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Pfizer Covid Pill Access Stymied by ‘Vague’ Prescribing Guidance

June 3, 2022, 9:35 AM

High-risk Americans are having a tough time getting Covid-19 antiviral pills as prescribers grapple with limited guidance on who is eligible and how many are available, infectious disease specialists say.

More than 2,500 Test-to-Treat sites are set up across the country where patients can get tested and prescribed Pfizer Inc.‘s Paxlovid or Merck & Co.’s molnupiravir by a health provider at a single location. But some providers are reluctant to prescribe the pills due to uncertainty over how they interact with other drugs, how to apply the risk factors that qualify people for the treatment, and limited awareness on available supply.

“There’s a lot of confusion out there,” said Scott Roberts, associate medical director of infection prevention at the Yale School of Medicine.

“I’ve had patients who, even from afar, just asked me, ‘I can’t get Paxlovid. What do I do?’ or, ‘My provider doesn’t know how to prescribe it, or if I should be prescribed it,’” he said.

The National Institutes of Health’s Covid-19 Treatment Guidelines Panel put together recommendations on drug-drug interactions and potential side effects associated with the two pills, and the Centers for Disease Control and Prevention has identified risk factors like age and underlying conditions that qualify people for the treatment. The FDA also issued a frequently asked questions document on Paxlovid and created an eligibility screening checklist to help prescribers determine if a patient would benefit from taking it.

But those recommendations don’t account for nuances in an individual patient’s underlying conditions and medication profile, a leading medical trade group and some infectious disease professors say. The issue is reigniting demands that the FDA give prescribing power to pharmacists who, according to pharmacy groups, have the knowledge on drug ingredients and interactions to assess whether an antiviral pill is appropriate for a particular patient.

The guidance for Paxlovid “has been a bit vague and open to some interpretation, which has left some doctors hesitant to prescribe it,” Andrea Garcia, the American Medical Association’s director of science, medicine and public health, said in a June 1 update.

Teladoc Health and Cigna subsidiary MDLIVE said in emailed statements that they have policies prohibiting their providers from prescribing the Covid-19 antiviral pills through virtual visits. The companies cited Paxlovid’s drug-drug interactions as well as safety concerns among patients who are pregnant or have pre-existing kidney and liver problems.

Less than half of the nearly 2.8 million courses of Pfizer’s treatment ordered have been administered as of June 1, according to data from the Department of Health and Human Services. The administration has also ordered approximately 1.9 million courses of Merck’s molnupiravir, of which roughly 272,000 have been administered.

The Biden administration doesn’t have available geographic and demographic data for the courses of Paxlovid and molnupiravir prescribed so far across the country, though it has asked all sites dispensing oral antivirals to collect this information to help address any gaps in access.

Risk Factors

The Food and Drug Administration authorized Paxlovid and molnupiravir to treat mild to moderate Covid-19 in people at high risk of severe disease. Rapid access to the pills is considered essential, as both pills are most effective when started within five days of symptom onset.

The FDA and NIH have urged health-care providers to consider certain factors recommended by the CDC when assessing a patient for “high risk for progression of severe Covid-19.” The CDC lists age as the strongest risk factor, and has also identified conditions like cancer, chronic kidney disease, HIV, and primary immunodeficiencies.

Infectious disease specialists say the prescribing guidance from federal health agencies lack detail and leave it up to prescribers to use their discretion to determine patient eligibility. These tips for providers are “a little bit ambiguous about who does qualify,” Roberts said.

“Cancer is on that list, but does that mean all cancer?” he asked. “What if you’re recovered and don’t currently have cancer?”

A common question facing prescribers is the level of immune suppression that qualifies a patient for treatment, said Michael Angarone, an associate professor at the division of infectious diseases at the Northwestern University Feinberg School of Medicine.

“That can vary from being on low doses of a steroid or certain medications that may alter the immune function, all the way to being on active chemotherapy,” Angarone said.

Roberts said Yale has a centralized hub in its medical record system where prescribers can go to determine the treatments for which their patients are eligible. He said the federal government should work toward a similar “centralized, streamlined process to very clearly and transparently display who qualifies and who does not qualify.”

Drug Interactions

Known drug interactions with Paxlovid that can affect its safety are also fueling prescriber hesitancy.

While molnupiravir has no known drug-drug interactions, Paxlovid has several potential interactions with some medications like blood thinners and anti-organ rejection medications given following transplants.

Phyllis Tien, an infectious disease physician at University of California, San Francisco, said not all providers are “comfortable prescribing a drug that has a lot of interactions with pretty common drugs that patients might be on.”

Patients with Covid-19 “who are at high risk of progression to severe disease” are often people who have conditions like “cardiovascular disease, or things where they will be taking some of these drugs that interact with Paxlovid,” said Tien, who serves on the NIH Covid-19 Treatment Guidelines Panel.

Locating Supply

Limited supply when the Covid-19 antiviral pills first became available prompted guidance to reserve treatment for those at highest risk of severe hospitalization or death. But the situation has substantially improved, with a total of approximately 1.2 million courses of Paxlovid and 1.4 million of molnupiravir available across the country as of June 2, according to the HHS’ Covid-19 Therapeutics Locator.

The NIH treatment panel says clinicians should only prioritize the Covid-19 pills for patients at highest risk of clinical progression when “logistical or supply constraints limit the availability of therapies.” When no constraints exist, the panel “recommends that therapies for the prevention or treatment of SARS-CoV-2 be prescribed for any eligible individual as recommended.”

The HHS therapy locator tool allows people to search by ZIP code which nearby pharmacies have Covid-19 treatments in stock and the number of courses available. But Angarone said he didn’t immediately know this tool existed.

“I found out about the COVID therapeutics locator from a friend, so I didn’t even find out from the CDC or from communication that came down from my hospital,” he said. “The CDC and/or the FDA could really help clinicians identify when there’s availability or where.”

Pharmacists’ Role

Pharmacists say their knowledge of the antiviral pills make them qualified to prescribe the therapeutics, and that this will limit delays in access.

The FDA has said the emergency use authorizations for both molnupiravir and Paxlovid state they should only be prescribed by traditional prescribers, including physicians and physician assistants, who “are licensed or authorized under state law to prescribe” anti-infective therapeutics.

Giving pharmacists prescribing power would help patients who don’t live near one of the test-to-treat sites, said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association.

“That would make every pharmacy a test-to-treat site,” Proctor said.

Angarone said he wouldn’t “have a problem” with allowing pharmacists to also prescribe these antiviral pills, “as long as they can obtain a complete list of the medications that the patient is on.” Tien said that if pharmacists are given the authority to prescribe, they must do so “in close coordination with a health-care provider.”

The uncertainty around antiviral treatment may only be a short-term problem, especially as more Covid-19 drugs are developed, Tien said.

“There will be newer antivirals coming down the line, they will be easier to take, they will be just as effective, and they over time may replace what we have now,” she said.

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com