Product Access

VEKLURY® (remdesivir) distribution and access

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Supplier

Gilead will continue to utilize ABC as the sole US distributor of VEKLURY through the end of this year.

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Ordering Process

Hospitals can place orders with ABC Specialty Division directly by calling 1-800-746-6273 or by emailing remdesivir@amerisourcebergen.com. ABC will confirm order quantity to be shipped to hospitals.

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Shipment

ABC will ship directly to hospitals.

We have a responsibility to ensure that EUA product is not wasted during this pandemic. Please continue to utilize all unexpired, unopened vials of VEKLURY and order VEKLURY using the NDCs associated with the EUA supply until instructed otherwise by ABC.

Please find the NDCs for VEKLURY as follows:

VEKLURY® (remdesivir) for injection, 100 mg/vial, lyophilized powder VEKLURY® (remdesivir) injection, 100 mg/20 mL (5 mg/mL), solution
New NDCs upon FDA approval 61958-2901-2 61958-2902-2
EUA supply; remaining quantity available for general ordering 61958-2901-1 61958-2902-1

For more information on variations in carton and vial labeling of VEKLURY, as well as emergency use in hospitalized pediatric patients <12 years of age weighing at least 3.5 kg or weighing 3.5 kg to <40 kg, please see the Dear HCP letter available here.

ABC=AmerisourceBergen Corporation.

Frequently Asked Questions

What will reimbursement look like for VEKLURY in the United States?

At this time, VEKLURY is approved for use in patients requiring hospitalization, so it is administered on an inpatient basis only. In this setting, hospitals generally receive a bundled reimbursement payment that includes all of the costs for a patient’s hospital stay, rather than a separate payment for VEKLURY. Gilead has worked to facilitate access to VEKLURY by setting the price well below the immediate health system savings that VEKLURY may provide.

How will a payer (Commercial, Medicaid, Medicare) reimburse the hospital for VEKLURY?

Reimbursement will vary for each provider depending on payer, geography, hospital teaching status, and proportion of low-income patients. Gilead recommends that you consult with your payers, reimbursement specialists, and/or legal counsel regarding specific questions related to coding, coverage, and reimbursement of VEKLURY.

As background, we understand that Medicare reimburses inpatient hospitalizations using a Medicare Severity Diagnosis Related Group (MS-DRG) such that most drugs and other services associated with a hospital stay are reimbursed in a bundled payment. Commercial payers and Medicaid programs may also use bundled payments systems or other payer-specific systems to pay hospitals for providing inpatient services. CMS has released guidance on COVID-19 MS-DRGs which may be assigned for COVID-19 related Medicare inpatient hospitalizations.

Indication

VEKLURY is indicated for the treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

Important Safety Information

Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of VEKLURY. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time ≤120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment (see Contraindications).
  • Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended due to antagonism observed in cell culture, which may lead to a decrease in antiviral activity of VEKLURY.

Adverse reactions

  • The most common adverse reaction (≥5% all grades) was nausea.
  • The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Drug interactions

  • Drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

Dosage and administration

  • Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes.
  • Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.
  • Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
  • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.
  • Dose preparation and administration: See full Prescribing Information.

Pregnancy and lactation

  • Pregnancy: There are insufficient human data on the use of VEKLURY during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. VEKLURY should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
  • Lactation: It is not known whether VEKLURY can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Please see full Prescribing Information for VEKLURY.



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Indication

VEKLURY is indicated for the treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

Important Safety Information

Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

tap for important safety information about veklury

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