The Food and Drug Administration is poised to authorize the first Covid-19 antiviral pill for at-home use as soon as next week. But ensuring the drug reaches the patients who’d most benefit from it will be a thorny task for regulators and health care providers.
Independent advisers to the FDA endorsed the pill, molnupiravir, in an unusually tight 13-10 vote this week after airing concerns about its low efficacy rate and potential safety risks to pregnant people. And the arrival of the Omicron Covid-19 variant is further complicating matters, driving up case counts and, potentially, demand for a simple treatment.
The FDA will likely specify which “high risk” populations should have access to the Merck-Ridgeback Biotherapeutics pill if they contract Covid-19. That still will leave doctors and other providers on the hook for making judgment calls on whether to prescribe the pill — and to do it within five days of a patient showing symptoms — in order to realize the potential benefits.
“It will probably end up being a quite limited subset of individuals who even qualify [for the drug],” said Leana Wen, an emergency physician and public health professor at George Washington University. Patients who qualify will still have to jump through several hoops — developing symptoms, testing positive, reaching a health care provider and finding a pharmacy — in an incredibly short span of time to be used effectively, she added.
Having a pill that can be taken at home would fill a major gap in the pandemic response toolkit. Health care providers now have a limited number of treatments for Covid-19 that each have to be administered in a clinic or hospital. If used effectively, Merck's pill could flatten future surges of infection and ease the burden on health systems, in combination with vaccines and public health measures like mask-wearing.
“For effectiveness of this product, time is of the essence,” said B. Douglas Hoey, the chief executive officer of the National Community Pharmacists Association.
But supplies of the pill will likely be limited at first. The federal government has purchased 3.1 million courses of molnupiravir, which it will acquire between the date of FDA authorization and early next year. It has the option of purchasing an additional two million doses later, if needed.
A senior federal health official said if authorized, the pills bought by the federal government will be provided free of cost to localities that can distribute them through health departments, community health centers and pharmacies. “We continue to work with jurisdictions to plan for distribution and use of these products that will be consistent with clinical guidelines and recommendations for who should receive them,” the official said.
States plan to use distribution strategies they employed for earlier Covid-19 therapies. "State health departments across the country have been meeting and communicating with HHS ... for a good month or two," said Jim Blumenstock, senior vice president for pandemic response and recovery for the Association of State and Territorial Health Officials. Their biggest tasks so far have been setting up ordering systems and helping determine which facilities could serve as a one-stop shop for patients, he added.
In Merck’s trials, however, the pill was only tested on unvaccinated adults, which makes some health experts wonder if the pills will only be available to that group. With an unvaccinated population at just over 99 million people, according to the Centers for Disease Control, three million doses is “a drop in the bucket,” said Eunice Neeley, a preventive medicine specialist and primary care provider based in New Orleans, Louisiana.
Merck, meanwhile, is assessing whether molnupiravir is effective against the Omicron variant. Carlos del Rio, an executive associate dean and infectious disease specialist at the Emory School of Medicine, said that the pills “should work” against other variants because of how they stop the virus from replicating. But it will be important to collect more clinical data to be sure, he added.
It’s also not yet clear how the pills would be distributed to patients. Pharmacy groups are warning that access could be even more limited if the Centers for Medicare and Medicaid Services doesn’t ensure that pharmacists are paid for evaluating patients for dispensing the drug. The Department of Health and Human Services has authorized pharmacists under the PREP Act to assess patients and prescribe them Covid treatments, but CMS hasn’t developed a way to compensate them for those clinical services.
“That takes time, and time is not free,” said Kurt Proctor, senior vice president of strategic initiatives at the community pharmacists group.
If pharmacists don’t participate, patients might have to make doctors appointments, delaying when they can begin the regimen.
“For what needs to be an agile nimble process, it’s really pushing it into a more clumsy, time-consuming process,” he said.
For all the possible distribution difficulties, some health care providers have concerns that the effort to distribute molnupiravir may not be worth it, given the limited effectiveness of the drug.
In late-stage clinical trials, molnupiravir was shown to be about 30 percent effective at preventing hospitalization in at-risk patients, compared to a placebo. For comparison, antibody treatments that are administered in clinics and hospitals are about 70 percent effective.
“This is incremental from a purely medical treatment standpoint … if everybody had access to monoclonal antibodies in early infection that would be better than this drug,” said Dorry Segev, a surgeon and professor at Johns Hopkins University. He acknowledged that due to health system inequities, some people may benefit more from an oral pill that can be taken at home rather than in a health care setting.
In the advisory committee meeting this week, experts also discussed safety concerns with the drug. Because it works by causing the SARS-CoV-2 virus to mutate, it could lead to new variants of the virus escaping if patients don’t take the full course — similar to the way that incomplete courses of antibiotics can create drug-resistant infections.
Experts also expressed concern about pregnant individuals who may need the drug. Pregnancy increases the risk of a person developing severe Covid; yet in animal testing, molnupiravir appeared to lead to miscarriages or serious birth defects. Merck asked the FDA not to prohibit pregnant individuals from taking it entirely, but rather to allow health care providers to work with pregnant patients to decide if the benefit is worth the risk.
Health care providers see the experimental pill as a weapon — but not a game-changer. “It's effective, but it's not as effective as some other tools,” said Neeley.
The most important thing, they argue, is stopping future infections before they happen. “This will not help us out of the pandemic because it is a treatment and not a prevention,” said Segev. “The way out of this pandemic is prevention.”
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By: Lauren Gardner and Katherine Ellen Foley
Title: Who should get the experimental Covid pill?
Sourced From: www.politico.com/news/2021/12/04/who-should-get-the-experimental-covid-pill-523757
Published Date: Sat, 04 Dec 2021 07:00:19 EST
