Co-pay & Samples

Broad coverage and access support

LYBALVI is covered for more than 80% of patientsa

aNationally, either with no restrictions or with prior authorization/step edits. Based on LYBALVI national coverage, all beneficiaries, rolling 6 months, through August 3, 2023.

Prior authorizations are commonly obtained for LYBALVI through CoverMyMeds
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71%
Average approval rateb
Time to a decision
<24 hours
for 89% of electronic prior authorization submissions, on averageb

bData shown is based on CoverMyMeds LYBALVI data from October 2022 through October 2023.

Data is not representative of all prior authorization submissions. Prior authorization through CoverMyMeds is not a guarantee of approval.

Prior authorization support for LYBALVI is available through CoverMyMeds

  • CoverMyMeds is a third-party platform external to Alkermes

  • Supports the prior authorization process online with plan-specific forms and information

  • Healthcare provider offices can quickly find and submit a prior authorization via the healthcare provider portal or via certain EHR platforms

  • Pharmacists can also send a prior authorization request to your office for you to complete and submit

  • Health plans can provide determinations via the CoverMyMeds portal to both your office and the local pharmacy

  • CoverMyMeds live agents can help you navigate the appeal process by providing health plan-specific appeal forms for you to complete and return to the plan, in the event coverage is denied

  • Available at no cost to your office

  • For questions, call 1-866-452-5017 or visit www.covermymeds.com for more information

Additional prior authorization & appeals assistance

Checklist for Letters of Medical Necessity and Appeals

Provided to help facilitate communications with health insurance companies to support a prior authorization, a formulary exception request, a medical exception, or an appeal of a denied claim for coverage of LYBALVI.

Download

Medicare Appeals and Exceptions Process Brochure

Information on the process for appeals of both Original Medicare and Part D coverage decisions.

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Prior Authorization Flashcard

Information you may want to consider including when completing a prior authorization, including ICD-10-CM diagnosis codes.

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Considerations when using ICD-10-CM diagnosis codes

Claims submitted for LYBALVI should include at least one ICD-10-CM diagnosis code to indicate the patient’s condition. Diagnosis codes should represent the condition as supported by the patient’s medical record. The diagnosis codes listed below may apply to patients for whom LYBALVI may be appropriate.

ICD-10-CM Diagnosis Codes for Bipolar I Disorder1

F31.10 Bipolar disorder, current episode manic without psychotic features, unspecified

F31.11 Bipolar disorder, current episode manic without psychotic features, mild

F31.12 Bipolar disorder, current episode manic without psychotic features, moderate

F31.13 Bipolar disorder, current episode manic without psychotic features, severe

F31.2 Bipolar disorder, current episode manic severe with psychotic features

F31.60 Bipolar disorder, current episode mixed, unspecified

F31.61 Bipolar disorder, current episode mixed, mild

F31.62 Bipolar disorder, current episode mixed, moderate

F31.63 Bipolar disorder, current episode mixed, severe, without psychotic features

F31.64 Bipolar disorder, current episode mixed, severe, with psychotic features

F31.70 Bipolar disorder, currently in remission, most recent episode unspecified

F31.73 Bipolar disorder, in partial remission, most recent episode manic

F31.74 Bipolar disorder, in full remission, most recent episode manic

F31.77 Bipolar disorder, in partial remission, most recent episode mixed

F31.78 Bipolar disorder, in full remission, most recent episode mixed

IMPORTANT: Healthcare providers are responsible for keeping current and complying with all applicable coverage requirements and for the selection of diagnosis and procedure codes that accurately reflect their patient’s condition and the services rendered.

Healthcare providers also are responsible for the accuracy of all claims and related documentation submitted for reimbursement. Additional insurance requirements may apply and healthcare providers should always contact the insurer directly to obtain complete and current information regarding coverage of LYBALVI.

Alkermes does not guarantee coverage or reimbursement. Under no circumstances will Alkermes, Inc., or its affiliates, employees, consultants, agents or representatives be liable for costs, expenses, losses, claims, liabilities or other damages that may arise from, or be incurred in connection with, the information provided here or any use thereof.

ICD-10-CM Diagnosis Codes for Schizophrenia1

F20.0 Paranoid schizophrenia

F20.1 Disorganized schizophrenia

F20.2 Catatonic schizophrenia

F20.3 Undifferentiated schizophrenia

F20.5 Residual schizophrenia

F20.89 Other schizophrenia

F20.9 Schizophrenia, unspecified

IMPORTANT: Healthcare providers are responsible for keeping current and complying with all applicable coverage requirements and for the selection of diagnosis and procedure codes that accurately reflect their patient’s condition and the services rendered.

Healthcare providers also are responsible for the accuracy of all claims and related documentation submitted for reimbursement. Additional insurance requirements may apply and healthcare providers should always contact the insurer directly to obtain complete and current information regarding coverage of LYBALVI.

Alkermes does not guarantee coverage or reimbursement. Under no circumstances will Alkermes, Inc., or its affiliates, employees, consultants, agents or representatives be liable for costs, expenses, losses, claims, liabilities or other damages that may arise from, or be incurred in connection with, the information provided here or any use thereof.

ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.

Additional LYBALVI access resources for healthcare professionals

Find out more information about the various services and resources available to help support access for LYBALVI patients.

Supporting Your Patients’ Access to LYBALVI Treatment Brochure

Information on prior authorizations, letters of medical necessity, appealing a claim denial, and more.

Download

Low Income Subsidy Guide

Information on the Medicare Part D Extra Help program, that may help eligible patients reduce out-of-pocket costs for their prescription drugs.

Download
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LYBALVI Care Support provides dedicated
patient access services

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LYBALVI Care Support: Administered by ASPN Pharmacies

A dedicated patient support service designed to help with access to LYBALVI

  • Benefit verification
  • Prior authorization education and coordination
  • Co-pay savings for eligible patients
  • Local pick up or home delivery option for patients
  • Refill reminders for ASPN mail order pharmacies
Get started now

Select ASPN Pharmacies in Your EHR

See above for a list of ICD-10 codes that may apply to patients appropriate for LYBALVI.

Discuss With Your Patient

If your patient would like services, inform them that they will receive a call or text from ASPN Pharmacies. Confirm that an accurate phone number is included in the prescription.

Learn about the Patient Assistance Program (PAP)

Provides qualifying uninsured patients who meet PAP eligibility requirements access to LYBALVI treatment at no charge for up to 12 months. Certain restrictions apply. For eligibility requirements please call LYBALVI Care Support at 1-844-LYBALVI.

Download PAP Enrollment Form
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Help your eligible patients get started with co-pay savings

Commercially insured eligible patients could pay

$0 FOR THE FIRST 3 FILLS OF LYBALVIc

No activation process needed.

After the first 3 fills, each refill may cost as little as $20 with a maximum savings of $450 per 30‑day supply.

View Program Info
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cThe LYBALVI Co-pay Savings Program (“Program”) is only available to commercially insured patients who are 18 years or older with a valid LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted, and an outcome documented, regardless of the outcome, prior to using this co-pay offer. This Program is not available to patients who are enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills in the Program. Beginning at fill 4 and thereafter, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Please see full Program Terms and Conditions.

Over 80% of all patients pay no more than $11/month for LYBALVId

Over 90% of commercial patients utilizing the LYBALVI Co-pay Savings
Program card pay $20 or less for LYBALVIe

dData based on national out-of-pocket costs for all payment methods. Source: IQVIA: OPC Provider for the period October 2022 – September 2023.

eData based on out-of-pocket costs for commercially insured patients in the LYBALVI Co-pay Savings Program from April 2023 to June 2023.

Get LYBALVI samples for your appropriate patients

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Order LYBALVI samples from your Alkermes representative

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Speak with a LYBALVI sales representative
Your local representative can provide you with information on LYBALVI, how to request product samples, and more.
Request a Rep
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Patient Resources
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Reference: 1. AAPC. ICD-10-CM Expert. Diagnosis codes for providers & facilities. Chapter 5: Mental, behavioral and neurodevelopmental disorders (F01-F99). 2022.

LYBALVI® Co-pay
Savings Program
Terms and Conditions:

Eligibility for LYBALVI® Co-pay Savings Program (Program): This Program is only available to commercially insured patients who are 18 years or older with a valid LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted, and an outcome documented, regardless of the outcome, prior to using this co-pay offer. This Program is not available to patients who are enrolled in, or covered by, any local, state, federal or other government program that pays for any portion of medication costs, including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program. Patients who become eligible for any government program that pays for any portion of medication costs will no longer be eligible for this Program. Program is not valid for cash paying patients. Patients must live in the United States or Puerto Rico. Patients must meet the Program requirements every time they use the LYBALVI Co-pay Savings Card.

Program Benefit:
Maximum savings limit applies; patients' out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills in the Program. Beginning at fill 4 and thereafter, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Eligible patients may receive benefits for valid claims submitted with a date of service that is up to 90 days prior to the initial enrollment date. All Program payments are for the benefit of the patient only. The LYBALVI Co-pay Savings Card expires after 5 years but may be renewed if all eligibility criteria are met.

Additional Terms of Use:
This Program offer is not conditioned on any past, present, or future purchase, including refills. To use this Program, participating patients are responsible for following any health plan requirements, including any requirements to inform the health plan how much co-payment support they get from this Program. Program may be subject to plan benefit design requirements. Alkermes may rescind, revoke, or amend this Program, eligibility, benefits, and requirements at any time without notice, including in specific states. This Program offer is limited to one per patient and may not be used with any other coupon, discount, prescription savings card, free trial, or other offer and is not transferable, and may not be sold, purchased or traded, or offered for sale, purchase, or trade. Void where prohibited by law, taxed or otherwise restricted. The Program is not insurance. Program Administrator or its designee will have the right upon reasonable prior written notice, during normal business hours, and subject to applicable law, to audit compliance with this Program.

Use and Disclosure of Information:
By using this offer, you authorize the Program Administrator to share your prescription information with CoverMyMeds so that CoverMyMeds may contact your healthcare provider to request submission of information to support coverage of your LYBALVI prescription by your health insurance plan. Program Administrator will not share the patient’s personal information with anyone except where legally permitted. Data shared with Alkermes by the Program Administrator will be aggregated and de-identified and may be used by Alkermes for its own internal business purposes and/or to improve or modify the Program. For more information, see Alkermes’ Privacy Policy at www.alkermes.com/privacy.

To the Patient:
Present this card and prescription for LYBALVI to the pharmacist to participate in this program. When using this card, you certify that you understand and agree to all of the Program Terms and Conditions and that you meet, or are the legal guardian of a patient who meets, the Program requirements. For questions about your eligibility or benefits, if your insurance has changed, or if you wish to discontinue your participation, call the LYBALVI Co-pay Savings Program at 1-855-820-9624 (8:00 AM-8:00 PM ET, Monday-Friday).

To the Pharmacist:
When using this card, you certify that you will comply with the above Terms and Conditions and that you have not submitted and will not submit a claim for reimbursement under any local, state, federal, or other government program for this prescription. Submit transaction to McKesson Corporation ("Program Administrator") using BIN 610524. Submit commercial insurance as primary coverage, input co-pay savings card information as secondary coverage, and transmit using the COB segment of the NCPDP transaction. Applicable discounts will be displayed in the transaction response. Acceptance of this card and your submission of claims for LYBALVI are subject to the LoyaltyScript® Program terms and conditions posted at www.mckesson.com/mprstnc. Claims submitted utilizing the program are subject to audit or validation. For questions regarding setup, claim transmission, patient eligibility, or other issues, call the LoyaltyScript® Program for the LYBALVI Co-pay Savings Program at 1-855-820-9624 (8:00 AM-8:00 PM ET, Monday-Friday).

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The LYBALVI Patient Assistance Program provides uninsured patients who meet program eligibility criteria access to treatment at no charge for up to 12 months.

Eligibility criteria

  • Patient must be uninsured
  • Patient must provide proof of household size and annual gross income and certify accuracy that they meet financial criteria
  • Prescription must be by a US licensed healthcare provider
  • Shipment must be delivered to a location within the 50 states (excluding PR and US territories)
  • Patient must be prescribed LYBALVI for an on-label use and be 18 years or older

Important Safety Information

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

Contraindications:

LYBALVI is contraindicated in patients who are using opioids or are undergoing acute opioid withdrawal. If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products.

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis,

including stroke, transient ischemia attack, and fatalities. See Boxed Warning.

Precipitation of Severe Opioid Withdrawal in Patients who are Physiologically Dependent on Opioids:

LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids, which can lead to an opioid withdrawal syndrome, sometimes requiring hospitalization. LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids. Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers.

Vulnerability to Life-Threatening Opioid Overdose:

Attempting to overcome opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued, subjecting the patient to high levels of unopposed opioid agonist as the samidorphan blockade wanes. Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI. In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia, discontinue LYBALVI. Opioids should be administered by properly trained individual(s) and patient should be continuously monitored in a setting equipped and staffed for cardiopulmonary resuscitation. Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued. Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at the previously tolerated dosage.

Neuroleptic Malignant Syndrome,

a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and close monitoring.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS),

a potentially fatal condition reported with exposure to olanzapine, a component of LYBALVI. Symptoms include a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue if DRESS is suspected.

Metabolic Changes,

including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Any patient treated with LYBALVI should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required anti-diabetic treatment despite discontinuation of the suspect drug. Measure weight and assess fasting glucose and lipids when initiating LYBALVI and monitor periodically.

Tardive Dyskinesia (TD):

Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible increases with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after discontinuation. Given these considerations, LYBALVI should be prescribed in a manner that is most likely to reduce the risk of tardive dyskinesia. If signs and symptoms of TD appear, drug discontinuation should be considered.

Orthostatic Hypotension and Syncope:

Monitor orthostatic vital signs in patients who are vulnerable to hypotension, patients with known cardiovascular disease, and patients with cerebrovascular disease.

Falls:

LYBALVI may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls, and consequently, fractures or other injuries. Assess patients for risk when using LYBALVI.

Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases):

Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count or history of leukopenia or neutropenia. Discontinue LYBALVI if clinically significant decline in WBC occurs in the absence of other causative factors.

Dysphagia:

Use LYBALVI with caution in patients at risk for aspiration.

Seizures:

Use LYBALVI with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment:

Because LYBALVI may cause somnolence, and may impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including motor vehicles, until they are certain that LYBALVI does not affect them adversely.

Body Temperature Dysregulation:

Use LYBALVI with caution in patients who may experience conditions that increase core body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Anticholinergic (Antimuscarinic) Effects:

Olanzapine, a component of LYBALVI, was associated with constipation, dry mouth, and tachycardia. Use LYBALVI with caution with other anticholinergic medications and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions. In postmarketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications.

Hyperprolactinemia:

LYBALVI elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Risks Associated with Combination Treatment with Lithium or Valproate:

If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for a description of the risks for these products.

Interference with Laboratory Tests for Opioid Detection:

LYBALVI may cause false positive results with urinary immunoassay methods for detecting opioids. Use an alternative analytical technique (e.g., chromatographic methods) to confirm positive opioid urine drug screen results.

Most Common Adverse Reactions observed in clinical trials were:

Concomitant Medication:

LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Concomitant use of LYBALVI is not recommended with strong CYP3A4 inducers, levodopa and dopamine agonists. Reduce dosage of LYBALVI when using with strong CYP1A2 inhibitors. Increase dosage of LYBALVI with CYP1A2 inducers. Use caution with diazepam, alcohol, other CNS acting drugs, or in patients receiving anticholinergic (antimuscarinic) medications. Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling.

Pregnancy:

May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with LYBALVI. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYBALVI during pregnancy.

Renal Impairment:

LYBALVI is not recommended for patients with end-stage renal disease (eGFR of <15 mL /minute/1.73 m2).

To report SUSPECTED ADVERSE REACTIONS, contact Alkermes at 1-888-235-8008 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indications

LYBALVI is indicated for the treatment of:

Please see full Prescribing Information, including Boxed Warning, for LYBALVI.

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