Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals ...when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.
This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported.
A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide.
The digital site-less approach employed in the "Test Us At Home" study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.
A seroprevalence study can estimate the percentage of people with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in the general population; however, most existing reports ...have used a convenience sample, which may bias their estimates.
We sought a representative sample of Connecticut residents, ages ≥18 years and residing in noncongregate settings, who completed a survey between June 4 and June 23, 2020, and underwent serology testing for SARS-CoV-2-specific immunoglobulin G (IgG) antibodies between June 10 and July 29, 2020. We also oversampled non-Hispanic black and Hispanic subpopulations. We estimated the seroprevalence of SARS-CoV-2-specific IgG antibodies and the prevalence of symptomatic illness and self-reported adherence to risk-mitigation behaviors among this population.
Of the 567 respondents (mean age 50 ± 17 years; 53% women; 75% non-Hispanic white individuals) included at the state level, 23 respondents tested positive for SARS-CoV-2-specific antibodies, resulting in weighted seroprevalence of 4.0 (90% confidence interval CI 2.0-6.0). The weighted seroprevalence for the oversampled non-Hispanic black and Hispanic populations was 6.4% (90% CI 0.9-11.9) and 19.9% (90% CI 13.2-26.6), respectively. The majority of respondents at the state level reported following risk-mitigation behaviors: 73% avoided public places, 75% avoided gatherings of families or friends, and 97% wore a facemask, at least part of the time.
These estimates indicate that the vast majority of people in Connecticut lack antibodies against SARS-CoV-2, and there is variation by race and ethnicity. There is a need for continued adherence to risk-mitigation behaviors among Connecticut residents to prevent resurgence of COVID-19 in this region.
As part of its stand against racial injustice and its commitment to action, AMCP dedicated a partnership forum to discussion of potential sources of racial health disparities and inequities in ...benefit design because these are primary drivers of medication use. This forum, held virtually March 23-24, 2021, convened more than 40 experts representing key stakeholders from managed care settings. Key principles that emerged from the forum discussion as means to mitigate racial health disparities were to acknowledge that structural racism exists and that it can impact the provision of health care, including but not limited to formulary development and benefit design processes; to integrate proactive strategies to improve equity, beginning with education and training, into all aspects of health care; and to view patients holistically with an understanding of the compounding effect of social determinants of health on their personal wellness. With these principles in mind, participants highlighted several priority considerations including improving existing gaps in data, addressing diversity and equity as they relate to formulary development, evaluating systems such as benefit offerings through a lens of increasing equity, recognizing cost-related factors that affect equity, considering patients' interactions with and their ability to access the system, and committing to patient-centered care. Participants also suggested areas for policy-related focus and noted the need to develop and deploy specific education and training.
This forum was sponsored by Amgen, the National Pharmaceutical Council, Pfizer, PhRMA, Sandoz, and Takeda. Their representatives joined the forum as panelists or participants. These proceedings were prepared as a summary of the forum to represent common themes; they are not necessarily endorsed by all attendees nor should they be construed as reflecting group consensus.
Rising specialty drug costs present a challenge for patients and payers. High-cost products, such as gene therapies or immunotherapies, can significantly affect the budget of a payer that does not ...have the ability to spread risk across a large population. Stakeholders are considering new reimbursement and benefit designs for specialty medications to improve efficiencies and better manage costs. The potential effect of changes to specialty medication benefit designs and reimbursement systems on patient care, access to medications, and the overall health care system are important considerations when assessing the benefits and challenges associated with reform proposals. Options to better manage the affordability of specialty medications are needed to ensure that patients can continue to access medications, while allowing payers to remain good stewards of health care dollars and supporting marketplace competition and incentives to stimulate innovation. New benefit designs that address these needs, while also supporting marketplace competition and providing incentives that stimulate innovation, have been considered. To explore options, AMCP convened a multidisciplinary stakeholder forum on December 10-11, 2019, in Alexandria, VA. Health care leaders representing academia, health plans, integrated delivery systems, industry leaders, pharmaceutical manufacturers, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations participated in the forum. The forum was designed for stakeholders to discuss strategies for the following: (a) reduce costs for beneficiaries while maintaining or improving access to prescription drugs; (b) support marketplace competition and incentives for biopharmaceutical innovation; (c) minimize physicians' financial risk associated with managing drug inventories; (d) remove adverse reimbursement incentives for prescribing higher priced drugs; (e) consider the cost-effectiveness of treatments and services across the health care continuum; and (f) support quality measurement and program evaluation metrics. Recommendations emerging from the forum included creation of novel payment models for the most expensive therapies that allow for larger risk pools, while maintaining the sustainability of the reinsurance market remains. Simplification and standardization were cited as goals for system reform and technological innovations that allow health care providers to view cost-effectiveness information at the point of prescribing, combined with value-based contracting were also recommended. Finally, ensuring that plans remain patient-centric and are designed to address patient needs holistically was stressed as an important goal. DISCLOSURES: This partnership forum was sponsored by Amgen, AstraZeneca, Bayer, GSK, Merck, Pfizer, PhRMA, Takeda, and Xcenda. These proceedings were prepared as a summary of the forum to represent common themes; they are not necessarily endorsed by all attendees nor should they be construed as reflecting group consensus.
Despite the opportunity for large health gains, there are many challenges associated with rare disease therapies. Among these are striking the appropriate balance between the urgency to respond to ...patient needs with the uncertainty that is often inherent in rare disease therapy datasets leading to concerns with developing and interpreting clinical data; uncertainty around financial impact, value determination, and affordability; and variation in approach to coverage and potential effects on access. To discuss these challenges and opportunities to address them, AMCP held a virtual multidisciplinary stakeholder forum on September 8-10, 2020. Forum participants represented diverse sectors of the health care industry, including integrated delivery systems, health plans, pharmacy benefit managers, employer groups, biopharmaceutical companies, patient advocacy organizations, health policy researchers, and consulting firms; they evaluated strategies to plan for and manage rare disease therapies and recommended best practices and next steps.
This forum was sponsored by the following: AstraZeneca, Dicerna, Genentech, National Pharmaceutical Council, Novo Nordisk, Pfizer, Precision Value, Sanofi, Sarepta Therapeutics, Seattle Genetics, Spark Therapeutics, and Takeda. These proceedings were prepared as a summary of the forum to represent common themes; they are not necessarily endorsed by all attendees nor should they be construed as reflecting group consensus.
In conjunction with asymmetric chemical syntheses and spectral, chiroptical, Chromatographic and stereochemical correlation methods, we have developed procedures for the quantification of sulfoxide ...enantiomers and tertiary amine
N-oxide diastereomer metabolites arising from the action of the adult human liver and other flavin-containing monooxygenases (FMOs). The parallel nature of the metabolic in vitro-in vivo studies and the use of chemical model oxidation systems allowed us to identify the FMO isoform involved. We investigated the enantioselective
S-monooxygenation of cimetidine and the diastereoselective tertiary amine
N-1′-oxygenation of (
S)-nicotine as stereoselective functional probes of adult human liver FMO action. In both cases, the majority of evidence points to adult human liver FMO3 as the principal enzyme responsible for cimetidine
S-oxygenation and (
S)-nicotine
N-1′-oxygenation in vitro and in vivo. The excellent agreement between the absolute configuration of the major cimetidine
S-oxide and (
S)-nicotine
N-1′-oxide metabolites isolated from human urine and the major metabolite formed in the presence of adult human liver microsomes suggests that in vitro hepatic preparations may serve as a useful model for the in vivo condition. Further, that adult human liver cDNA-expressed FMO3 in
Escherichia coli also gave the same absolute stereoselectivity (i.e. for (
S)-nicotine
N-1′-oxygenation) confirms the identity of the monooxygenase in vivo. Although we cannot rule out the involvement of minor contributions of cytochrome P-450 monooxygenases in cimetidine and (
S)-nicotine oxidation, the majority of the data support the fact that cimetidine
S-oxygenation and (
S)-nicotine
N-1′-oxygenation are stereoselective functional probes of adult human liver FMO3 activity. Finally, because the stereochemistry of the principal metabolite of cimetidine and (
S)-nicotine in small experimental animals is distinct from that observed in humans, it is likely that species variation in predominant FMO isoforms exist and this may have important consequences for the choice of experimental animals in human preclinical drug design and development programs.
The Food and Drug Administration Modernization Act (FDAMA) of 1997 included Section 114 as a regulatory safe harbor with the goal of increasing the dissemination of health care economic information ...(HCEI) to those responsible for formulary decision making. HCEI is typically not included within FDA-approved labeling. Although it has been nearly 20 years since passage and enactment of Section 114, proactive distribution of HCEI has been underutilized by biopharmaceutical companies partly because of (a) vague wording in the statute and (b) the absence of FDA-implementing regulations. Consequently, companies and health care decisions makers have had to speculate about the scope of the provisions. As a result, the biopharmaceutical industry has significant concerns about stepping over the line when using the safe harbor. Also, payers and other "payer-like" decision makers (e.g., self-funded corporate insurers) who are trying to make appropriate coverage and utilization decisions are demanding this information but are not receiving it because of the uncertainties in the statute. Considering this renewed interest by multiple stakeholders regarding the need for revisions and/or guidance pertaining to Section 114, the Academy of Managed Care Pharmacy held a partnership forum on March 1-2, 2016, with a diverse group of health care stakeholders to provide the FDA with considerations for disseminating a guidance document on current thinking for the sharing of HCEI with health care decision makers. Forum participants represented the managed care industry, biopharmaceutical industry, health care providers, pharmacoeconomic experts, policy experts, and patient advocacy groups with specific expertise in the development, use, and dissemination of HCEI. The multistakeholder group represented the key professionals and entities affected by the provisions of Section 114 and present the collective credibility necessary for Congress and the FDA to modernize and operationalize the safe harbor by using the consensus recommendations developed during the forum. Speakers, panelists, and attendees focused on 4 terms in Section 114 that remain open to interpretation by companies and enforcement bodies: (1) the scope of HCEI, (2) the scope of "formulary committee or similar entity," (3) the definition of "competent and reliable scientific evidence (CRSE)," and (4) the parameters of how information "directly relates to an approved indication." Based on the forum results, it was recommended that the safe harbor for companies' proactive dissemination of information under Section 114 should include health care decision makers beyond health plan formulary committees, including organizations, or individuals in their role in an organization, who make health care decisions for patient populations. Recommendations also suggested expansion to organizations that evaluate HCEI or develop value frameworks and compendia and individuals in such organizations. Forum participants also recommended that HCEI be truthful, and not misleading, and be based on the expertise of professionals in the relevant area. HCEI must also be developed and disclosed in a transparent, reproducible, and accurate manner. Forum participants also discussed and agreed on the types of information, format, and processes by which managed care pharmacy and other health care decision makers seek to receive HCEI from biopharmaceutical companies. Finally, participants encouraged the FDA, Congress, and other stakeholders to find ways to ensure that patients or their representative organizations have appropriate access to a full range of information about their medications and that information related to the medication pipeline is communicated to appropriate stakeholders in a timely manner.
The AMCP Partnership Forum on FDAMA Section 114-Improving the Exchange of Pharmacoeconomic Data and the development of this proceedings document were supported by AbbVie, Amgen, Boehringer Ingelheim Pharmaceuticals, Merck & Co., National Pharmaceutical Council, Pharmaceutical Research and Manufacturers of America, Precision for Value, Pfizer, Takeda Pharmaceuticals, U.S.A., and Xcenda. All sponsors participated in the forum and participated in revising and approving the manuscript.
New developments that provide opportunities to enhance cost-effective diabetes care include advances in the pharmacologic treatment of diabetes, new drug delivery devices, innovations in patient ...management strategies, contracting strategies that incentivize effective interventions, and mobile health technologies. Payers must carefully consider the utility of these advances when making coverage decisions and designing benefits. To engage national stakeholders in a discussion about how to utilize innovations in diabetes care to optimize patient outcomes, the Academy of Managed Care Pharmacy organized the Partnership Forum on Navigating Innovations in Diabetes Care in Arlington, Virginia, on July 19-20, 2016. The forum explored current trends and advances in diabetes treatments and engaged in discussions about how organizations can leverage these emerging options to develop strategies that improve coordination of care and patient outcomes, while managing limited health resources. Additionally, stakeholders were tasked with identifying gaps in evidence that hinder decision making around novel therapies and other advances that are of direct relevance to managed care organizations.
The AMCP Partnership Forum on Navigating Innovations in Diabetes Care and the development of this proceedings document were supported by Boehringer Ingelheim, Lilly, Dexcom, Insulet Corporation, Intarcia Therapeutics, and Merck.
Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors are specialty medications approved for the treatment of dyslipidemia. Because dyslipidemia is a prevalent and chronic condition, the costs ...associated with PCSK9 inhibitors must be carefully weighed against the benefits that they provide. However, the long-term clinical benefits of these agents are not yet fully defined, creating a complex situation for third-party payers who must determine how to allocate limited resources. To engage national stakeholders in a discussion of how to wisely use PCSK9 inhibitors in health care, the Academy of Managed Care Pharmacy organized a forum in Washington, DC, on September 16, 2015. The forum began with presentations reviewing the current environment for dyslipidemia treatment. Following these presentations, participants engaged in discussions regarding how to best select patients for treatment based on current treatment guidelines, how managed care pharmacy can best manage high-cost specialty products that may be indicated for large numbers of patients, and how managed care organizations can use real-world evidence to assess the impact of evolving treatment guidelines and options. Participants called for the development of a national database to gather more meaningful data regarding the impact of PCSK9 inhibitors on clinical outcomes. Such a database would be invaluable for determining the real-world impact of specialty medications and would support the development of sensible third-party payer benefit structures, coverage decisions, medical policies, and risk-sharing contracts. In the meantime, participants recommended enhanced collaboration among stakeholders for improved information sharing, increased collection and evaluation of real-world evidence, use of available cost-effectiveness analyses, and the implementation of strategies that optimize the use of evidence-based therapies.
The AMCP Partnership Forum on Driving New Advances in Dyslipidemia Management and the development of this proceedings document was supported by Lilly USA, MedImpact Healthcare Systems, Merck & Co., PerformRx, Pfizer, and Sanofi.
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