Abby Robinson gasped for air as she drove to an emergency room in Long Beach, California on Jan. 19, fearful that her cystic Fibrosis and what she thought was Covid-19 would be fatal.
After being flagged by a nurse as a high risk patient, and after a rapid coronavirus testing came back positive, a doctor offered hope to the 24-year-old student: a prescription for Paxlovid, Pfizer’s latest antiviral cocktail.
Robinson was as sick as she was. She had to find the medication.
Since its Dec. 22 crisis authorization, Paxlovid (a 5-day oral Covid treatment that can dramatically reduce the risk of death and hospitalization) has been in critical short supply.
California was experiencing a record-breaking, omicron-fueled spike in cases when Robinson received the prescription. Robinson was competing with scores of newly diagnosed patients for a share in the latest two week allotment, which only 9,560 pills.
Robinson called a number of local pharmacies before finding a nearly empty Paxlovid supply at an Orange County CVS. She said that the pharmacy would have been within 30 minutes if she hadn’t driven in the “fast lane” to make sure she got there before the drug disappeared.
She described her successful search for Paxlovid, saying, “It was really humble, for someone who desperately required this drug, how difficult it was to get it, and how my timing had been so perfect.” Paxlovid has made her feel much better, but she’s still not feeling quite right.
These acute shortages have caused serious problems for health care providers. The winter surge from the omicron variant has created a dire need for treatment to keep Covid patients out of hospitals. This situation is made worse by the fact that states do not prioritize people at highest risk for severe illness or death, such as those who have underlying medical conditions and people who are immunecompromised.
Robinson, an emergency doctor, stated that the only monoclonal anti-inflammatory treatment for omicron was GlaxoSmithKline’s sotrovimab and Vir Biotechnology.
Once someone is diagnosed with severe Covid, it is important to act quickly. To avoid anxiety about filling a prescription, the pills should be taken within five days.
Limiting antiviral prescriptions
Robinson’s chaotic medical odysseys show the extreme lengths that many Americans have had to go to obtain this rare, potentially lifesaving antiviral medication.
The Biden administration purchased 20,000,000 Paxlovid course. Pfizer stated that half of the courses will be delivered by June, and the rest by September 30. It is unlikely that the treatment will be available in sufficient quantities until April.
The federal government has so far been able only 265,000 Paxlovid course to state healthcare departments. This despite the fact that the U.S. reported some 20 million Covid cases as well as 55,000 -related deaths just in January. Although omicron cases are decreasing, more than 140,000 hospitalizations are occurring each day, and many people are dying of Covid every day.
The federal government currently distributes the Paxlovid supply as a grant to the state health departments. They then distribute their portion to the local pharmacies and long-term care facilities, according to their discretion.
Richard Freeman, Loyola Medicine’s regional chief clinical officer, stated that “not unlike the entire Covid response,” the federal government has refused to release any other guidance. “Then it’s up the states so you have fifty different versions. It’s not helpful, I think.
Robinson didn’t know that California’s health department did not restrict Paxlovid’s access to only those who are at highest risk of death or hospitalization.
A NBC News survey found that only a handful of states have implemented systems to limit access. This includes those in Minnesota, New Mexico, and Michigan. These states require that Paxlovid be prescribed only to high-risk patients by directing clinicians. These restrictions can be enforced by the collaboration between health departments and pharmacies or health care systems to which Paxlovid is sent.
Dr. Natasha Bagdasarian is the chief medical executive of Michigan Department of Health and Human Services. She stated that “our primary goal, with an eyes on equity, it’s to protect the most vulnerable amongst us and to prevent as many severe outcomes as possible.”
Michigan’s state health department regularly updates and issues a guidance to direct physicians to determine if a Paxlovid Candidate is at the highest tiers of Covid Risk. The eligibility documentation is then confirmed by pharmacists at Meijer, the state’s primary Paxlovid purveyor.
Others states, such as Indiana and Maryland, North Carolina, Pennsylvania West Virginia, West Virginia, West Virginia, West Virginia, and Wisconsin, take a more relaxed approach. They issue communiques to health providers that advise but not require them to prescribe the therapy to those who are most likely to benefit. The National Institutes of Health Covid-19 treatment priority guidelines are often urged on providers.
Some states, such as Tennessee, have not provided guidance to clinicians on how to prioritize access to antivirals.
Dr. William Parker, a medical ethicist, argued that Covid treatment supplies should be restricted based on narrow criteria.
Parker, a University of Chicago health services researcher, stated that “we are justified in restricting the access to only the highest-risk patients to reduce strain on our health care system, and maximize lives saved.”
Jeffrey Klausner, an infectious diseases specialist at the Keck school of medicine at the University of Southern California was critical of California’s management of the Covid treatments.
Klausner stated that he has not received communication from the state, or any local health department regarding Paxlovid and other Covid therapies. “I had to contact the state on my own and often received conflicting or outdated information.”
Many hospitals in the United States, including the Zuckerberg San Francisco General Hospital, Trauma Center and Trauma Center have placed restrictions on Paxlovid access. Experts pointed out that even though this may prevent people on the lower end of high-risk spectrum, it doesn’t mean they can’t find an independent physician willing to write a prescription.
A better distribution system?
It is common for states to spread Paxlovid via chain pharmacies. This leaves frantic residents to race, sometimes over considerable distances to fill a prescription.
When supplies are scarce, some health systems have used lottery methods to dispense other Covid therapies. The University of Pittsburgh Medical Center, which includes 40 hospitals, launched a lottery in 2020 to distribute Gilead Sciences’ Remdesivir to eligible hospitalized people.
Even if states limit Paxlovid to high-risk tiers of the state, the allocation system invites feverish competition and favors those with financial resources and the ability to obtain the drug, according to Dr. Douglas White, a critical care physician and medical ethicist at the University of Pittsburgh.
White stated that “it’s become a free-for all.” “First come, first served is a horrible way to accomplish the greatest good with a limited resource and ensure that it is equally distributed.”
Who should receive the antivirals first
According the NIH the highest risk for severe Covid are those who are in the highest priority tier.
Persons with immunocompromised.
People over 75 who have not been vaccinated.
People over 65 who have not been vaccinated and are at higher risk for developing cancer, diabetes, or other diseases such as obesity, diabetes, heart disease, kidney disease, liver disease, or lung disease, should be vaccinated.
The next level of risk is for all people over 65 who are not vaccinated, and all people with risk factors.
It is not known whether Paxlovid has any benefits for people who have been vaccinated. Although the study submitted by the FDA did not include high-risk individuals who were unvaccinated, the authorization of the FDA applies to all people at “high risk” for severe COVID-19 regardless of their vaccination status.
“If you take the FDA at face-value, you’re giving Paxlovid a lot of people who won’t benefit,” Dr. John Hick from Hennepin County Medical Center, Minneapolis said.
Despite having severe breathing problems after she developed Covid, Abby Robinson is in the NIH’s fourth and final tier of high risk individuals. She has had a booster vaccination and is younger that 65. Cystic fibrosis was the only factor that pushed her into the high-risk category.
Multiple medical ethicists have stated that Paxlovid is available to people at lower risk levels. However, they must comply with the authorization terms of the FDA and any state rules.
JP Leider, a researcher from the University of Minnesota School of Public Health who helped to create Minnesota’s Covid Therapy prioritization guidance, stated that “people are being rationally behaved in an irrational setting.” To ensure that the system is going to save as many people and promote equity, you should set up guardrails.
Patients who are unable to access Paxlovid may be able to use other antivirals approved by the FDA. Merck’s oral antiviral drug molnupiravir, which is fourfold more plentiful than Paxlovid, has been made available to patients in a fourfold increase . The drug is only 30% effective against death and hospitalization, and this has raised safety concerns.
Accordingly, the FDA states that molnupiravir is only to be used when there are no other options. However, some health care professionals may still consider using the drug, Bagdasarian of Michigan said.
Remdesivir, another antiviral, was recently granted an expanded authorization by the FDA in order to prevent high-risk Covid patients needing hospitalization. However, remdesivir is only allowed for milder Covid cases and requires intravenous infusions for three days.
Bagdasarian said that remdesivir might be possible for people at high risk with moderate to severe Covid.
Bagdasarian stated, “It is important to note that Paxlovid therapy is not the only option and that we are really trying to match our tools with the right candidate.”
