Resources & Support

Eligible commercially-insured
patients may pay as little as $0*

See financial-assistance programs for your patients.

*Free Drug Program provides ZULRESSO at no cost for eligible patients who would not otherwise have access to ZULRESSO and who meet certain income criteria. See the full Free Drug Program terms and conditions below.

Sage Central financial-assistance programs

We understand that paying for treatment can sometimes be challenging for your patients. Sage Central has financial-assistance programs that may be able to help eligible patients with out-of-pocket costs related to their treatment. Once patients are enrolled in Sage Central, they will automatically have access to the financial-assistance programs they may be eligible for. Patients with commercial insurance may be able to pay as little as $0 in out-of-pocket costs, restrictions apply. Patients’ eligibility and continued eligibility is subject to the satisfaction of the terms and conditions of the financial assistance programs.

ZULRESSO Drug Copay Assistance Program†

This program is designed to help reduce a patient’s eligible out-of-pocket copay costs related to the drug. If your patient has commercial insurance, they may be eligible for copay assistance to help reduce out-of-pocket, drug-related copay costs up to $15,000—regardless of income level and subject to certain terms and conditions and eligibility criteria

ZULRESSO Infusion Copay Assistance Program‡

Update to read: This program is designed to help reduce a patient’s eligible out-of-pocket copay costs related to the administration of the ZULRESSO infusion. If your patient has commercial insurance, they may be eligible for copay assistance to help reduce out-of-pocket, infusion-related copay costs up to $2,000—regardless of income level and subject to certain terms and conditions and eligibility criteria.

Residents of Massachusetts and Rhode Island are not eligible for infusion copay assistance.

Free Drug Program§

This program provides ZULRESSO at no cost for eligible patients who would not otherwise have access to ZULRESSO and who meet certain income criteria. If your patient is uninsured or underinsured and meet the financial eligibility criteria, they may qualify for the Free Drug Program. Subject to terms and conditions and eligibility criteria.

The healthcare setting will be required, among other things, to provide an attestation that it will not bill the patient or the patient’s insurer for any costs associated with ZULRESSO.

†ZULRESSO Drug Copay Assistance Program

To be eligible to participate in the ZULRESSO® Drug Copay Assistance Program (the “Drug Copay Program”), the patient must: (i) Have private, commercial health insurance; (ii) Reside in the United States or a U.S. territory; (iii) Be treated by a healthcare professional in the United States or a U.S. territory; (iv) Be 15 years of age or older; and (v) Be prescribed ZULRESSO® (brexanolone) injection for an on-label diagnosis. The Drug Copay Program will cover the patient’s out-of-pocket costs (i.e., deductible, copay, or coinsurance obligations) for ZULRESSO up to a maximum of $15,000. The treating healthcare provider must itemize the out-of-pocket cost for the drug on the Copay Program Reimbursement Form for the patient to be eligible to receive financial assistance under the Drug Copay Program. The patient may not participate in the Drug Copay Program if the entire cost of the patients’ ZULRESSO prescription is reimbursable by her private insurance plan or other private health or pharmacy benefit programs. The patient may not participate in the Drug Copay Program if the patient is eligible for a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). This offer is not valid for cash paying patients. The patient must deduct the value of assistance received from the Drug Copay Program from any reimbursement request submitted to her private insurance plan, either directly by the patient or on her behalf. The patient is responsible for reporting her participation in the Drug Copay Program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription. The patient should not participate in the Drug Copay Program if her insurer or health plan prohibits use of manufacturer coupons/copay assistance. The patient savings under the Drug Copay Program cannot be combined with any other savings, free trial or similar offer for the drug. Claims must be submitted in a timely manner. An Explanation of Benefits (EOB) from the patient’s private insurance must be submitted within 180 days of the date of service for the patient to receive out-of-pocket assistance. The EOB must reflect the patient’s out-of-pocket cost for ZULRESSO and submission of the claim by the patient’s physician for the cost of the medication. The Drug Copay Program is not health insurance. This offer is not conditioned on any past or future purchases. Data related to the patient’s participation in the Drug Copay Program may be collected, analyzed, and shared with Sage Therapeutics, Inc. (“Sage”) for market research and other purposes related to assessing Sage’s patient support programs. Data shared with Sage will be aggregated and de-identified; it will be combined with data related to other Drug Copay Program use and will not identify the patient. In the event that the Drug Copay Program is terminated, the EOB must be submitted no more than 90 days after the termination date and EOB must be within the patient’s enrollment dates. Sage reserves the right to rescind, revoke or amend this offer without notice.

‡ZULRESSO Infusion Copay Assistance Program

To be eligible to participate in the ZULRESSO® Infusion Copay Assistance Program (the “Infusion Copay Program”), the patient must: (i) Have private, commercial health insurance; (ii) Reside in the United States or a U.S. territory; (iii) Be treated by a healthcare professional in the United States or a U.S. territory; (iv) Be 15 years of age or older; and (v) Be prescribed ZULRESSO® for an on-label diagnosis. The Infusion Copay Program will cover the patients’ out-of-pocket costs (i.e., deductible, copay, or coinsurance obligations) associated with the infusion of ZULRESSO (administration, needles, tubing, infusion bags, syringes, infusion pump, preparation of medication, IV access and room and board) up to a maximum of $2,000. The treating healthcare provider must itemize the out-of-pocket infusion costs on the Copay Program Reimbursement Form for the patient to be eligible to receive financial assistance under the Infusion Copay Program. Expenses not specifically related to the infusion of ZULRESSO are not eligible for assistance. The patient may not participate in the Infusion Copay Program if all costs of the drug infusion are reimbursable by the patient’s private insurance plan or other private health or pharmacy benefit programs. The patient may not participate in the Infusion Copay Program if the patient is eligible for a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). Residents of the following states are not eligible to participate in the Infusion Copay Program: Massachusetts and Rhode Island. This offer is not valid for cash paying patients. Patient must deduct the value of assistance received from the Infusion Copay Program from any reimbursement request submitted to her private insurance plan, either directly by the patient or on her behalf. Patient is responsible for reporting her participation in the Infusion Copay Program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription. The patient should not participate in the Infusion Copay Program if her insurer or health plan prohibits use of manufacturer-supported financial assistance. Claims must be submitted in a timely manner. An Explanation of Benefits (EOB) from the patient’s private insurance must be submitted within 180 days of the date of service for the patient to receive out-of-pocket assistance. The EOB must reflect the patient’s out-of-pocket cost for infusion of ZULRESSO and submission of the claim by the patient’s physician for the infusion costs. The patient savings under the Infusion Copay Program cannot be combined with any other savings, free trial or similar offer for the drug infusion. The Infusion Copay Program is not health insurance. This offer is not conditioned on any past, present or future purchases. Data related to the patient’s participation in the Infusion Copay Program may be collected, analyzed, and shared with Sage Therapeutics, Inc. (“Sage”) for market research and other purposes related to assessing Sage’s patient support programs. Data shared with Sage will be aggregated and de-identified; it will be combined with data related to other Infusion Copay Program use and will not identify the patient. In the event that the Infusion Copay Program is terminated, the EOB must be submitted no more than 90 days after the termination date and the EOB must be within the patient’s enrollment dates. Sage reserves the right to rescind, revoke or amend this offer without notice.

§Free Drug Program

To be eligible to participate in the ZULRESSO® Free Drug Program (the “FDP”), the patient must: (i) Be prescribed ZULRESSO® for an on-label diagnosis; (ii) Have household income less than or equal to 500% of the Federal Poverty Level (FPL); (iii) Be uninsured or rendered uninsured under any of the following circumstances: (a) Patient has no healthcare insurance, (b) Patient is insured but such insurance does not cover ZULRESSO, or (c) Patient is insured with coverage for ZULRESSO, but is ineligible for the ZULRESSO Copay Assistance Program, and cannot afford the medication (patient out-of-pocket costs are greater than $25); (iv) Reside in the United States or a U.S. territory; (v) Be treated by a healthcare professional in the United States or a U.S. Territory; and (vi) Be 15 years of age or older. Patients enrolled in Medicare, Medicaid or any other federal or state funded health plan may participate in the FDP if they receive the free product outside of their government-funded benefits. The treating healthcare provider must certify that based on his/her independent medical judgment, ZULRESSO is a medically appropriate treatment for the patient. The healthcare provider must certify not to bill the patient or the patient’s insurer for the cost of ZULRESSO. If the patient is enrolled in any federal or state funded health plans, the healthcare provider must not bill any costs associated with ZULRESSO and corresponding treatment costs within a Diagnostic Related Group (DRG). The patient will be informed that she must not (i) seek reimbursement for the free drug from their health plan, and (ii) count the cost of the free drug towards her out-of-pocket spending requirements, if any, under her insurance. The free drug provided under the FDP is not conditioned on any past or future purchases. For any patient enrolled in a readily identifiable Medicare, Medicaid or other government funded plan, Sage will send a letter to the plan informing it that: (i) the patient is receiving free product from the ZULRESSO FDP outside of the patient’s Medicare/Medicaid plan benefit, (ii) the patient and her physician have been informed that they must not seek reimbursement for the free drug from their health plan or count the cost of the free product towards the patient’s out-of-pocket spending requirements, and (iii) the plan should discontinue any pending prior authorization or coverage appeal associated with the patient.

INDICATION

ZULRESSO® is indicated for the treatment of postpartum depression (PPD) in patients 15 years and older

ZULRESSO IMPORTANT SAFETY INFORMATION

WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS

Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.

Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).

Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.

WARNINGS AND PRECAUTIONS

Excessive Sedation and Sudden Loss of Consciousness

In clinical studies in adults, 5% of ZULRESSO-treated patients compared to 0% of placebo-treated patients experienced sedation and somnolence that required dose interruption or reduction during the infusion. Loss of consciousness or altered state of consciousness was reported in 4% of ZULRESSO-treated patients compared with 0% of placebo-treated during the infusion.

In an open-label clinical study in 20 patients ages 15 to 17 years, one patient experienced dizziness and loss of consciousness.

During the infusion, monitor patients for sedative effects every 2 hours during planned, non-sleep periods. Immediately stop the infusion if there are signs or symptoms of excessive sedation. After symptoms resolve, the infusion may be resumed at the same or lower dose as clinically appropriate. Immediately stop the infusion if pulse oximetry reveals hypoxia. After hypoxia, the infusion should not be resumed.

Concomitant use of opioids, antidepressants, or other CNS depressants such as benzodiazepines or alcohol may increase the likelihood or severity of adverse reactions related to sedation. Patients must be accompanied during interactions with their child(ren) while receiving the infusion because of the potential for excessive sedation and sudden loss of consciousness.

Patients should be cautioned against engaging in potentially hazardous activities requiring mental alertness, such as driving, after infusion until any sedative effects of ZULRESSO have dissipated.

ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)

ZULRESSO is available only through a restricted program under a REMS called the ZULRESSO REMS because excessive sedation or sudden loss of consciousness can result in serious harm.

Notable requirements of the ZULRESSO REMS include:

  • Healthcare facilities must enroll in the program and ensure that ZULRESSO is only administered to patients who are enrolled in the
    ZULRESSO REMS
  • Pharmacies must be certified with the program and must only dispense ZULRESSO to healthcare facilities who are certified in the
    ZULRESSO REMS
  • Patients must be enrolled in the ZULRESSO REMS prior to administration of ZULRESSO
  • Wholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies

Further information, including a list of certified healthcare facilities, is available at www.zulressorems.com or call 1-844-472-4379.

Suicidal Thoughts and Behaviors

In pooled analyses of placebo-controlled trials of chronically administered antidepressant drugs (SSRIs and other antidepressant classes) that include approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated 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. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with major depressive disorder (MDD).

ZULRESSO does not directly affect monoaminergic systems. Because of this and the comparatively low number of exposures to ZULRESSO, the risk of developing suicidal thoughts and behaviors with ZULRESSO is unknown. If depression becomes worse or patients experience emergent suicidal thoughts and behaviors, consider changing the therapeutic regimen, including discontinuing ZULRESSO.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.

Adverse reactions reported in an open-label study in patients 15 to 17 years were generally similar to those observed in clinical studies of ZULRESSO in adults with PPD.

Use in Specific Populations

  • Pregnancy: Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm
  • Lactation: Brexanolone is transferred to breastmilk in nursing mothers. There are no data on the effects of ZULRESSO on a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZULRESSO and any potential adverse effects on the breastfed child from ZULRESSO or from the underlying maternal condition
  • Pediatric Use: The safety and effectiveness of ZULRESSO for the treatment of PPD have been established in patients 15 to 17 years. The safety and effectiveness of ZULRESSO in patients less than 15 years of age have not been established
  • Renal Impairment: No dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment. Avoid use of ZULRESSO in patients with end stage renal disease (ESRD)

Controlled Substance

ZULRESSO contains brexanolone, a Schedule IV controlled substance.

To report SUSPECTED ADVERSE REACTIONS, contact Sage Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information including Boxed Warning.

INDICATION
ZULRESSO® is indicated for the treatment of postpartum depression in patients 15 years and older.

IMPORTANT SAFETY INFORMATION
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS
Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.
Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).
Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.