Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) (2021) / Chapter Skim
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Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021)
Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021)
Pages 1-34
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Bratcher-Bowman: Attached please find a rapid expert consultation on allocating COVID-19 monoclonal antibody (mAbs) therapies that was prepared by Donald Berwick, Alta Charo, John Hick, and Kent Kester, with the assistance of staff of the National Academies of Sciences, Engineering, and Medicine (the National Academies)
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We believe the models and strategies described in this rapid expert consultation provide insight into the ways to achieve equitable allocation of scarce medical treatments, and we hope it is helpful to responsible officials and clinicians at the federal, state, and local levels. Sincerely, Harvey V
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As outlined in the Statement of Task in Box 1, the standing committee produced this rapid expert consultation to assist decision makers in efforts to fairly and equitably allocate COVID-19 mAb therapies at the state and local levels. Drawing from a public information-gathering workshop held on December 16–17, 2020,9 input from experts, and the published literature, this rapid expert consultation examines ways to achieve equitable allocation of COVID-19 mAb therapies.
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Limited Evidence for Clinical Benefit of COVID-19 Monoclonal Antibody Therapies The limited available evidence about the clinical benefit of COVID-19 mAb therapies, which comes primarily from the Phase II trials with relatively small numbers of participants, suggests that the therapies may reduce hospitalizations when administered early on to patients with mild or moderate symptoms who are at high risk of progression.11 The therapies may also have benefit 10 As this document was being prepared for release, Eli Lilly and Company released preliminary findings by press release that showed bamlanivimab may have a role in reducing COVID-19 infections in nursing home residents as well as staff. Eli Lilly and Company.
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2020. Large clinical trial will test combination monoclonal antibody therapy for mild/moderate COVID19.
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. To guide providers in allocating COVID-19 mAb therapies equitably, more data and evidence will be needed to prioritize patients according to likely clinical benefit, to understand which combinations of risk factors increase a patient's likelihood of poor clinical outcomes, and to remove obstacles that disproportionately reduce demand or access in disadvantaged communities.
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. To better understand the effectiveness of COVID-19 mAb therapies, key questions include the replicability of the initial clinical trials, the impact of treatment on outcomes proportional to the risk of hospitalization, the comparative effectiveness of different COVID-19 mAbs, as well as the optimal dosing and timing.
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Better understanding of the effectiveness of COVID-19 mAb therapies will require a continual learning process to gain more clinical evidence in real time, evaluate whether the treatments are working in the field at levels predicted by the clinical trials, and determine whether the benefits of rolling them out at a large scale are worth the opportunity costs of failing to invest in other means to combat the pandemic. LIMITED SUPPLY, UNCERTAIN DEMAND FOR AND UTILIZATION OF COVID-19 MONOCLONAL ANTIBODY THERAPIES During the public information-gathering workshop, several participants reported that the demand for and utilization of COVID-19 mAbs have been limited.
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Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues. For instance, providers may be reluctant to prescribe, and patients may decline due to the lack of evidence about benefit.
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Establishing these allocation systems will likely yield further benefits for delivering future scarce novel therapeutics granted EUA or FDA approval. Current Federal Allocation Efforts and Guidance Redd remarked that it is incumbent on the USG to use scarce COVID-19 mAb therapies that it has procured in a way that is transparent, equitable, fair, and understandable to its citizens.33,34,35 He outlined four foundational principles for federal allocation of scarce resources.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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Developing common, evidence-based criteria for providers would help to guide them in allocating the treatments, if scarce, to the right and eligible patients.37 However, as described earlier, these data do not yet exist. 37 Wosinska et al.
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Some strategies make choices about how COVID-19 mAb therapies are delivered and to whom -- for example, by constraining COVID-19 mAb therapy to <10 days after onset of symptoms, increasing the body mass index (BMI) threshold, or selecting only immunocompromised patients.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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. For many of these groups, the implementation of these therapies is hampered by logistical challenges, chief among them difficulty making appointments and obtaining safe transportation to infusion sites for the at-risk population, lack of infusion capacity, and the shortage of qualified staff to administer the infusions.
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The EUA's restrictions on settings that can administer COVID-19 mAb therapies (i.e., those that are equipped to treat severe infusion reactions and activate emergency medical systems if needed) can complicate access to and undermine the equitable allocation of these therapies, especially among populations that face barriers to accessing appropriate infusion sites.
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Challenges in Expanding Infusion Capacity According to Brian Nyquist, president and chief executive officer of the National Infusion Center Association (NICA) , infusion providers nationwide are struggling to safely integrate patients with COVID-19 with immunocompromised patients in existing sites -- or to operationalize temporary infusion capacity that physically separates those patient populations -- while also mitigating exposure risk among frontline health care workers.62 Infusion providers need resource support, standardized guidance, flexibility, and creativity to expand the number of safe settings in which patients can receive consistent, high-quality preparations of COVID-19 mAb therapies.
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Settings such as home infusion, temporary infusion sites, and longterm care facilities can broaden safe access to COVID-19 mAb therapy to more patients, including those for whom transport to an outpatient infusion site is a barrier and those in rural and underserved populations. However, these models require specialized staff who can administer the therapy and monitor for adverse reactions; these staff need to be transported along with the equipment to the sites of care.
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Thus, in the absence of CPT codes for observing patients during the 2-hour infusion procedure, the established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity. Due to the requisite 1:1 nurse-to-patient ratio, the cost-reimbursement delta is a barrier in the home infusion space as well.
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Broadening Access and Promoting Equity A major concern is that the inverse care law may be operating in the context of COVID-19 mAb allocation and administration.71 The inverse care law holds that the availability of good medical care tends to vary inversely with the need of the population being served.72 This was updated with the inverse equity hypothesis, which holds that newly introduced health interventions will initially be adopted by wealthier segments of the population, who likely have the least need.73 Absolute health inequalities will increase in the short term and decline only as the intervention gradually reaches the most deprived sectors of the population, by which time the most privileged sectors will have complete coverage. Intentional efforts to overcome logistical and financial barriers are needed to counteract the effects of the inverse care law and the inverse equity law in the allocation of COVID-19 mAb therapies, as well as increasing the capacity of providers to help patients understand when COVID-19 mAbs might be an option.
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American Indian and Alaska Native populations that live in rural areas with under-resourced health centers in hard-to-reach communities, as well as those who live in urban areas, are experiencing disproportionate burdens of COVID-19 incidence and mortality, yet they are not receiving COVID-19 mAb therapies at a rate commensurate with their elevated risk levels.74 Rural populations tend to be served by under-resourced rural hospitals and safety net hospitals that have the potential to serve huge numbers of high-risk patients. However, these facilities are not being optimally targeted for allocation and their capacity to administer infusions is limited by workforce and lack of infusion options.75 Adults living in nursing homes, assisted living, long-term care facilities, or other congregate residential settings including group homes for the disabled cannot easily travel to infusion centers, so treatments need to reach them in the facilities where they live.76 Similar logistical challenges are faced in providing infusions to people in home care who are at very high risk due to COVID-19, but may have multiple comorbidities and/or mobility challenges that prevent them from traveling to infusion centers.
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The University of Michigan system contracts with ambulance and transport services to offer access to outpatient COVID-19 mAb therapy to people who face transportation barriers to ensure that access to a car is not a prerequisite for accessing treatment.79 78 Redd, J 2020 Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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Maximizing the impact of limited manufacturing capacity for COVID-19 mAb therapies while concurrently maintaining an adequate supply of other biologics will be critical.86 However, manufacturers must take on financial risk and establish production capacity prior to the completion of clinical trials to ensure a sufficient supply of the therapy to meet the uncertain potential demand. Furthermore, when different manufacturers work independently to acquire sufficient capacity in advance, it can complicate efforts to match limited supply with COVID-19 mAbs that demonstrate clinical efficacy.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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Eligible patients from underserved communities are at risk of being denied access, whether due to provider biases or structural obstacles like insurance or proximity of facilities. The infusion community, long-term care facilities, health care and hospital systems, and community-based health centers, acting in concert, could develop improved models for connecting the pieces from test result to treatment criteria to patient care to ensure that health needs are met.
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2020. Presentation at the Workshop on Allocation of COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
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Because COVID-19 mAbs originate from the plasma of people who have recovered from COVID-19 they can target SARS-CoV-2 specifically.96 By entering the bloodstream directly via infusion, COVID-19 mAbs are thought to provide immediate protection against infection that can last for weeks or months. These COVID-19 mAb therapies represent the only treatment option for outpatients with COVID-19 that is thought to prevent hospitalization, thus potentially alleviating the burden on hospitals by reducing COVID-19 admissions.
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FDA issued EUAs after determining that it is reasonable to believe that the therapies may be effective for treating mild-to-moderate COVID-19 in adults and pediatric patients (aged ≥12 years and weighing ≥40 kg) with a positive result on a direct SARS-CoV-2 viral test who are at high risk for progressing to severe COVID-19 and/or hospitalization.100,101 In their respective clinical trials, both COVID-19 mAb therapies were shown to reduce hospitalizations and emergency room visits related to COVID-19 within 28 days after treatment among patients at high risk of disease progression compared to those who received placebo.
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APPENDIX B Authors and Reviewers of This Rapid Expert Consultation This rapid expert consultation was prepared by staff of the National Academies of Sciences, Engineering, and Medicine, and committee members on behalf of the National Academies' Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats: Donald Berwick, Harvard Medical School; Alta Charo, University of Wisconsin–Madison; John Hick, Hennepin County Medical Center; and Kent Kester, Sanofi Pasteur. We are grateful to the Report Review Committee of the National Academies and to individual reviewers who provided many valuable corrections, comments, and suggestions on an earlier draft.
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