The Food and Drug Administration’s (FDA’s) emergency use authorization (EUA) of two new COVID-19 monoclonal antibody treatments could soon bring some welcome relief for the alarming surge in COVID-19 hospitalization rates throughout the country. For the first time since the pandemic began, doctors now have treatments that—if given within the first few days of infection—may prevent some hospitalizations and perhaps even deaths. As indicated by Colette DeJong and colleagues in a recent blog post, these monoclonal antibody therapies are still experimental. Yet, they offer hope, and a potentially important bridge until vaccines are administered on a broad scale. Despite this potential, the vast majority of COVID-19 patients will not be able to access them. For the foreseeable future, the number of patients who may benefit from the treatment will far exceed supply.
This creates a clinical and ethical conundrum: Effective, rational allocation of monoclonal antibodies will require predicting which COVID-19 patients are at highest risk of severe outcomes merely days into their disease course. If we wait to see which patients escalate, we will miss the optimal treatment window. These predictions will necessitate difficult, life-changing decisions based on limited evidence; each decision to provide treatment will be a decision to deny treatment to someone else. The treatment also presents considerable logistical challenges. It must be given as an hour-long infusion, with an additional hour to monitor for adverse reactions, so already overstretched facilities must find the dedicated space and staffing to accommodate this. These challenges are so daunting that, when the federal government began distributing the first shipment of monoclonal antibodies, some institutions considered declining their allotments.
Fortunately, we have every reason to believe that these logistical and ethical challenges are surmountable with continued planning and dialogue. However, one additional consideration has received comparably little attention: the law. Legal restrictions may prevent health systems from prioritizing treatment for the patients who need it most.
Who Should Get Monoclonal Antibody Treatment?
The FDA authorized Eli Lilly’s bamlanivimab on November 9, followed by Regeneron’s REGN-COV2 on November 21, for COVID-19-infected patients with mild or moderate disease who are at high risk for hospitalization or other severe outcomes. Under the EUAs, adults who meet any of a relatively long list of criteria, including being age 65 or older, being obese, or having certain chronic health conditions such as chronic kidney disease, qualify as high risk. Time is of the essence: Treatment must occur within 10 days of symptom onset and ideally as soon as possible after testing positive. Once patients require supplemental oxygen or hospitalization, treatment has not been demonstrated to be beneficial and may, in fact, be harmful.
On a given day, treatment centers might see 1,000 high-risk patients but only have 100 (or far fewer) doses of treatment to administer. Who should get the 100 doses? Are some of those 1,000 patients higher risk than others? States and institutions around the country are currently grappling with these questions, with varied answers. Some have adopted a first-come, first-served approach, while others are prioritizing patients with multiple high-risk factors or specific populations, such as health care workers. Others are not distributing it at all. At present, there is no consistent national approach.
Epidemiologically, however, we know that some key groups have been disproportionately devastated by the disease. For example, we know from multiple studies that COVID-19-infected men have a higher risk of severe outcomes compared to women. In our own research, across more than 66,000 patients hospitalized with COVID-19, we found that men had a higher risk of death in every decade of life. Overall, male sex carried an independent, 30 percent higher risk of death, even when accounting for the many other risk factors, such as hypertension and obesity, that are more common among men. Severe COVID-19 outcomes also continue to affect minority populations disproportionately in the US. Hospitalization and death rates for Black and Hispanic patients with COVID-19 are two to four times higher than the rate for White patients, believed to be due to higher rates of socioeconomic disadvantage and other social inequalities experienced by these groups. Gender, race, and ethnicity, however, are not currently listed in the high-risk criteria for monoclonal antibody treatment.
From a public health and clinical perspective, when allocating treatment among the vast pool of high-risk patients, clinical centers should consider prioritizing monoclonal antibody access for older, male, Black, and Hispanic patients with multiple chronic conditions. Patients, who are informed about the experimental nature of the treatment and who choose to be considered to receive it, could simply complete brief demographic and health questionnaires while being tested for COVID-19. This would both establish treatment eligibility and could be scored through a blinded system to identify priority treatment candidates. Based upon current epidemiological data, and the effectiveness of the treatment, this approach has the potential to maximize lives saved. It could also provide broader societal benefits by preventing the greatest number of hospitalizations, a critical necessity as hospitals around the country reach or exceed capacity. All patients suffer when care is delayed and hospital beds are unavailable.
This approach would not be perfect, and additional tie-breaker methods such as lotteries would still likely be necessary. However, using these risk factors to guide allocation decisions among the large number of eligible patients offers a practical initial roadmap in the coming weeks and months. As more data accrue, a national advisory committee could update risk factors and issue scoring system consensus guidelines.
But Is It Legal?
Such a risk-based scoring method, however, would likely face legal challenges. Section 1557 of the Affordable Care Act (ACA) makes it unlawful for any health care provider who receives funding from the federal government to refuse to treat an individual or to otherwise discriminate against the individual based on race, color, national origin, sex, age, or disability.
When allocating treatment among high-risk patients, prioritizing older patients or those with multiple chronic health conditions (disability) is likely legally permissible under the ACA and other relevant antidiscrimination laws. The Age Discrimination Act of 1975 and its accompanying regulations provide an explicit exception to the prohibition of using age as a basis for differential treatment when age is a proxy for other factors that are impractical to measure on an individual basis. And, neither Section 504 of the Rehabilitation Act, nor the Americans with Disabilities Act, prohibit giving preference to persons with a disability in employment or the allocation of benefits. However, use of race and sex, may be unlawful.
Race
The ACA incorporates the protections of Title VI of the Civil Rights Act of 1964, which prohibits discrimination on the basis of race, color, and national origin. Although the Civil Rights laws were passed to remedy discrimination against minority groups, the laws also prohibit discrimination against majority groups. A scoring system that prioritizes treatment for Black patients could constitute illegal discrimination.
Neither the US Supreme Court nor federal appellate courts have directly considered a case involving race-based distinctions for treatment during a pandemic, but their decisions on affirmative action—dealing with the allocation of limited seats at educational institutions—provide some insights into how the law might be applied to the allocation of scarce medical treatments. In these cases, the US Supreme Court has held that to satisfy Title VI’s protections an institution must show that race-based discrimination is necessary to further a compelling governmental interest and the means used to further that interest are “narrowly tailored.”
In the case of COVID-19 antibody treatments, an allocation scoring system would likely use statistical models to assign points based upon a patient’s race; this is a standard methodological approach for building clinical scoring rules, including for COVID-19. Epidemiologically, such a system’s strength lies in its data-driven objectiveness. However, a scoring system that gave explicit points based on race would likely fail the US Supreme Court’s “narrowly tailored” test. In the alternative, institutions could use other factors, such as socioeconomic status or housing location (for example, ZIP code), as race-neutral proxies. A similar argument was recently advocated by Harald Schmidt and colleagues in a Viewpoint in JAMA, discussing allocation of COVID-19 vaccines. Using these factors to allocate monoclonal antibody treatment would be less efficient, and less evidence-based, than considering race and ethnicity explicitly, but it would also be less open to legal challenge.
Sex
The ACA also incorporates the protections of Title IX of the Education Amendments of 1972, which prohibits discrimination on the basis of sex. Thus, prioritizing men over women for monoclonal antibody treatment would appear to violate the law. However, to satisfy Equal Protection standards, the US Supreme Court has said that gender-based standards are legally permissible if they are substantially related to an important governmental objective, and the Court has upheld such classifications when they were based on real physical differences. Consistent with these cases, the Department of Health and Human Services (HHS) stated that it “has long recognized that the practice of medicine and biomedical research routinely involves decisions and diagnoses that legitimately make distinctions based on sex, including decisions made at triage; research studies (including clinical trials); questions of medical history; and requests for a medical consultation.” There are now compelling data establishing sex-based differences in COVID-19 outcomes, including biologically different immune responses, that may help explain men’s higher risk of severe outcomes and mortality from COVID-19. However, whether these data and the scant legally supportive language would be persuasive to hospital counsel, or a court, for that matter, is not clear.
No Easy Solution
While hospitals and other health care providers may be reluctant to adopt these demographic factors as a basis to distribute limited supplies of monoclonal antibodies, they can expect some protection from the Public Readiness and Emergency Preparedness Act. This legislation authorizes the HHS secretary to limit legal liability for those who administer “countermeasures” during a declared public health emergency. Such countermeasures include vaccines, medical treatments, and devices that the FDA has authorized for emergency use. The protections are broad sweeping and include immunity from individual claims under both state and federal law. The secretary declared a public health emergency in February of this year, triggering the immunity provisions.
Still, health care institutions could face legal action by the Office for Civil Rights. Without assurance that use of race and sex as a basis for allocation of monoclonal antibodies would meet legal standards, we realize health care providers will not take the risk of using these characteristics in their allocation decisions. The situation illustrates the tension between public health and legal priorities—a tension with no easy solution.
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December 24, 2020 at 08:08PM
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Legal Challenges To Allocating New COVID-19 Antibody Therapies To Those Who Need Them Most - Health Affairs
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