COVID-19 Therapeutics 

 

How to find and access COVID-19 therapeutics information video

Background

At various times during the COVID-19 pandemic, Montana DPHHS has been involved in the distribution of therapeutics purchased by the federal government. Currently, the state receives oral antiviral medication allocation every week. This website is designed to provide brief background material on the state-allocated COVID-19 medications and provide information to assist in identifying administration or distribution site locations. Facilities interested in offering the state-allocated COVID-19 medications should email margaret.cook-shimanek@mt.gov for additional information.

The National Institutes of Health (NIH) offers the Therapeutic Management of Nonhospitalized Adults with COVID-19, which provides recommendations for the preferred and alternative COVID-19 medications used as treatment for nonhospitalized patients with mild to moderate COVID-19 who are high risk of progressing to severe disease. Health and Human Services (HHS) has created the Side by Side Therapeutics Overview and the COVID-19 Therapeutics Decision Aid.

Oral antivirals

Two oral COVID-19 antiviral medications for non-hospitalized patients at high risk for progression to severe COVID-19 have received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Federal pharmacy partners distributing the oral antiviral medications in Montana include Albertsons, Cardinal Health, CVS, Topco, Walgreens, and Wal-Mart. DPHHS has flexibility in offering to specific pharmacy sites as not all Montana counties have access to one of the federal partners.

On February 1, 2023, the FDA updated the Paxlovid and Lagevrio Emergency Use Authorizations. The scope of the authorization was revised to no longer require positive test results of direct SARS-CoV-2 viral testing. The FDA continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment for COVID-19 is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high-risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the authorization are met, as detailed in the Fact Sheet for Healthcare Providers. As revised, the scope of authorization for both products now requires, in addition to other requirements, that adults and pediatric patients (12 years of age and older weighing at least 40 kg) have a current diagnosis of mild-to-moderate COVID-19.

Both oral antivirals must be initiated within 5 days of symptom onset. A test-to-treat model is an ideal strategy for the oral antiviral products, given the short window between symptom onset and treatment required by the EUA. Federal HHS has created the Test to Treat program, which provides fast access to the oral antiviral products through co-located testing, evaluation, and treatment. Please visit the HHS Get Medication for COVID-19 webpage for sites in Montana.

PAXLOVID

Paxlovid (Pfizer product) received EUA on December 22, 2021. Paxlovid is comprised of nirmatrelvir, a SARS-CoV-2 main protease inhibitor, co-packaged with ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor. Ritonavir, which has no activity against SARS-CoV-2 on its own, is included to inhibit the CYP3A-mediated metabolism of nirmatrelvir and consequently increase nirmatrelvir plasma concentrations to levels anticipated to inhibit SARS-CoV-2 replication.

On February 1, 2023, the FDA updated the Paxlovid Emergency Use Authorization. The scope of the authorization was revised to no longer require positive test results of direct SARS-CoV-2 viral testing. The FDA continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment for COVID-19 is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high-risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the authorization are met, as detailed in the Fact Sheet for Healthcare Providers. As revised, the scope of authorization for both products now requires, in addition to other requirements, that adults and pediatric patients (12 years of age and older weighing at least 40 kg) have a current diagnosis of mild-to-moderate COVID-19.

The EUA directs readers to the Centers for Disease Control and Prevention Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals for information on medical conditions and factors associated with increased risk for progression to severe COVID-19 and state the healthcare providers should consider the benefit-risk for an individual patient. Individuals at risk for severe COVID-19 outcomes, including individuals who are 50 years and older, those who have an underlying condition, and individuals with moderate to severe immunosuppression who have tested positive for COVID-19 are eligible for antiviral treatment within 5 days of symptom onset.

The EUA Fact Sheet for Healthcare Providers includes important information on potential drug interactions, drug resistance, and special dosing considerations for individuals with moderate renal impairment. The FDA revised the Paxlovid EUA on July 6, 2022 to allow state-licensed pharmacists to prescribe Paxlovid in certain circumstances. Healthcare providers and state-licensed pharmacists should carefully review the EUA prior to prescribing this medication. Additionally, the National Institutes of Health has published Ritonavir-Boosted Nirmatrelvir (Paxlovid), which includes important information on potential drug interactions. Paxlovid is also offered in a renal dose presentation. The Paxlovid Fact Sheet for Healthcare Providers [gcc02.safelinks.protection.outlook.com] was also revised to reflect the current indication for Veklury [gcc02.safelinks.protection.outlook.com], an approved alternative to Paxlovid, and to include new information on drug-drug interactions.

LAGEVRIO (MOLNUPIRAVIR)

Lagevrio (molnupiravir) received EUA on December 23, 2021. Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis. Molnupiravir may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which the oral antivirals belong (i.e., anti-infectives).

On February 1, 2023, the FDA updated the Lagevrio Emergency Use Authorization. The scope of the authorization was revised to no longer require positive test results of direct SARS-CoV-2 viral testing. The FDA continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment for COVID-19 is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high-risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the authorization are met, as detailed in the Fact Sheet for Healthcare Providers. As revised, the scope of authorization for both products now requires, in addition to other requirements, that adults and pediatric patients (12 years of age and older weighing at least 40 kg) have a current diagnosis of mild-to-moderate COVID-19.

Molnupiravir may only be used for the treatment of mild-to-moderate COVID-19 in adults: who are at high-risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.

The EUA directs readers to the Centers for Disease Control and Prevention People with Certain Medical Conditions for information on medical conditions and factors associated with increased risk for progression to severe COVID-19 and state the healthcare providers should consider the benefit-risk for an individual patient.

The EUA Fact Sheet for Healthcare Providers includes important information on the use of this product in individuals of reproductive age with childbearing potential. Molnupiravir is not recommended for use during pregnancy. Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. On February 1, 2023, the FDA updated the Lagevrio EUA Fact Sheet to include instructions on administration via nasogastric or orogastric tube. Healthcare providers should carefully review the EUA prior to prescribing this medication.

MONOCLONAL ANTIBODY PRODUCTS

What are monoclonal antibodies?

Our bodies naturally make antibodies to fight infection. Monoclonal antibodies are like the antibodies your body makes to fight other viruses, but they are made in a lab and are designed to target the coronavirus spike protein. When the antibodies bind to the spike protein, they block the virus from entering your body’s cells. This keeps the virus from spreading to more of your cells and can help those who are at higher-risk of being hospitalized with COVID-19. 

Getting vaccinated is the best way to prevent COVID-19 and the monoclonal antibody treatments are not a substitute for vaccination.

BEBTELOVIMAB 

On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for the treatment of COVID-19 in any US region due to the prevalence of resistant circulating variants. 

On January 26, 2023, the FDA announced that Evusheld is no longer authorized for the prevention of COVID-19 in any US region due to the prevalence of resistant circulating variants.

There are many things that healthcare providers can do to protect patients from COVID-19, including vaccination, developing a COVID-19 Action Plan, and using multiple layers of protection against COVID-19. 

REQUESTING STATE-ALLOCATED COVID-19 MEDICATIONS

HHS has enabled COVID-19 therapeutic Direct Order Request (DOR) through the HPoP portal for registered users. Therapeutic providers (dispensing sites) can request a specific therapeutic allotment by submitting an order in HPoP. The requested order will then be reviewed by the state for approval, denial, or adjustment. Requests for products will be processed on weekdays. Approved order requests will be sent to AmerisourceBergen for distribution. Sites can email margaret.cook-shimanek@mt.gov directly if they are interested in requesting therapeutics, but do not have an active HPoP account. 

REPORTING INVENTORY AND UTILIZATION

Inventory reporting is required on Monday and Thursdays each week in the HPoP system. Please find additional information on facility-level reporting here.

COVID-19 MEDICATION SITES IN MONTANA

To identify COVID-19 medication dispensing sites in Montana, please visit the links below and search for administration sites by zip code.

To find sites reporting inventory of molnupiravir, Paxlovid, Renal Paxlovid, and outpatient commercial remdesivir visit the HHS Therapeutics Distribution Locator for Provider Use

To find sites reporting inventory of the oral antiviral medications, visit HHS Get Medication for COVID-19

Patients must qualify for treatment. Product availability may change based on access to the monoclonal antibody products and demand. Potential recipients should contact the site before presenting for treatment.  Please note that this website discusses therapeutics distributed as a part of the state-led allocation and may not reflect all treatment sites in the state. Sites purchasing product commercially and those involved in a direct federal allocation are not included on this map, as that allocation occurs independent of the state (e.g., Veterans Affairs or Indian Health Service).

Veklury (remdesivir) is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog polymerase inhibitor indicated for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilograms) who are:

  • Hospitalized, or
  • Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

 

Veklury is commercially available for hospital purchase through any of the following distributors:

  • AmerisourceBergen Specialty Distribution, 1-800-746-6273
  • Cardinal Specialty, 1-855-855-0708
  • McKesson Plasma, 1-877-625-2566

 

Non-hospitals can contact AmerisourceBergen Specialty Distribution or Cardinal Specialty:

  • AmerisourceBergen Specialty: (t) 1-800-746-6273 (e) C19therapies@AmerisourceBergen.com
  • Cardinal Specialty: (t) 1-855-855-0708 (e) GMB-SPD-CSORDERENTRY@cardinalhealth.com