New Defenses Against COVID-19 Deaths

Health care providers have a new weapon in the fight against COVID-19, and it’s coming to a pharmacy near you.

More than 1.04 million people in the United States have died since the advent of COVID-19. But although new infections, hospitalizations, and deaths have declined since their peak, more than 100,000 new cases still are reported every day – likely significantly less than the actual number. Fortunately, treatment for COVID-19 infection is now readily available in this country.

Paxlovid is the first at-home oral antiviral medication authorized for treating COVID-19. It helps keep high-risk patients ages 12 and older from getting so sick that they need to be hospitalized.*https://www.nejm.org/doi/full/10.1056/NEJMoa2204919 Therapy for eligible patients should begin within five days of symptom onset.** It is highly effective, reducing hospitalizations and deaths by 89 percent.

Manufactured by Pfizer and distributed under an Emergency Use Authorization from the US Food and Drug Administration (FDA) , Paxlovid is the brand name for two separate medications that are packaged together: nirmatrelvir and ritonavir. Here’s how they work in a three-pill dose:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

The history of antivirals

Antivirals are prescription medications that help the body fight off viruses that cause disease. They also can ease symptoms and shorten the length of an infection. They are commonly used to prevent or treat hepatitis, herpes, HIV, and seasonal flu.

Antivirals come in pill, liquid, inhaled powder, topical, and intravenous solution forms. Remdesivir, the first approved treatment for COVID-19, is administered intravenously.

Paxlovid is an investigational SARS-COV-2 protease inhibitor. Protease inhibitors are a class of medications that interfere with the ability of certain enzymes to break down proteins and thus inhibit the virus’s ability to replicate.https://www.pfizer.com/news/articles/how_a_coronavirus_protease_inhibitor_works_to_fight_covid_19

The first antiviral drug was approved in 1963.De Clercq E, Li G. Approved Antiviral Drugs over the Past 50 Years. Clin Microbiol Rev. 2016 Jul;29(3):695-747. doi: 10.1128/CMR.00102-15. PMID: 27281742; PMCID: PMC4978613. Since then, more than 90 antiviral drugs have been approved by the FDA to treat nine infectious diseases (more than 200 human viruses have been discovered).Ibid. Their development is complex, but “combined and specific targeted antiviral therapy has proved to be the best approach to follow for viral disease treatment.”Bryan-Marrugo O.I. at al. History and progress of antiviral drugs: From acyclovir to direct-acting antiviral agents for Hepatitis C. Medicina Universitaria, Vol. 17 No. 68, July 2015. DOI: 10.1016/j.rmu.2015.05.003

Pfizer began working on protease inhibitors in 2003, during the SARS outbreak. Although the project had been shelved in the interim, it positioned the company well for the rapid development of a treatment for COVID-19 – nirmatrelvir.https://www.npr.org/sections/health-shots/2021/12/03/1061060446/how-pfizer-developed-a-covid-pill-in-record-time Ritonavir was an existing drug that was combined with nirmatrelvir to make it more effective.Ibid.

Although there have been some COVID-19 “rebound” cases reported after the administration of Paxlovid, experts still believe it is the strongest defense against hospitalization and death for high-risk patients.https://www.cdc.gov/mmwr/volumes/71/wr/mm7125e2.htm

Expanding the role of pharmacists

The FDA’s Emergency Use Authorization permits state-licensed pharmacists to prescribe Paxlovid.https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations This represents another advance in the evolution of pharmacists as holistic health care providers and may help to ensure equitable access to the therapy. Pharmacists are members of their communities – familiar faces to many – and may be perceived as more approachable by those who distrust the health care system. Studies have shown pharmacist involvement reduces fragmentation of care, lowers health care costs, and improves health outcomes.Milosavlevic A, Aspden T, Harrison J. Community pharmacist-led interventions and their impact on patients’ medication adherence and other health outcomes: a systematic review. Int Jnl Pharm Practice, Vol. 26, Issue 5, Oct. 2018. https://doi.org/10.1111/ijpp.12462

Pharmacists are among the most trusted professionals in the United States, and they’re also nearby: Ninety percent of Americans live within five miles of a pharmacy, and most make an average of 35 pharmacy visits a year.https://www.cvshealth.com/news-and-insights/articles/why-trust-in-pharmacists-remains-highhttps://www.beckershospitalreview.com/pharmacy/90-of-americans-live-close-to-a-pharmacy-analysis-finds.htmlIbid. Because it’s important to initiate Paxlovid within five days of symptom onset, pharmacist prescribing is likely to help improve access to treatment.

Not all patients are eligible for a Paxlovid prescription. Under the FDA’s emergency use authorization, patients with an increased risk of developing severe COVID-19 side effects are eligible for Paxlovid if they:

• tested positive for COVID-19
• have not yet been admitted to the hospital
• are at high risk for developing severe COVID-19 symptoms
• are 12 years of age or older
• weigh at least 88 pounds

At CVS Pharmacy, patients can check their eligibility for Paxlovid through our convenient digital screener and, if eligible, schedule an appointment with a pharmacist; verify details, and authorize payment; or receive a referral for care if not eligible for a prescription from a pharmacist.

In order to prescribe Paxlovid, a pharmacist must have access to the member’s medical records, including a list of medications he or she is already taking, and blood test results to assess for kidney or liver impairment from the last 12 months. Our pharmacists are equipped with access to electronic health records (EHRs), an important and foundational step to supporting the evolution of health care at pharmacy.

Like our pharmacists’ ability to access electronic health records, the digital screener is a key part of our program to ensure a positive member experience and facilitate pharmacists’ ability to provide patient care for eligible patients. Ultimately, these and other programs serve our goal of increasing access to affordable care and positioning pharmacists as integrated providers within the patient health care team.

Pharmacists evolve to provide holistic health care

In recent years, pharmacists’ scope of practice has expanded to include essential care and services such as administering immunizations, providing disease education and medication management services, offering nicotine cessation support, and in some states (where permissible), prescribing hormonal contraceptives.

We believe pharmacists would be even better equipped for their role as holistic health care providers if we continue to expand the types of clinical care services that pharmacy teams can provide in local communities, from expanded women’s health care services to chronic disease and lifestyle management; and if these privileges are separated from special emergency rules and made permanent.

At CVS Health, we have made important changes to our operating model to allow for the expanded role of pharmacists and freeing up their time for this purpose-driven work. We look forward to providing even more essential care and services in our convenient, affordable pharmacy setting.