Broad access and resources to support your patients1

CAPLYTA has broad formulary coverage1

For patients with Commercial Insurance only

UNRESTRICTED ACCESS on the two largest PBMs — CVS Caremark & Express Scripts National Formulary

CAPLYTA is COVERED FOR ~90% of patients

CAPLYTA Savings Card: additional support for eligible adult patients

For patients with Medicare Part D/Medicaid

CAPLYTA is COVERED FOR >99% of patients

Source: Data on file, Intra-Cellular Therapies, Inc. Formulary data provided by Managed Markets Insight and Technology, LLC™, a trademark of MMIT, as of June 2024. Because formularies do change and many health plans offer more than one formulary, please check directly with the health plan to confirm coverage for individual patients.

277 million Americans (or 93% of American lives) have access to CAPLYTA across all payer channels

Find help with a Prior Authorization

CAPLYTA offers a range of resources to assist you with Prior Authorizations.

This guide can help you complete prior authorization forms for your patients

Prior Authorization Guide

Download this guide for step-by-step information on working with pharmacies

Pharmacy Callback Guide

Visit CoverMyMeds to initiate the Prior Authorization process for both commercially- and government-insured patients

CoverMyMeds services include: support for submitting requests to any health plan, faster determinations (often in real-time and with live monitoring), and appeal forms generated for denied requests.

Visit CoverMyMeds.com and click “Create an Account” to register. Once registered, you can log into CoverMyMeds and begin the ePA.

Call CoverMyMeds

1-866-452-5017

Chat live with CoverMyMeds

Live Chat

Generally, 8 out of 10 Prior Authorization submissions for CAPLYTA are approved

CAPLYTA® (lumateperone) savings card
Learn about the CAPLYTA Savings Card

See how Medicare Part D/
low‑income subsidy patients can receive help with prescription costs through Medicare1,2*

Medicare Part D patients are automatically enrolled in Extra Help if they are:

  • Dual eligible: receive both Medicare and Medicaid, or are older than 65 years and on Medicaid
  • Receiving Supplemental Security Income
  • Members of a Medicare Savings Program

Patients who are enrolled in Extra Help pay a maximum of $11.20 for brand name prescriptions3

Medicare beneficiaries receiving LIS get assistance in paying for their Part D monthly premium, annual deductible, coinsurance, and copayments. Also, individuals enrolled in the Extra Help program do not have a gap in prescription drug coverage, also known as the coverage gap, or the Medicare "donut hole"1

*This government program is also known as Extra Help.

Find out about the resources that can help your patients get started with CAPLYTA
Resources

CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Important Safety Information

Boxed Warnings:

  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
  • Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and provide intensive symptomatic treatment and monitoring.
  • Tardive Dyskinesia (TD), a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. Given these considerations, CAPLYTA should be prescribed in a manner most likely to reduce the risk of TD. Discontinue CAPLYTA if clinically appropriate.
  • Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
  • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
  • Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
  • Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
  • Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
  • Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
  • Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
  • Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

Drug Interactions: Avoid concomitant use with CYP3A4 inducers. Reduce dose for concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4 inhibitors (21 mg).

Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Reduce dose for patients with moderate or severe hepatic impairment (21 mg).

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs placebo were:

  • Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%).
  • Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9% vs 4%), and dry mouth (5% vs 1%, 5% vs 1%).

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Indications

CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Please see full Prescribing Information, including Boxed Warnings.

References: 1. Data on File. 2. eHealth Insurance. Low-income subsidy-Medicare Extra Help Program. Accessed May 1, 2024. https://www.ehealthinsurance.com/medicare/cost/low-income-subsidy-medicare-extra-help-program. 3. Centers for Medicare and Medicaid Services. Help with drug costs. Updated May 1, 2022. Accessed May 1, 2024. https://www.medicare.gov/basics/costs/help/drug-costs.

Boxed Warnings:

  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.