benefit of this intervention on MDD symptoms as early as 4 hours after the first dose. Effective for dates of service on or after October 1, 2019, clinician administered drug esketamine (Spravato) will become a benefit of Texas Medicaid. Spravato (esketamine) Nasal Spray NOTICE This policy contains information which is clinical in nature. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO ® and discuss any questions you may have with your healthcare provider. 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. Documented diagnosis of severe Major Depressive Disorder medical necessity and other coverage determinations. (2.1) Assess blood pressure prior to and after administration. Cigna covers esketamine products (Spravato™) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence: Prior Authorization is recommended for prescription benefit coverage of Spravato. You may report side effects to FDA at 1-800-FDA-1088. If blood pressure is elevated prior to Spravatoadministration a decision to delay Spravato therapy should take into account the balanceof benefit and risk in individual patients. NP On Call TMS offers Transcranial Magnetic Stimulation (TMS) depression therapy, which has proven to be more accurate and efficient in targeting the brain while maintaining safe levels of stimulation effectively treating depression. 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. NPF Coverage Policy . Because of the specialized an individual must be monitored by a healthcare provider while administering the medication and for at … Esketamine can increase your blood pressure for several hours after each dose. Program limits apply. Spravato® (esketamine) is managed through both the Pharmacy and Medical benefit. Esketamine, sold under the brand name Spravato among others, is a medication used as a general anesthetic and for treatment-resistant depression. This cutting-edge technology is expanding and changing the field of mental health beyond what was thought possible. The member is 18 years of age and older AND 2. (2.2) Medicare Coverage for Spravato. According to Janssen, the benefit of Spravato plus comprehensive SOC on symptoms of MDD was apparent as early as four hours after the first dose. Depending on how your 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 23 devices in a 24-day period. Esketamine (Spravato) is available only as a medical benefit and may be distributed through specialty pharmacy providers with dates of service on or after July 1, 2020. Evidence of therapeutic benefit should be evaluated at the end of the induction phase to determine need for continued treatment. Spravato® must be administered under the direct supervision of a healthcare provider and a treatment session consists of nasal administration of Spravato ® and …
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