Barriers to Paxlovid are exacerbating our health inequities

In Canada, access to Paxlovid, a treatment for mild to moderate COVID-19 infection, has become increasingly challenging, with dwindling stock, significant shortages and concerns about affordability since the end of the federal program last April.

In almost all provinces, eligibility criteria have narrowed significantly; in some, even adults between the ages of 60-77 and living in congregate settings do not qualify. Further, most provinces have downloaded the cost of the drug – at $1,500 – to patients. For instance, in Ontario, the cost of Paxlovid is only covered for those who qualify for the Ontario or Trillium Drug Benefit program after they meet eligibility criteria. Those without private insurance or part of a public drug program must pay out of pocket, even if they meet the eligibility criteria as set forth by provincial health guidelines

Critics say these barriers to access are driven by data – but are they? Let’s examine recent data to determine whether Paxlovid offers discernable benefits and, if so, to whom.

Paxlovid is an antiviral drug that consists of a protease inhibitor nirmatrelvir and is co-administrated with a low dose of ritonavir, another antiviral drug that is typically used in combination with other drugs to treat HIV. In a Phase 2-3 randomized, double-blind, placebo-controlled trial in non-hospitalized symptomatic adult patients with SARS-CoV-2 infection and with at least one risk factor for severe disease, there was an 89 per cent reduction in COVID-19-related hospitalization or death from any cause compared to a placebo.

However, questions on its effectiveness in otherwise vaccinated and not at high risk for severe disease remained. A subsequent Phase 2-3 clinical trial included individuals who were: fully vaccinated; fully vaccinated and who had at least one risk factor for severe disease; and, unvaccinated but did not have any risk factors for severe disease. This study was stopped since there were no significant time differences in symptom alleviation between the Paxlovid groups and the placebo group.

In our haste in judging the primary endpoint as a wash, some key aspects of the study have been overlooked. Specifically, there was an obvious benefit in the high-risk group sub analysis when it came to a decrease in hospitalization and risk of death (0.9 per cent in the nirmaltrelvir-ritonavir group vs. 2.2 per cent in the placebo group; 95 per cent CI, −3.3 to 0.7). While the study included 1,296 participants, fewer than 50 per cent were considered to have at least one risk factor for severe illness, resulting in small participant size in the sub analysis. A larger study would be better able to quantify what this benefit would be, and further tease out which subpopulations would most benefit. Secondly, the median age in the nirmaltrelvir-ritonavir group was 41 years. Recognizing that older age is a considerable risk factor for SARS-CoV-2 related health outcomes, this study simply did not include participants who would most benefit from the drug.

In addition, COVID-19-related medical visits for high-risk participants were drastically reduced among the nirmatrelvir-ritonavir group – six compared with 26 in the placebo group. For those hospitalized, the hospital stay was substantially shorter among the nirmatrelvir-ritonavir group, with five being the mean number of days in the hospital per 100 participants compared to 18 in the placebo group. In a time of stretched health-care resources, reduced medical visits and hospital stays make good policy.

Thus, a study originally targeted to individuals at lower risk for severe outcomes from COVID-19 infection has been used to influence policy for high-risk populations. To make funding and eligibility decisions based on a trial that did not include the most vulnerable seems to be a policy that is, at best, not evidence-based and, at worst, inequitable.

We know from the past five years that COVID-19 is a disease that disproportionately impacts those from marginalized communities. In the U.S., data from the Centres for Disease Control and Prevention shows that dispensing rates for Paxlovid were lowest in high-vulnerability zip codes. Similar data exists in Australia, with those living in the most disadvantaged areas being 15 per cent less likely to receive Paxlovid.

Canada needs to do a better job at making Paxlovid more accessible to those who would benefit most, including people who are older or immunocompromised, with factors that put them at a higher risk for severe COVID-19 outcomes. This has become even more critical due to a lacklustre uptake of the COVID-19 boosters, resulting in an increasingly under-vaccinated population.

To do any less further exacerbates our existing health inequities.

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Sabina Vohra-Miller is the co-founder of the Toronto-based Vohra Miller Foundation, which aims to improve the health of the planet and its people.

This article was originally published in Healthy Debate.