Related Materials: CDPH Respiratory Virus Dashboard | CDPH COVID-19 Coverage Change Table (PDF)| COVID-19 Test to Treat Locator English  ​​​​​​​

Background

Lagevrio (molnupiravir) and Paxlovid (nirmatrelvir/ritonavir) are oral antiviral drugs that are highly effective for preventing hospitalization and death in patients with mild to moderate COVID-19 infection who are at higher risk​ for severe disease. Multiple factors are involved to ensure timely administration of oral antivirals, including adequate drug supply and distribution, acceptance of the therapy by health care providers and the public, and patient access to testing, prescriptions, and drug dispensing sites.

The California Department of Public Health (CDPH) has been made aware of continued occasions where pharmacists have turned away patient prescriptions for COVID-19 oral antiv​​iral therapy due to misinformation or a lack of information. 

This document provides recommendations to clarify what information is necessary to dispense these therapeutics.  It is intended to aid pharmacies serving as dispensing sites for ​these critical medications. For more information on COVID-19 therapeutics and California's efforts to increase accessibility, please see the CDPH COVID-1​​9 Treatm​ent Resources.

While treatments are important tools in the fight against COVID-19, vaccines are also a critical component of mitigating the spread and impact of COVID-19. All individuals are recommended to stay up to date with COVID-19 vaccinations, which increase protection against severe COVID-19. Learn more about vaccines at the CDPH Vacc​ines Site.​​

Treatment Resources for Healthcare Providers

In all situations, clinical concerns about inappropriate prescriptions or inappropriate dosing should be weighed against the clinical consequences of delaying or denying treatment that prevents severe illness from COVID-19, which has caused more than 105,000 deaths in California to date.

As we are likely to continue to see periodic surges of COVID-19 cases, it is important to remain up to date on the latest clinical guidance to ensure patients receive appropriate and timely access to highly effective COVID-19 treatment. Pharmacies and pharmacists should be aware they may see a rise in prescriptions for COVID-19 medications for a number of reasons including:

• All Facility Letter (AFL) for Skilled Nursing facility (SNF) residents AFL 23-29 that provides guidance and resources for evaluating, prescribing, and obtaining COVID-19 therapeutics for SNF residents. AFL 23-29 supersedes AFL 22-20.

• All other AFLS including those relating to COVID-19 therapeutics may be accessed at the All Facilities Letters – Library. CDPH health advisories related to respiratory viruses including COVID-19,  can be found in the health advisories page.

• ​​CDPH health advisories related to respiratory viruses including COVID-19,  which can be found in the CDPH health advisories page.​

• CDPH has developed shareable communication- materials on COVID-19 treatments, including videos, social media, and handouts in different lanugages. Find shareable content on the CDPH COVID-19 Communication Treatments page.​
  

The following information is intended to clarify topics that pharmacies and pharmacy staff may need to prevent delayed access to critical COVID-19 treatment.​

M​ost insured patients continue to have a right to free, low-cost, and/or reimbursable over-the-counter COVID-19 tests.

• ​Ensure all staff are knowledgeable about patients' benefits for COVID-19 tests.

• Pharmacists should order and/or dispense allotted test kits for Medi-Cal beneficiaries at the point-of-sale in accordance with the following information: CDPH COVID-19 Medical Coverage Changes (PDF).

• Most insurance plans still cover COVID-19 at-home tests. If you do not have an at-home test, testing locations​ at Find a testing site (ca.gov) or No-Cost COVID-19 Testing (cdc.gov). Refer to the DMHC Know Your Health Care Rights Fact Sheet (PDF) for information on commercial plans.​

• ​Refer to this webpage for Medicare recipients and to the COVID-19 Medical Coverage Changes (PDF) table for a summary of COVID-19 health care benefits. ​

• For insurance plans that allow p​atients to pick up tests at pharmacies within their network free of charge, including Medi-Cal, pharmacists should write an order for the COVID-19 tests and submit the claim as a pharmacy benefit. 

• If tests are not covered by insurance at point of sale in the pharmacy, patients may elect to pay at the counter and submit a claim for reimbursement from their insurance company directly.

The number of free test kits varies by health plan in network benefits. Uninsured patients can get information on testing at the: CDC No-Cost COVID-19 Testing Locator.​ 

Pharmacies should maintain an adequate supply of COVID-19 oral antivirals during seasonal surges.

CDPH has learned of several pharmacies that have notified patients that they are out of stock of COVID-19 oral antivirals and have not replenished their supply. This puts the public at risk for not receiving treatment quickly. 

• Even pharmacies that have not dispensed many oral COVID-19 antivirals in the past are recommended to be prepared for potential incoming patients and ensure on-shelf availability during seasonal surges. Seasonal COVID-19 surges can be tracked at the CDPH Respiratory Virus Dashboard.

• Supplies of these medications are available from drug wholesalers with no concerns of shortages.
  

• Pharmacies should monitor expiration dates to retain stock and not discard product that potentially has not expired. HHS/ASPR shelf-life extensions are issued frequently. A full list of HHS/ASPR's updates related to oral antiviral shelf-life extensions are available here:

• Shelf-Life Extension for Specific Lots of Paxlovid | HHS/ASPR

• Shelf-Life Extension Evaluation of Lagevrio | HHS/ASPR

• Pharmacies that are temporarily out of stock are strongly encouraged to aid patients in finding COVID-19 therapeutics using the COVID-19 Therapeutics Locator (arcgis.com).  ​
  

There are several ways patients can be eva​​luated for COVID-19 treatment.

Phar​macists may furnish COVID-19 oral therapeutics. Note: Paxlovid is now FDA approved in adults but remains under EUA for those aged 12-17 years of age.

• ​The California Business and Professions Code (BPC) 4052.04 states a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2. Pharmacy staff may also find additional assessment and treatment information at ​​​​ ​​COVID-19 Treatments.

• If a pharmacy has any additional methods for access to treatment, those should also be shared with patients.​
  

Pharmacies should accept all valid hard copy prescriptions.

• Patients do not need to have a prescription submitted electronically.
  

• California (BPC) section 688(i) states pharmacists are not required to ​verify that a written, oral, or faxed prescription falls under one of the exceptions of the e-prescription law.

• BPC section 688(i) also states pharmacists may continue to dispense medications from legally valid written, oral, or faxed prescriptions pursuant to law. When deciding whether to refuse to dispense an​ otherwise legally valid written, oral, or faxed prescription solely because it was not transmitted electronically, a pharmacist should consider the impact on the patient and continuity of care.​

• This is also addressed in Question 3 of the BPC's Electronic Data Transmission Prescriptions – Frequently A​​​sked Questions.
  

Pharmacies and pharmacy staff should be aware that pati​ent assistance are available to ensure COVID-19 treatment remain free or low-cost. 

• Provide patients with the best option based on programs below so that  patients are not charged or are provided the lowest possible cost for COVID-19 oral antivirals​.

• Organizations must not sell or seek reimbursement for publicly funded COVID-19 therapeutics that the federal government provides at no cost to an organization.

• For Medi-Cal patients, both Paxlovid and Lagevrio are on the Medi-Cal Contract Drug List. Patients should not be charged a co-pay.

• Manufacturers are offering programs to assist patients regardless of insurance status:

• ​​Uninsured, Medicare, or other state/federal insurance program such as CHIP, Tricare, or VA:

• ​Paxlovid: US Government Patient Assistance Program operated by Pfizer (USG PAP)

• ​​PAXCESS Patient Support Program 
  

• ​​Customer Support: 877-450-4412

• ​​Not all pharmacies are participating in the USG PAP Program. Retail pharmacies interested in learning more about participating in the Paxlovid U.S. Government PAP please email: PharmacyNetworkContract102101@assistrx.com

• ​Lagevrio: MerckHelps

• ​​Merck Programs to Help Those in Need
  

• ​​URGENT NEED ONLY, please call 800-727-5400, and a program representative will help you

• Commercially Insured:

• ​Paxlovid: Paxcess Co-Pay Savings Program

• ​​PAXCESS™ | PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)

• ​​Customer Support: 877-450-4412

• ​Lagevrio: MerckHelps
  

• ​Merck Programs to Help Those in Need (merckhelps.com)

• ​​URGENT NEED ONLY, please call 800-727-5400, and a program representative will help you

• For information on how to access free virtual care and treatment for COVID-19 and Flu, 24 hours a day, 7 days a week, visit testtotreat.org

Pharmacists should NOT reject COVID-19 prescriptions solely due to the absence of patient renal function and liver function test results​.

• According to ASPR-HHS under "Are lab results required before a patient can be prescribed Paxlovid? - Licensed physicians and advanced practice providers are not required to perform additional laboratory testing when prescribing Paxlovid. Providers should use clinical judgement to determine if labs are necessary." Typically lab results are not necessary. 
  

• In making a reasonable attempt to clarify any concerns with the provider and/or patient, pharmacists should use clinical judgement and consider the impact of delayed COVID-19 treatment. Treatment must be started within 5 days of symptom onset.
  

​Pharmacists should NOT ​​​​reject COVID-19 prescriptions due to the absence of a "positive test" date or "symptom onset" date written on the prescription.

​​These items are not required to be written on the prescription and patients can self-attest to the symptom onset dates.

• The FDA revised its emergency use authorizations on Paxlovid and Lagevrio on February 1, 2023, to no longer require positive results of direct SARS-CoV-2 viral testing before a provider can prescribe them. Additional testing is not required.

• Paxlovid received full FDA approval on May 25, 2023, for the treatment of mild to moderate COVID-19 in adults who are at risk for progression to severe COVID-19, including hospitalization or death. There is no mention of a requirement for a positive test.
  

• Pharmacists only require a positive test when furnishing Paxlovid to a patient without a prescription. Business and Professions Code 4052.04 states a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2.​

Pharmacists should not reject COVI​D-19 prescriptions due to the presence of only mild symptoms.

• Patients with mild symptoms are, in fact, included​ in criteria for outpatient treatment according to the FDA EUA and National Institutes of Health recommendations.

This information should be shared with stores and facility staff to ensure that correct information and the best possible patient experience is provided.

The CDPH Call Center (1-833-422-4255) should also be shared as a hotline, staff are available to respond to all questions related to COVID-19. Additional information can also be found at COVID-19 Treatment page.

Additional information for staff and clinicians can be found at  COVID-19 Treatment Resources for Healthcare Providers.​​​