Arthur Allen: Why patients who could most benefit from Paxlovid aren't getting it
From Kaiser Family Foundation Health News
“Proactive and health-literate people get the drug. Those who are receiving information more passively have no idea whether it’s important or harmful.’’
— Michael Barnett, M.D., a primary-care physician at Brigham and Women’s Hospital, in Boston, and an associate professor at Harvard Medical School
Evangelical minister Eddie Hyatt believes in the healing power of prayer but “also the medical approach.” So on a February evening a week before scheduled prostate surgery, he had his sore throat checked out at an emergency room near his home in Grapevine, Texas.
A doctor confirmed that Hyatt had COVID-19 and sent him to CVS with a prescription for the antiviral drug Paxlovid, the generally recommended medicine to fight COVID. Hyatt handed the pharmacist the script, but then, he said, “She kept avoiding me.”
She finally looked up from her computer and said, “It’s $1,600.”
The generally healthy 76-year-old went out to the car to consult his wife about their credit-card limits. “I don’t think I’ve ever spent more than $20 on a prescription,” the astonished Hyatt recalled.
That kind of sticker shock has stunned thousands of sick Americans since late December, as Pfizer shifted to commercial sales of Paxlovid. Before then, the federal government covered the cost of the drug.
The price is one reason that Paxlovid is not reaching those who need it most. And patients who qualify for free doses, which Pfizer offers under an agreement with the federal government, often don’t realize it or know how to get them.
“If you want to create a barrier to people getting a treatment, making it cost a lot is the way to do it,” said William Schaffner, M.D., a professor at Vanderbilt University School of Medicine and spokesperson for the National Foundation for Infectious Diseases.
Public and medical awareness of Paxlovid’s benefits is low, and putting people through an application process to get the drug when they’re sick is a non-starter, Schaffner said. Pfizer says it takes only five minutes online.
It’s not an easy drug to use. Doctors are wary about prescribing it because of dangerous interactions with common drugs that treat cholesterol, blood clots and other conditions. It must be taken within five days of the first symptoms. It leaves a foul taste in the mouth. In one study, 1 in 5 patients reported “rebound” COVID symptoms a few days after finishing the medicine — though rebound can also occur without Paxlovid.
A recent JAMA Network study found that sick people 85 and older were less likely than younger Medicare patients to get COVID therapies such as Paxlovid. The drug might have prevented up to 27,000 deaths in 2022 if it had been allocated based on which patients were at highest risk from COVID. Nursing-home patients, who account for around 1 in 6 U.S. COVID deaths, were about two-thirds as likely as other older adults to get the drug.
Shrunken confidence in government health programs is one reason the drug isn’t reaching those who need it. In senior living facilities, “a lack of clear information and misinformation” are “causing residents and their families to be reluctant to take the necessary steps to reduce covid risks,” said David Gifford, chief medical officer for an association representing 14,000 health-care providers, many in senior care.
The anti-vaxxers spreading falsehoods about vaccines have targeted Paxlovid as well. Some call themselves anti-paxxers.
“Proactive and health-literate people get the drug. Those who are receiving information more passively have no idea whether it’s important or harmful,” said Michael Barnett, a primary-care physician at Brigham and Women’s Hospital and an associate professor at Harvard, who led the JAMA Network study.
In fact, the drug is still free for those who are uninsured or enrolled in Medicare, Medicaid, or other federal health programs, including those for veterans.
That’s what rescued Hyatt, whose Department of Veterans Affairs health plan doesn’t normally cover outpatient drugs. While he searched on his phone for a solution, the pharmacist’s assistant suddenly appeared from the store. “It won’t cost you anything!” she said.
As Hyatt’s case suggests, it helps to know to ask for free Paxlovid, although federal officials say they’ve educated clinicians and pharmacists — like the one who helped Hyatt — about the program.
“There is still a heaven!” Hyatt replied. After he had been on Paxlovid for a few days his symptoms were gone and his surgery was rescheduled.
About That $1,390 List Price
Pfizer sold the U.S. government 23.7 million five-day courses of Paxlovid, produced under an FDA emergency authorization, in 2021 and 2022, at a price of around $530 each.
Under the new agreement, Pfizer commits to provide the drug for the beneficiaries of the government insurance programs. Meanwhile, Pfizer bills insurers for some portion of the $1,390 list price. Some patients say pharmacies have quoted them prices of $1,600 or more.
How exactly Pfizer arrived at that price isn’t clear. Pfizer won’t say. A Harvard study last year estimated that the cost of producing generic Paxlovid at about $15 per treatment course, including manufacturing expenses, a 10 percent profit markup, and 27 percent in taxes.
Pfizer reported $12.5 billion in Paxlovid and COVID-vaccine sales in 2023, after a $57 billion peak in 2022. The company’s 2024 Super Bowl ad, which cost an estimated $14 million to place, focused on Pfizer’s cancer drug pipeline, newly reinforced with its $43 billion purchase of biotech company Seagen. Unlike some other recent oft-aired Pfizer ads (“If it’s covid, Paxlovid”), it didn’t mention COVID products.
Connecting With Patients
The other problem is getting the drug where it is needed. “We negotiated really hard with Pfizer to make sure that Paxlovid would be available to Americans the way they were accustomed to,” Department of Health and Human Services Secretary Xavier Becerra told reporters in February. “If you have private insurance, it should not cost you much money, certainly not more than $100.”
Yet in nursing homes, getting Paxlovid is particularly cumbersome, said Chad Worz, CEO of the American Society of Consultant Pharmacists, specialists who provide medicines to care homes.
If someone in long-term care tests positive for COVID, the nurse tells the physician, who orders the drug from a pharmacist, who may report back that the patient is on several drugs that interact with Paxlovid, Worz said. Figuring out which drugs to stop temporarily requires further consultations while the time for efficacious use of Paxlovid dwindles, he said.
His group tried to get the FDA to approve a shortcut similar to the standing orders that enable pharmacists to deliver anti-influenza medications when there are flu outbreaks in nursing homes, Worz said. “We were close,” he said, but “it just never came to fruition.” “The FDA is unable to comment,” spokesperson Chanapa Tantibanchachai said.
Los Angeles County requires nursing homes to offer any covid-positive patient an antiviral, but the Centers for Medicare & Medicaid Services, which oversees nursing homes nationwide, has not issued similar guidance. “And this is a mistake,” said Karl Steinberg, chief medical officer for two nursing home chains with facilities in San Diego County, which also has no such mandate. A requirement would ensure the patient “isn’t going to fall through the cracks,” he said.
While it hasn’t ordered doctors to prescribe Paxlovid, CMS on Jan. 4 issued detailed instructions to health insurers urging swift approval of Paxlovid prescriptions, given the five-day window for the drug’s efficacy. It also “encourages” plans to make sure pharmacists know about the free Paxlovid arrangement.
Current COVID strains appear less virulent than those that circulated earlier in the pandemic, and years of vaccination and covid infection have left fewer people at risk of grave outcomes. But risk remains, particularly among older seniors, who account for most COVID deaths, which number more than 13,500 so far this year in the U.S.
Steinberg, who sees patients in 15 residences, said he orders Paxlovid even for COVID-positive patients without symptoms. None of the 30 to 40 patients whom he prescribed the drug in the past year needed hospitalization, he said; two stopped taking it because of nausea or the foul taste, a pertinent concern in older people whose appetites already have ebbed.
Steinberg said he knew of two patients who died of COVID in his companies’ facilities this year. Neither was on Paxlovid. He can’t be sure the drug would have made a difference, but he’s not taking any chances. The benefits, he said, outweigh the risks.
Arthur Allen is a Kaiser Family Foundation Health News reporter. Reporter Colleen DeGuzman contributed to this report.
Judith Graham: What elderly people should know about taking Paxlovid for COVID
Paxlovid blister pack
— Photo by Kches16414
“There’s lots of evidence that Paxlovid can reduce the risk of catastrophic events that can follow infection with COVID in older individuals.’’
— Dr. Harlan Krumholz, a professor of medicine at Yale University
A new coronavirus variant is circulating, the most transmissible one yet. Hospitalizations of infected patients are rising. And older adults represent nearly 90% of U.S. deaths from COVID-19 in recent months, the largest portion since the start of the pandemic.
What does that mean for people 65 and older catching COVID for the first time or those experiencing a repeat infection?
The message from infectious-disease experts and geriatricians is clear: Seek treatment with antiviral therapy, which remains effective against new COVID variants.
The therapy of first choice, experts said, is Paxlovid, an antiviral treatment for people with mild to moderate COVID at high risk of becoming seriously ill from the virus. All adults 65 and up fall in that category. If people can’t tolerate the medication — potential complications with other drugs need to be carefully evaluated by a medical provider — two alternatives are available.
“There’s lots of evidence that Paxlovid can reduce the risk of catastrophic events that can follow infection with COVID in older individuals,” said Dr. Harlan Krumholz, a professor of medicine at Yale University.
Meanwhile, develop a plan for what you’ll do if you get the disease. Where will you seek care? What if you can’t get in quickly to see your doctor, a common problem? You need to act fast since Paxlovid must be started no later than five days after the onset of symptoms. Will you need to adjust your medication regimen to guard against potentially dangerous drug interactions?
“The time to be figuring all this out is before you get COVID,” said Dr. Allison Weinmann, an infectious-disease expert at Henry Ford Hospital, in Detroit.
Being prepared proved essential when I caught COVID in mid-December and went to urgent care for a prescription. Because I’m 67, with blood cancer and autoimmune illness, I’m at elevated risk of getting severely ill from the virus. But I take a blood thinner that can have life-threatening interactions with Paxlovid.
Fortunately, the urgent-care center could see my electronic medical record, and a physician’s note there said it was safe for me to stop the blood thinner and get the treatment. (I’d consulted with my oncologist in advance.) So, I walked away with a Paxlovid prescription, and within a day my headaches and chills had disappeared.
Just before getting COVID, I’d read an important study of nearly 45,000 patients 50 and older treated for the disease between January and July 2022 at Mass General Brigham, the large Massachusetts health system. Twenty-eight percent of the patients were prescribed Paxlovid, which had received an emergency use authorization for mild to moderate covid from the FDA in December 2021; 72% were not. All were outpatients.
Unlike in other studies, most of the patients in this one had been vaccinated. Still, Paxlovid conferred a notable advantage: Those who took it were 44% less likely to be hospitalized with severe COVID-related illnesses or die. Among those who’d gotten fewer than three vaccine doses, those risks were reduced by 81%.
A few months earlier, a study out of Israel had confirmed the efficacy of Paxlovid — the brand name for a combination of nirmatrelvir and ritonavir — in seniors infected with COVID’s omicron strain, which arose in late 2021. (The original study establishing Paxlovid’s effectiveness had been conducted while the delta strain was prevalent and included only unvaccinated patients.) In patients 65 and older, most of whom had been vaccinated or previously had covid, hospitalizations were reduced by 73% and deaths by 79%.
Still, several factors have obstructed Paxlovid’s use among older adults, including doctors’ concerns about drug interactions and patients’ concerns about possible “rebound” infections and side effects.
Dr. Christina Mangurian, vice dean for faculty and academic affairs at the University of California-San Francisco School of Medicine, encountered several of these issues when both her parents caught covid in July, an episode she chronicled in a recent JAMA article.
First, her father, 84, was told in a virtual medical appointment by a doctor he didn’t know that he couldn’t take Paxlovid because he’s on a blood thinner — a decision later reversed by his primary care physician. Then, her mother, 78, was told, in a separate virtual appointment, to take an antibiotic, steroids, and over-the-counter medications instead of Paxlovid. Once again, her primary care doctor intervened and offered a prescription.
In both cases, Mangurian said, the doctors her parents first saw appeared to misunderstand who should get Paxlovid, and under what conditions. “This points to a major deficit in terms of how information about this therapy is being disseminated to front-line medical providers,” she told me in a phone conversation.
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, agrees. “Every day, I hear from people who are misinformed by their physicians or call-in nurse lines. Generally, they’re being told you can’t get Paxlovid until you’re seriously ill — which is just the opposite of what’s recommended. Why are we not doing more to educate the medical community?”
The potential for drug interactions with Paxlovid is a significant concern, especially in older patients with multiple medical conditions. More than 120 medications have been flagged for interactions, and each case needs to be evaluated, taking into account an individual’s conditions, as well as kidney and liver function.
The good news, experts say, is that most potential interactions can be managed, either by temporarily stopping a medication while taking Paxlovid or reducing the dose.
“It takes a little extra work, but there are resources and systems in place that can help practitioners figure out what they should do,” said Brian Isetts, a professor at the University of Minnesota College of Pharmacy.
In nursing homes, patients and families should ask to speak to consultant pharmacists if they’re told antiviral therapy isn’t recommended, Isetts suggested.
About 10% of patients can’t take Paxlovid because of potential drug interactions, according to Dr. Scott Dryden-Peterson, medical director of COVID outpatient therapy for Mass General Brigham. For them, Veklury (remdesivir), an antiviral infusion therapy delivered on three consecutive days, is a good option, although sometimes difficult to arrange. Also, Lagevrio (molnupiravir), another antiviral pill, can help shorten the duration of symptoms.
Many older adults fear that after taking Paxlovid they’ll get a rebound infection — a sudden resurgence of symptoms after the virus seems to have run its course. But in the vast majority of cases “rebound is very mild and symptoms — usually runny nose, nasal congestion, and sore throat — go away in a few days,” said Dr. Rajesh Gandhi, an infectious-disease physician and professor of medicine at Harvard Medical School.
Gandhi and other physicians I spoke with said the risk of not treating COVID in older adults is far greater than the risk of rebound illness.
Side effects from Paxlovid can include a metallic taste in the mouth, diarrhea, nausea and muscle aches, among others, but serious complications are uncommon. “Consistently, people are tolerating the drug really well,” said Dr. Caroline Harada, associate professor of geriatrics at the University of Alabama-Birmingham Heersink School of Medicine, “and feeling better very quickly.”
Judith Graham is a Kaiser Health News reporter.