Indications: LYBALVI® is indicated for the treatment of adults with schizophrenia or bipolar I disorder for acute treatment of manic or mixed episodes as monotherapy and as an adjunct to lithium or valproate, or as a maintenance monotherapy treatment.

Support

Access Support for Your Patients

LYBALVI (olanzapine and samidorphan) Co-pay Savings Program

Now with no activation process needed.

Commercially insured eligible patients could pay:

$0 for the first 3 fills of LYBALVI*

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

Co-pay Savings Card for LYBALVI® (olanzapine and samidorphan) For illustrative purposes only.
View Program Information
*Maximum savings limit applies; patients’ out-of-pocket expenses may vary. Maximum 30-day supply per fill for the first 3 fills. Beginning at fill 4, a maximum savings of $450 per 30-day supply will be provided towards the cost of the LYBALVI prescription. Health plan requirements for a prior authorization and/or step therapies must be attempted prior to using this co-pay offer. Patient must be 18 years of age or older and have a prescription for LYBALVI. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Offer not valid for cash paying patients. Please see full Program Terms and Conditions.

LYBALVI Care Support provides support services to help patients access treatment

To enroll your patients in LYBALVI Care Support and to learn more about these services, call 1-844-LYBALVI (1-844-592-2584), Monday through Friday, 9 AM to 8 PM ET.

LYBALVI Care Support offers these benefits:

LYBALVI Care Support provides general coverage information and can conduct a full benefit investigation, including a written summary of benefits, usually within 24 hours for enrolled patients.

Provides qualifying uninsured patients who meet PAP eligibility requirements access to LYBALVI treatment at no charge for up to 12 months. Certain restrictions apply.

Patient Assistance Program Eligibility

Enroll your patients
in LYBALVI Care Support

Download
Enrollment Form
Download Enrollment Form Guide for
information on completion of the form.
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Actor portrayals.

Prior authorizations are commonly obtained for LYBALVI

LYBALVI Prior Authorizations Submitted Through CoverMyMeds:

70%

average
approval rate1*

Time to a decision

<24 hours

for 87% of submissions, on average2†

*Data shown is based on LYBALVI data from October 2021 to September 2022.

†Data shown is based on LYBALVI data from February 2022 to February 2023.

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

Supporting your patients with prior authorizations and appeals

  • If a prior authorization or appeal is required, you may be able to support your patient’s coverage request using the checklist below or through CoverMyMeds

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
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Actor portrayals.
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.

Download

Prior Authorization Flashcard

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

Download
Woman representing a healthcare provider helping a person understand their diagnosis and how LYBALVI® (olanzapine and samidorphan) may help
Actor portrayals.

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. Specific 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.

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.

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=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

Access Support Q&A: A Guide for Healthcare Professionals

Answers to your access questions, including those about insurance coverage, prior authorization, co-pay, 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
Patient Resources
References: 1. LYBALVI CMM: CoverMyMeds Approval Rate and Approval Time. CoverMy Meds. 2022. 2. LYBALVI CMM: CoverMyMeds Approval Rate and Approval Time. CoverMyMeds. 2023. 3. AAPC. ICD-10-CM Expert. Diagnosis codes for providers & facilities. Chapter 5: Mental, behavioral and neurodevelopmental disorders (F01-F99). 2022.

Important Safety Information

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 above.

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 creatinine 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, 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.

Most common adverse reactions observed in clinical trials were:

  • Schizophrenia (LYBALVI): weight increased, somnolence, dry mouth, and headache
  • Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor
  • Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (olanzapine): dry mouth, dyspepsia, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia

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:

  • Schizophrenia in adults
  • Bipolar I disorder in adults
    • Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
    • Maintenance monotherapy treatment

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

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