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Eligible commercial patients may pay as little as $0

See financial-assistance programs for your patients.

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. Patients’ eligibility and continued eligibility is subject to the terms and conditions of the financial assistance programs.

The ZULRESSO Drug Copay Assistance Program

The program is designed to help with eligible out-of-pocket copay costs related to the drug. Subject to certain terms and conditions, commercially insured patients may be eligible for copay assistance to reduce their out-of-pocket, drug-related copay costs up to $15,000—regardless of income level.*

The ZULRESSO Infusion Copay Assistance Program

The program is designed to help with eligible out-of-pocket copay costs related to the infusion. Subject to certain terms and conditions, commercially insured patients may be eligible for copay assistance to reduce their out-of-pocket, infusion-related copay costs up to $2,000—regardless of income level.†

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

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. If your patient is uninsured or underinsured and meets our 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 TERMS AND CONDITIONS

The ZULRESSO Drug Copay Assistance Program (the “Drug Copay Program”) helps eligible patients with private, commercial health insurance pay for a patient’s out-of-pocket costs associated with the drug up to a maximum of $15,000. Cash-paying patients and patients 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”), are not eligible to participate in the Drug Copay Program. Sage Therapeutics, Inc., may rescind, revoke, or amend the Drug Copay Program at any time. For full patient eligibility requirements and program terms and conditions, visit SageCentralSupport.com.

†ZULRESSO INFUSION COPAY ASSISTANCE PROGRAM TERMS AND CONDITIONS

The ZULRESSO Infusion Copay Assistance Program (the “Infusion Copay Program”) helps eligible patients with private, commercial health insurance pay for a patient’s out-of-pocket, infusion-related costs associated with ZULRESSO up to a maximum of $2,000. Cash-paying patients and patients 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”), are not eligible to participate in the Infusion Copay Program. Residents of Massachusetts and Rhode Island are not eligible to participate in the Infusion Copay Program. Sage Therapeutics. Inc., may rescind, revoke, or amend the Infusion Copay Program at any time. For full patient eligibility requirements and program terms and conditions, visit SageCentralSupport.com.

‡FREE DRUG PROGRAM TERMS AND CONDITIONS

To be eligible to participate in the ZULRESSO “Free Drug Program” (the “FOP”), 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 Programs, 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 FOP if they receive the free product outside of their government-funded benefits. The treating healthcare provider must certify that based on their independent medical judgment, ZULRESSO is a medically appropriate treatment for the patient. The healthcare provider must agree not to bill the patient or the patient’s insurer for any costs associated with ZULRESSO and the corresponding treatment, including costs associated with the infusion of ZULRESSO (administration, needles, tubing, infusion bags, syringes, infusion pump, preparation of medication, and IV access) and hospital room and board costs. The healthcare provider must certify that they will not seek reimbursement from any third-party payer or government program for the cost of ZULRESSO or any costs associated with the infusion of ZULRESSO. The patient will be informed that they must not (i) seek reimbursement for the free drug from their health plan, and (ii) count the cost of the free drug towards their out-of-pocket spending requirements, if any, under her insurance. The free drug provided under the FOP 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 FOP outside of the patient’s Medicare/Medicaid plan benefit, (ii) the patient and their 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.

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, ZULRESSO caused sedation and somnolence that required dose interruption or reduction in some patients during the infusion (5% of ZULRESSO-treated patients compared to 0% of placebo-treated patients). Some adult patients were also reported to have loss of consciousness or altered state of consciousness during the ZULRESSO infusion (4% of the ZULRESSO-treated patients compared with 0% of the placebo-treated patients). Time to full recovery from loss or altered state of consciousness, after dose interruption, ranged from 15 to 60 minutes in clinical studies in adults. A healthy 55-year-old man participating in a cardiac repolarization study experienced severe somnolence and <1 minute of apnea while receiving two times the maximum recommended dosage of ZULRESSO (180 mcg/kg/hour).

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

All patients with loss of or altered state of consciousness recovered with dose interruption. There was no clear association between loss or alteration of consciousness and pattern or timing of dose. Not all patients who experienced a loss or alteration of consciousness reported sedation or somnolence before the episode.

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 under the Controlled Substances Act.

Please also see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO.

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.

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.