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From page 256... ... 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) Read the entire page →
From page 257... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Read the entire page →
From page 258... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) In November 2020, FDA issued EUAs for two investigational monoclonal antibody (mAb) Read the entire page →
From page 259... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) The consultation also explores variation in and challenges to access to treatment as well as limitations in data about the degree to which different populations may benefit from treatment with COVID-19 mAbs. Read the entire page →
From page 260... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) in reducing viral load.12,13 Recently, the National Institute of Allergy and Infectious Diseases announced it is sponsoring a Phase II/III clinical trial to examine two additional experimental antibodies, BRII-196 and BRII-198.14 The EUAs for both FDA therapies were based on limited data regarding clinical benefit and no evidence of benefit with respect to mortality.15 The single published peer-reviewed interim analysis of bamlanivimab's Phase II trial found that only the 2800-mg dose (but not the 700-mg or 7000-mg doses) Read the entire page →
From page 261... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) identify differential benefits and risks across different groups of COVID-19 patients.18 Moreover, no comparative data are currently available about the differences in clinical efficacy or safety between casirivimab plus imdevimab and bamlanivimab.19 These limitations indicate the critical need for ongoing assessment so that a clearer picture of effectiveness and appropriate use can emerge over time. Read the entire page →
From page 262... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Potential Unintended Consequences of EUA EUAs based on limited evidence pose unintended consequences.23 For instance, the EUAs for both COVID-19 mAbs allow for use in groups beyond those studied in the clinical trials, for which there are no group-specific safety or efficacy data (e.g., children) Read the entire page →
From page 263... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) evidence is needed on the costs, safety, and access implications of different models (e.g., traditional or alternative infusion sites) Read the entire page →
From page 264... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) monitor patients, and treat complications, including anaphylaxis. Read the entire page →
From page 265... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) of patients from underserved and at-risk populations.31 If efforts to expand referral and infusion are successful to the extent that all eligible patients were treated, it has been estimated that the near-term supply of antibodies would be depleted in just 4 days, based on an estimated supply of 150,000 doses per month. Read the entire page →
From page 266... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Read the entire page →
From page 267... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) states there have been multiple local efforts to achieve these goals, resulting in well-intentioned but inconsistent inclusion criteria that could potentiate unfairness or inequity. Read the entire page →
From page 268... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) At present, states are employing one of three basic models to identify candidates for a limited supply of scarce treatments: (1) Read the entire page →
From page 269... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) BMI criteria to ≥40.40 Wisconsin's SSM Health System targets the most at-risk population by assigning patients with a score based on high-risk comorbidities, gender, and age.41 Michigan created its own case definition of high-risk patients (i.e., those who are elderly, have obesity, and/or immunosuppressed) Read the entire page →
From page 270... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) supply is not currently an issue.44 Other jurisdictions utilize the Centers for Disease Control and Prevention's Social Vulnerability Index (SVI) Read the entire page →
From page 271... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Randomized Lottery Models Randomized lottery models focus on one version of fairness by transparently and consistently ensuring an equal opportunity to receive the scarce therapy among those patients identified as clinically appropriate. Read the entire page →
From page 272... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) that make health less accessible to disadvantaged populations by using a weighted lottery informed by the ADI. Read the entire page →
From page 273... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) randomly on a daily basis as the capacity allowed within each system. Read the entire page →
From page 274... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) for and presents reasonable belief that COVID-19 mAbs may be an effective treatment option. Read the entire page →
From page 275... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) qualified health centers [FQHCs] Read the entire page →
From page 276... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Uncertainty Regarding Base Payment Models and Reimbursement Mechanisms The Centers for Medicare & Medicaid Services (CMS) Read the entire page →
From page 277... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Cost-Reimbursement Disparity in Furnishing Infusion Services Total practice cost associated with furnishing infusion services and the underlying cost reimbursement disparity is a major factor driving reluctance among community-based infusion providers to invest in expanding infusion capacity to accommodate COVID-19 mAb therapies, said Nyquist.68 Currently, provider reimbursement for administering COVID-19 mAb therapies under the buy-and-bill model comprises two payments: one for the treatment and another for the professional services associated with furnishing the treatment (i.e., the "admin" payment) Read the entire page →
From page 278... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) gaps, while public and private payers could potentially adjust payment rates to incentivize faster testing and referral of eligible high-risk patients for COVID-19 mAb treatment. Read the entire page →
From page 279... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) those communities are also more likely to work in essential, frontline industries with the high risk of exposure, have lost their jobs and employer-based health insurance during the pandemic, and are more likely to have been uninsured before the pandemic. Read the entire page →
From page 280... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) probable need.78 No data are available on the number of doses allocated by states to their state, county, and municipal prisons and jails, where COVID-19 rates and risks are high. Read the entire page →
From page 281... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) FIGURE 1 COVID-19 monoclonal antibody therapy process considerations. Read the entire page →
From page 282... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) of the value of COVID-19 mAbs, in levels of staffing and in relationships with some patients, can affect how well patients are informed about COVID-19 mAbs and how energetically the eligible patients are encouraged to request the therapy. Read the entire page →
From page 283... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) No one system perfectly achieves mitigation of existing health disparities, maximum benefit overall from the use of the therapy, or simply understood distribution schemes perceived as equitable and fair to all people. Read the entire page →
From page 284... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) typical production process for a new therapeutic without compromising quality or safety standards.87 The manufacture of COVID-19 mAbs is highly complex; it takes place under carefully controlled conditions -- with numerous quality and safety checks -- that require a specialized workforce and large volumes of manufacturing space and supplies. Read the entire page →
From page 285... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) CONCLUDING COMMENTS The challenges experienced and lessons learned in initial efforts to equitably, safely, and effectively allocate COVID-19 mAbs have value both in continuing to improve these systems, and also in rolling out future novel therapeutics, especially those where the relationship between need and supply is uncertain. Read the entire page →
From page 286... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) regional level, so as more efficiently to assess use, effectiveness, complications, etc. Read the entire page →
From page 287... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) neutralizing the SARS-CoV-2 virus in people who have been exposed or infected.92 Bamlanivimab, casirivimab, and imdevimab are neutralizing IgG1 mAbs that target the receptor binding domain of the SARS-CoV-2 spike protein and are designed to block the SARS-CoV-2 virus from attaching to and entering human cells.93,94 In addition to these two products that have been issued EUAs, more than 70 mAb candidates that specifically target SARS-CoV-2 are currently being developed and investigated worldwide.95 Research is also under way to determine whether mAbs developed for other indications may be effective against COVID-19. Read the entire page →
From page 288... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Emergency Use Authorizations for COVID-19 Monoclonal Antibody Therapies As mentioned above, FDA has currently issued EUAs for two investigational COVID-19 mAb therapies for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients: bamlanivimab monotherapy (Eli Lilly and Company; Indianapolis, Indiana) Read the entire page →
From page 289... ... Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics (January 29, 2021) Furthermore, the EUAs restrict the administration of both bamlanivimab monotherapy and casirivimab and imdevimab combination therapy to only those settings with immediate access to medications for treating severe infusion reactions (e.g., anaphylaxis) Read the entire page →

From page 256...

... 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)