Community pharmacists prescribe and dispense Paxlovid despite hurdles
Every at-home COVID-19 test that leaves Moose Pharmacy in Charlotte, NC, carries a sticker bearing a QR code. Beside the code, the text reads, “Test POSITIVE for COVID-19? At Moose Pharmacy, we offer a $75 consultation to see if you are eligible for Paxlovid. If eligible, the pharmacist can prescribe and dispense the antiviral medication right to you! Scan here to schedule your consultation.”
During assessments for Paxlovid (Pfizer) eligibility, Tory Grooms, PharmD, runs through an exhaustive list of conditions.
“If you take an antidepressant, that counts. If you have any sort of mood disorder, or even ADHD, that counts, too. They’ve pretty much lowered all the barriers to qualifying for Paxlovid,” Grooms said. She attributes the expanded access to increased supply and ongoing data to support the benefits of the antiviral medication.
According to CDC, from December 2022 to February 2023, weekly COVID-19 deaths averaged 3,756. New hospital admissions during that time averaged 3,953 a day, which underscores the ongoing need for easy access to Paxlovid.
While federal agencies have made it simpler for patients to qualify to receive the antiviral, pharmacies still face major barriers to prescribing and dispensing the drug. But those who offer the medication say that the benefits for patients and for the pharmacy profession may make the trouble worthwhile.
Paxlovid in the pharmacy
The Coronavirus Aid, Relief, and Economic Security (CARES) Act gives pharmacists the authority to prescribe Paxlovid to eligible patients.
To check for eligibility, pharmacists must first get confirmation of a COVID-19 infection. This happens via a positive test result or, in rare instances, individuals with a recent known exposure who develop signs and symptoms consistent with COVID-19 may be diagnosed by a health care provider as having COVID-19 even if they have a negative test result. Next, they check that the patient has risk factors for progression to severe disease. As this often means the patient is taking other medications, the pharmacist has to review the medication to list to make sure there aren’t any that might interact with Paxlovid. The list of contraindicated medications is lengthy.
“There are whole classes of drugs that interact with it,” said Grooms, “so we have to be cautious about those patients who are already complex with their medication regimens.”
OTC medications make the list, too, said Coleman Cutchins, PharmD, lead pharmacist with the Alaska Department of Health and Social Services. “You have to do a very thorough medication review—all prescriptions, all over-the-counters, all herbal supplements—to check for interactions. Pharmacists are very good at that. We deal with it every day.”
Finally, pharmacists need access to patients’ lab values to confirm that their kidney and liver function are sufficient to metabolize the drug.
“That’s the greatest barrier and what makes it hard for some pharmacies to do this because it takes digging and you’ve got to have the time to be able to do that,” Grooms said.
As an independent pharmacy, Moose Pharmacy has relationships with many of the local medical centers and access to patients’ electronic health records (EHR). When Grooms cannot access a patient’s record, she encourages them to register for their health care facility’s patient portal and share lab results with her directly.
“Pharmacists can be proactive about this, too, by encouraging patients to sign up for their patient portal even outside of the Paxlovid assessment,” Cutchins added. “Ask them, ‘Have you had your COVID-19 vaccines? Do you have a plan for if you were to get COVID-19? Do you have access to your patient portal?’”
When Grooms is not able to complete all the steps to determine a patient’s eligibility for Paxlovid, she contacts their physician for lab values or refers them to urgent care for a Paxlovid prescription. But both strategies run the risk of pushing patients past the 5-day window to start the medication.
Barriers to better patient care
While patients face fewer hurdles to eligibility for Paxlovid, many barriers are still firmly in place for the pharmacies where the drug is prescribed and dispensed.
Since Paxlovid earned EUA status, the federal government has provided it to participating pharmacies at no cost to the pharmacy or the patient. Thus far, patients have received the prescription for free, and pharmacies have billed insurance for the cost of dispensing.
However, this year, the federal government will stop paying for the antiviral drug, which it gets from Pfizer at the discounted price of $530 per course. Patients and insurers will have to cover the cost (as of press time, Pfizer has not yet released that figure). It remains to be seen how much of the undisclosed cost will fall to patients.
Government funding of the treatment is expected to end sometime in mid-2023. Until then, select pharmacies will continue to dispense the drug for free.
To prescribe the drug, pharmacies typically also charge patients a cash fee for the assessment for eligibility that they are required to do but for which they aren’t reimbursed by insurance. This may prevent some pharmacies from choosing to become Paxlovid prescribers at all.
“We all need to acknowledge the sustainability of these clinical services,” Cutchins said. “It takes a lot of time to assess the patient, do a full medication review, and make those clinical assessments, and that medical encounter isn’t universally reimbursed for pharmacists.”
If they are not able to bill for these services, pharmacies may not be able to hire the staff necessary to carry out the services. “You don’t want to be the only pharmacist in a [community pharmacy] and have to spend 30 minutes assessing a patient for Paxlovid, while you’re also handling dispensing duties on top of that,” he added.
For uninsured patients, pharmacies used to bill the Health Resources and Services Administration’s (HRSA) COVID-19 Claims Reimbursement program for the cost of dispensing until federal funding for that program ran out.
“Pharmacists are in a pickle here,” Grooms said. “The HRSA funding is dry, so we are no longer paid to offer COVID-19 vaccines or treatments to patients who are uninsured, but we are still required to provide these services at no cost to the patient, so we are forced to provide these services at a loss.”
Other rules made by individual payers cause problems, too. Some insurers, for example, set a limit of only one course of Paxlovid per patient every 6 months. “If patients need a repeat, we still have to fill the prescription, but we can’t bill the insurance plan for it. We just have to eat the cost,” said Stephanie Rice-Erlenbusch, CPhT, from Fred Meyer Pharmacy in Portland, OR.
Raising the profile of the profession
The CARES Act has expanded pharmacists’ scope of practice in several ways. Pharmacists have led the charge in vaccinating adults and children against COVID-19. They’ve prescribed and administered COVID-19 treatments including Paxlovid and monoclonal antibody therapy.
Cutchins sees the use of CLIA-waived tests to test and treat COVID-19 with Paxlovid as an opportunity to advance the profession that pharmacists should seize.
“Since the 90s, as a pharmacy profession, we’ve been saying we need to provide more medical care, we need to advance our practice, we need to fill in gaps in primary care,” he said. “This is another big opportunity to do that.”
While the requirements pharmacists must meet to prescribe Paxlovid may seem difficult to achieve, Grooms stresses the importance of leaning on support staff for every step of the process that does not require a pharmacist.
Pharmacies that don’t have the staff necessary to assess for Paxlovid every day can choose to provide the service only on certain days. “Anything we can do to increase access is going to help patients and advance the profession,” Cutchins said.
Better outcomes for patients
Prescriptive authority for Paxlovid is also an opportunity to help more patients at risk of severe illness, hospitalization, and death from COVID-19.
Patients at risk of severe illness from COVID-19 and seeking Paxlovid have a few options: They can try to see their regular doctor; they can go to urgent care; or they can see a pharmacist who prescribes Paxlovid.
Patients may not want to risk the time it could take to see or get a prescription from their physician, and urgent care is costly. A man who called Moose Pharmacy was in exactly this predicament. He was concerned about his 80-year-old mother as they waited for a call back from her doctor.
“He was nervous because she was so old and fragile. The son drove his mother over, we retested, got a positive result, pulled up her EHR, current med list, and lab values, and got Paxlovid out the door in about 30 minutes,” Grooms said. “It was so fast in comparison to the broken health care system that people are used to, and that normally works in most circumstances, but that doesn’t work well in a pandemic.”
For all the trouble Rice-Erlenbusch has had chasing down reimbursement for Paxlovid dispensing fees at Fred Meyer Pharmacy in Portland, OR, the pharmacy technician says providing the service is the pharmacy’s duty.
“Our number one priority is to take care of our community,” she said. “Even though it does make it hard on the business side when we do not receive reimbursement, it is something that we owe our community in order to help them if they need that medication.” ■
Qualifying conditions to receive Paxlovid
- Cerebrovascular disease
- Chronic kidney disease
- Chronic lung diseases limited to
- Chronic obstructive pulmonary disease
- Interstitial lung disease
- Pulmonary embolism
- Pulmonary hypertension
- Chronic liver diseases limited to
- Non-alcoholic fatty liver disease
- Alcoholic liver disease
- Autoimmune hepatitis
- Cystic fibrosis
- Diabetes mellitus, type 1
- Diabetes mellitus, type 2
- Disabilities, including Down syndrome
- Heart conditions (such as heart failure, coronary artery disease, or cardiomyopathies)
- Mental health conditions limited to
- Mood disorders, including depression
- Schizophrenia spectrum disorder
- Neurologic conditions limited to dementia
- Obesity (BMI ≥30 kg/m2 or ≥95th percentile in children)
- Physical inactivity
- Pregnancy and recent pregnancy
- Primary immunodeficiencies
- Smoking, current and former
- Solid organ or blood stem cell transplantation
- Use of corticosteroids or other immunosuppressive medications
Source: CDC. COVID-19: Underlying medical conditions associated with higher risk for severe COVID-19: Information for healthcare professionals.
Medications without clinically relevant interactions
These medications may be coadministered without dose adjustment and without increased monitoring.a This list is not inclusive of all noninteracting medications within each drug category.
- Isosorbide dinitrate
- Corticosteroids (inhaled)
- Contraceptives (oral)b
Most monoclonal antibody productsc
aThis list is primarily based on the most common medication searches by U.S. users on the Liverpool COVID-19 Drug Interactions website between January 1 and July 31, 2022 (internal communication, August 2022).
bThe FDA EUA for ritonavir-boosted nirmatrelvir suggests that individuals who use contraceptive products containing ethinyl estradiol consider using a backup, nonhormonal contraceptive method because coadministration may result in low ethinyl estradiol levels. However, the low level is not expected to be clinically significant during the 5 days of therapy. The progestin concentration of a combined hormonal contraceptive is expected to remain similar or increase with coadministration, which would maintain the effectiveness of the oral contraceptive.
cRitonavir-boosted nirmatrelvir interacts with certain conjugated monoclonal antibodies, such as those conjugated to the drug monomethyl auristatin E (or vedotin). These include brentuximab vedotin, enfortumab vedotin, polatuzumab vedotin, and tisotumab vedotin. Before coadministering ritonavir-boosted nirmatrelvir and any of these conjugated monoclonal antibodies, refer to the drug’s FDA prescribing information and consult with the patient’s specialist providers as needed.
Source: NIH. COVID-19 treatment guidelines: Drug–drug interactions between ritonavir-boosted nirmatrelvir (Paxlovid) and concomitant medications.
Paxlovid: An oral antiviral for COVID-19
Paxlovid, an oral antiviral that contains a combination of nirmatrelvir and ritonavir, is a SARS-CoV-2 protease inhibitor that prevents replication of the coronavirus.
In the clinical trials that earned the drug its EUA from FDA, Paxlovid twice daily for 5 days and started within 5 days of symptom onset reduced COVID-19–related hospitalizations and deaths in unvaccinated people who had the Delta variant by 89% for 28 days.
More recently, NIH research has found that Paxlovid reduces the risk of severe COVID-19 illness, hospitalization, and death in adults over age 50 infected with the Omicron variant by 44%. These risks were 81% lower in people who weren’t vaccinated. Notably, hospitalization and death in general were less likely among people infected with the Omicron variant compared to those infected with Delta. Among the 44,500 people whose medical records were analyzed for this study, hospitalizations and deaths were below 1%. ■
Who can get Paxlovid?
Once recommended only for older adults, Paxlovid is now indicated for anyone age 12 or older who has a condition that might put them at risk for progression to severe disease. The list of conditions is sweeping and includes some that clinicians might expect to see and others that may be surprising, such as mood disorders, obesity, and physical inactivity.
“There’s really good data to show that, across the board, vaccinated or not, especially if you’re over 50, Paxlovid will reduce your risk even further,” said Coleman Cutchins, PharmD, lead pharmacist with the Alaska Department of Health and Social Services. “Anyone, especially if they have high-risk criteria—age being the number one risk factor for severe disease—should get tested if they have symptoms and be offered Paxlovid." ■