Game-changing Covid pills remain out of reach for some patients

Covid pills are cheaper and more convenient than the single antibody treatment that has been shown to be effective against the fast-spreading Omicron variant, which must be administered in a clinical setting. The key is that a series of pills should be started within days of the onset of symptoms – and after a test confirms a Covid-19 infection.

Limited supply and bureaucratic hurdles can make this difficult to achieve.

Emergency use authorizations for pills are written so that prescribing authority is limited to physicians and certain health care workers often found in a physician’s practice. It could create an access carousel where patients might need to go to a testing site, a doctor‘s office, and then a participating pharmacy just to get the drugs — a prospect that a state health official said was tantamount to “sending you on a goose chase trying to find these drugs.

“It can mean three ins and outs,” said Anne Zink, Alaska’s chief medical officer and president-elect of the Association of State and Territory Health Officials. “And that’s assuming all three go well,” meaning patients can get appointments and avoid having to go to multiple pharmacies to find the drugs.

The requirements could also end up sending Covid-positive people to several public places. A state Nomi Health’s Newman works with had planned to replicate its Covid vaccination campaign by making Paxlovid available at grocery store pharmacies — until officials realized none of those places had an option drive-thru to allow Covid patients to stay out.

“The whole distribution architecture of this is crazy,” Newman said.

Pharmacy groups say one way to alleviate this problem would be to give pharmacists the power to prescribe antivirals, just as they can administer Covid-19 vaccines under the PREP law. This, however, would not be among the “traditional” categories of prescribers that the FDA stipulated in its authorization – physicians, physician assistants and advanced practice registered nurses who are authorized by states to dispense anti-infective drugs.

“This determination was based on several factors, including the side effect profiles of the drugs, the need to assess the potential for drug interactions, the need to assess potential problems with kidney function…and the need to evaluate patients for pre-existing conditions that may put them at high risk of progression to severe Covid-19, including hospitalization or death,” FDA spokesperson Chanapa Tantibanchachai told POLITICO.

Pharmacists say their omission from this list ignores the work they have already done to test and counsel Covid patients and what they are doing to educate consumers and doctors about how the pills may interact with others prescriptions or supplements they take, as well as how to complete multi-day courses.

That means pharmacists can go so far as to order treatments before they’re stopped in their tracks, said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association.

“You have a lot of doctors who don’t know about these drugs yet, don’t know how to prescribe them, and so pharmacists spend a lot of time educating doctors about it,” he said. “And ultimately the problem that created is that payers just see pharmacies as distributors.”

The nature of drugs requires pharmacists to thoroughly review patients’ medical histories and medication regimens to ensure that the pill they are prescribed is the best option for them.

Molnupiravir is not recommended for use in pregnant women based on animal reproduction tests which suggest the drug could harm an unborn child, although it may be prescribed in consultation with the patient if it is believed to significantly increase the person’s chance of avoiding serious illness. Its effectiveness pales in comparison to that of Paxlovid, which trials have shown reduces the risk of hospitalization and death by 89%, compared to 30% 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 controller medications or avoid Paxlovid altogether.

“I thought this drug was designed for people who couldn’t get the vaccine in the first place,” Newman said. “How many people in America take a statin?”

Compounding pharmacists’ frustration is that they report getting paltry reimbursement rates of $1 or less for counseling patients on antivirals.

“How many pharmacies will even continue to partner with state health services?” 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 lot of money.”

Pharmaceutical organizations are pushing the Centers for Medicare and Medicaid Services to release guidelines on how pharmacies should be paid for their services.

“To get this federal asset to the patients who need it – given the guardrails that need to be in place for proper use – it cannot be an unfunded mandate, either on insurers or on our pharmacies” , Snead said.

A spokesperson for CMS could not respond to a request for comment within the time limit.

While officials work out bureaucratic issues, the pills themselves remain in short supply.

During the two-week period beginning Jan. 10, the Department of Health and Human Services distributed nearly 400,000 courses of Molnupiravir to states; the Paxlovid allowance was only a quarter of that. The federal government also resumed sending three monoclonal antibody treatments to states and territories, although only one — GlaxoSmithKline and Vir’s sotrovimab — was found to be effective against the Omicron variant.

“We’re trying to let the public know that we don’t have enough” pills, said Zink, Alaska’s chief medical officer, adding that his department has been trying to ensure every region of his vast state has access to either a monoclonal antibody or one of the antiviral regimens.

However, “it is difficult to take [a few dozen] doses and put it in a state the size of Montana, California and Texas combined,” she said, referring to the most recent allocation of sotrovimab in Alaska.

The Biden administration has highlighted its efforts to accelerate research and manufacturing of Paxlovid with Pfizer, arguing that the country is awash with 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 treatments are available now than at any other time during the pandemic, but they are 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 from his hometown – a hurdle for Covid patients who are older, unable to drive or cannot afford such a long trip.

A monoclonal antibody infusion center is 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 populated areas would get a preferential distribution,” he said, “but again, we like to see it a bit fairer.”

Joshua Barocas, an infectious disease specialist at the University of Colorado School of Medicine, fears that only patients with access to hospitals could benefit from Covid therapies.

“This means that only people with transport will be treated,” he said. “People with access to the tests will receive the treatments.”

The federal government, perhaps in conjunction with the National Guard, could help ensure that treatments are directed to vulnerable populations, Barocas added.

“We cannot expect vulnerable and sick patients to do everything themselves,” he said.

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