'Paxlovid reduces the risk of deaths in high-risk groups'

'Should be prescribed to even those with mild symptoms '

Pfizer Korea holds a press conference to celebrate the official approval of Paxlovid

“Used to prevent severe disease, not to treat symptoms.... patients with high-risk factors should use Paxlovid”

May be switched to a private system in 2H...”is currently discussing reimbursement listing with the health authorities”

‘Paxlovid,’ the oral COVID-19 treatment used to prevent progression to severe COVID-19, has finally removed its ‘temporary’ approval tag, 1 year and 7 months after its introduction to Korea.

 

Although the drug has now been officially approved as a new drug, it is still not being well utilized on-site.

 

Therefore, whether the misunderstandings and misconceptions regarding the drug can be cleared and be actively prescribed to patients by HCPs is gaining attention.

 

The Ministry of Food and Drug Safety officially approved Pfizer’s COVID-19 treatment ‘Paxlovid (nirmatrelvir ritonavir tablets)’ on the 14th.

 

The approval comes 1 year and 7 months after the company had received the emergency use approval (EUA) in December 2021.

 

Paxlovid’s official approval was based on data from the Phase 2/3 EPIC-HR and EPIC-SR studies.

 

The EPIC-HR study enrolled unvaccinated, non-hospitalized adults, aged 18 years and older, with confirmed COVID-19 who were at increased risk of progressing to severe disease.

 

Results showed an 86% reduction in risk of COVID-19-related hospitalization or death from any cause through Day 28 in patients who initiated treatment with Paxlovid within 5 days of symptoms onset, compared to placebo.

 

Recent real-world studies further support Paxlovid’s effect.

 

According to a real-world study, the relative risk reduction effect of Paxlovid was confirmed in all high-risk patients regardless of whether they had been vaccinated or not.

 

Based on this, the U.S.

 

Food and Drug Administration (FDA) estimated in March that taking Paxlovid ‘could lead to 1,500 lives saved and 13,000 hospitalizations averted each week” in the U.S.’ Despite such supporting data, Paxlovid is not well used in Korea.

 

The government and the company had carried out extensive promotional and education activities, but the prescription rate of Paxlovid in elderly patients remains in the 30% range, unable to break the 40% wall.

 

Pfizer Korea Eun-Ji Kim, (COVID-19 Marketing Lead), and Hyemin Oh (Policy & Public Affairs Lead), Jae-Yoon Ryu, (Medical Sr.

 

Manager), and Hyemin Oh (Policy & Public Affairs Lead) (Source: Pfizer Korea)

On the 24th, Pfizer Korea held a meeting to celebrate the official approval of Paxlovid at its headquarters in Jung-gu, Seoul.

 

Jae-Yoon Ryu, (Medical Sr.

 

Manager) Eun-Ji Kim, (COVID-19 Marketing Lead), and Hyemin Oh (Policy & Public Affairs Lead) attended the event to correct the misunderstandings and explain the truth about Paxlovid.

 

At the same time, the members shared the company’s plans on transitioning Paxlovid into a general medical system.

 

The following are the common misunderstandings and truths about Paxlovid that were addressed at the event.

 

# Misunderstanding 1: Paxlovid can only be used on patients with severe symptoms = Paxlovid’s is indicated for ‘the treatment of patients with mild-to-moderate COVID-19 whose condition is at high risk of progressing to severe disease, including hospitalization or death.’ However, in the field, there remains a strong impression that Paxlovid should only be used on patients whose conditions are so severe that they should be transferred to general hospitals immediately.

 

And symptomatic therapy is still mainly used on high-risk patients with mild symptoms.

 

This misconception is the biggest hurdle to increasing the prescription rate of Paxlovid in the high-risk group.

 

To be clear, Paxlovid is not a symptomatic treatment- the drug was approved based on its evidence in preventing severe disease, in lowering the risk of serious illness and death in high-risk patients.

 

Although the symptoms are getting milder with the mutation of the COVID-19 virus, the disease burden is still high and about 10 people still die from worsening COVID-19 every day.

 

Even if the symptoms are mild, if you have any of the high-risk factors, you need to be prescribed Paxlovid.

 

# Misunderstanding 2: Elderly patients that take many medications cannot use Paxlovid due to contraindications = That is one reason why patients find it difficult to receive Paxlovid prescriptions - Paxloivd has too many contraindications.

 

Doctors avoid prescribing Paxlovid if a patient says they take other medications.

 

26 drug ingredients are known to be dangerous or are not allowed to be used in combination with Paxlovid.

 

However, just the fact that you are using one of the 26 ingredients does not forbid your use of Paxlovid.

 

Those who use 19 of the 26 ingredients can use Paxlovid if they discontinue use of their respective drugs or receive alternative medications.

 

Paxlovid’s use is contraindicated only for the other 7 ingredients.

 

# Misunderstanding 3: The drug is difficult to use as it is cumbersome to check all the contraindicated drugs = In Korea, HCPs can use the Drug Utilization Review (DUR) program to check for contraindications of each ingredient.

 

If the doctor wants to use Paxlovid, Korea has a system in place that allows doctors to quickly check for contraindications.

 

Of course, some ingredients like St.

 

John’s Wort that are nutritional supplements are not listed in the DUR and have to be checked separately.

 

However, most of the prescription drug ingredients can be checked automatically with DUR, and we have been distributing medication guides for pharmacists, educational material, and use guides for the elderly.

 

We are also contemplating ways to increase patient convenience.

 

For example, if patients need to be prescribed alternative medications, they have to pick through all of the medications they take to replace the ones in need.

 

And they need to visit the pharmacy to do this.

 

So we are trying to find ways to make it easier for patients to take alternate medications safely.

 

# Misunderstanding 4: Paxlovid’s emergency use status will be converted and be subject to the general medical system in the first half of next year =Currently, the Korean government purchases Paxlovid in advance and supplies it free of charge to patients in need.

 

We are discussing when this system should be converted into a general medical system.

 

Please understand that there are still a lot of government purchases left, and we need to undergo the reimbursement process, therefore, it is not clear how its use will be converted to the private sector and whether there will be an overlapping period.

 

However, the government and the company are continuing close discussions so that patients who need the drug do not experience inconvenience in the middle.

 

It is not ordinary for a drug that is approved just now to be registered in the first half of next year.

 

We will be going through all the procedures that existing new drugs go through, but are negotiating on the timeline for quicker listing.

 

The company is doing its best to submit the data required for listing to the government in a timely manner.