Is it time to expand access to Paxlovid, the treatment that reduces symptoms, risk of hospitalization and risk of death from COVID-19?
Some health professionals believe so, now that the treatment is available in sufficient quantities, but that the prescription criteria remain very restrictive.
“I think we are being too cautious,” says microbiologist Karl Weiss, an infectious disease specialist at the Jewish General Hospital in Montreal, in an interview with The Canadian Press.
“I prescribed a lot of Paxlovid to a lot of people. Of course patients at risk, ”he says, but also to others who did not necessarily meet the criteria established by the National Institute of Excellence in Health and Social Services (INESSS).
“I sometimes prescribed it to people who did not meet the criteria, but who, in my opinion, had clinically severe criteria, because they were doubly vaccinated but they had other important factors and then they were sick. I said to myself: I had better treat them before they come to the emergency room,” he admits candidly.
Very restrictive criteria
In Quebec, the directives of the Ministry of Health and Social Services (MSSS) limit treatment to certain very restricted groups of patients. These guidelines were established based on criteria established by the National Institute of Excellence in Health and Social Services (INESSS).
Approved by Health Canada last January and delivered in miniscule quantities – 6,000 treatments for all of Quebec initially – Paxlovid was initially authorized only for immunosuppressed people and non-vaccinated people who presented risk factors for complications. These criteria had been widened slightly in February and again in March, but have not changed since.
“It’s normal that at the beginning, there was first a limit on the quantity of drugs that were available. There was also an unknown on the part of many doctors about the ability to use the drug,” says Dr. Weiss. Also, he notes that even INESSS has given some leeway to prescribe to people who fall outside the criteria, but who may seem at risk according to the doctor’s clinical judgment.
“There is a certain code that we can put that allows us to prescribe the drug. There is still some leeway. INESSS was correct on that,” he says.
Criteria retained by the MSSS
115,000 doses received in Quebec
The question of available quantities, for its part, can no longer be raised. A check with the MSSS tells us that Quebec has so far received 115,000 Paxlovid treatments and that only 14,900 have been dispensed in pharmacies.
In an email to The Canadian Press, the MSSS adds that to this number “are added the treatments used directly in health establishments. In this regard, we do not have data on Paxlovid treatments served or used in healthcare settings.”
Although he does not want to risk giving an absolute figure, Karl Weiss nevertheless asserts that the establishments certainly did not come close to exhausting the stocks.
“It’s definitely a few thousand treatments. But even if you get to 20,000, you see we still have a lot of room to manoeuvre,” he says, referring to the 115,000 treatments received.
Pharmacists follow INESSS
Benoit Morin, president of the Association of Proprietary Pharmacists of Quebec (APPQ), explains that pharmacists, who now have the right to prescribe Paxlovid themselves, are sticking to the directives of the INESSS.
“We have an organization chart drawn up by INESSS that we must respect and which reflects these exclusions. Yes, that means that there are a lot of people who would like it and who don’t have it, ”he admits.
Benoit Morin does not hide, however, that he is eager to see new data on Paxlovid.
“Some people need to be collected on the risks, the side effects, to see if we can’t reduce these restrictions and increase the target audience, because if it’s ever a very safe treatment, people could benefit from it, that’s for sure.
“Could, for example, elderly people who have been vaccinated, but who develop less immunity to the vaccine, be able to benefit from it? That’s what the data will tell us. »
“There is no turning back”
He cautions, however, to avoid pushing too hard too fast because, when it comes to getting new treatments approved, it’s always hard to get the toothpaste back in the tube.
“Before giving the go, you need to have more solid data because there is no going back afterwards. When you let it go and you take risks, if something happens, on a large scale, it can be dramatic,” says Mr. Morin.
Dr. Weiss, for his part, believes, however, that much of the current caution is based less on a lack of data than on raised fears because Paxlovid is a treatment that relies on the combined use of two drugs. generics, nirmatrelvir and ritonavir.
“Because it has two drugs, it can have drug interactions that have been greatly magnified in nature. People like me who treat patients who have HIV have been using ritonavir for over 20 years, 25 years, and honestly, drug interactions with ritonavir, who cares.
“They are very limited. They are very manageable and that is not a problem. But, it was presented as something very complex, which discouraged many people and therefore the implementation to start using the drug was difficult. It was a bit laborious, ”he laments.
Expanded criteria in the United States
Moreover, in the case of certain expected data, such as the example mentioned by Benoit Morin of giving Paxlovid to elderly people who have been adequately vaccinated, the data is already conclusive in the United States, where the treatment is prescribed to anyone aged 65 and over, regardless of their vaccination status or the presence of comorbidities.
“Could we do the same thing in Quebec, asks Mr. Morin? If the data is solid, I would say yes, but we are at that stage. I want it because the more we can use it, the better. And the benefits, even for people who don’t go to the hospital but are very sick, at some point, it could be used for those people. »
Karl Weiss believes that this is precisely where we must look, on the side of trials with populations for whom fears of serious consequences are less.
“For example, if you are not someone at risk, I will not treat you to prevent you from being hospitalized because you will not be very sick anyway. On the other hand, if I treat you and, instead of being sick for eight days, you are sick for two and instead of being infectious for seven days, you are infectious for three, there is a societal impact ”, he argues.
These are the studies that are impatiently awaited by the medical community, as well as those on “a dozen other treatments that are in the pipeline”, explains Dr. Weiss.
“Cost doesn’t matter”
Some have cited the cost of Paxlovid’s treatment, which hovers around $900, as a barrier to wider use, a claim Weiss brushes aside.
“Cost doesn’t matter. I will be honest with you: if we save a hospitalization, in the context of our current health care system, if we are able to save a hospitalization, the cost really does not matter. It’s not a problem,” he says.
What does INESSS say about a possible broadening of its criteria?
“INESSS updated its tool on the optimal use of Paxlovid in April 2022. For the moment, INESSS’ position remains the same as in April. However, INESSS remains on the lookout for new data or new studies related to COVID-19. If necessary, INESSS will update its clinical tool, as for all assessments related to COVID,” we wrote in a terse email in response to our requests.
As for the professional orders, we avoid getting wet on the issue: both the Order of Pharmacists and the College of Physicians have taken refuge behind the expertise of INESSS when questioned on the subject.
Benoit Morin, who reiterates the obligation to respect the criteria proposed to him, nevertheless goes forward to say that “for me, at first sight, it seems promising in the sense that the risks, the side effects are not major versus the effectiveness that it demonstrates. I’m confident that yes, we’re going to come to (an extension of the criteria), but we need convincing data. »
A learning curve to overcome
Karl Weiss, he believes that it is the use that the criteria will be expanded.
“INESSS is a guide. As we say in English, these are “guidelines” (guidelines), not “godlines” (proclamation of God). Practical practice, it is ultimately up to the doctor to have the ultimate decision, because you are responsible for your patient.
“The rub is when people go to see doctors who are unfamiliar with prescribing this drug or who don’t have the clinical experience to prescribe it. This is where the problem is, rather than anything else. There are people in whom, sometimes, it is worth treating them, because they are people who are at risk. Now there is no longer a problem with the supply of Paxlovid, so it is no longer a problem to administer it.
“I think it’s a learning curve thing. The more we learn, the more people will become comfortable. It will be interesting to see the situation in a year. There we are quietly educating family doctors to get used to prescribing the molecule. When they have prescribed twice, three times, four times, they will see that it is going well and will become more and more ready to prescribe it. »