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Informed Consent Document | Spravato® (esketamine)

Informed Consent

This is the patient informed consent document (ICD) for Spravato® (esketamine) nasal spray. This ICD describes the treatment that your psychiatrist has prescribed and outlines the risks, potential benefits, and alternative treatments if you decide not to proceed with Spravato® (esketamine).

You will be receiving Spravato® (esketamine) nasal spray for the treatment of Major Depressive Disorder (MDD) or Treatment Resistant Depression (TRD).

What is Spravato® (esketamine)?

Spravato® (esketamine) is an FDA-approved medication used to treat symptoms of major depressive disorder and treatment-resistant depression. It is administered via nasal spray.

Spravato® works through NMDA receptor antagonism to relieve symptoms of depression and is indicated for use in conjunction with an oral antidepressant medication.

How does it work?

Spravato® is an intranasal treatment requiring a minimum two-hour observation visit (longer if medically necessary before safe discharge).

A physician will assist in administering the medication, and dosage will be determined and adjusted by the treating psychiatrist over the course of treatment.

A trained staff member will monitor the patient, including blood pressure checks at least every 40 minutes. Once medically stable, the patient will be discharged to a responsible adult for transportation home.

Patients must arrange transportation prior to treatment, as they should not drive or operate heavy machinery on the day of treatment.

Treatment typically begins with twice-weekly sessions for four weeks, followed by once-weekly treatments for an additional four weeks. Ongoing treatment frequency will be determined by the psychiatrist based on individual response.

During treatment, patients will complete the Hamilton Depression Rating Scale (Ham-D) to monitor symptom severity and treatment progress.

The duration of treatment varies and will be determined collaboratively between patient and provider based on a risk-benefit assessment.

Is the treatment effective?

Multiple studies have demonstrated that Spravato® is effective in improving depressive symptoms, often within the first month, and may support sustained remission compared to placebo.

Patients with questions regarding clinical data are encouraged to discuss these with their psychiatrist.

Contraindications and Risks

Spravato® is administered intranasally and carries certain risks and contraindications. The treating psychiatrist will evaluate suitability for treatment.

Patients must inform their provider if they have:

  • Blood vessel disorders (aneurysmal vascular disease)
  • Arteriovenous malformations
  • History of intracerebral hemorrhage
  • Allergy to ketamine, esketamine, or its components

Boxed Warnings:

  • Risk of sedation and dissociation
  • Potential for abuse and misuse
  • Available only through Spravato® REMS program
  • Increased risk of suicidal thoughts in certain populations

Spravato® may cause temporary increases in blood pressure. Blood pressure will be monitored and treatment may be stopped if levels become unsafe.

Nausea and vomiting may occur. Patients should not eat for 2 hours prior or drink liquids within 30 minutes before treatment.

Patients must not drive or operate machinery until the following day.

Other nasal medications should not be used within one hour of Spravato® administration.

Possible side effects include sedation, dissociation, dizziness, lethargy, and vertigo. All side effects should be reported to the psychiatrist.

Patients must disclose all medications to ensure safe treatment.

Female patients should use effective birth control during treatment. Notify your provider immediately if pregnancy occurs. Breastfeeding is not recommended during treatment.

Insurance coverage will be coordinated by providers; however, patients are responsible for any costs not covered by insurance.

I understand that alternative treatments exist, including medications, psychotherapy, Transcranial Magnetic Stimulation (TMS), and Electroconvulsive Therapy (ECT).

I understand that no guarantees of results have been made. I authorize emergency treatment if deemed necessary by the provider.

I understand I may withdraw consent at any time and choose alternative treatment. I voluntarily consent to receive Spravato® (esketamine) treatment.

Important Information about Spravato®

  • Spravato® treatment is scheduled as follows:
    • Twice a week for 4 weeks
    • Weekly for 4 weeks
    • Maintenance as decided with your physician
  • You will most likely experience dissociation, sedation, and/or feel disconnected from your body. This is temporary and typically lasts an hour or less. You will be monitored for 2 hours by nursing staff.
  • You must have a responsible adult (18 years or older; no ride share services) available to sign you out and drive you home approximately 2 hours after your start time.
  • No alcohol or substance use 24 hours prior to, and 24 hours after treatment.
  • Please inform your physician of any blood pressure, heart, or arrhythmia medications you are taking.
  • It is very important that you arrive on time for your scheduled treatments. Appointments are carefully scheduled to ensure appropriate care from both physician and nursing staff.
  • You will not be permitted to return to work, drive, or operate heavy machinery until the following day after treatment and after a full night’s sleep.
  • You will be billed separately for the Spravato® medication from Genoa Pharmacy. PAKC will submit claims for physician and observation fees. For cost information, contact your insurance company and reference procedure codes: 99215 and 99417 x 4 or G2212 x 4.
  • Patients receiving Spravato® treatment must notify the director at least 48 hours in advance if they cannot attend a scheduled appointment. Failure to provide 48-hour notice will result in a $100 fee.

By signing below, I acknowledge that I have read the information contained in this Consent Form about Spravato® (esketamine). I understand the risks and benefits of this treatment.

I have discussed this treatment with my treating psychiatrist and/or their designee, and all of my questions have been answered. I have reviewed the list of potential contraindications and have informed my psychiatrist of any that may apply to me.

With this understanding, I voluntarily choose to proceed with Spravato® (esketamine) treatment as prescribed.

Spravato® (esketamine) treatment for Treatment Resistant Depression
Pregnancy and Breastfeeding
Informed Consent Document
SECTION 1: PATIENT INFORMATION

SECTION 2: PROCEDURE

In a separate document, Psychiatry Associates of Kansas City described the use of Spravato® (esketamine) therapy for treating depression to help you decide if you want to be treated with Spravato® (esketamine). In addition, that document provided information about the risks and benefits of Spravato® (esketamine). This form is a supplement to that Informed Consent Document.

Your treating provider has recommended Spravato® (esketamine) for the treatment of depression and you have, by the Informed Consent Document, given permission for the use of Spravato® (esketamine) for the treatment of depression. Before this can happen, Advanced Psychiatric Solutions needs to make sure that you are not pregnant or breastfeeding.

Pregnancy and breastfeeding are among the exclusion criteria for Spravato® (esketamine). Pregnant women and nursing mothers are not eligible for Spravato® (esketamine) due to potential effects on the fetus or nursing child.

The effects of Spravato® (esketamine) on pregnancy and the fetus are undetermined, and therefore, it is advisable to protect against pregnancy while being exposed to Spravato® (esketamine) (or in the immediate aftermath of its use).

Please fill out the following questions related to your pregnancy and/or breastfeeding status. If you are uncertain whether you are pregnant, Advanced Psychiatric Solutions will perform a pregnancy test to verify the same upon your consent.

SECTION 3: INFORMED CONSENT FOR TREATMENT

I understand the potential risks and benefits associated with Spravato® (esketamine) for depression as explained in the Informed Consent Document and this form.

I have been given adequate opportunity to have my questions answered by the treating psychiatrist.

By signing below, I acknowledge that I am not pregnant or breastfeeding and I have been given the chance to receive a pregnancy test to verify the same.

REVIEW OF SYSTEMS

2021 Advance Beneficiary Notice of Noncoverage (ABN)

NOTE: If the provided insurance doesn’t pay for D. below, you may have to pay.

Some insurances will not pay for everything, even some care that you or your health care provider have good reason to think you need. We expect your insurance may not pay for the D. listed below.

D. CPT codes E. Reason Medicare May Not Pay: F. Estimated Cost
99215
99417
G2214

CPT codes that might be used for Spravato treatments. 		Non-covered reasons:

- Not Medically Necessary
- Deemed experimental
- Does not meet treatment criteria
- Non-covered service 		99215 = $260.00
99417 = $93.75
G2214 = $93.75

WHAT YOU NEED TO DO NOW:

  • Read this notice so that you can make an informed decision about your care.
  • Ask us any questions that you may have after you finish reading.
  • Choose an option below about whether to receive the D. Spravato treatment listed above.

Note: If you choose Option 1 or 2, we may help you to use any other insurance that you might have, but Medicare cannot require us to do this.

H. Additional Information:

This notice gives our opinion, not an official insurance decision. If you have other questions on this notice or Medicare billing, call 1-800-MEDICARE (1-800-633-4227 / TTY: 1-877-486-2048) or the Customer Service number on your insurance card.

Signing below means that you have received and understand this notice. You also receive a copy.

SPRAVATO REMS

Patient Enrollment Form - Outpatient Use Only

This section is to be completed by the patient.

Your healthcare provider will help you complete this form and provide you with a copy.

Patient Agreement:

By signing this form, I understand and acknowledge that:

Before my treatment begins, I will:

  • Enroll in the Spravato REMS by completing this Patient Enrollment Form with my healthcare provider. Enrollment information will be submitted to the SPRAVATO REMS.
  • Receive counseling on safety risks and the need for monitoring to observe for resolution of sedation and dissociation, and for any changes in vital signs.

During treatment, and after administration I will:

  • Use the SPRAVATO nasal spray myself under the direct observation of a healthcare provider.
  • Be observed at the healthcare setting where I receive SPRAVATO for at least 2 hours after each treatment until the healthcare provider determines I am ready to leave.

I understand:

  • Sedation and dissociation can result from treatment with SPRAVATO and I must stay after each treatment.
  • Until these effects resolve, I may feel:
    • sleepy and/or
    • disconnected from myself, my thoughts, feelings, and surroundings
  • I should make arrangements to get home safely.
  • I should not drive or use heavy machinery for the rest of the day on which I receive SPRAVATO.
  • I should contact my doctor or inform them at my next visit if I believe I have a side effect or reaction from SPRAVATO.

In order to receive SPRAVATO as an outpatient, I am required to be enrolled in the REMS, and my information will be stored in a database of all outpatients who receive SPRAVATO in the United States.

Janssen Pharmaceuticals, Inc. and its agents, including trusted vendors, may use, disclose, and share my personal health information for the purpose of the operations of the REMS.

Janssen Pharmaceuticals, Inc. and its agents, including trusted vendors, may use, disclose, and share my personal health information for the purpose of the operations of the REMS, including enrolling me into the REMS, administering the REMS, coordinating the dispensing of SPRAVATO, and releasing and disclosing my personal health information to the Food and Drug Administration (FDA), as necessary, and as otherwise required by law.

Phone: 1-855-382-6022

© Janssen Pharmaceuticals, Inc. 2020 08/20

www.SPRAVATOrems.com
Fax: 1-877-778-0091