Efforts by the National Alliance for Caregiving

The National Alliance for Caregiving (NAC) conducts research, does policy analysis, develops national best-practice programs, and works to increase public awareness of family caregiving issues. In addition to national research and advocacy, NAC provides technical assistance to a national network of caregiving coalitions representing nearly 30 states. NAC recognizes that family caregivers provide important societal and financial contributions toward maintaining the well-being of those in their care. The need to support the nation’s nearly 53 million family caregivers and sustain them as the backbone of our chronic and long-term care system is a central issue in national and state efforts to reform healthcare, especially in light of the challenges presented by the COVID-19 pandemic. This presentation will provide information on the current status of these national and state efforts.

Family Caregivers as Advocates

This presentation discusses the growing influence of family caregiver advocacy and its prospects for impacting policy under the Biden administration, at both the federal and states levels. In particular, it will describe the National Alliance for Caregiving’s 50-state unified strategy for establishing the caregiver support infrastructure that is needed to coordinate efforts and to support caregivers across the nation and the lifespan. Historically, family caregivers have had difficulty acting as effective advocates, given the multiple roles they often play and their widely divergent interests, based on the varying needs of their care recipient and their divergent life circumstances. However, the Biden administration has indicated receptivity to caregiver issues, and the public has become increasingly aware of the caregiver role (in part, due to the pandemic), resulting in improved prospects for policy action at both the state and federal levels. This presentation reviews recent developments and discusses strategies for moving forward.

Breaking New Ground: Incentivizing Innovative Caregiving Programs

Caring for someone with chronic illness is a demanding job, and as a result 46% of caregivers caring for adults with chronic illnesses report a significant level of burden (AARP and National Alliance of Caregiving, 2015). Recent reviews note a prevalence rate of 31.2% for depression (Collins & Kishita, 2019) and 32.1% for anxiety (Kaddour & Kishita, 2020). In addition, most caregivers also report high levels of negative emotions including frustration, guilt, and a sense of hopelessness regarding the future (Schulz & Eden, 2016). This symposium will focus on innovative programming to address caregiver needs and concerns. The first presenter will set the foundation as she explores her caregiver journey and the issues she experienced as a caregiver. Using her personal experience, this healthcare professional will explore her interactions with the medical system as a caregiver, including the unique issues experienced during the pandemic. The second presenter will examine why are caregiver program needed, what benefits can be expected, and what is considered best practices when addressing the unmet needs of family caregivers in caregiver programs. The third and fourth presenters will discuss two exemplar caregiving programs - Caregiver Clinic at the Memorial Sloan Kettering Cancer Center and the Caregiver Initiative from the Rush University Medical Center. They will describe the program, the process of creation, funding, barriers experienced, and working solutions. Pertinent data regarding the integration of the programs within the medical systems, the programs scope, and the effects of the pandemic on the programs will be shared.

Early Evaluation of the Use of Crizanlizumab in Sickle Cell Disease: A National Alliance of Sickle Cell Centers Study

Background: Vaso-occlusive crises (VOC) are the most common acute complication of sickle cell disease (SCD). Crizanlizumab, an anti-P-selectin monoclonal antibody, is an FDA-approved disease-modifying therapy (DMT) for SCD patients (pts) aged ≥16 yrs to reduce the frequency of VOC. To better understand its use and impact, the National Alliance for Sickle Cell Centers (NASCC) conducted a retrospective study of pts prescribed crizanlizumab from 11/2019-6/30/2021. NASCC is a non-profit organization formed to support SCD centers in delivering quality comprehensive care by setting and adopting specific standards and advocating for improved health outcomes in SCD. This study describes the largest real-world cohort of pts treated with crizanlizumab. Methods: This is a two-part study. Part 1 was to evaluate NASCC center crizanlizumab practice and to summarize data on insurance approval and the frequency of drug discontinuation. Part 2 includes pt level data to evaluate reasons for discontinuation and acute care utilization pre and post therapy. Acute care use includes day hospital/infusion, emergency department visits, and hospitalizations for VOC (excluding COVID-19). The index date for each pt is defined as the 1st crizanlizumab infusion date. Chart review (electronic health records) was used to identify all acute care visits 12 months pre-index and ≤12 months post index. Acute care data will be analyzed in aggregate. Evaluation of center-specific use of crizanlizumab, time to initial site level formulary approval and drug discontinuation were analyzed. Pt level data collection is ongoing to include sufficient time post index date. VOC characteristics will be summarized using medians, median differences (pre/post treatment), and 95% confidence intervals. Additional evaluation of effectiveness of crizanlizumab will include analysis based on number of doses received, pre-treatment VOC burden, concomitant hydroxyurea (HU) use and genotype. Results: Data includes pts prescribed crizanlizumab at 11 NASCC centers. Site- formulary approvals to use crizanlizumab varied from 12/2019-12/2020. As a result, the 1st pt to receive treatment at each site varied from 1/15/2020-1/20/2021. Mean time from site-level approval to first infusion was 77 days (range: 0-394). Over 50% of sites received insurance denials mainly due to "insufficient medical necessity" or "medication not covered by the prescription plan." Sites were able to successfully appeal denials for 71% of pts (Table 1). Treatment Delivery: Each site gives infusions over 30 minutes and the majority (64%) do not use pre-medication unless pts had reactions. Some sites use diphenhydramine/acetaminophen (3) or normal saline and ketorolac (1). All sites prescribe crizanlizumab to pts of all SCD genotypes. Pts Treated: 297 pts were prescribed crizanlizumab of whom 238 received ≥ 1 infusion. There was variation in number of pts/site (range 6-73, mean 21) due to time to site-level approval, insurance and pt population. Of these 238, 75 pts (32%) discontinued treatment (0-17 pts/site). Sites reported pts perceived lack of improvement or feeling their overall pain was increased, transportation issues and infusion related reactions (IRRs) characterized by pain as some of the reasons for discontinuation. Evaluation of real-world efficacy measured by changes in acute care utilization, including sub-analysis by genotype, pre-treatment VOC burden and concomitant HU use, are pending sample size dependent feasibility. Discussion: This is the first multi-center real-world analysis of crizanlizumab. Findings demonstrate some insurance barriers to therapy. The majority of pts who initiated crizanlizumab have remained on therapy; however, 1/3 of pts had lack of effect or barriers to care. Pt level data will include characteristics related to treatment failure or IRR. Improving the understanding of phenotype-specific response to novel therapies is essential in SCD. Conclusion: Post-approval therapies for rare diseases must undergo real-world evaluation to ensure study results translate to the community. NASCC uses defined criteria for multidisciplinary care for Alliance inclusion and findings reflect the use of DMT in such centers. This is the first NASCC study of DMT in SCD. Part 2 of the study will give early insights into the effectiveness of crizanlizumab; long term follow-up is needed for a full understanding of its utility in SCD. Figure 1 Figure 1. Disclosures Kanter: Fulcrum Therapeutics, Inc.: Consultancy; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Forma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees; Beam: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Graphite Bio: Consultancy; GuidePoint Global: Honoraria; Fulcrum Tx: Consultancy. Manwani: Novartis: Consultancy. Idowu: Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Research Funding; Global Blood Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Forma Therapeutics, Inc.: Research Funding; Ironwood: Research Funding. Treadwell: National Alliance of Sickle Cell Centers: Other: Early Evaluation of the Use of Crizanlizumab in Sickle Cell Disease. Clay: GBT: Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria. Little: Hemex Health, Inc.: Patents & Royalties; Biochip Labs: Patents & Royalties. Desai: Global Blood Therapeutics: Honoraria, Research Funding; Novartis: Research Funding, Speakers Bureau; Pfizer: Other: Publication Fee, Research Funding; Forma: Consultancy; Foundation for Sickle Cell Research: Honoraria. Lanzkron: Shire: Research Funding; Pfizer: Current holder of individual stocks in a privately-held company; Bluebird Bio: Consultancy; Teva: Current holder of individual stocks in a privately-held company; Novo Nordisk: Consultancy; GBT: Research Funding; Imara: Research Funding; CSL Behring: Research Funding; Novartis: Research Funding.

Courage under fire: Re-evaluating Black Hawk Down and the Battle of Mogadishu

The current understanding of Black Hawk Down is based on two assumptions: allegations of tired tactics and claims by Somali National Alliance leader Mohammed Farrah Aideed. These assumptions, accepted without much analysis or supporting evidence, stem from analysing Black Hawk Down working backwards from after the event, with a predeterminant methodology. This article examines the causation objectively, showing these assumptions as evidentiary weak, and instead highlights the actions of another American unit, Team Courage, as a potential factor in the events of 3 October, universally overlooked thus far, prompting a reinterpretation of the existing narrative, the SNA as an enemy, and the veracity of Aideed’s claims.