| COVID-19 Therapeutics Options by Exposure and Infection Status | | 175 | | COVID-19 Therapeutics Options by Exposure and Infection Status | <p><strong>āāSARS-CoV-2 Negative (-)</strong></p><table cellspacing="0" width="100%" class="ms-rteTable-7" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-7" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-7" rowspan="1" colspan="1" style="box-sizing:border-box;width:298.5px;"><p><strong>Not Exposed</strong></p></th><th class="ms-rteTableHeaderOddCol-7" rowspan="1" colspan="1" style="box-sizing:border-box;width:298.5px;"><p><strong>Exposed</strong></p></th></tr><tr class="ms-rteTableOddRow-7" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-7" style="box-sizing:border-box;"><p>Pre-Exposure Prophylaxis (PrEP)</p></td><td class="ms-rteTableOddCol-7" style="box-sizing:border-box;"><p>Post-Exposure Prophylaxis (PEP)</p></td></tr><tr class="ms-rteTableEvenRow-7" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-7" style="box-sizing:border-box;height:66px;"><p></p><p></p><p>Currently no āauthorizeād treatmentsā<br></p><p></p><br></td><td class="ms-rteTableOddCol-7" style="box-sizing:border-box;height:66px;"><p>Currently no authorized treatmeānts<br></p></td></tr></tbody></table><p><br></p><p><strong>SARS-CoV-2 Positive (+)</strong></p><table cellspacing="0" width="100%" class="ms-rteTable-9" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-9" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-9" rowspan="1" colspan="1" style="box-sizing:border-box;width:597px;"><p><strong>Mild to Moderate Illness in Individual at High Risk for Disease Progression</strong></p></th></tr><tr class="ms-rteTableOddRow-9" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-9" style="box-sizing:border-box;"><p>Treatment options, in order of preference:</p><p>1. Nirmatrelvir/ritonavir (Paxlovid)</p><p>2. Remdesivir (Veklury)<br></p><p>If above options are unavailable or not medically appropriate, can consider (in alphabetical order):<br></p><p>3. Molnupiravir (Lagevrio)</p><div><br><br></div></td></tr></tbody></table><br><div>āU.S. Department of Health and Human Services (HHS) summary table:Ā <a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/side-by-side-overview.pdf" target="_blank">Side-by-Side Overview of Therapies</a>Ā (PDF).</div><div><br></div><div>FDA approved/authorized COVID-19 drugs:Ā <a href="https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs" target="_blank">Coronavirus (COVID-19) | Drugs | FDA</a><br></div> | | | |
| Clinical Decision Making Guides | | 181 | | Clinical Decision Making Guides | <p>āāāEffective treatment for outpatients with mild-to-moderate COVID-19 is available and should be offered to all eligibleĀ patients. <strong>Providers should have a low threshold to prescribe COVID-19 therapeutics given the broad range of individuals who are at higher risk for severe COVID-19 and can benefit from COVID-19 treatment.</strong>Ā <br></p><p>Multiple factors must be considered when selecting the appropriate treatment for outpatient with COVID-19, includingĀ patient-specific factors such as clinical/medical conditions and potential drug-drug interactionsĀ and healthcare system factors such as drug availability and feasibility of drug administration.Ā Providers should review product information orĀ EUAs as well as the NIH Treatment Guidelines linked below.<br><br></p><p><strong>Treatment Guidelines</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/" target="_blank">COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/management/">Clinical ManagementĀ | COVID-19 āTreatment Guidelines (nih.gov)ā</a><br></p></li><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Pages/default.aspx" target="_blank">HHS Clinical Implementation Guide</a>Ā (PDF)<br></p></li><li style="box-sizing:border-box;"><p><a href="https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/">Infection Disease Society of America (IDSA) Treatment Guidelines</a><br></p></li></ul><p>T<strong>reatment Algorithms (Flow Charts)</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/COVID-Therapeutics-Decision-Aid.pdf" target="_blank">HHS Outpatient Therapeutics Decision Aid</a>Ā (PDF)</p></li><li style="box-sizing:border-box;"><p><a href="https://www.idsociety.org/globalassets/covid-19-real-time-learning-network/outpatientroadmap-v10.pdf" target="_blank">IDSA Outpatient Treatment Roadmap</a>Ā (PDF)</p></li></ul><p><strong>Drug Interaction Checker</strong></p><ul><li><p><a href="https://covid19-druginteractions.org/view_all_interactions" target="_blank">Liverpool COVID-19 Interactions (covid19-druginteractions.org)</a><br></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antivirals-including-antibody-products/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions/">NIH Paxlovid Interaction Guide (nih.gov)ā</a><br></p></li></ul><p><strong>COVID-19 Variant Information</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank">CDC Variant Tracker</a></p></li><li><p><a href="https://covid.cdc.gov/covid-data-tracker/#circulatingVariants" target="_blank">CDC Nowcast Estimates</a></p></li></ul><p><strong>Underlying Medical Conditions</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html" target="_blank">Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals | CDC</a></p></li><li style="box-sizing:border-box;"><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html" target="_blank">COVID-19 Vaccines for Moderately or Severely Immunocompromised People | CDC</a><br></p></li></ul> | | | |
| Viral Rebound | | 305 | | Viral Rebound | <p>ā<br></p><div>Recurrence of symptoms, or ārebound,ā of COVID-19 has been noted in a small but significant percentage of cases. Media reports labelled COVID-19 symptom recurrence after treatment with the oral antiviral agentĀ Paxlovid (nirmatrelvir/ritonavir)Ā as āPaxlovid rebound,ā creating misperceptions in both healthcare providers and the public that Paxlovid is the root cause of COVID-19 rebound. COVID-19 viral rebound may occur in both untreated and treated people.<br></div><div><br></div><div>Although COVID-19 rebound may occur after treatment with antivirals, there is currently no evidence that this rebound is the result of SARS-CoV-2 resistance to therapeutics. Based on case reports, recurrent symptoms after treatment with antivirals appear to be mild. Because the goal of antiviral treatment is avoiding progression to severe disease, recurrent mild to moderate symptoms do not indicate treatment failure. Individuals with COVID-19 symptom recurrence shouldĀ follow CDPHĀ and <a href="https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html">CDCĀ guidance regarding isolationā</a> of infected patients regardless of their treatment status. Paxlovid continues to be recommended for the treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.<br></div><div><br></div> | | | |
| Antivirals Overview | | 177 | | Antivirals Overview | ā<br><table cellspacing="0" width="100%" class="ms-rteTable-4" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-4" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:145.672px;"><p><strong>āāāDrug</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:102.328px;"><p><strong>Route</strong></p></th><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:105.75px;"><p><strong>Age groups authorized for treatment</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:96.4688px;"><p><strong>Timing of Treatment</strong></p></th><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:130.031px;"><p><strong>āEffectiveness</strong></p></th></tr><tr class="ms-rteTableOddRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Nirmatrelvir with ritonavir (Paxlovid)</strong></p><p>Orally twice daily for 5 days</p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;"><li style="box-sizing:border-box;"><p>For patients with normal/mild renal impairment (eGFR > 60 mL/min): 300 mg nirmatrelvir with 100 mg ritonavir</p></li><li style="box-sizing:border-box;"><p>For patients with moderate renal impairment (eGFR ā„ 30 to < 60 mL/min): 150 mg nirmatrelvir with 100 mg ritonavir</p></li></ul></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Oral</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>FDA approved for age 18 and over; authorized forĀ 12 years and older and weighing at least 40 kg under Emergency Use Authorization (EUA)<br></p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 5 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo, <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2118542">a relative risk reduction of 44-87%ā</a>Ā in hospitalizations for patients over 50 yearsĀ of age, and over 75% for patients over 65 years of age.</p></td></tr><tr class="ms-rteTableEvenRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Remdesivir (Veklury)</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;"><li style="box-sizing:border-box;"><p>For adults and pediatric patients weighing ā„ 40 kg: 200 mgĀ IV on Day 1, followed by 100 mgĀ IV daily on Days 2 and 3</p></li><li style="box-sizing:border-box;"><p>For pediatric patients ā„ 28 days old and weighing ā„ 3 kg to < 40 kg: 5 mg/kg IV on Day 1, followed by 2.5 mg/kg IV daily on Days 2 and 3.</p></li></ul></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Intravenous</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>FDA approved for mild to moderately ill adult and pediatric (28 days of age and older weighing at least 3 kilograms) outpatients who are at risk of disease progression.<br></p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 7 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo,Ā <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116846" target="_blank">a relative risk reduction of 87%</a>Ā in hospitalizations or deaths.</p></td></tr><tr class="ms-rteTableOddRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Molnupiravir (Lagevrio) 800 mg</strong></p><p>Orally twice daily for 5 days</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Oral</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>18 years and older</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 5 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo, <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2822%2902597-1/fulltext">a relative risk reduction of 30-50%ā</a>Ā in hospitalizations or deaths in patients over 65 years of age.</p></td></tr></tbody></table><p><br></p><p><br></p> | | | |
| Guidance on Antivirals | | 180 | | Guidance on Antivirals | <p>āāāāAntivirals prevent viral replication through multiple processes. There are currently two oral antivirals, nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio), that are authorized or approved for outpatient treatment of COVID-19. Nirmatrelvir/ritonavir (Paxlovid) is FDA approved for use in adults, and remains under anĀ emergency use authorization (EUA) for patients aged 12 to 17.Ā Molnupiravir (Lagevrio) is authorized for adults under anĀ EUA.Ā Additionally, remdesivir (Veklury) is an intravenous antiviral that has FDA approval for inpatient and outpatient treatment of COVID-19 in adult and pediatric patients 28 days and older weighing at least 3 kg.</p><p><strong>General Information on antivirals</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/summary-recommendations/" target="_blank">Antiviral Therapy Summary Recommendations | COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/table--characteristics-of-antiviral-agents/" target="_blank">Characteristics of Antiviral Agents | COVID-19 Treatment Guidelines (nih.gov)</a><br></p></li><li><p><a href="https://www.covid19-druginteractions.org/">Liverpool InteractiveĀ Drug-Drug Interaction Checker</a>Ā <br></p></li></ul><p><strong>Nirmatrelvir/ritonavir (Paxlovid):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://labeling.pfizer.com/ShowLabeling.aspx?id=19599">Paxlovid Product Informationā</a> (PDF)<br></p></li><li><p><a href="https://www.fda.gov/media/155049/download" target="_blank">Paxlovid EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155050/download" target="_blank">Paxlovid Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155071/download" target="_blank">Paxlovid Dear Healthcare Provider Letter</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155052/download" target="_blank">Paxlovid EUA Frequently Asked Questions</a>Ā (PDF)<br></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions/" target="_blank">NIH Paxlovid Drug-Drug interactions</a></p></li><li><p><a href="https://www.pfizermedicalinformation.com/en-us/drug-interaction-checker?product=PAXLOVID%E2%84%A2+%7c+nirmatrelvir+tablets%3b+ritonavir+tablets" target="_blank">Pfizer Paxlovid Drug Interaction Checker</a></p></li><li><p><a href="https://covid19-sciencetable.ca/sciencebrief/nirmatrelvir-ritonavir-paxlovid-what-prescribers-and-pharmacists-need-to-know-3-0/" target="_blank">Ontario COVID-19 Science Advisory Table</a></p></li><li><p><a href="https://www.fda.gov/media/158165/download" target="_blank">Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers</a>Ā (PDF)</p></li><li><p><a href="https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/management-of-drug-interactions-with-nirmatrelvirritonavir-paxlovid/" target="_blank">Management of Drug Interactions With Nirmatrelvir/Ritonavir (PaxlovidĀ®): Resource for Clinicians (idsociety.org)</a><br></p></li></ul><p><strong>Molnupiravir (Lagevrio):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.fda.gov/media/155053/download" target="_blank">Lagevrio EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155054/download" target="_blank">Lagevrio Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155101/download" target="_blank">Lagevrio Dear Healthcare Provider Letter</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155056/download" target="_blank">Lagevrio EUA Frequently Asked Questions</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155118/download" target="_blank">Lagevrio Prescriber Checklist</a>Ā (PDF)</p></li></ul><p><strong>Remdesivir (Veklury):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi.pdf" target="_blank">Veklury Prescribing InformationĀ </a>Ā (PDF)</p></li><li><p><a href="https://www.vekluryhcp.com/downloads/Outpatient_Product_Information_Guide.pdf" target="_blank">Veklury Outpatient Product Information GuideĀ </a>(PDF)</p></li><li><p><a href="https://www.gilead.com/-/media/gilead-corporate/files/pdfs/covid-19/dhcp-letter_peds-labeling.pdf?la=en&hash=EBD10EB91622F6D797DC49C813FE7E01" target="_blank">Veklury Dear Healthcare Provider Letter</a>Ā (PDF)<br></p></li><li><p><a href="https://www.vekluryhcp.com/downloads/Coding_and_Reimbursement_information.pdf" target="_blank">Veklury Coding and Reimbursement information</a>Ā (PDF)<br></p></li></ul><p><br></p> | | | |
| Guidance on Monoclonal Antibodies | | 179 | | Guidance on Monoclonal Antibodies | <p>āāāāāMonoclonal antibodies are synthetic proteins that block virus from attachment and entry into human cells.Ā <span data-contrast="none" lang="EN-US">Due to resistance patterns of currently circulating subvariants in the United States, <strong>there are no anti-SARS-CoV-2 monoclonal antibody agents authorized for COVID-19 treatment or pre-exposure prophylaxisĀ at this time</strong>.</span>Ā <br></p><p><strong>General information on monoclonal antibodies:</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/" target="_blank">Anti-SARS-CoV-2 Monoclonal Antibodies | COVID-19 Treatment Guidelines (nih.gov)</a><br></p></li></ul><p><strong>Infusion locations</strong><br></p><ul><li><p><a href="https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Therapeutics Locator (arcgis.com)</a><br><br></p></li></ul><p><strong>COVID-19 Pre-exposure ProphylaxisĀ </strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care.html#pre" target="_blank" style="text-decoration-line:underline;">Clinical Care Information for COVID-19 Pre-exposure Prophylaxis</a>Ā (cdc.gov)</li><li><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Products/Evusheld/Pages/default.aspx">āEvusheld Not Authorized in US| Important Update | HHS/ASPRĀ ā</a><br></li></ul><p><br></p> | | | |
| Pre-Exposure Prophylaxis | | 178 | | Pre-Exposure Prophylaxis | <p>āāāThere are currently no FDA approved or authorized treatments for pre-exposure prophylaxis against COVID-19.</p><p><ul><li><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care.html#pre">CDC Clinical Care Information: Pre-Exposure Prophylaxis (cdc.gov)ā</a>ā<br></li></ul><br></p> | | | |
| Treatments for Post-COVID Conditions | | 193 | | Treatments for Post-COVID Conditions | <p>āHealthcare providers can get current information on post-COVID conditions, or "long COVID," from the following sources:</p><p></p><ul><li><a href="/Programs/CID/DCDC/Pages/COVID-19/Post-COVID.aspx">Post-COVID Conditions (Long COVID)</a>ā (ca.gov)</li><li><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html">Post-COVID Conditions: Information for Healthcare Providersā</a> (cdc.gov)</li><li><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-science.html">Post-COVID Conditions: CDC Science</a> (cdc.gov)</li><li><a href="https://www.nhlbi.nih.gov/covid/long-covid">Long COVID</a> (nih.gov)āāāāāā</li></ul><br><p></p> | | | |
| Locating COVID-19 Therapeutics | | 182 | | Locating COVID-19 Therapeutics | <p>āāHHS maintains a TherapeuticsĀ Locator of sites that currently have outpatient therapeutics available.</p><p>The federal government launched the Test to Treat initiative to facilitate expedited access to testing, assessment, and treatment. Through this program, various clinic-based pharmacies provide on-site testing (including the evaluation of at-home test results), clinical assessment, and prescription and dispensing of COVID-19 oral antiviral medications.</p><p>Additionally, the California Department of Public Health (CDPH) supportsĀ a program to provide free and confidentialĀ oral antiviral treatment to individuals who are eligible for COVID-19 treatment, including for uninsured, underinsured, undocumented, and unhoused individuals.</p><p><strong>Therapeutics locator</strong></p><ul><li><p><a href="https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Therapeutics Locator (arcgis.com)</a></p></li></ul><p><strong>Test to Treat Program ā General Information</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://aspr.hhs.gov/TestToTreat/Pages/default.aspx" target="_blank">Test To Treat (hhs.gov)</a><br></p></li></ul><p><strong>Test to Treat Site Locator</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Test to Treat Locator English (arcgis.com)</a><br></p></li></ul><p><strong>California Resources</strong></p><ul><li><p><a href="https://covid19.ca.gov/treatment/#find-treatment">Find treatment in California (ca.gov)ā</a><br></p></li></ul> | | | |
| Increasing Equitable Access | | 304 | | Increasing Equitable Access | <p>āāāāFor an overview of California's commitment to health equity in the COVID-19 response, please visit theĀ <a href="https://covid19.ca.gov/equity/">California for All COVID-19 equity page</a> (ca.gov).ā<br></p><p>On April 18, 2023, the Department of Health and Human Services (HHS) announced a <a href="https://www.hhs.gov/about/news/2023/04/18/fact-sheet-hhs-announces-hhs-bridge-access-program-covid-19-vaccines-treatments-maintain-access-covid-19-care-uninsured.html#msdynttrid=D6LqzCNTGfa3rSYdyaK5L5by8mtvovbfprYVNdqNJHQ">Bridge Access Program For COVID-19 Vaccines and Treatments (hhs.gov)ā</a>.<br></p><p>Free COVID-19 vaccinations and treatments will be offered to the uninsured through a novel, funded partnership with pharmacy chains enabling access through their network or retail locations as was available during the COVID-19 Public Health Emergency (PHE).ā<br></p><p>This program will also leverage the public commitments by drug manufacturers to provide vaccines and treatments, such as Nirmatrelvir/ritonavir (Paxlovid), free-of-charge for the uninsured. CDC will establish contracts with pharmacies to enable them to continue offering COVID-19 vaccines and designated treatments with no out-of-pocket costs to uninsured individuals, maintaining this critical access point for this population. These contracts will also allow uninsured individuals to receive access to certain COVID-19 treatments, including the drugs Paxlovid and molnupiravir (Lagevrio), from participating pharmacies with no out-of-pocket costs.</p><p>Over the next few months, HHS will establish new contractional relationships with pharmacies, so that this component of the program could be launched sometime this Fall. Many details of the pharmacy program are still being worked out, including which chains will participate and what degree of independent pharmacy involvement there will be.Ā The partnership will be timed to coincide with vaccine and nirmatrelvir/ritonavir (Paxlovid) commercialization, to prevent gaps in coverage for the uninsured.</p><p>Vaccine access will also leverage the existing public sector safety net health centers. For full details and more information about vaccine and therapeutics access, read the <a href="https://urldefense.com/v3/__https:/ab1ee995966d418da4b12a48bc7a4390.svc.dynamics.com/t/t/0wyvTlvsDaQfgpfcJ0pDPojWjSFdyQfpcsEZXh62pZkx/cPJx83cw7YUX2NcrUbZfnk610Nnx5tfJuGCCkVDdQc8x__%3b%21%21AvL6XA%21y0pA8e4Kn_HHvBSwrFcrb-ojBhxYoG5NnG1xozWnzcBIJ-i5vdVPnEJ92Bwl_jizFnkn6KYkBjPybxryPtuIe-n2sRifV0le_80O$">HHS fact sheet (hhs.gov)</a> about the program.</p><p><span class="ms-rteStyle-Emphasis">Please alsoĀ use the below guidance to increase equity in access toĀ COVID-19 treatments.Ā </span><br></p><p>Best practices for caring for uninsured patients and/or a patient new to your clinic or system:<br></p><div><ul><li>Lower barriers to seek urgent care for evaluation and treatment for COVID-19, including shortening or bypassing standard enrollment processes.Ā </li><li>Become a Medi-Cal Qualified Provider.</li><li>Equity and Reporting: Develop metrics and tracking systems to regularly review COVID-19 utilization data, identify disparities to help prioritize resources. Example metrics include:</li></ul><ul><ul><li>Time from symptom onset to receipt of therapeutic</li><li>Time from initial contact with member to receipt of therapeutic</li><li>Member demographics accessing treatment, including: SDOH, race, ethnicity, zip code, and age</li><li>Percent of symptomatic and COVID-19 positive patients that are evaluated by a prescriber</li><li>Percent of symptomatic and COVID-19 positive patients that receive a prescription for a therapeuticĀ </li><li>Reasons why a patient was not prescribed a therapeuticā<br></li></ul></ul><p></p></div> | | | |
| Allocation and Distribution of Therapeutics | | 183 | | Allocation and Distribution of Therapeutics | <p>āā<br></p><p></p><div>The U.S. Department of Health and Human Services (HHS) currently manages a state/territory-coordinated distribution system for federally purchased COVID-19 therapeutic oral antiviral products.Ā āĀ <br></div><div><br></div><div>HHS uses a monthly "threshold and replenishment" strategy to provide allocations to each state, territory, the District, and federal partners. Each partner gets a threshold for nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio), and the first week ofĀ each monthĀ the federal government replenishes products up to the monthly threshold.Ā <br></div><div><br></div><div>The California Department of Public Health (CDPH) is allocating COVID-19 therapeutics active against current variants and included in the HHS jurisdictional distribution system using the below strategies:<br><br></div><div><div><div><table cellspacing="0" width="100%" class="ms-rteTable-default"><tbody><tr class="ms-rteTableEvenRow-default"><td class="ms-rteTableEvenCol-default" style="width:33.3333%;"><span class="ms-rteThemeForeColor-5-0"><span><strong>āPrāoduct</strong></span><br></span></td><td class="ms-rteTableOddCol-default" style="width:33.3333%;"><span class="ms-rteThemeForeColor-5-0"><span><strong>āAuthorized Indication</strong></span><br></span></td><td class="ms-rteTableEvenCol-default" style="width:33.3333%;"><span class="ms-rteThemeForeColor-5-0"><strong>āAllocation Strategy</strong></span><br></td></tr><tr class="ms-rteTableOddRow-default"><td class="ms-rteTableEvenCol-default">ā<strong>nirāāāāmatrelvir/ritoāāāāāāāāānavir (Paxlovid)Ā </strong><div>Oral protease inhibitor</div><div>&</div><div><strong>molnupiravir (Lagevrio)</strong></div><div>Oral nucleoside analogue<br></div><div><br><br></div><br></td><td class="ms-rteTableOddCol-default">āTreatment of mild to moderately ill outpatients with current diagnosis of COVID-19<br></td><td class="ms-rteTableEvenCol-default">āAllocated to counties based on the <a href="https://www.healthyplacesindex.org/">Healthy Places Index</a> (HPI); with 40% to Q1 (most disadvantaged); 30% to Q2; 20% to Q3; 10% to Q4 (most advantaged).<br></td></tr></tbody></table></div></div><br><div>Additionally, the federal <a href="https://aspr.hhs.gov/testtotreat/Pages/default.aspx">Test to Treat program</a> allows for individuals to receive testing, assessment, and treatment all in one location. The Administration for Strategic Preparedness and Response (ASPR) distributes the oral antiviral products directly to Test to Treat pharmacy-based clinics, health centers, and long-term care facilities. Certain providers within the state allocation program are also participants in the Test to Treat Program. For more information, please refer to <a href="https://aspr.hhs.gov/TestToTreat/Documents/Fact-Sheet.pdf">ASPR's Test to Treat fact sheet</a> (PDF) or the <a href="https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/">ASPR Test to Treat map</a> for a list of all Test to Treat sites.Ā <br></div><div><br></div><div><span class="ms-rteStyle-Accent1"><strong>Ordering COVID-19 Therapeutics</strong></span><br></div><div><br></div><div>Facilities that are able to operationalize COVID-19 therapeutics and would like to be considered for product allocations should contact their <a href="https://emsa.ca.gov/medical-health-operational-area-coordinator/">Medical and Health Operational Area Coordinator</a> (MHOAC).<br></div><div><br></div><div>Remdesivir is not being allocated by the federal government and can be <a href="http://www.wsha.org/wp-content/uploads/AmerisourceBergen-Remdesivir-Distribution.pdf">purchased </a>(PDF) directly from the distributor.<br></div><div><br></div><div><span class="ms-rteStyle-Accent1"><strong>ResourcesĀ </strong></span><br></div><div><br></div></div><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Documents/ASPR-Fact-Sheet_Therapeutics-Utilization.pdf" target="_blank">ASPR Therapeutics Distribution fact sheet</a>Ā (PDF)</p></li><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Orders/Pages/default.aspx" target="_blank">COVID-19 Therapeutics Thresholds, Orders, and Replenishment by Jurisdiction | HHS/ASPR</a><br></p></li><li style="box-sizing:border-box;"><div style="color:#444444;background-color:rgba(255, 255, 255, 0.85);"><a href="https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/">HHS/ASPR COVID-19 Test to Treat Locator English</a> (arcgis.com)<br></div></li></ul><p><br></p> | | | |
| Information for Pharmacists | | 303 | | Information for Pharmacists | <p>āāāPharmacists can use the<a href="https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/Resource-Guide-for-Pharmacies-to-Prevent-Delayed-COVID-19-Treatment.aspx"> Resource Guide for Pharmacies to Prevent Delayed COVID-19 Treatmentā</a> for guidance regarding best practices for prescribing and dispensing COVID-19 therapeutics.ā<br></p><p>Ask your legal counsel to review the <a href="https://www.pharmacy.ca.gov/laws_regs/pharmacy_lawbook.shtml">Board of Pharmacyās lawbook</a> to understand dispensing limitations. If you do not have counsel on hand, consider hiring counsel to review these regulations and to provide you with risk assessment of any dispensing pathways you are interested in pursuing.Ā Ā <br><br></p><p><strong>Pharmacist dispensing when receiving a prescriptionĀ </strong></p><ul><li>Pharmacy receives patient prescription (electronic, written, or verbal).Ā </li><li>Pharmacy should prioritize the prescription fill and ensure timely turnaround to support initiating therapy as soon as possible.Ā </li><li>Pharmacist verifies prescription is appropriate and safe for patient by checking the <a href="https://www.fda.gov/media/158165/download">eligibility criteria</a>.Ā <br></li><ul><li>Pharmacists are reminded that all types of positive COVID-19 tests are enough to qualify for Paxlovid, including a home test.Ā </li><li>A patient may attest to their own symptom start date or it may be written on the prescription by the provider.Ā Ā </li><li>A reasonable attempt should be made to clarify any concerns with the provider to comply with the patient eligibility criteria under the EUA. <strong>Pharmacists should use professional clinical judgement and consider the</strong><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html"><strong> impact on the patient</strong></a><strong> and timelines of care.Ā </strong></li></ul><li>Check for drug-drug interactions and contradictions.Ā </li><li>Some patients with certain forms of kidney disease may need to <a href="https://www.covid19treatmentguidelines.nih.gov/tables/antiviral-antibody-characteristics/">take Paxlovid differently</a>. Contact prescriber if renal impairment is suspected and dosing may not coincide with recommendations.Ā </li><ul><li><strong>Confirmation of eGFR is not a necessity to fill a COVID-19 therapeutic prescription, as it is only used as a guidance for recommended Paxlovid dosing. Patients with no past medical history of renal impairment may not have an available eGFR.Ā </strong></li></ul><li>If after a thorough medication reconciliation, a pharmacist suspects compromised renal function, a reasonable attempt should be made by the pharmacist to obtain pertinent information to ensure appropriateness of therapy.Ā </li><ul><li><strong>If pertinent information is not obtained, such as eGFR, after a reasonable attempt has been made, a pharmacist should use professional clinical judgement and consider the impact on the patient and timeliness of care in the decision to dispense.Ā </strong></li></ul><li>Pharmacist consults patient on medication therapy and directs patient to start immediately. Patient to begin prescribed therapy right away and continue for 5 days.Ā </li><li>Patient to report any adverse effects to their health care provider and to <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program">FDA MedWatch</a>.Ā <br><br></li></ul><p><strong>Pharmacists independently initiating Paxlovid therapy</strong>Ā </p><p>In July 2022, the FDA updated the <a href="https://www.fda.gov/media/155049/download">Emergency Use Authorization (EUA) letter for Paxlovid</a> to allow pharmacists to prescribe the medication under specific circumstances. This change applies to all state-licensed pharmacists.Ā Ā <br></p><p>The Department of Consumer Affairs<a href="https://www.dca.ca.gov/licensees/dca_22_217.pdf"> Order Waiving Restrictions on Pharmacists Independently Initiating and Furnishing Paxlovid to Individual Patientsā</a> expired on February 28, 2023.Ā <br></p><p>The State Board of Pharmacy is encouraging interested persons to evaluate the federal Public Readiness and Emergency Preparedness ActĀ (PREP Act) with an attorney, if necessary, to determine eligibility for pharmacists to continue independently initiating and furnishing Paxlovid for individual patients.Ā <br></p><p>Please see additional information on the Board of Pharmacyās website: <a href="https://www.pharmacy.ca.gov/covid19/covid19_info_feb_2023.shtml">COVID-19 Information 2/22/23 - California State Board of Pharmacy.Ā </a><br></p><p>Also see HHS <a href="https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx#:~:text=HHS%20PREP%20Act%20Declaration:%209th%20Amendment&text=To%20support%20this%20priority%20effort%2cpharmacy%20technicians%2c%20and%20pharmacy%20interns.">PREP Act Declaration: 9th Amendment</a>.ā<br><br></p> | | | |
| Billing and Coverage Information | | 184 | | Billing and Coverage Information | <ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;font-family:"source sans pro", sans-serif;font-size:15px;background-color:#ffffff;"><li><p><a href="/Programs/CID/DCDC/CDPH%20Document%20Library/COVID-19/COVID-19-Coverage-Change.pdf" title="COVID-19 Medical Coverage Changes Following End of Federal Public Health Emergencyā (PDF)" target="_blank">COVID-19 Medical Coverage Changes Following End of Federal Public Health Emergencyā</a>Ā (PDF)<br></p></li><li><p>āā<a href="https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies" target="_blank" title="CMS reimbursement information for monoclonal antibodies">CMS reimbursement information for monoclonal antibodies</a>Ā (PDF)<br></p></li><li><p><a href="https://www.cms.gov/files/document/hpms-memo-oral-antiviral-guidance.pdf" target="_blank" title="CMS reimbursement information for oral antivirals">CMS reimbursement information for oral antivirals</a>Ā (PDF)<br></p></li></ul><p><br></p> | | | |