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U.S. Department of Health and Human Services

Remdesivir for the Commercial Marketplace FAQs

About the Agreement with Gilead Science, Inc. and AmerisourceBergen

  1. Did the U.S. government purchase remdesivir directly from Gilead Sciences, Inc.?
  2. How much of the drug is available for allocation to U.S. hospitals?
  3. According to the agreement, HHS secured approximately 500,000 treatment courses. The Emergency Use Authorization for remdesivir states that patients may receive either a 10 day, 11 dose course of remdesivir or a 5 day, 6 dose treatment course depending on severity of illness. Is the 500,000 treatment course amount based on a 10 day or 5 day treatment plan?
  4. The HHS memorandum of agreement with Gilead Sciences, Inc. ends on September 30, 2020. What role will the federal government have in the allocation and distribution process after the conclusion of the agreement?


Allocation and Distribution

  1. What is HHS-ASPR’s strategy for ensuring remdesivir reaches healthcare providers quickly?
  2. How are allocations for commercially available remdesivir determined? Is the current methodology the same that was used for allocating the donated drug?
  3. What states and U.S. territories have received remdesivir? How much has each received?
  4. Where can hospitals find the AmerisourceBergen order form/template?
  5. Can a hospital purchase additional remdesivir above its allocation if the state/territory’s allocation has not been exhausted?
  6. If a hospital does not need the amount of remdesivir allocated to it for a given distribution period, is the excess amount returned to HHS/ASPR for reallocation or will the state/territory reallocate? Additionally, what happens if a state/territory declines to receive all of the remdesivir allocated to it by HHS/ASPR for a given distribution period?
  7. Does a hospital’s allocation of remdesivir for a given distribution period have to be purchased and shipped all at one time?
  8. Is there a base or minimum amount of remdesivir that a hospital can purchase?
  9. Will AmerisourceBergen ship in quantities less than a case/40 vials?
  10. Will HHS continue to ship donated (free) amounts of remdesivir to state/territorial health departments?


Data Collection

  1. HHS recently updated its COVID-19 data collection process. Why was this instituted and how does it benefit hospitals and COVID-19 patients?
  2. How is HHS-ASPR obtaining the data needed for the allocation of commercially available remdesivir?
  3. What data is requested from hospitals to help HHS/ASPR allocate remdesivir to states and territories?
  4. Hospitals are now asked to report their current inventory of remdesivir. Is this data element used in the allocation process?
  5. If a hospital does not provide the requested COVID-19 patient hospitalization data on a daily basis, will that hospital not receive remdesivir for that given distribution period? Will the state or territory receive less of the drug to allocate as a result?


Drug Pricing

  1. How much will hospitals pay for the drug?
  2. According to Gilead Sciences, Inc., there are two different prices for remdesivir: $390 per vial for patients covered under government programs and $520 per vial for patients covered by commercial insurance. Will American hospitals pay the non-government price for all vials?


Payment and Reimbursement

  1. How will hospitals be billed for the drug allotted to them by their state/territory?
  2. Should hospitals proactively establish accounts with AmerisourceBergen?
  3. How will reimbursement work under Medicaid and Medicare? Will hospitals receive an add-on payment or the regular negotiated bundled payment?
  4. Will the drug be covered by commercial insurers?
  5. What steps are being taken to ensure the uninsured have equal access to remdesivir?


International Supplies

  1. Did the U.S. buy up all of the available supply of remdesivir for the next three months (June-September)?
  2. Will the U.S. government make any of its supply of remdesivir available to other countries? If so, how will those decisions be made?
  3. Gilead is pricing remdesivir at $3,120 for a typical patient in the U.S., including Medicare and Medicaid patients. This price is a third higher than the price set for all other developed countries. Can HHS comment on the pricing of the drug, particularly in the context of your prior criticisms of foreign nations paying less for drugs than the U.S.?


Emergency Use Authorization

  1. What is an Emergency Use Authorization?
  2. What does this EUA allow?
  3. Is remdesivir approved by the FDA to treat COVID-19?


Administering Remdesivir

  1. Who can take remdesivir?
  2. What are the potential side effects of remdesivir?
  3. Is there a requirement for providers to report side effects as part of the EUA?
  4. Is there data showing remdesivir might benefit patients with COVID-19?
  5. Is there any guidance or parameters available to help hospitals decide which patients should receive the treatment?
  6. Will the commercially available remdesivir be lyophilized or is it available in liquid form?



About the Agreement the Gilead Science, Inc. and AmerisourceBergen

  1. Did the U.S. government purchase remdesivir directly from Gilead Sciences, Inc.?

On June 28, 2020, HHS signed a memorandum of agreement with Gilead Sciences, Inc. (the manufacturer of remdesivir) and AmerisourceBergen (the distributor of remdesivir) to secure approximately 500,000 treatment courses of commercially available remdesivir for use in American hospitals. This agreement allows American hospitals to purchase the drug in amounts allocated by HHS to state/territorial health departments and other federal agencies.


  1. How much of the drug is available for allocation to U.S. hospitals?

HHS has secured more than 500,000 treatment courses of the drug for American hospitals through September. This represents 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of production in August (174,900 treatment courses), and 90 percent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials. A treatment course of remdesivir is, on average, 6.25 vials.

Prior to commercial availability, HHS also led the allocation and distribution efforts for 150,000 treatment courses of the drug that were donated by Gilead Sciences, Inc. to the U.S. government. This effort took place between May 4 and June 29, 2020.


  1. According to the agreement, HHS secured approximately 500,000 treatment courses. The Emergency Use Authorization for remdesivir states that patients may receive either a 10 day, 11 dose course of remdesivir or a 5 day, 6 dose treatment course depending on severity of illness. Is the 500,000 treatment course amount based on a 10 day or 5 day treatment plan?

The course treatment numbers used for calculation are based on current clinical practice – what we know from the administration of donated remdesivir. The majority of patients who received donated remdesivir received the 5-day, 6-dose course. As a result, the 500,000 course treatment is based on an average course of 6.25 vials.


  1. The HHS memorandum of agreement with Gilead Sciences, Inc. ends on September 30, 2020. What role will the federal government have in the allocation and distribution process after the conclusion of the agreement?

The federal government will no longer have oversight of the allocation and distribution process for remdesivir after September 30, 2020. Beginning October 1, hospitals will work directly with the identified distributor to purchase remdesivir just as they do other COVID-19 associated drugs.


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Allocation and Distribution

  1. What is HHS-ASPR’s strategy for ensuring remdesivir reaches healthcare providers quickly?

It is the priority of the federal government’s priority to allocate the limited doses of commercial remdesivir in an efficient, fair and equitable manner to locations in the country that need it most. The HHS Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) oversees this process using the following steps:

Step 1: State and territory allocations for each distribution period are determined using information from the HHS Protect platform.

Step 2: HHS/ASPR notifies state/territorial health departments regarding their allocated amounts of remdesivir for the given distribution period.

Step 3: Health departments determine how much remdesivir hospitals within their respective jurisdictions may purchase based on the state/territory’s overall allocation. Health departments communicate information regarding receiving hospitals and allowable purchase amounts to AmerisourceBergen (the distributor of the drug). Neither AmerisourceBergen nor Gilead Sciences, Inc. (the manufacturer of the drug) are involved in allocation decisions for the remdesivir.

Step 4: AmerisourceBergen coordinates shipping details with receiving hospitals and generates invoices for upon shipping.

Step 5: Hospitals pay for remdesivir just as they do for other products used for the treatment of their COVID-19 patients.


  1. How are allocations for commercially available remdesivir determined? Is the current methodology the same that was used for allocating the donated drug?

The allocation process for commercially available remdesivir has changed from the process used to determine allocations of the donated drug. As of July 15, 2020, allocations are based on TeleTracking data (part of the HHS Protect system) from the previous seven days and include information on patients admitted into U.S. hospitals during that seven-day timeframe.

The current methodology uses the same proportional strategy as before; however, slightly different data elements are used. Instead of basing the allocations on the proportion of all admitted COVID-19 patients (confirmed or suspected), whether old or new patients, the allocations are now based on a state’s/territory’s proportion of newly admitted COVID-19 patents (confirmed or suspected over the previous seven-day period. Please reference the ‘Data Collection’ section of this site to see the information requested from hospitals to support allocation determinations.


  1. What states and U.S. territories have received remdesivir? How much has each received?

HHS-ASPR maintains a dashboard of allocations to states and territories. This information is posted at www.phe.gov.


  1. Where can hospitals find the AmerisourceBergen order form/template?

Hospitals may contact AmerisourceBergen directly at sales@asdhealthcare.com.


  1. Can a hospital purchase additional remdesivir above its allocation if the state/territory’s allocation has not been exhausted?

State/territorial health departments are expected to allocate the product in a fair and equitable manner, and they have the authority to control the reallocation of product within their jurisdictions.


  1. If a hospital does not need the amount of remdesivir allocated to it for a given distribution period, is the excess amount returned to HHS/ASPR for reallocation or will the state/territory reallocate? Additionally, what happens if a state/territory declines to receive all of the remdesivir allocated to it by HHS/ASPR for a given distribution period?

Prior to delivery of commercially available remdesivir, we encourage states/territories to contact hospitals within their jurisdictions to ensure hospitals desire and can purchase the full amount of remdesivir allocated to them for a given distribution week. This will help decrease the likelihood of hospitals declining product when contacted by AmerisourceBergen, and, most importantly, will allow states/territories the opportunity to quickly reallocate remdesivir to other hospitals in need within their jurisdictions.

AmerisourceBergen will auto-ship quantities determined by state/territorial health departments to hospitals confirmed by health departments. The “auto-ship-to” hospitals are identified by health departments by marking a “Y” in the Auto-Confirm column of the allocation template provided to AmerisourceBergen. AmerisourceBergen will not contact these hospitals prior to shipment. However, AmerisourceBergen will contact all other receiving hospitals prior to delivery to confirm that the hospitals still need and have the capacity to store what has been allocated to them by their respective state/territory. During that outreach, hospitals may opt not to purchase their full allocated amounts. Should this happen, the information is communicated back to the state/territorial health departments via a real-time, online report as well as to HHS/ASPR. Additionally, AmerisourceBergen tracks the amounts declined by hospitals. We encourage states/territories to check the AmerisourceBergen database during each distribution period for this information.

HHS/ASPR understands that the current distribution cycle of one week makes it challenging for states/territories to reallocate remdesivir not purchased by hospitals in their jurisdictions for a given distribution period. As such, we do encourage states/territories to develop plans that allow for efficient reallocation of remdesivir across their jurisdictions. States/territories should monitor AmerisourceBergen’s real-time online reporting of remdesivir declined by hospitals. States/territories can use this information to reallocate remdesivir to other hospitals in their jurisdictions by end of day on Wednesdays. We encourage states/territories to develop plans that allow for product declined by one hospital in their jurisdiction to be quickly re-allocated to other hospitals in their jurisdictions that are in need. If states/territories cannot reallocate remdesivir declined by hospitals in their jurisdictions by 4:00 pm local time on Wednesdays, HHS/ASPR will reallocate this product to other states/territories in need. 

If a state/territory determines that it does not need the amount of remdesivir allocated to it for a given distribution period, AmerisourceBergen will notify HHS/ASPR of this decision. HHS/ASPR will then reallocate the drug to other states/territories in need. Unallocated amounts of remdesivir do not roll over.


  1. Does a hospital’s allocation of remdesivir for a given distribution period have to be purchased and shipped all at one time

No. There is no requirement for a hospital to purchase any or all of the commercial remdesivir supply allocated to it. AmerisourceBergen will coordinate the delivery and purchase of available quantities allocated for a given distribution period to hospitals. Hospitals must then respond with the amount of commercial remdesivir they would like to purchase, up to the quantity allocated. Please also see answer to Question 6.


  1. Is there a base or minimum amount of remdesivir that a hospital can purchase?

The amount of the product distributed to hospitals is determined by the state/territory health department in consultation with receiving hospitals. AmerisourceBergen has committed to shipping vials of the product in quantities requested by receiving hospitals. The average treatment course per patient is 6.25 vials.


  1. Will AmerisourceBergen ship in quantities less than a case/40 vials?

AmerisourceBergen has committed to shipping remdesivir in quantities requested by hospitals. The average treatment course per patient is 6.25 vials.


  1. Will HHS continue to ship donated (free) amounts of remdesivir to state/territorial health departments?

No. The final allotment of donated remdesivir was shipped the week of June 29, 2020. HHS/ASPR led the allocation and distribution of donated vials of remdesivir (approximately 150,000 treatment courses) to states, the District of Columbia, territories, the Veterans Health Administration, the Department of Defense, and the Indian Health Service during the period of May 3 – June 29, 2020. HHS/ASPR will oversee the allocation and distribution of approximately 500,000 commercially available treatment courses of remdesivir. Hospitals will be responsible for purchasing any commercially available drug they receive.


  1. Will HHS/ASPR continue to manage the allocation of remdesivir after September?

The current Emergency Use Authorization (EUA) for remdesivir requires the U.S. government to control allocation of the drug for use consistent with the terms and conditions of the EUA. HHS/ASPR will maintain its current role and responsibilities on behalf of the U.S. government unless the terms and conditions of the EUA change.


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Data Collection

  1. HHS recently updated its COVID-19 data collection process. Why was this instituted and how does it benefit hospitals and COVID-19 patients?

HHS is moving to a more streamlined 21st century data collection system that allows for better data automation, more transparency, reduced burdens on hospitals, and greater data access for health care experts and government officials. As part of our updated data collection process, we are able to collect information on the previous day’s admission for confirmed and suspected COVID-19 patients. The ability to collect near-real-time hospital data within 24 hours of a patient’s admission is critical to our allocation efforts and is part of our effort to identify more recent cases, for which remdesivir use is advised based on updated NIH guidelines released July 17, 2020.

The updated NIH guidelines note that in situations where remdesivir supplies are limited, prioritizing the drug for use in hospitalized patients with COVID-19 who require supplemental oxygen but who are not mechanically ventilated or on extracorporeal membrane oxygenation is recommended. This means we can now follow the most recent hospital admissions for COVID-19 and allocate based on these new-onset patients, for whom remdesivir appears most beneficial. Our updated data collection process provides better data, allowing us to more accurately pinpoint patients in need and allocate amounts of remdesivir to states/territories accordingly.

  1. How is HHS-ASPR obtaining the data needed for the allocation of commercially available remdesivir?

As of July 15, 2020, HHS will utilize information that hospitals input into the TeleTracking system and the HHS Protect platform on a daily basis to determine allocations for each distribution period for commercially available remdesivir. Allocations are determined on Wednesdays of each distribution week and are based on hospital data input into TeleTracking/HHS Protect over the previous seven days. Hospitals’ final input must be made by 11:59 pm PT on Tuesdays to be considered as part of allocation decisions.

Prior to July 15, hospitals used the TeleTracking platform and HHS Protect to enter COVID-19 patient data on a recurring basis (approximately every two weeks). The new data collection plan gives us near-real-time patient data and is part of our effort to identify more recent cases of COVID-19 patients, for whom remdesivir use is advised based on National Institutes of Health (NIH) guidelines for remdesivir use updated on August 27, 2020.

The NIH guidelines note that in situations where remdesivir supplies are limited, prioritizing the drug for use in hospitalized patients with COVID-19 who require supplemental oxygen but who are not mechanically ventilated or on extracorporeal membrane oxygenation is recommended. With the new daily data collection requirements, HHS/ASPR can follow the most recent hospital admissions for COVID-19 and allocate remdesivir based on these new-onset patients, for whom remdesivir appears most beneficial. This methodology also highlights recent case increases in states/territories and allows us to allocate more amounts of commercially available remdesivir to areas of the country with the most need.


  1. What data is requested from hospitals to help HHS/ASPR allocate remdesivir to states and territories?

HHS-ASPR uses data hospitals input into the TeleTracking data platform on a daily basis to ensure the drug gets into the hands of health care providers quickly and fairly, focusing on the areas of the country hardest hit by the pandemic and current patient hospitalizations. The data fields specifically used for determining the allocation of remdesivir include:

  • Previous day’s new adult admissions for confirmed COVID-19
  • Previous day’s new adult admissions for suspected COVID-19
  • Total adults hospitalized for COVID-19 (suspected and confirmed)
  • Total hospitalized for COVID-19 (confirmed only)
  • Total adults in Intensive Care Unit with COVID-19 (suspected and confirmed)
  • Total adults in Intensive Care Unit with COVID-19 (confirmed)

Additionally, we are also collecting the following utilization data points:

  • Previous day’s remdesivir used
  • Current inventory of remdesivir
  1. Hospitals are now asked to report their current inventory of remdesivir. Is this data element used in the allocation process?

No; the “remdesivir on hand” data element is not used to determine remdesivir allocations to states and territories. Allocations are based on data related tonewly-admitted COVID-19 patients (confirmed or suspected over the previous seven day period.


  1. If a hospital does not provide the requested COVID-19 patient hospitalization data on a daily basis, will that hospital not receive remdesivir for that given distribution period? Will the state or territory receive less of the drug to allocate as a result?

The federal government does not determine specific allocations for hospitals. HHS uses information that hospitals input into the TeleTracking system or HHS Protect platform on a daily basis to determine the weekly allocations of commercial remdesivir for each state and U.S. territory. Once states/territories are advised of the amount of remdesivir allocated to them for a distribution period, the state/territorial health departments determine which hospitals in their jurisdictions can purchase remdesivir and how much remdesivir those hospitals may buy. It is certainly beneficial to hospitals, states, territories and the federal government for all hospitals to input their COVID-19 patient data on a daily basis as this will help ensure accurate and timely data is available for federal analysis and allocation determinations for states/territories.

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Drug Pricing

  1. How much will hospitals pay for the drug?

Hospitals will pay no more than the wholesale acquisition cost (WAC) set by Gilead Sciences, Inc., which amounts to approximately $3,200 per treatment course. A treatment course of remdesivir is, on average, 6.25 vials.


  1. According to Gilead Sciences, Inc., there are two different prices for remdesivir: $390 per vial for patients covered under government programs and $520 per vial for patients covered by commercial insurance. Will American hospitals pay the non-government price for all vials?

The government price of $390 per vial is for federal entities that purchase the drug for use within their healthcare systems, such as the Veterans Health Administration, the Indian Health Service, the U.S. Coast Guard. All other entities, including American hospitals, will purchase remdesivir at $520 per vial, to include vials used to treat Medicare and Medicaid patients.


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Payment and Reimbursement

  1. How will hospitals be billed for the drug allotted to them by their state/territory?

Gilead Sciences, Inc. has partnered with AmerisourceBergen to distribute remdesivir. The drug will be billed per the standard relationship between AmerisourceBergen and the receiving hospital. AmerisourceBergen will generate invoices for receiving hospitals upon shipment.


  1. Should hospitals proactively establish accounts with AmerisourceBergen?

Yes. AmerisourceBergen is the sole distributor of remdesivir. Hospitals that do not currently have accounts with AmerisourceBergen should email sales@asdhealthcare.com to complete this process.


  1. How will reimbursement work under Medicaid and Medicare? Will hospitals receive an add-on payment or the regular negotiated bundled payment?

Medicare payment for hospitalizations is based on the diagnosis related group (DRG) of the patient. The DRG payment depends on a variety of factors, including the patient’s principal diagnosis, the severity of illness, the treatment strategies, the team employed, and the procedures performed. All of the therapies provided to a patient in the hospital inpatient setting would be bundled into that DRG payment. If the cost of care is above the threshold payment allotted to hospitals, an additional outlier payment from the Medicare program is available. At this time, there is not an add-on Medicare payment for remdesivir.


  1. Will the drug be covered by commercial insurers?

Private insurers (including Humana, Cigna, UnitedHealth Group, and the Blue Cross Blue Shield system) have committed to waive cost-sharing payments for treatment related to COVID-19 for plan members.


  1. What steps are being taken to ensure the uninsured have equal access to remdesivir?

HHS is using a portion of the $100 billion CARES Act Provider Relief Fund to reimburse healthcare providers, at Medicare rates, for COVID19-related treatment of the uninsured. Hospitals can apply for reimbursement of hospitalization costs through this program.


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International Supplies

  1. Did the U.S. buy up all of the available supply of remdesivir for the next three months (June-September)?

According to the Memorandum of Agreement between HHS and Gilead Sciences, Inc. (the manufacturer of remdesivir) and AmerisourceBergen (the distributor of remdesivir), the U.S. will secure approximately 500,000 treatment courses of commercially available remdesivir for use in American hospitals. This represents 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of projected production in August (174,900 treatment courses), and 90 percent of projected production in September (232,800 treatment courses), in addition to an allocation for clinical trials. This allocation agreement was determined after an analysis of the significant rise in incidence of COVID-19 in some areas of the U.S. and the urgent need to help treat patients impacted by these outbreaks.


  1. Will the U.S. government make any of its supply of remdesivir available to other countries? If so, how will those decisions be made?

The U.S. government anticipates using all of the approximately 500,000 treatment courses of remdesivir secured through the Memorandum of Agreement with Gilead Sciences, Inc. within U.S. hospitals. HHS-ASPR will allocate the drug in a fair and equitable manner across states and U.S. territories in accordance with the U.S. Food and Drug Administration’s Emergency Use Authorization for remdesivir.


  1. Gilead is pricing remdesivir at $3,120 for a typical patient in the U.S., including Medicare and Medicaid patients. This price is a third higher than the price set for all other developed countries. Can HHS comment on the pricing of the drug, particularly in the context of your prior criticisms of foreign nations paying less for drugs than the U.S.?

As we stated in the press release: Hospitals will receive the product shipped by AmerisourceBergen and will pay no more than Gilead’s wholesale acquisition cost (WAC), which amounts to approximately $3,200 per treatment course. Generally, patients do not pay directly for hospital-administered drugs like remdesivir; rather, for Medicare and most private insurers, the drug’s cost is incorporated into payments made by the insurer, such as Medicare paying for the drug through a diagnostic-related group.

Under President Trump’s leadership, private insurers (including Humana, Cigna, UnitedHealth Group, and the Blue Cross Blue Shield system) committed to waive cost-sharing payments for treatment related to COVID-19 for plan members, and HHS is using a portion of the $100 billion Provider Relief Fund to reimburse healthcare providers, at Medicare rates, for COVID-related treatment of the uninsured.


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Emergency Use Authorization

  1. What is an Emergency Use Authorization?

In certain types of emergencies, the HHS Secretary may issue a determination and declaration under the Food Drug and Cosmetic Act that permits FDA to issue emergency use authorizations (EUAs) to facilitate access to medical countermeasures (drugs, biologics, vaccines, and devices) that can be used to diagnose, treat or prevent a serious disease or condition in a public health emergency.

Products authorized for use in this way may not be approved by FDA for any use, or they may be approved for other uses but not for the emergency use. FDA decides whether the use of the product is likely to be more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks.

This authorization is reserved for emergency situations and is NOT the same as FDA approval or licensure.


  1. What does this Emergency Use Authorization allow?

The EUA for remdesivir was originally released on May 1, 2020 and allowed remdesivir, manufactured by Gilead, to be distributed and used by licensed health care providers to treat adults and children hospitalized with severe COVID-19. Severe COVID-19 was defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO), a heart-lung bypass machine.

On August 28, 2020, based on the totality of scientific information available, including data that have become available since the May 1 original issuance of the EUA, the Food and Drug Administration (FDA) revised the EUA for remdesivir to broaden the scope of its authorized uses. Under the revised EUA, remdesivir is authorized for emergency use by healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients, irrespective of their severity of disease.


  1. Is remdesivir approved by the FDA to treat COVID-19?

No. Remdesivir is an investigational antiviral drug. It is not currently FDA-approved to treat or prevent any diseases, including COVID-19.


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Administering Remdesivir

  1. Who can take remdesivir?

The Emergency Use Authorization provides instructions for healthcare providers in administering remdesivir. On August 28, 2020, the FDA revised the EUA for remdesivir to broaden the scope of its authorized uses. Under the revised EUA, remdesivir is authorized for emergency use by healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients, irrespective of their severity of disease.


  1. What are the potential side effects of remdesivir?

As stated in the FDA’s Fact Sheet for Patients and Caregivers, possible side effects of remdesivir are:

  • Infusion-related reactions. Infusion-related reactions have been seen during a remdesivir infusion or around the time remdesivir was given. Signs and symptoms of infusion-related reactions may include: low blood pressure, nausea, vomiting, sweating, and shivering.

  • Increases in levels of liver enzymes, seen in abnormal liver blood tests. Increases in levels of liver enzymes have been seen in people who have received remdesivir, which may be a sign of inflammation or damage to cells in the liver.

These are not all the possible side effects of remdesivir. Remdesivir is still being studied so it is possible that not all of the risks are known at this time.

Relatively few people have taken remdesivir. Serious and unexpected side effects may happen. The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site.


  1. Is there a requirement for providers to report side effects as part of the Emergency Use Authorization?

Yes. As part of the EUA, FDA is requiring health care providers who prescribe remdesivir to report all medication errors and serious adverse events considered to be potentially related to remdesivir through FDA’s MedWatch Adverse Event Reporting program.

Providers can complete and submit the report online; or download and complete the form, then submit it via fax at 1-800-FDA-0178. This requirement is outlined in the EUA’s health care provider fact sheet. FDA MedWatch forms should also be provided to Gilead.


  1. Is there data showing remdesivir might benefit patients with COVID-19?

In vitro (laboratory) testing of remdesivir demonstrated it is active against SARS-CoV-2 (the virus causing COVID-19). Preliminary results from a placebo-controlled clinical trial of remdesivir by the National Institute for Allergy and Infectious Diseases suggested that patients taking remdesivir experienced faster time to recovery as compared to patients taking a placebo.

Preliminary results from a Phase 3 clinical trial evaluating 5-day and 10-day dose durations of remdesivir in hospitalized patients with severe COVID-19 disease, but most of whom were not receiving mechanical ventilation or ECMO at baseline, reported that patients receiving a 10-day treatment course achieved similar improvement as those taking a 5-day treatment course.

The safety and efficacy of remdesivir for the treatment of COVID19 are being evaluated in multiple ongoing clinical trials. Because remdesivir may possibly help very sick patients, FDA is allowing this drug to be provided to hospitalized patients with severe COVID-19 under an EUA issued May 1, 2020.

Under the EUA, health care providers and patients are provided with information about the risks of remdesivir. However, final data from clinical trials included in an FDA application are necessary for us to determine whether the drug is safe and effective in treating or preventing COVID-19.


  1. Is there any guidance or parameters available to help hospitals decide which patients should receive the treatment?

The decision regarding which patients receive the drug is determined by individual hospitals in accordance with the FDA’s Emergency Use Authorization, and guidance provided in the health care provider fact sheet. Additional recommendations for prioritizing the use remdesivir can be found in recently updated NIH guidance.


  1. Will the commercially available remdesivir be lyophilized or is it available in liquid form?

The majority of the commercially available remdesivir the U.S. has secured for the next three months (July-September) will be lyophilized. Hospitals may work directly with AmerisourceBergen if they have specific requests for the liquid form of the drug.


  
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  • This page last reviewed: October 01, 2020