Antiviral Covid-19 pills were billed as game-changers for the way they could provide a convenient way to treat infections at home and keep people out of the hospital. But that assumed patients could get the drugs quickly.
Instead, a flurry of regulatory, testing and logistical issues is complicating the rollout, potentially requiring people with symptoms to make multiple stops at doctors' offices or testing sites within the five-day window when the drugs are recommended.
“It should be easy, and it’s chaos,” said Mark Newman, CEO of Nomi Health, which runs testing sites around the country.
The two pill options — Molnupiravir from Merck and Ridgeback Biotherapeutics and Paxlovid from Pfizer — already came with some caveats. Trials have shown Molnupiravir is the less effective of the two and is not recommended for pregnant people or children because of possible side effects. Paxlovid interacts with a host of blood pressure, cholesterol and other widely used drugs, meaning patients may have to suspend taking those medications.
The Covid pills are less expensive and more practical than the single antibody treatment shown to be effective against the rapidly spreading Omicron variant, which has to be administered in a clinical setting. The key is, a series of pills must be started within days of the onset of symptoms — and after a test confirms a Covid-19 infection.
Tight supplies and bureaucratic hurdles may make that hard to pull off.
The pills’ emergency use authorizations are written so that prescribing power is limited to doctors and certain health care workers often found in a physician's practice. That could create an access merry-go-round where patients may need to visit a testing site, a doctor’s office and then a participating pharmacy just to get the drugs — a prospect one state health official said was akin to “sending you on a goose chase to try and find these meds.”
“That may mean three entries in and out of places,” said Anne Zink, Alaska’s chief medical officer and the Association of State and Territorial Health Officials’ president-elect. “And that’s assuming all three of those go well” — meaning patients can get appointments and avoid visiting multiple pharmacies to find the drugs.
The requirements also could wind up sending Covid-positive individuals into several public places. One state Nomi Health's Newman works with had planned to replicate its Covid vaccine drive by making Paxlovid available in grocery store pharmacies — until officials realized that none of those locations has a drive-through option to allow Covid patients to stay outside.
“The whole distribution architecture of this is crazy,” Newman said.
Pharmacy groups say one way to mitigate that issue would be to give pharmacists prescribing authority for the antivirals, just like they can administer Covid-19 vaccines under the PREP Act. That would, however, fall outside the “traditional” categories of prescribers the FDA stipulated in its authorization — physicians, physician assistants and advanced practice registered nurses who are licensed by states to dole out anti-infective drugs.
“This determination was based on several factors, including the drugs’ side effect profiles, the need to assess potential for drug interactions, the need to assess potential kidney function problems ... and the need to evaluate patients for pre-existing conditions that may put them at high risk for progression to severe Covid-19, including hospitalization or death,” FDA spokesperson Chanapa Tantibanchachai told POLITICO.
Pharmacists say their omission from that list ignores the work they already put into testing and advising Covid patients and what they're doing to educate both consumers and doctors about how the pills may interact with other prescriptions or supplements they take, as well as how to take the multi-day courses.
What that means is pharmacists can go as far as ordering the treatments before they're stopped in their tracks, said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association.
“You’ve got a lot of physicians who don’t know these drugs yet, don’t know how to prescribe them, and so pharmacists are spending a lot of time educating the physicians on it,” he said. “And the bottom line is, the problem that this has created is that the payers are just viewing pharmacies as dispensers.”
The nature of the drugs requires pharmacists to extensively review patients’ medical histories and medication regimens to ensure the pill they’re prescribed is the best option for them.
Molnupiravir isn’t recommended for use in pregnant people based on animal reproductive testing that suggests the drug could harm fetuses, though it can be prescribed in consultation with the patient if it’s believed to significantly increase the odds that person will avoid severe illness. Its effectiveness pales in comparison to Paxlovid’s, which trials showed cut the risk of hospitalization and death by 89 percent, compared to 30 percent for the Merck pill.
But Paxlovid also interacts with dozens of drugs, from cholesterol and blood pressure medications to steroids and cancer drugs. Patients may need to temporarily stop their maintenance medications or avoid Paxlovid altogether.
“I thought this drug was made for people that couldn’t get vaccinated in the first place,” Newman said. “How many people in America take a statin?”
The pharmacists' frustration is compounded by the fact they say they're getting paltry reimbursement rates of $1 or less advising patients on the antivirals.
“How many pharmacies are going to continue to even partner with the state health departments?” said Rebecca Snead, executive vice president and CEO of the National Alliance of State Pharmacy Associations. “They want to serve their communities, but they’re losing a tremendous amount of money.”
The pharmacy organizations are pushing the Centers for Medicare and Medicaid Services to issue guidance on how pharmacies should be paid for their services.
“To provide this federal asset to patients that need it — given the guardrails that must be in place for appropriate utilization — it can’t be an unfunded mandate, whether it be on the insurers or on our pharmacies,” Snead said.
A CMS spokesperson couldn't respond to a request for comment by deadline.
While officials work out the bureaucratic questions, the pills themselves remain in short supply.
For the two-week period starting Jan. 10, the Department of Health and Human Services distributed nearly 400,000 courses of Molnupiravir to states; the Paxlovid allocation was just a quarter of that. The federal government also resumed shipping three monoclonal antibody treatments to states and territories even though only one — GlaxoSmithKline and Vir’s sotrovimab — has been shown to be effective against the Omicron variant.
“We’re trying to message to the public we don’t have enough” of the pills, said Zink, the Alaska chief medical officer, adding her department has tried to ensure every region of her vast state has access to either a monoclonal antibody or one of the antiviral regimens.
Still, “it’s hard to take [a few dozen] doses and put it in a state the size of Montana, California and Texas combined,” she said, referring to Alaska’s most recent allocation of sotrovimab.
The Biden administration has highlighted its efforts to accelerate research and manufacturing for Paxlovid with Pfizer, making the case the country is awash with the treatments.
“Our nation’s medicine cabinet has never been more stocked, with 4 million effective treatments available in January alone,” Jeff Zients, the White House’s Covid response coordinator, told reporters last week.
More therapeutics are available now than at any other point in the pandemic, but they're not always easily accessible.
In coastal Virginia, Sterling Ransone, president of the American Academy of Family Physicians, said the closest retail pharmacy with Covid antivirals on hand is an hour away from his hometown — a barrier for Covid patients who are older, unable to drive or can’t afford to take that long of a trip.
A monoclonal antibody infusion center is located about half an hour away, Ransone said, but the only treatments available were the two that don’t work against Omicron.
“I understand why more populous areas would get preferential distribution,” he said, “but again, we like to see it a little more equitable.”
Joshua Barocas, an infectious disease specialist at the University of Colorado School of Medicine, he’s worried only patients with access to hospitals will be able to get Covid therapies.
“This means that only people with transportation are going to get treated,” he said. “People with access to testing are going to get the treatments.”
The federal government, perhaps in conjunction with the National Guard, could help ensure treatments get steered toward vulnerable populations, Barocas added.
“We cannot expect vulnerable and sick patients to do everything themselves,” he said.