In Israel, Pfizer’s COVID drug faces critical obstacle

Less than three weeks after it arrived in Israel and at a time when the infection numbers have broken records, only about 2,800 high-risk coronavirus patients have received the drug Paxlovid for the prevention of severe illness.

The medication is supposed to save many lives and relieve the pressure on hospitals, but getting it to the patients who need and qualify for it is turning out to be a complex challenge with many limitations, both medical and administrative. The health maintenance organizations face complex challenges in administering the drug and high levels of patient refusal to take it.

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Developed by Pfizer and administered as a tablet, Paxlovid’s efficacy in preventing severe illness is estimated at 89 percent, according to the company. For Israel, it promised to be an important tool for preventing severe illness and saving lives as it wrestles with the fifth wave of COVID. “The medications are arriving at exactly the critical point in time. Right now, we are going into the peak of the wave, so I am very glad it is arriving now,” Prime Minister Naftali Bennett said when the first shipment of the drug arrived on December 30.

In practice, the situation is more complex. The window of time during which the drug is effective is narrow – up to five days after infection, and preferably within 72 hours, especially in a situation of widespread infection. That requires identifying the suitable patients and contacting them quickly.

Moreover, prescribing the medication requires a thorough review of the patient’s medical history and list of other medications he or she is taking, as well as an evaluation of each patient’s risk of becoming severely ill.

That is because Paxlovid can’t be taken together with many drugs prescribed for chronic conditions. In some cases, it’s impossible for the patient to get Paxlovid at all; in others, the patient must temporarily stop taking his or her regular medications. Other patients require close monitoring, for example, those who suffer from problems of liver and kidney function.

The list of drugs that for which there is a contraindication to Paxlovid or require close monitoring is long, including those for high blood pressure, anticoagulants, statins (for lowering cholesterol), painkillers of various sorts, steroids, a host of cancer treatments. All these require doctors to consider carefully whether to give Paxlovid at all.

Even the Magen Avot VeImahot program for protecting the residents of geriatric facilities, which covers about 100,000 elderly people, is in no hurry to give the medication to coronavirus patients.

“The main difficultly is finding sufficiently symptomatic patients who aren’t taking piles of other drugs with interactions that are liable to be dangerous. Fortunately, the omicron variant is turning out to be very mild in older people who are vaccinated, so most of the elderly, after an examination, aren’t found to need the treatment,” says Prof. Nimrod Maimon, who heads the nursing home program.

Patients who are found to be suitable candidates must take the drug within five days after becoming infected or showing the first appearance of symptoms. The HMOs are supposed to deliver the drugs to the homes of the patients, but some of them are having difficulty doing this. As a result, they have asked the Health Ministry to allow a family member to pick up the medication.

Paxlovid, a Pfizer's coronavirus pill, manufactured in Freiburg, Germany
PFIZER/ REUTERS

“The difficulty is on the logistical side,” says Haim Fernandes, CFO of the Leumit Health Fund. “After we locate a suitable patient according to a model that weighs all the demographic data and the individual’s medical condition, we have to make contact, carry out the medical review and get the patient’s consent – and then bring the medication to the patient quickly. Starting the treatment quickly is critical for success. This means we need to be able to get to every home in Israel quickly. It’s a complex logistical matter.”

The ministry says it is not opposed to family pickup, but prefers that Paxlovid be delivered to the user. “It is the HMO’s prerogative to decide how to distribute the drug to patients who are entitled to it. The Health Ministry prefers that the medication be sent to the patient’s home, and we are acting to make the conditions for transporting the drug easier,” a spokesman said.

At-risk groups include, among others, immunosuppressed individuals, people who suffer from diabetes, high blood pressure or obesity, patients who have not been vaccinated or whose vaccination is out of date, and people who have been hospitalized in recent years. However, each HMO has formulated its own algorithm-based model that weighs the data and assigns points to the patient in slightly different ways.

But that doesn’t mean all candidate patients agree to take it.

“There’s excess demand for the drug. We give it in accordance with risk-factor criteria. We have a distribution model for degrees of risk from which we contact those at the highest levels. About 30 percent of them don’t want the treatment. On the other hand, there are many people who call to ask for it but don’t meet the criteria and are turned down. For the State of Israel, this is a scarce resource,” says Dr. Doron Netzer, head of medicine in the community division of Clalit Health Services.

At Maccabi Healthcare Services the rate of refusal among suitable patients is 25 percent, mostly due to fear of side effects or contraindication to other medications.

In principle, the drug is intended for use in the community, but it has sometimes also been used at hospitals, for example, when a person is hospitalized for reasons other than the coronavirus or has tested positive during an unrelated stay in the hospital.

Pfizer's coronavirus Paxlovid pills
thomas hansmann.fotograf /AP

“The medication is mainly for use in the community. I have used it at the hospital a number of times, but in some of the cases I have given a referral for dispensing the drug in the community,” says Prof. Dror Mevorach, director of the coronavirus unit at Hadassah Ein Kerem Medical Center. “Each HMO has organized slightly differently and with slightly different criteria. For some it is working well and for some less so. There are also limitations to the medication, and there are situations in which it isn’t recommended to give it, such as inadequate liver function and interactions with other medications, especially blood pressure drugs. Another thing is that the clinical trials of the drug relate to non-vaccinated patients, and we don’t yet know for sure how the drug will affect people who have been vaccinated.”

A survey released on Monday by Maccabi found that 74 percent of its patients who took the medication felt improvement after the treatment. Another 25 percent felt no change and only 1 percent felt worse. About 850 patients belonging to Maccabi have been treated with Paxlovid thus far, but it must be stressed that the survey was based on a sample of only 85 of them.

The survey found that 88 percent of the patients who had the drug delivered to their homes did not suffer any side effects during the course of the treatment. Most of the side effects reported were a bitter, metallic taste (33 percent), diarrhea (18 percent), loss of taste and smell (11 percent), as well as muscle pains (7 percent) and headaches (4 percent).

Of those who felt an improvement, 60 percent felt relief within 24 hours. The relief was manifested mainly in feeling better overall and by a drop in fever, easing of headaches and less coughing. Of those who felt relief, 92 percent felt it within three days. Maccabi also noted that none of its patients who have been treated with the drug has been hospitalized thus far either during the treatment or afterwards.

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