Via Teleconference

6:06 P.M. EDT

MR. MUNOZ:  Hi, everybody.  Thank you for joining tonight our press call on the Biden administration’s efforts to increase access to COVID-19 treatments and boost patient and provider awareness.

You all should have received a embargoed factsheet for 5:00 a.m. tomorrow in your inbox.  If not, please email me. 

This call will be embargoed until 5:00 a.m. as well, and attributable to senior administration officials.

For your awareness, on the line we’ll have brief remarks from [senior administration official].  We have [senior administration official] and [senior administration official].

And with that, I will kick it to [senior administration official].

SENIOR ADMINISTRATION OFFICIAL:  Wonderful.  Thanks, Kevin.  Can you hear me?  Thank you for joining us.

I want to provide an overview of new actions to increase access to COVID-19 treatments and boost patient and provider awareness.

First, let me step back.  Over the past 15 months, the administration had pulled levers across the federal government and deployed resources Congress provided to expedite the development, production, and procurement of COVID-19 treatment. As a result, the U.S. now has several treatments available that can help keep people out of the hospital and save lives.

Pfizer’s oral antiviral pill, Paxlovid, is one of the most effective available treatments and has been shown to reduce the risk of hospitalization or death by about 90 percent.  Although Paxlovid was originally in short supply after the Food and Drug Administration authorized it, the administration has worked with Pfizer to accelerate the delivery of these pills, which are now widely available.

The President’s National COVID-19 Preparedness Plan lays out a roadmap for ensuring that these pills, along with other treatments, are available for any American that needs one. 

Since December 2021, the administration has distributed COVID-19 oral antivirals directly to states, Tribes, territories, and community health centers for free.  States and territories play an important role in distributing these treatments to healthcare providers, pharmacies, and other locations.

In March, as supply began to ramp up, the President announced the Test to Treat initiative to help make it easier for people at high risk of severe disease to quickly access oral antiviral treatments.  While any doctor can prescribe treatment, the Test to Treat initiative creates additional locations where people can get a COVID-19 test, a visit with a medical provider, and, if needed, free oral antiviral pills — all in one visit.

To date, the administration has worked with pharmacies, long-term care facilities, community health centers, and other healthcare settings to establish more than 2,200 Test to Treat sites around the country, including sites specifically for military families and veterans.  As a result, usage of oral antivirals has more than doubled over the last several weeks.

But more is needed to make these treatments even easier to access and make sure healthcare providers and patients know about their safety, efficacy, and availability.

And tomorrow, the administration is announcing new actions to do just that.  These actions will help strengthen and further build the infrastructure to ensure that lifesaving treatments for COVID-19 are quickly distributed around the country, widely available, and easy to access.  At the same time, ensuring that this remains the case and securing more and even better treatments will require additional funding from Congress.

Now, let me walk through the actions that we are gathered here to talk about.

First, we’re going to nearly double the number of places oral antivirals are available in the coming weeks.  Now that we have ample supply of these treatments, we can make it easier for pharmacies to order from the federal government.

Starting this week, the administration will allow all pharmacy partners in the federal antiviral pharmacy program representing tens of thousands of pharmacy locations nationwide to order free antiviral treatments directly from the federal government.  The administration expects that oral antivirals will soon be available in more than 30,000 locations.

In the coming weeks, the Department of Health and Human Services will work with pharmacy partners to increase the availability even further, up to 40,000 sites.

We are also going to launch a new effort to stand up federally supported Test to Treat sites.  Building on the current footprint of 2,200 Test to Treat sites and pharmacies and other clinical settings, the federal government will work with states and jurisdictions to stand up additional Test to Treat locations with federal support.  These sites will co-locate testing, an assessment from a medical provider, and oral antiviral treatments in one convenient stop, launching in partnership with state, Tribal, and territorial governments, and with support and coordination from HHS and FEMA.

These sites will be targeted to meet demand and increase equitable access to lifesaving COVID-19 treatments and will function in direct collaboration with state and local health agencies.

We also are going to support medical providers with more guidance and tools to understand and prescribe treatment.  Keeping healthcare providers informed is critical in the effective prescription of COVID-19 treatments, including their benefits, contraindications, drug-to-drug interactions, and other side effects, so that doctors are in a position to quickly prescribe one of these treatments where appropriate.

The administration has been working for months with healthcare providers around the country to inform them about new treatments with weekly webinars with state and territorial health officials, healthcare and medical organizations, as well biweekly clinical webinars with healthcare providers, including those who specialize in treating high-risk patients.

The administration will continue actively engaging the clinical community to broaden awareness and understanding of these treatments and to make sure that healthcare providers are counseling their patients about these effective treatments, prescribing them when appropriate, and helping patients identify where their prescription can be filled.

We are also going to communicate to the American people that safe, effective treatments are widely available.  Now that the administration has made treatments widely available and there are tens of thousands of sites around the country where they can be dispensed, the administration will ramp up its public awareness and education efforts on COVID-19 treatments. 

The administration’s efforts will focus on making sure people know that COVID-19 oral antiviral treatments must be taken within the first five days of symptom onset and their role in reducing the risk of severe disease and death from COVID-19. 

These efforts build on steps the administration has taken in recent weeks to help people access treatment. 

MR. MUNOZ:  Thank you, [senior administration official].  With that, we have time for a few questions.  Let’s go to Hannah Recht at Kaiser News. 

Q    Hi, can you hear me?

SENIOR ADMINISTRATION OFFICIAL:  Yes.

MR. MUNOZ:  Yes.

Q    Great.  Thank you so much for taking my call.  If we could take a step back for a second on the therapeutics program in general.  You know, you said earlier that usage of oral antivirals has more than doubled in the last several weeks.  That is really the only type of detail that we’ve been provided — these sort of broad strokes of the utilization is low, now it’s doubling.  We really don’t have any actual data on how they’re being distributed and how they’re being utilized in contrast to the vaccine programs.  We have really robust data there.  But when it comes to the therapeutics, we have none at all, and requests for that data from HHS have been declined. 

Can you talk about why the administration is refusing to share actual numbers on where these therapeutics have been distributed, where they’ve been utilized, and any real data on that front?  I think it’s really important for the American people to actually have more specific insight into this program.

MR. MUNOZ:  [Senior administration official], do you want to provide those numbers and give a little bit of context here? Thanks, Hannah.

SENIOR ADMINISTRATION OFFICIAL:  Yeah, definitely. Definitely agree it’s important to understand usage trends.  As we’ve mentioned, Hannah, we have seen usage increase.  I think, overall, we are — have had more than 500,000 courses of antivirals used — reported as used so far.  I think we are always working with our partners that are distributing and administering these treatments to improve and — improve data collection and make sure that we’re collecting as much as possible. 

I think, in recent weeks — you know, I think about a month ago we were at around 22,000 courses reported as used in a week.  And I think this past week we were over 55,000.  So, we’ve seen it grow by two and a half times.

I think — you know, again, we want to continue to make sure we’re getting the best data collection as possible.  But I think, more importantly, we don’t really track success necessarily by usage.  I think we are really focused on making sure that everybody understands that treatments are — safe, effective treatments are available widely, and that providers and prescribers and everybody understands the parameters around them, understands the eligibility criteria, and can work with their patients to help them get them as quickly as possible.

Thanks. 

MR. MUNOZ:  All right.  Next question, Nancy Cordes at CBS.

Q    Hey, thank you so much.  Two questions.  So you said that the Test to Treat program is going to expand from 2,200 sites now.  How many more sites do you envision, and how quickly?  And then, also, are you expanding the range of adults who are going to be eligible to get Paxlovid, or is it still just people who have a preexisting condition?

MR. MUNOZ:  [Senior administration official], do you want to take the first one?  And then, [senior administration official], do you want to take the second question?

SENIOR ADMINISTRATION OFFICIAL:  Yes.  So I think, importantly, we will let demand be our guide here.  We have set up 2,200 Test to Treat sites so far, as you mentioned.

I think we’re going to be working really closely with these new federally supported sites to work directly with state, territorial, and jurisdictional leadership to kind of identify the places that need more support, identify what kinds of support could be available, how many sites they might need. 

And so, I think it remains to be seen, but the most important thing is that we are committed to work with our jurisdictional partners to add additional capacity, as well as, as we mentioned at the top, really opening widely the distribution channel to pharmacies right now.  I think we are greatly expanding that, that we expect an additional 10,000 sites to come online right away, and we’ll keep pushing to add even more there.

So, overall, we’re trying to dramatically increase the footprint of the ways treatments are available, including Test to Treat, which has been one part of it, as you know.

[Senior administration official]?

SENIOR ADMINISTRATION OFFICIAL:  Yeah, absolutely.  And thanks for the question.  I think, you know, for the second part of your question about whether or not we’re going to expand eligibility, I think it’s really important to clarify that the eligibility in that emergency use authorization, that comes from FDA, in the EUA that they issued. 

And so that’s pretty clear in terms of who’s eligible, specifically for the treatment of mild to moderate COVID in adults or kids older than the age of 12 who have a positive COVID test, and then they have to be at high risk for progression to severe COVID-19. 

And I think what’s important — there’s a full range of conditions.  We’ve had some estimates that up to almost 60 percent of adults who get COVID-19 may be eligible.  This includes things like diabetes, like cardiovascular disease, obesity.  So there’s a full range of conditions that are correlated to, you know, a higher risk of progression of severe COVID-19. 

What’s important to note, though, is that, you know, ostensibly this may feel like an expansion to some folks because a lot of providers early on, in that scarcity mindset when there were fewer — you know, fewer courses available across the country, were really reserving this for only the folks who they thought would be the sickest of the sick.  And that’s why the provider education component, the provider engagement component is so critical of this work. 

It’s making sure that all over the country, in every community, providers know that we’ve got Paxlovid available for their patients, all of whom — any of whom are at risk — or at high risk for progression of severe COVID-19.  We really want them to know that full range of the existing eligibility and make sure that they’re connecting patients to these lifesaving therapeutics.  So, not an expansion of the eligibility but, really, fully taking advantage of who this is meant to benefit.

MR. MUNOZ:  Thank you both.  Let’s go to Peter Sullivan at The Hill.

Q    Hi, thanks.  Two quick ones.  One, there’s also been similar concerns about awareness and availability for Evusheld for immunocompromised people.  Are you going to take any steps — similar steps around that?

And, two, to talk about the funding in Congress: Do you have an update on if you don’t get any more money from Congress, when is your supply of Paxlovid going to run out or have to be cut back?

MR. MUNOZ:  Let’s go to [senior administration official] and [senior administration official] for the first question.

SENIOR ADMINISTRATION OFFICIAL:  Certainly.  And so, Evusheld, you know, very similarly there was more scarcity earlier on.  I think Evusheld is pretty broadly available at this point.  And so there’s a similar thrust that we — that we have to get more and more folks connected. 

We’ve been meeting regularly with provider organizations, with patient organizations.  It’s a narrower group of individuals who are eligible for Evusheld, so it’s specifically for immunocompromised individuals.  And so it creates an opportunity through our deep engagement with providers.

There’s kind of a select group of doctors who disproportionately take care of these patients — these patients who are — who are immunocompromised.  And so, really working closely with them to make sure that they know that Evusheld is available, that they know that they can and should be prescribing it, and they have specific details and updates on the prescribing pattern.  So we continue to do that deep engagement. 

But in terms of supply of Evusheld, I think we’re in a pretty good spot with the supply presently.  But again, you know, that’s not going to last us forever.  And so it’s part of why, you know, we did incorporate our future needs for Evusheld into our request of Congress. 

And I’ll pass it to [senior administration official] for any additions there.

SENIOR ADMINISTRATION OFFICIAL:  Yeah, I would just add, on that point on the Evusheld, that we did purchase 1.7 million courses of this treatment.  But we know that without further funding from Congress, we will not be able to purchase more.  And we know that as adoption increases and usage increases here, it’s something that is very important. 

As you know, Evusheld is a really nice complement to vaccination and boosting for those that may not generate a strong immune response to vaccines.  And so it’s a really important tool in our toolkit here, and so we do need to make sure that we get additional funding from Congress to make sure that we can continue to have our supply available there.

SENIOR ADMINISTRATION OFFICIAL:  And — it’s [senior administration official] — on the second — was it the second question or the first one?  The second question.  

Regarding funding, you know, just to echo what [senior administration official] just said, you know, we currently have the funds to buy — or we’re in the process of buying 20 million pills of Paxlovid.  You know, we have sufficient funding to secure these treatments.  And what I think we’re really worried about going forward are future treatments.  And so we need funding from Congress to secure the essential needs for treatments going forwards.

MR. MUNOZ:  All right.  Next question.  Let’s go to Cheyenne Haslett at ABC News.

Q    Thank you.  Hi.  So, we’re talking about how many courses are going out each week.  How many courses of Paxlovid are available each week to the pharmacies?  And what’s that going to be increasing to?  Just for sort of, like, some context on how many courses that is — that are going out to people.

And then, on Test to Treat, putting this pill in more pharmacies, that doesn’t necessarily mean that more pharmacies will have the people that are able to prescribe them, right? That whole issue of Test to Treat and it not being able to happen in every single pharmacy; it’s more like CVS MinuteClinic.

SENIOR ADMINISTRATION OFFICIAL:  Yeah, Cheyenne, I can chime in on this one.

So, on the first question about how many courses of Paxlovid are available to pharmacies, my understanding is — and we can follow up with more details of — when I check.  But my understanding is we’re — we’ll be making — HCORE will be making a tranche of the 100,000 courses available through the pharmacy channel at first and — to the specific pharmacy channel at first, and we’ll continue to monitor demand and uptake there and, you know, adjust accordingly. 

Going forward, as we mentioned, we’re not really in a supply-constrained posture right now.

On number two, yes, the expansion of sites — the pharmacies that will be dispensing — it is not the case that all of those pharmacies are also Test to Treat sites because, as you mentioned, under the scope of the emergency use authorization, they must be prescribed by a licensed provider.  That’s why it’s so important that we continue to engage with physicians and doctors and others that can prescribe these treatments, as well as working with states and jurisdictions to stand up additional sort of one-stop-shop Test to Treat sites.

We know that a lot of states have been doing this, and we’re really encouraged by that.  I think we want to redouble our efforts and make sure that they have all the federal supports available so that they can stand up additional sites that would be sort of the more traditional one-stop shopping that we think of as Test to Treat.

[Senior administration official]?

SENIOR ADMINISTRATION OFFICIAL:  Yeah, this is [senior administration official].  So, just to add on to that, one important dynamic here: Remember that Test to Treat — the whole purpose of that initiative is to really compress that all the steps that need to be taken. 

For Paxlovid specifically, you’ve got about six steps that have to be completed in five days’ time.  You have to, you know, develop COVID symptoms, you have to subsequently get a test for COVID-19, get the result of that test, find and go to see a provider, get a prescription, and then fill that prescription.  That’s six steps, five days.

What Test to Treat allows us to do is really compress that into a shorter amount of time.  And, you know, from — from an equity standpoint, that’s really critical because we know that there are 25 percent of Americans who don’t have a usual source of care, so being able to go to a space that eliminates that step of finding that provider, that becomes so important.

But we don’t ignore the fact that there are 75 percent of folks who do have a usual source of care.  And we want to encourage them to reach out to their providers — you know, especially if they’re able to get in and see them quickly — to see their provider.  That’s going to help them navigate some of the nuances of what is a new medication for them and make sure that they have that opportunity to have those conversations and subsequently get that prescription filled at one of the participating pharmacies.

So, the two work in concert.  They’re a good complement, having Test to Treat sites and having broad availability across pharmacies.  And it helps us cover much more ground.  And that’s a large part of what equity is about.  It’s about making sure there’s broad access, broad availability.  And I think that’s what we’re aiming to expand even more so through these steps today.

MR. MUNOZ:  All right.  We have time for two more questions.  Let’s go to David Lim at Politico.

Q    Hey.  Thanks for taking my question.  I wanted to loop back around to provider education for the indicated population of Paxlovid again.  I know the EUA is for people older than 12, at high risk of progressing to severe COVID-19. 

There’s a lot of anecdotal evidence that many providers are mainly prescribing to older adults.  And like Hannah said, there’s kind of a lack of hard data on this. 

Should more Americans, especially those seeking treatment at pharmacy clinics they don’t have a medical history with, be receiving these antivirals?  Is it the administration’s perspective that doctors aren’t diagnosing — or, excuse me, aren’t prescribing the drug to as many people as should be receiving it?

MR. MUNOZ:  [Senior administration official], [senior administration official] do you guys want to go?

SENIOR ADMINISTRATION OFFICIAL:  Yeah, I can — I can start here.  I think that, you know, that it’s pretty clear from the uptake of Paxlovid that — and the rate of hospitalizations and deaths over the months that Paxlovid has been available that there are still some folks who could have benefited from these medications. 

So, we certainly know that there — there’s more room to go.  We can save more lives by getting this medication to more people. 

Always, you know, we want to make sure that we’re connecting people in a way that serves them the best.  And I think for a large percentage of folks, that’s going to be going through their own provider, someone who’s familiar with their health history, who’s familiar with their medications, and make sure that they can navigate appropriately. 

For other folks who don’t have that usual source of care, I think we also have the opportunity to connect them in a way that’s safe and effective with an appropriate prescriber.  And so, I think that when you put those together — yes, we do think that there are additional folks. 

You mentioned the anecdote of folks — early on, kind of limiting this to the folks who are older and potentially at risk of getting sicker.  And we believe that some providers were making that decision, because we’ve had experience with pandemic before of operating in a scarcity mindset, of thinking we’ve got this really limited resource so I can only give it to my patients who are the absolute sickest. 

And one thing that we’ve worked hard to do in recent weeks and even more so through these steps is to really drive home that we’ve got enough Paxlovid for patients who meet the criteria under the EUA.  And that’s the full range of those patients. 

Again, we can save more lives if we extract the full benefits of who this medication is meant to benefit — or meant to help prevent, you know, death.  And so that’s the idea here.  It’s really, you know, getting as much mileage out of this as we can and, you know, do so as safely as we can at the same time. 

But, [senior administration official], anything to add?

SENIOR ADMINISTRATION OFFICIAL:  No, I think you covered it.  The only thing I would sort of say is that, you know, the nuances involved in prescribing antiviral treatments is obviously a lot different than vaccines — right? — where we know there’s a large, massive group of people for whom vaccines will maximally benefit, and you can sort of target all of your efforts and outreach efforts and engagement efforts accordingly. 

I think we need to be and have been more nuanced with this one, and that’s why provider education can become so important. 

But I think as [senior administration official] mentioned, the opportunity we have now by having significantly more supply cannot be understated.  And so, we do want to make sure that providers are no longer proceeding from the assumption that we don’t have enough, because we do.  And so we want to make sure that they can make it available to all the patients that would benefit. 

We know that there are drug-to-drug interactions and various contraindications that they work through, but we’re hopeful that part of our efforts can start to drive more awareness that this can benefit a lot of people.

Q    And one quick follow-up.  Can you quantify how big of an issue inappropriate prescribing of antibiotics and steroids has been?  I know that the CDC put out that advisory.

SENIOR ADMINISTRATION OFFICIAL:  I’m not in a position to comment on that, but we can look into it.

MR. MUNOZ:  All right, next question.  Let’s go to Josh Wingrove.

Q    Hi there.  Thank you for doing this.  And I have a question for [senior administration official].  Congratulations on your new post.  This one, I guess, relates to your new and former post about that Paxlovid order. 

You said earlier on the call that it is a committed order of 20 million courses, but you also indicated that there is enough money now that you (inaudible) that.  There’s been some reporting to the contrary — that the new funding request is needed in order to finalize that order.  In particular, the White House has told Congress, quote, “HHS plans to” — sorry — “plans to use $5 billion to secure additional courses of antivirals from Pfizer.” 

Are you referring there to expanding the order beyond the 20 million?  Or do you need the new money to finish the order of the 20 million?  And if it’s the latter, are we correct in understanding that if Congress doesn’t give you any more money, that that 20 million may not come in full?  Thank you very much. 

SENIOR ADMINISTRATION OFFICIAL:  Hi.  Thank you.  We have sufficient funding to secure the treatments we have committed to purchase to date.

MODERATOR:  All right.  Well, thanks —

Q    So what is the $5 billion referring to?  When it says HHS plans to use $5 billion to secure additional courses of antivirals, are you talking about a new order or are you talking about finishing off the one you already have?

SENIOR ADMINISTRATION OFFICIAL:  We’re talking about the 20 million that we’ve already committed to purchase. 

MODERATOR:  Thank you, everybody, for joining.  As a reminder, all of this is embargoed until 5:00 a.m. tomorrow and attributable to senior administration officials.

Thanks for joining us on a Monday night.  Have a good night.

6:32 P.M. EDT

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