Tag: paxlovid

‘If it’s COVID, Paxlovid’? For many, it should be easier to get. Here’s what to know about antivirals

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The commercials make it sound so simple: “If it’s COVID, Paxlovid.”

But the slogan, catchy though it may be, belies a harsher reality that some public health and elected officials have long acknowledged and worked to rectify: For many, getting access to the therapeutic should be much easier than it has been.

The issue is not one of scarcity, as the antiviral is widely abundant. Nor is pricing a major barrier, as Paxlovid is cheap or even free for many. Nor even is it an issue of how well it works, as studies have shown it to be highly effective.

The drug’s biggest impediment has been, and remains, the simple fact that a number of doctors are still declining to prescribe it.

Some healthcare providers hinge their reluctance on outdated arguments, such as the idea of “Paxlovid rebound” — the chance that people who take the drug have a chance of developing COVID symptoms again, generally about two to eight days after they recover.

As it turns out, anyone who gets COVID-19 has a similar rare chance of rebound.

COVID “rebound can occur with or without [Paxlovid] treatment,” scientists with the Food and Drug Administration wrote in a study published in December. “Viral RNA rebound was not restricted to [Paxlovid] recipients, and rebound rates were generally similar to those in placebo recipients.”

When told about one patient who was declined a prescription to Paxlovid because of concern about “Paxlovid rebound,” UC San Francisco infectious-diseases expert Dr. Peter Chin-Hong groaned.

“Oh my God, that’s so, like, bogus,” Chin-Hong said. “Clinicians having this weird idea about rebounds, it’s just dumb.”

Data indicate that most people don’t get COVID rebound, Chin-Hong said. And while rebound can occur, the possibility should not dissuade people “who might really need it” from taking an antiviral.

Even if COVID rebound happens, and symptoms do occur, “they tend to be mild and do not require repeating the treatment,” according to the California Department of Public Health.

Officials at both the federal and state level have implored healthcare providers to properly prescribe Paxlovid and other antivirals when indicated.

“Antivirals are underused,” the Centers for Disease Control and Prevention said in a statement Thursday. “Don’t wait for symptoms to worsen.”

In its own advisory, the California Department of Public Health said, “Most adults and some children with symptomatic COVID-19 are eligible for treatments … Providers should have a low threshold for prescribing COVID-19 therapeutics.”

Aside from Paxlovid, one alternative oral antiviral treatment is known as molnupiravir. There’s also remdesivir, which is administered intravenously.

The CDC says Paxlovid and remdesivir are the preferred treatments for eligible COVID-19 patients.

“Don’t delay: Treatment must be started within five to seven days of when you first develop symptoms,” the CDC says.

A reference to Paxlovid and other antivirals is even in a musical radio ad from California health authorities that has been broadcast throughout the state: “Test it. Treat it. You can beat it,” with the ditty later continuing: “Medication is key / To slow the virus in your body.”

Yet there is wide documentation of the low frequency of prescribing Paxlovid and other antivirals, and that can have significant consequences for higher-risk COVID-19 patients. A report published by the CDC Thursday reviewed 110 COVID-19 patients considered high-risk and found that 80% of them were not offered antiviral treatment.

A big reason given by the patients’ providers, all of whom were under the Veterans Health Administration, was that their patient’s COVID symptoms were mild.

But as officials note, that’s exactly what antivirals are for.

“There is strong scientific evidence that antiviral treatment of persons with mild-to-moderate illness, who are at risk for severe COVID-19, reduces their risk of hospitalization and death,” the CDC says.

Risk factors for severe COVID-19 include being age 50 and up; not being current on COVID vaccinations; and a wide array of medical conditions, such as diabetes, asthma, kidney disease, heart disease, having anxiety or depression, and being overweight. Other factors that influence health, such as limited access to healthcare and having a low income, can also heighten someone’s risk.

Another reason providers may cite to not prescribe COVID antivirals, California officials said, is the chance of serious side effects. But that fear is largely erroneous, as “most people have little-to-no side effects,” the California Department of Public Health says. Some of the more common side effects after taking Paxlovid are developing a temporary metallic taste in the mouth, which occurs in about 6% of recipients, and diarrhea (3%).

However, some people who do take Paxlovid may need to have other medications adjusted, according to the agency.

The other antiviral pill option, molnupiravir, “has very few side effects, but you cannot take it if you are pregnant,” the state agency said.

Clinicians may also be reluctant to prescribe Paxlovid for younger adults, “not because it causes harm, but because it in some studies doesn’t show as much benefit,” Chin-Hong said. Younger, healthy people are generally unlikely to die from COVID or become ill enough to require hospitalization even without antiviral treatment.

But some data do suggest that patients who take Paxlovid clear out coronavirus from their bodies faster.

“What we’re finding is that people are turning negative very quickly with Paxlovid,” Chin-Hong said.

And one report, published in the journal Emerging Infectious Diseases, suggests widespread use of Paxlovid “would not only improve outcomes in treated patients but also … reduce risks of onward transmission.”

So if an initial clinician turns you down for a Paxlovid prescription, and you think you qualify, what other options are there?

One possibility is reaching out to another healthcare provider who might be either more knowledgeable about Paxlovid and other antiviral medications or more open to prescribing them.

Los Angeles County residents can call the county’s public health info line, (833) 540-0473, to discuss treatment options with a health provider.

Californians who don’t have insurance or have a hard time getting anti-COVID-19 medication can schedule a free telehealth appointment by calling (833) 686-5051 or visiting sesamecare.com/covidca. Medication costs may be subject to a copay, depending on your insurance.

A program funded by the National Institutes of Health, featured at test2treat.org, gives adults who test positive for COVID-19 or flu free access to telehealth care and treatment.

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Rong-Gong Lin II

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January 28, 2024
America May Be Missing Out on a Better COVID Treatment

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Japan is home to an untold number of conveniences and delights that American consumers regularly go without: Faster public transit! Better sunscreen! Lychee KitKats! But as we head into sick season, one Japanese invention would be especially welcome on the U.S. market: an antiviral pill that appears to shorten COVID symptoms, might protect against chronic disease, and doesn’t taste like soapy grapefruit.

Ensitrelvir, a drug made by the Osaka-based pharmaceutical company Shionogi, was conditionally approved in Japan last November. Like Paxlovid, ensitrelvir works by blocking an enzyme that the SARS-CoV-2 virus uses to clone itself inside the human body. But for the millions of Americans who will likely get COVID in the coming months, the new drug is almost certain to be out of reach. In 2021, Pfizer waited just five weeks for Paxlovid to receive its emergency use authorization. But ensitrelvir is still sitting in the approval pipeline, stuck in another round of clinical trials that may run well into 2024.

Existing data (not all of which have been peer-reviewed) show that people with COVID who promptly take ensitrelvir, marketed as Xocova in Japan, test negative about 36 hours faster than people who take a placebo. Fever, congestion, sore throat, cough, and fatigue disappear about a day earlier too. Even smell and taste loss appear to resolve more quickly. The company also has some tentative evidence suggesting that the drug can help protect patients from developing long COVID.

These findings were not enough for the FDA, but they are extremely encouraging, says Michael Lin, a bioengineering professor at Stanford University who works on drugs for treating coronavirus infections. Xocova “looked as good or a little bit better than Paxlovid,” he says. For instance, Pfizer’s clinical trials failed to show that Paxlovid clears symptoms any faster than a placebo in people who aren’t at high risk of developing severe COVID. Shionogi’s did just that.

Reshma Ramachandran, a family physician at Yale, told me that if the early Xocova results hold up in additional trials, she’d be inclined to prescribe it to her vaccinated patients in place of Paxlovid, simply because the evidence supporting its use is more direct. She said she’d be especially keen to give Xocova if the long-COVID finding can be reproduced.

Read: Rebound COVID is just the start of Paxlovid’s mysteries

No lab or pharmaceutical company has yet published a study that pits Xocova against Paxlovid head-to-head in treating COVID, so it’s impossible to say with certainty which one is better. You can’t draw conclusions just by comparing Pfizer’s clinical-trial results with Shionogi’s: Their drugs were tested in different populations with different levels of immunity at different points in the pandemic when different variants were circulating. Shionogi also required clinical-trial participants to start taking Xocova within three days of feeling sick, whereas patients in the Paxlovid trials began their treatment up to five days after symptoms started. Daniel Griffin, an infectious-disease specialist at Columbia University, told me that timing is everything when it comes to antivirals: In general, the sooner a patient starts taking a drug, the better it works.

A Pfizer spokesperson told me that the efficacy and adverse-event rates of Paxlovid and Xocova cannot directly be compared, and emphasized Paxlovid’s power to stave off hospitalization and death. (Xocova’s clinical trials were not able to provide meaningful data on those outcomes, which are now much rarer than they were in 2021.) “Since the beginning of the pandemic, we’ve known it will take multiple treatment options and preventative measures for the world to overcome the challenges of COVID-19,” he said in an email.

Even if Xocova turns out to be no more effective than Paxlovid, it still has several practical advantages. For one thing, it is literally easier to swallow. Paxlovid must be taken twice a day for five days, and each time you have to gulp down three pills: two containing nirmatrelvir (which actively combats the virus), plus one containing ritonavir (which slows the metabolism of nirmatrelvir, keeping it in your system longer). Xocova is taken just once a day for five days, and after the first three-pill dose, it’s one pill at a time. Paxlovid can also cause dysgeusia, a.k.a. Paxlovid mouth—a sour, metallic, taste that may last for hours after swallowing. Xocova seems to taste just fine.

Read: Paxlovid mouth is real—and gross

Experts hope that Xocova will be more widely accessible than Paxlovid, too. Pfizer announced last week that the price of Paxlovid will soon rise from $529 to $1,390 when the drug enters the commercial market. Shionogi hasn’t decided on Xocova’s price in the U.S. market, but there’s reason to think it will be cheaper. In Japan, the only market where both drugs are currently available, a course of Xocova costs 51,851 yen (about $346), and Paxlovid is nearly double the price, at 99,027 yen (about $661). And whereas Japanese health authorities—like those in the U.S.—have recommended Paxlovid for use by patients at high risk of severe COVID, Xocova has been shown to benefit people with infections regardless of their risk status. Finally, whereas Paxlovid’s reach is limited by its many harmful interactions with other drugs, Xocova might pose fewer problems because it doesn’t contain ritonavir, Lin told me. The newer drug’s interaction profile is still being ironed out, but a company spokesperson pointed me to a running list from the University of Liverpool. (According to that source, you should avoid taking Paxlovid and Adderall at the same time—but going on Xocova is fine.)

Xocova may also sidestep one of patients’ most commonly voiced concerns about Paxlovid: that it will make their COVID go away and then return. One recent observational study of COVID patients found that symptoms rebounded among 19 percent of Paxlovid takers, versus 7 percent of nontakers. By contrast, Shionogi has reported that symptom rebound was vanishingly rare in its clinical trials of Xocova.

Read: Inside the mind of an anti-Paxxer

Neither Shionogi nor the FDA would give me an estimate of Xocova’s approval timeline in the U.S., but earlier this year, the company’s CEO estimated that it might get the nod in late 2024. This past spring, the FDA gave the drug “fast track” status, which means Xocova will be eligible for an expedited review process once the company submits its application. (The FDA declined to comment on Xocova’s prospects for approval, citing federal disclosure laws.) Until then, it’s running more clinical trials in the U.S. and abroad. One of them, conducted in partnership with the National Institutes of Health, will evaluate the drug’s performance in hospitalized patients. Another will evaluate its efficacy against long COVID, among other things.

To some experts, Xocova’s track is not nearly fast enough. David Boulware, an infectious-disease specialist at the University of Minnesota, told me that the FDA appears to be “slow walking” the approval process. Lin, too, would like to see more action. But it’s not clear how, exactly, that would happen. “I think the FDA is doing all that they can,” Ramachandran said; an emergency use authorization for Xocova isn’t a realistic option, given that the COVID public-health emergency has expired. Plus, Griffin said, caution is prudent when dealing with new drugs. “We want to make sure it’s safe. We want to make sure it’s effective,” he told me. “We also don’t want to fall into the trap we fell in with molnupiravir,” an earlier antiviral that looked promising at first, but ultimately offered disappointing benefits to COVID patients (though a surprising utility for cats).

If the FDA were to approve Xocova tomorrow, demand for Paxlovid likely wouldn’t disappear, experts told me. Lin said the two drugs might compete for users, like Motrin and Aleve. People who are in danger of being hospitalized or dying from COVID could still opt for Paxlovid. “But there’s a much larger group of people who just feel crummy, and they just want to feel better,” Griffin told me. For them, Xocova could make more sense. They just won’t have a choice until the FDA approves it.

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Rachel Gutman-Wei

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October 25, 2023
Pfizer Will Charge $1,390 For 1 Course Of COVID Drug Paxlovid On Commercial Market

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Pfizer told pharmacies and clinics this week it will soon price a five-day course of COVID-19 treatment Paxlovid at almost $1,400, more than two-and-a-half times what the federal government has paid for the antiviral pills.

The Wall Street Journal first reported Wednesday that Pfizer plans to price a course of the oral antiviral at $1,390, far higher than the U.S. had paid at $529. The drug was authorized in the U.S. in 2021 and quickly became a key tool to help treat those at risk of developing severe infections from COVID-19.

While the figure will be the drug’s list price on the commercial market, many health plans will likely negotiate far better terms that will limit copays or out-of-pocket charges for people who need the pills, the Journal reported.

Those on Medicare, Medicaid and the uninsured will also still be able to access Paxlovid via the Department of Health and Human Services for free through the end of 2024. HHS added that Pfizer would run a program between 2025 and 2028 for un- and underinsured people to help assist with the cost.

But as Axios notes, the list price on the commercial market could make it more difficult for patients to access the drug. The U.S. has so far maintained the exclusive purchasing agreement with Pfizer for Paxlovid.

“Pricing for Paxlovid is based on the value it provides to patients, providers and health care systems due to its important role in helping reduce COVID-19-related hospitalizations and deaths,” a spokesperson for Pfizer told the Journal, adding that many people will pay “as little as $0” under the copay assistance program through 2028.

Multiple studies have shown reductions in hospitalization for adults who test positive for COVID-19 and are treated with Paxlovid. The Food and Drug Administration gave its full approval to Paxlovid in May, advising treatment for adults with high risk of getting severely ill from COVID-19.

Pfizer recently cut its sales forecast for the year due to a plunge in Paxlovid prescriptions and sales of its COVID-19 vaccines. Company CEO Albert Burl said recently the U.S. was “in the middle of COVID fatigue, where everyone wants to forget about the disease.”

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October 19, 2023
Pfizer’s Paxlovid still free, for now, after FDA grants full approval to COVID drug

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The Biden administration will continue to manage the distribution of free courses of Pfizer’s Paxlovid treatment for COVID-19 for at least another few months, the drugmaker said, even after the Food and Drug Administration granted Pfizer full approval Thursday to market the pills.

“At this time, the U.S. government will continue to oversee the distribution of PAXLOVID, and U.S. residents eligible for PAXLOVID will continue to receive the medicine at no charge,” Pfizer said in a release.

Federal officials have previously said that the widely-expected approval of the drug, as well as the unwinding of the public health emergency earlier this month, would have no immediate impact on distribution of government-bought supplies of the pills.

“We bought a little bit more anticipating a winter surge that never really materialized. And we don’t want the American people to pay twice,” Dawn O’Connell, head of the Administration for Strategic Preparedness and Response, said at an event hosted by the Health Affairs journal last week.

O’Connell’s agency, ASPR, has distributed nearly 14 million courses of Pfizer’s pills to date. Around 9.3 million of those have been reported administered to patients across the country.

The Biden administration still has around 9.6 million courses of the pills in its stockpile that have yet to be distributed.

“If we’ve purchased it for them with their taxpayer dollars, we want to make what we’ve purchased available to them for free, as we’ve been promising,” said O’Connell.

Planning to end free Paxlovid

O’Connell said officials have been actively planning for the end of their supply of free Paxlovid, which would mean Pfizer’s drug would switch to the commercial market.

That means Americans’ access to the drug would now become the same as other medications that require navigating insurance and pharmacies to fill their prescriptions.

“We weren’t designed, nor has there been an expectation that we would continue to do that ad infinitum for future generations of vaccines and therapies. And we know that we’ve not been funded to do that,” said O’Connell.

Pfizer has not disclosed a list price for its Paxlovid pills for once they launch commercially in the U.S. later this year.

The company had been selling it in China for reportedly around $292, state media reported in January. The Biden administration had paid around $530 per course for its supply, which is close to the range outside experts said would be cost-effective for the drug.

Pfizer has said it plans to “help ensure the appropriate patient support programs are in place” for underinsured Americans who cannot afford the drugs. The U.S. also plans to cover administration costs of the drug as part of its “bridge access program” through pharmacies.

Both the drugmaker and O’Connell said that switch will likely come by the end of this year, dictated in part by when government stocks run low. Health authorities are also preparing to end distribution of current government-bought vaccines, ahead of expected updates this fall.

“There’s a lot of complexity here. So simply thinking about this: vaccine, probably in the fall, treatment, probably sometime in the late summer or fall, we’ll start seeing that switch over,” then-White House COVID-19 Response Coordinator Dr. Ashish Jha said earlier this month, in a webinar published by the Annals of Internal Medicine journal.

No off-label Paxlovid yet

The FDA’s approved label for Paxlovid is limited to treating infected “adults who are at high risk for progression to severe COVID-19.”

Doctors typically have the freedom to prescribe fully approved drugs “off-label” for other reasons to their patients, beyond the FDA’s approval.

But because Paxlovid has only been allowed under emergency use authorization, doctors could not prescribe the drug for any unapproved reason outside of clinical trials, like for treating long COVID symptoms or to try and prevent infections.

Since all current U.S. supplies of the drug were labeled under emergency use authorization, this restriction will effectively remain for now.

The agency will continue its emergency authorization to allow Paxlovid for eligible children ages 12 and older, as well as to permit pharmacists to prescribe it.

“PAXLOVID that is labeled for use under the Emergency Use Authorization (EUA) remains subject to the terms and conditions of the EUA,” James McKinney, an FDA spokesperson, said in a statement.

Coronavirus Pandemic

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Alexander Tin

CBS News reporter covering public health and the pandemic.

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May 25, 2023
With COVID cases rising fast, critics question why there’s no push for face masks in indoor settings

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A growing chorus of voices is questioning why there is no concerted effort to persuade Americans to wear face masks in public settings again as COVID cases, hospitalizations, fatalities and test-positivity rates rise across the nation.

The Centers for Disease Control and Prevention continues to encourage people to keep up with vaccines and boosters and to urge others to do so too. But for now, there is no push for face masks or social distancing, the public safety measures that helped contain the spread of the virus at the peak of the pandemic.

The daily average for new cases stood at 65,528 on Monday, according to a New York Times tracker, up 56% from two weeks ago. Cases are climbing in 47 states, led by Mississippi, where they are up 356% from two weeks ago.

The average for hospitalizations is up 24% to 38,331. Hospitalizations are climbing in 44 states, led by Vermont, where they are up 83% from two weeks ago.

The number of COVID deaths is up 48% to a daily average of 468, a disappointing reversal of the declining trend seen over the past several months. The test-positivity rate has climbed 25% to 12%.

New York City and New York state have emerged as hot spots, with an average of 6,405 new cases a day in the state in the last week, the tracker shows. Cases are up 74% from two weeks ago.

The omicron strains called BQ.1 and BQ.1.1 have become dominant in the Empire State, replacing BA.5. Both are sublineages of BA.5 but are more infectious than the original variant, meaning they can spread faster and more easily.

Meanwhile, other respiratory illnesses including flu, RSV and strep throat are also circulating, adding to the burden on healthcare systems.

Children are having an especially rough winter so far amid shortages of medicines to treat common childhood illnesses such as flu, ear infections and sore throats, CNN reported.

“Right now, we are having severe shortages of medications. There’s no Tamiflu for children. There’s barely any Tamiflu for adults. And this is brand-name and generic,” Renae Kraft, a relief pharmacist in Oklahoma City, told the network. Additionally, she said, “as far as antibiotics go, there’s not a whole lot.”

Physicians are reporting high numbers of respiratory illnesses like RSV and the flu earlier than the typical winter peak. WSJ’s Brianna Abbott explains what the early surge means for the winter months. Photo illustration: Kaitlyn Wang

Families have taken to social media to highlight their hunt for oseltamivir, the generic for Tamiflu, as well as for the antibiotics amoxicillin and augmentin, said CNN. And there is also a shortage of the inhaler albuterol, which helps open airways in the lungs, according to the American Society of Health-System Pharmacists.

Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began

Other COVID-19 news you should know about:

• Some two years after they were first introduced, COVID vaccines have prevented more than 3 million additional deaths and about 18 million additional hospitalizations in the U.S., according to a new study from the Commonwealth Fund. More than 655 million doses of vaccine have been administered in the U.S., and 80% of the overall population has had at least one dose. “The swift development of the vaccine, emergency authorization to distribute widely, and rapid rollout have been instrumental in curbing hospitalization and death, while mitigating socioeconomic repercussions of the pandemic,” the authors wrote.

• Chinese universities say they will allow students to finish the semester from home in hopes of reducing the potential for a large COVID-19 outbreak during the January Lunar New Year travel period, the AP reported. It wasn’t clear how many schools were participating, but universities in Shanghai and nearby cities said students would be given the option of returning home early or staying on campus and undergoing testing every 48 hours. The Lunar New Year, which falls on Jan. 22, is traditionally China’s busiest travel season.

Some movie theaters in China reopened and COVID-testing booths were dismantled ahead of an announcement by authorities on Wednesday to scrap most testing and quarantine requirements. The changes come after nationwide protests against Beijing’s zero-COVID policy. Photo: Ng Han Guan/Associated Press

• The Nasdaq-listed 111 Inc.
YI,
+4.80%
has started retail sales of Pfizer’s
PFE,
+1.74%
oral COVID-19 treatment pill in China, according to the healthcare platform’s website, Dow Jones Newswires reported. The sales page for the Chinese platform on Tuesday showed it is now offering Paxlovid, the COVID medication that Beijing approved in February, for customers with positive results from polymerase chain reaction or antigen tests. Paxlovid has been used by medical practitioners to treat patients in China since March, when Shanghai was hit by a COVID outbreak, according to local media reports.

Here’s what the numbers say:

The global tally of confirmed cases of COVID-19 topped 650.1 million on Monday, while the death toll rose above 6.65 million, according to data aggregated by Johns Hopkins University.

The U.S. leads the world with 99.5 million cases and 1,084,766 fatalities.

The Centers for Disease Control and Prevention’s tracker shows that 228.6 million people living in the U.S., equal to 68.9% of the total population, are fully vaccinated, meaning they have had their primary shots.

So far, just 42 million Americans have had the updated COVID booster that targets the original virus and the omicron variants, equal to 13.5% of the overall population.

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December 13, 2022
Paxlovid has been free so far. Next year, sticker shock awaits.

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Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug — the uninsured and seniors — may have to pay the full price.

And that means fewer people will get the potentially lifesaving treatments, experts said.

“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.

In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.

But soon the Department of Health and Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.

The antiviral drug Paxlovid can reduce the risk of severe illness or death from COVID-19.

Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images

The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to KHN, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year — those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.

Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”

Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D — the prescription drug program that covers nearly 50 million seniors — from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.

Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.

Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare — the very people who would benefit most from the drug, wrote federal health experts.

“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’ Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.

In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved — the Senate voted that same day to end the public health emergency and denied similar requests in recent months.

Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than white patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.

People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates — instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.

About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available seven days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.

States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.

“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Rosenthal said.

People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.

Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.

And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Corlette said.

One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.

HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.

Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.

HHS did not make officials available for an interview or answer written questions about the commercialization plans.

The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.

Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.

“The medications are so worthwhile,” said Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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December 7, 2022
Black, Hispanic COVID Patients Less Likely to Get Antiviral Paxlovid

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“The issue of equity and distribution of Paxlovid is similar to what we saw in the distribution of the vaccine,” she said. “You have to think about access to primary care pharmacies, particularly in economically disadvantaged communities.”

Community hesitancy also plays a role, Salas-Lopez noted. “These are new vaccines, new treatments, so the familiarity isn’t there with all of our community members, but in particular, our community members who have experienced a lack of trust in the health care system.

“In addition, guidelines for testing and vaccines and medications for treatment can quickly change, making it difficult for providers and community members to stay abreast of all the changes — your head spins,” she said.

Structural racism may also play a role, Salas-Lopez added.

One weakness of the study, she noted, is that the researchers didn’t account for prescriptions given directly at walk-in clinics and drug stores, which gave out thousands of doses of Paxlovid and might have altered the results.

Salas-Lopez said that it’s partly the responsibility of health care systems to end these disparities.

At her health care system, they created a health equity task force to identify the weak spots in health care in their community. They then began outreach programs to close these gaps.

“Health systems have to work hard to address the issue of inequity,” Salas-Lopez said. “It takes a mission and a vision to do that, and then action.”

The report, which followed patients from January to July of this year, was published Oct. 28 in the CDC’s Morbidity and Mortality Weekly Report.

More information

For more on COVID-19, see the U.S. Centers for Disease Control and Prevention.

SOURCES: Tegan Boehmer, PhD, acting lead, Healthy Community Design Initiative, U.S. Centers for Disease Control and Prevention; Debbie Salas-Lopez, MD, MPH, senior vice president, Community and Population Health, Northwell Health, New Hyde Park, N.Y.; Morbidity and Mortality Weekly Report, Oct. 28, 2022

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October 28, 2022