SPRAVATO® Patient Support & Resources | SPRAVATO® (esketamine) HCP

Dedicated Case Managers provide you with educational support and resources to help you guide your patients through the access process so your patients can start treatment quickly.

SPRAVATO withMe can help navigate access and affordability processes efficiently so you can focus on your patients

SPRAVATO withMe Case Managers provide you with educational support to help your patients start and stay on track.

Learn how to minimize delays in the approval process and get your patients on treatment quickly with the help of our Case Managers.

Benefits investigations for medical and pharmacy coverage

Prior authorization and appeals support

Coding and reimbursement support

Real-time notifications via a custom portal view with updates on your individual patients and accounts

A progress tracker that provides visibility to your patients’ access status

Patient affordability support

Confirmation on which pharmacies accept your patients’ insurance

Enrolling your patients in SPRAVATO withMe allows them to receive the following, regardless of insurance coverage:

Care Navigators, mental health professionals* who can offer one-to-one dedicated support
Basic product information
Motivational encouragement
Affordability support

*Care Navigators do not provide medical advice.

Information about your patients' insurance coverage, cost support options, and treatment support is given by service providers for SPRAVATO withMe. The information you get does not require you or your patient to use any Janssen product. Because the information we give you comes from outside sources, SPRAVATO withMe cannot promise the information will be complete. SPRAVATO withMe cost support is not for patients in the Johnson & Johnson Patient Assistance Foundation.

If you have any questions or to get your patients enrolled today, please give us a call at
1-844-4S-WITHME (1-844-479-4846),
Monday through Friday, 8 AM to 8 PM ET.

Access & Reimbursement Support

Get a full view of your patients’ insurance to help get them on treatment quickly by avoiding approval delays

Have drug and observation access and reimbursement information to help minimize denials and delays when getting your patients on treatment.

Once your patient is enrolled, as part of the benefits investigations, we'll evaluate:

Medical and pharmacy benefit coverage

Behavioral health organizations (BHO) and employee-subsidized plan coverage

Prior authorization requirements, followed by appeals process if needed

REMS-certified pharmacy options that are accepted by the patient's insurance

Coding and reimbursement information, as well as appeals process

Affordability program eligibility

If you have any questions or to get your patients enrolled today, please give us a call at
1-844-4S-WITHME (1-844-479-4846),
Monday through Friday from 8 AM to 8 PM ET.

Help simplify the Prior Authorization (PA) process to get patients on treatment quickly*

We'll help provide information and updates about the prior authorization and appeals process.

Our team can educate you on the prior authorization process by providing:

Payer-required documentation for submissions to support patients who have medical benefits
Tracking of submissions status
Support for appeals
Prior re-authorization notifications

To help minimize timing delays and frustration due to coverage denials, SPRAVATO withMe has contracted with CoverMyMeds to offer electronic prior authorization support for pharmacy benefit access. As a result, you will be able to access your existing CoverMyMeds account and patients' history in the SPRAVATO withMe Provider Portal. This will help give you visibility into the process and allow you to track your patients^' progress.

*We do not fill out any information that requires the medical judgment of the prescriber, and only the prescriber can determine whether to pursue a prior authorization.

FDA Approval Letter for SPRAVATO®

Check if the selected pharmacy accepts your patients' insurance

Count on our Case Managers to identify pharmacy options for your patients.

You'll receive pharmacy options that have been verified for REMS certification and payer-mandated requirements. You will also be informed/know if the pharmacy accepts your patients' medical insurance or pharmacy drug benefits.

SPRAVATO® service code reimbursement support

SPRAVATO withMe, alongside the PAS team, can help educate you and your staff on which codes are accepted by your patients' insurance plans.

Specific E/M Codes accepted by the payor
Codes accepted for Medicare and Non-Medicare Plan Coverage
Behavioral health organizations (BHO) and employee-subsidized plan coverage
Appeals Process Educational Support
Your Case Manager can contact the payer on your patient's behalf to help you understand the reason for a denial to help you move forward with the process

SPRAVATO withMe Care Navigators

SPRAVATO withMe Care Navigators—dedicated support for your patients

In addition to the support you provide, a SPRAVATO withMe Care Navigator will support your patients to help them start and stay on track throughout their treatment journey.

The treatment journey can be challenging for some patients. This is why the SPRAVATO withMe program offers a dedicated Care Navigator with mental health experience.* Within 24 hours of enrollment,† a Care Navigator will be assigned to every patient, regardless of insurance coverage.

*Care Navigators do not provide medical advice.
†Or within the next business day.

They’ll offer one-to-one support and:

Help patients understand their insurance coverage

Provide patients with affordability options

Provide a Starter Kit to help patients at the beginning of their journey

Tailor communications to your patients and work with them to understand their needs

Assist with finding a REMS-certified SPRAVATO® treatment center

Help patients troubleshoot affordability challenges

Provide product and disease
state educational support

Most importantly, SPRAVATO withMe Care Navigators will be there with emotional support and encouragement at every step.

Care Navigators are available Monday through Friday, 8:00 AM to 8:00 PM ET. They will return your patients’ calls within the same day or the next business day.

Enroll your patients in SPRAVATO withMe to get them connected to our Care Navigators. Please call us at
1-844-4S-WITHME (1-844-479-4846),
Monday through Friday, 8:00 AM to 8:00 PM ET.

The SPRAVATO withMe Savings Program could help your eligible patients save

Eligible commercially insured patients pay $10 per treatment for SPRAVATO® out-of-pocket medication costs.

Eligible patients with commercial insurance pay as little as $10 per treatment for their SPRAVATO® medication. There are quantity limits and savings limits each year. Program does not cover the cost of treatment observation. Patients may participate without sharing their income information. See program requirements.

See how SPRAVATO withMe can help your eligible patients save on treatment. Call us at
1-844-4S-WITHME (1-844-479-4846) or visit JanssenCarePathPortal.com/express to express enroll your patients in the Savings Program.

Affordability support for patients with government coverage or no insurance coverage

SPRAVATO withMe can provide information about other resources that may be able to help your patients with their out-of-pocket medication costs:

State Pharmaceutical Assistance Programs (SPAPs)
State Health Insurance Programs (SHIPs)
Medicare Savings Program
Medicare Part D Extra Help Low-Income Subsidy

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don’t have insurance, if their medicine is not covered by insurance, or if they have Medicare coverage and can’t pay for their medicine.

Do you have patients who may need help?

They can see if they are eligible and get an application at JJPAF.org or call 800-652- 6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

Getting Started

Enrolling patients in SPRAVATO withMe is simple

There are 2 ways to help your patients get started with their enrollment:

Utilize the portal

Download and fill out the Prescription Enrollment Form and send it via fax to 844-577-7282

If you have any questions about enrolling your patients, give us a call at 1-844-4S-WITHME (1-844-479-4846), Monday through Friday, 8:00 AM to 8:00 PM ET.

SPRAVATO withMe is limited to education for patients about SPRAVATO®, its administration, and/or their disease, and is not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, or provide case management services.

Resources

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Patient and clinical resources

Download these resources to learn more and educate your patients about how and when to use SPRAVATO®.

Dosing & Administration Guide

Download guide

TRD Patient Brochure

Download brochure

MDSI Patient Brochure

Download brochure

Dual Indication Conversation Guide

Download guide

Patient Referral Form for SPRAVATO® Treatment

Download form

TRD Clinical Brochure

Download brochure

Access resources

Learn more about SPRAVATO® coverage, coding, and the overall reimbursement process by clicking on the resources below.

Access & Reimbursement Guide

Download guide

Exceptions & Appeals Guide

Download guide

Letter of Medical Necessity

Download form

Letter of Exception

Download form

Helpful Access & Affordability Resources

Learn More

Next: Start patients on SPRAVATO®

Learn more

Reference:

1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning

Risk for sedation and dissociation after administration. Monitor patients for at least two hours after administration (5.1, 5.2).
Potential for abuse and misuse. Consider the risks and benefits of using SPRAVATO^® prior to use in patients at higher risk of abuse. Monitor for signs and symptoms of abuse and misuse (5.3).
SPRAVATO^® is only available through a restricted program called the SPRAVATO^® REMS (5.4).
Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. SPRAVATO^® is not approved for use in pediatric patients (5.5).

CONTRAINDICATIONS

SPRAVATO^® is contraindicated in patients with:

Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation.
History of intracerebral hemorrhage.
Hypersensitivity to esketamine, ketamine, or any of the excipients.

WARNINGS AND PRECAUTIONS

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.

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.

Closely monitor for sedation with concomitant use of SPRAVATO^® with CNS depressants (e.g., benzodiazepines, opioids, alcohol).

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). 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.

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.

Abuse and Misuse: SPRAVATO^® contains esketamine, a Schedule III controlled substance (CIII), and may be subject to abuse and diversion. 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. 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.

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.

Important requirements of the SPRAVATO^® REMS include the following:

Healthcare settings must be certified in the program and ensure that SPRAVATO^® is:
- Only dispensed and administered in healthcare settings.
- Patients treated in outpatient settings (e.g., medical offices and clinics) must be enrolled in the program.
- 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^® to healthcare settings that are certified in the program.

Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022.

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. SPRAVATO^® is not approved in pediatric (<18 years of age) patients.

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.

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. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. 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.

Increase in Blood Pressure: SPRAVATO^® causes increases in systolic and/or diastolic blood pressure (BP) at all recommended doses. Increases in BP peak approximately 40 minutes after SPRAVATO^® administration and last approximately 4 hours.

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. A substantial increase in blood pressure could occur after any dose administered even if smaller blood pressure effects were observed with previous administrations. 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). 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.

Assess BP prior to administration of SPRAVATO^®. 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.

BP should be monitored for at least 2 hours after SPRAVATO^® administration. Measure blood pressure around 40 minutes post-dose and subsequently as clinically warranted until values decline. If BP remains high, promptly seek assistance from practitioners experienced in BP management. 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.

Closely monitor blood pressure with concomitant use of SPRAVATO^® with psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil) or monoamine oxidase inhibitors (MAOIs).

In patients with a 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.

Cognitive Impairment

Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO^® caused cognitive performance decline 40 minutes post-dose. Compared to placebo-treated subjects, SPRAVATO^®-treated subjects required a greater effort to complete the cognitive tests at 40 minutes post-dose. Cognitive performance and mental effort were comparable between SPRAVATO^® and placebo at 2 hours post-dose. Sleepiness was comparable after 4 hours post-dose.

Long-Term Cognitive Impairment: Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse. 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.

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. Patients will need to arrange transportation home following treatment with SPRAVATO^®.

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. 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. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year.

Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO^® and refer to an appropriate healthcare provider as clinically warranted.

PREGNANCY, EMBRYO-FETAL TOXICITY, AND LACTATION

SPRAVATO^® is not recommended during pregnancy. SPRAVATO^® may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO^® in utero. Advise women of reproductive potential to consider pregnancy planning and prevention.

There are risks to the mother associated with untreated depression in pregnancy. 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.

Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO^®, during pregnancy. 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/.

SPRAVATO^® is present in human milk. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO^®.

SELECT USE IN SPECIFIC POPULATIONS

Geriatric Use: 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. At the end of a 4-week, randomized, double-blind study, there was no statistically significant difference between groups on the primary efficacy endpoint.

Hepatic Impairment: SPRAVATO^®-treated patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time.

SPRAVATO^® has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Use in this population is not recommended.

ADVERSE REACTIONS

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.

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.

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO^®.

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Resources

SPRAVATO withMe can help navigate access and affordability processes efficiently so you can focus on your patients

About SPRAVATO withMe

SPRAVATO withMe can help navigate access and affordability processes efficiently so you can focus on your patients

Access & Reimbursement Support

Get a full view of your patients’ insurance to help get them on treatment quickly by avoiding approval delays

Help simplify the Prior Authorization (PA) process to get patients on treatment quickly*

Check if the selected pharmacy accepts your patients' insurance

SPRAVATO® service code reimbursement support

SPRAVATO withMe Care Navigators

SPRAVATO withMe Care Navigators—dedicated support for your patients

The SPRAVATO withMe Savings Program could help your eligible patients save

Affordability support for patients with government coverage or no insurance coverage

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

Getting Started

Enrolling patients in SPRAVATO withMe is simple

Resources

Patient and clinical resources

Access resources

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