Nobody in Israel’s healthcare system anticipated this scenario: Many at-risk COVID patients who are candidates to receive the drug Regeneron have refused to take it since the health maintenance organizations began offering it on September 23. It’s been administered to only 256 patients so far, with 291 declining it.
The medication, which costs $1,500 dollars per patient, is given intravenously, and according to studies it reduces the risk of severe illness substantially if it’s given within 72 hours of infection. The drug made headlines last year when it was given to former U.S. President Donald Trump, who was diagnosed with COVID-19. About a month later it was FDA-approved for emergency use.
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Until recently the drug was administered in Israel mainly to inpatients at hospitals and geriatric facilities. But since September 23 its use was expanded through the HMOs.
The Health Ministry designated the expensive medication as a limited national asset and feared excessive demand by patients, particularly ones who don’t meet the criteria. A letter by ministry director general Nachman Ash to the HMOs requested that clearly defined criteria be drawn up as to who is eligible for the drug, and that professional committees be formed in each fund to consider exceptional requests by patients who do not meet all the clinical criteria. Noting the shortage of the drug which he called “a national asset,” Ash wrote that “all steps must be taken to prevent waste and destruction of doses or administering doses to those who do not meet the criteria.”
Accordingly, the HMOs set criteria based on the patient’s age, number of hospitalizations in the past three years, vaccination status, and whether they had chronic conditions such as kidney disease, diabetes and coronary disease, among others, or were heavy smokers or suffering from immunosuppression. Each criterion is worth so many points, and if the patients “scores” seven points – they are eligible for the drug. Non-vaccination is worth five points and is the heaviest-weighted criterion. The HMOs prepared for rapid deployment of the drug. In addition, IDF Medical Corps teams were called up to help the HMOs deliver the drugs to home-bound patients, and the very day the Health Ministry announced expansion of the drug’s use, the HMOs began approaching prospective patients.
But it turns out that demand is very low and the HMOs find themselves urging patients to take a drug meant to protect them from severe illness.
“We’ve administered the drug to over 140 patients so far, mostly in patients’ homes all over the country, with Medical Corps aid,” says Dr. Doron Netzer, head of medicine in the community division of Clalit Health Services. Netzer tells Haaretz that the entire process at the patient’s home, including the infusion (which takes about 20 minutes) and observation afterwards, lasts 90 minutes to two hours. Netzer’s teams contact COVID-19 patients who have risk factors for serious disease and explain the importance of taking the medication. But to his surprise, a substantial number refuse. This includes many who are not vaccinated and are therefore at greater risk for serious illness and are also eligible for the costly drug.
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“Another group of ‘Regeneron refusers’ are those whose condition is mild and who feel well and do not sense the danger. It’s human and understandable, but they have a 20-25 percent risk of developing severe illness, and we can’t persuade them [to take the drug],” he says. Others express willingness, make an appointment, and then renege at the last moment – often due to consultation with friends and family. “It’s their right. It’s a novel treatment that is undoubtedly the best available right now, but there’s still distrust among some patients,” says Netzer.
Criteria being eased
A senior figure at another HMO tells Haaretz, “We’re investing a lot in Regeneron, but we have four times as many refusals as takers. On one hand we were surprised. On the other – why would someone who declined the vaccination take a drug? If at first we thought we’d have to ration it, now we’re easing criteria and giving it to willing patients even if they don’t fully meet criteria.”
The drug is manufactured by U.S. firm Regeneron under the trademark REGEN-COV. It made headlines last year, when it was given to former U.S. President Donald Trump, who was diagnosed with COVID-19. About a month later it was FDA-approved for emergency use.
Since approval, a study published in The New England Journal of Medicine showed efficacy of 81 percent in preventing symptomatic illness, and 66 percent in preventing contagion among those living with confirmed patients. In addition, duration of symptoms among those who were infected was shorter by half compared to those who did not receive the drug.
Regeneron contains two antibodies – Casirivimab and Imdevimab – which adhere to the viral envelope of the coronavirus and disrupt its ability to penetrate the cell and replicate itself.
Company studies showed it to be 70 percent effective in preventing severe illness among non-admitted patients when given within 72 hours of infection – as long as it is given close to the appearance of symptoms, and not after deterioration has begun. Studies have found next to no side effects except for an allergic reaction or local bleeding and swelling related to the injection itself.