XOCOVA Co-Pay Savings Program Terms and Conditions

By using this co-pay offer, you acknowledge and certify that you meet the eligibility criteria and will comply with the terms and conditions described below:

Eligibility criteria

  • This co-pay offer helps eligible, commercially insured patients with their out-of-pocket cost for XOCOVA. Patient out-of-pocket expense and available support through the co-pay offer may vary based on the patient's commercial insurance.
  • Eligible patients may pay $0 per prescription fill.
  • Eligible patients must have a valid prescription for XOCOVA from a licensed healthcare provider.
  • Eligible patients must have commercial insurance that provides coverage for XOCOVA. This offer is not valid for cash paying patients, patients with no insurance, or patients with state or federal health insurance, including but not limited to: Medicare, Medicare Advantage, Medicaid, VA health benefit programs, TRICARE, or the Indian Health Service program.

Terms and conditions

  • The co-pay offer benefit will not exceed the amount of the patient's co-insurance or co-pay for XOCOVA as determined by the patient's commercial insurance. The co-pay offer is subject to monthly and annual maximum benefits. Once a patient reaches the annual maximum benefit, patient is responsible for paying the remaining monthly out-of-pocket costs.
  • The value of the co-pay offer is intended exclusively for the benefit of the patient.
  • This offer cannot be combined or utilized with any other program, discount, discount card, cash discount card, coupon, free trial, incentive, or similar offer involving XOCOVA. Additionally, the co-pay benefit may not be transferred, sold, purchased, traded, or offered for sale.
  • This offer is not valid when the entire cost of the patient's prescription drug is eligible to be reimbursed by the patient's private insurance plan or other private health or pharmacy benefit program.
  • By redeeming this offer, the patient and the pharmacist agree not to seek reimbursement for all or any part of the benefit received by the patient through the co-pay offer from any third party, such as insurance plans, flexible spending plans or health savings accounts. The patient and/or the pharmacist will report the receipt of the co-pay benefit to the patient's insurer if required by his or her plan.
  • The co-pay offer may not be redeemed more than once per 30 days per patient. Claims must be submitted within 365 days of prescription fill.
  • This co-pay offer is not health insurance. The availability of benefits under the co-pay offer does not constitute a guarantee of coverage under insurance.
  • No other purchase is necessary to participate. The co-pay offer is not conditioned on any past, present, or future purchases, including additional doses of XOCOVA.
  • This co-pay offer may be terminated, rescinded, revoked or amended by Shionogi Inc. at any time without notice.
  • This co-pay offer is only valid in the United States, District of Columbia, Puerto Rico and the U.S. Virgin Islands.
  • This co-pay offer is not valid where prohibited by law.
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INDICATION & IMPORTANT SAFETY INFORMATION

INDICATION

XOCOVA (ensitrelvir) is indicated for post-exposure prophylaxis (PEP) of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.

IMPORTANT SAFETY INFORMATION

Contraindications

XOCOVA is contraindicated in patients with a history of clinically significant hypersensitivity reactions to XOCOVA or any of its components. XOCOVA is also contraindicated when administered with drugs primarily metabolized by CYP3A for which elevated concentrations may be associated with serious and/or life-threatening reactions or when administered with strong CYP3A inducers because they may significantly reduce XOCOVA plasma concentrations leading to potential loss of virologic response.

Embryofetal Toxicity

Based on animal data, XOCOVA may cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential that XOCOVA may cause fetal harm. Verify pregnancy status of females of reproductive potential before initiating XOCOVA and advise using effective contraception during XOCOVA use and for 2 weeks after the final dose.

Risk of Serious Adverse Reactions Due to Drug Interactions

XOCOVA is a strong CYP3A inhibitor and an inhibitor of P-gp and BCRP. In patients receiving or initiating medications metabolized by CYP3A or transported by P-gp or BCRP, XOCOVA may increase plasma concentrations of those medications and may potentially lead to severe, life-threatening, or fatal events from increased exposure. CYP3A inducers may decrease concentrations of XOCOVA, leading to loss of therapeutic effect.

Before prescribing XOCOVA, review all concomitant medications to assess potential drug-drug interactions and determine if those medications require a dose adjustment, interruption, and/or additional monitoring. Consider the benefit of XOCOVA and whether risk of potential drug-drug interactions can be managed.

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, and angioedema have been reported. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue XOCOVA and initiate appropriate treatment.

Lactation

There are no data on the presence of XOCOVA in human milk, effects on breastfed infants, or effects on milk production. XOCOVA was present in the milk of lactating rats. Advise women not to breastfeed while on XOCOVA and for 2 weeks after the final dose.

Adverse Reactions

The most common adverse events occurring in ≥1% of XOCOVA patients and at greater frequency than placebo, respectively, were headache (2.9% vs 2.6%), diarrhea (1.7% vs 1.3%), and cough (1.1% vs 0.6%).

Laboratory Abnormalities

Asymptomatic hemoglobin declines from baseline of >2 g/dL occurred in XOCOVA and placebo patients (3% vs 1%, respectively).

Please see full Prescribing Information.