scholarly journals Early Treatment with fluvoxamine among patients with COVID-19: a cost-consequence model

2021 ◽  
Author(s):  
Fergal P Mills ◽  
Gilmar Reis ◽  
Kristian Thorlund ◽  
Jamie I Forrest ◽  
Christina M Guo ◽  
...  
Keyword(s):  
High Risk ◽  
Cost Saving ◽  
Early Treatment ◽  
Eligible Patient ◽  
Resource Planning ◽  
Third Party ◽  
Decision Analytic Model ◽  
Current Standard ◽  
The Us ◽  
Cost Consequence

ABSTRACT Background Three randomized trials have been conducted indicating a clinical benefit of early treatment with fluvoxamine versus placebo for adults with symptomatic COVID-19. We assessed the cost-consequences associated with the use of this early treatment in outpatient populations. Methods Using results from the three completed trials of fluvoxamine vs. placebo for the treatment of COVID-19, we performed a meta-analysis. We conducted a cost-consequence analysis using a decision-model to assess the health system benefits of the avoidance of progression to severe COVID-19. Outcomes of relevance to resource planning decisions in the US and elsewhere, including costs and days of hospitalization avoided, were reported. We constructed a decision-analytic model in the form of a decision tree to evaluate two treatment strategies for high-risk patients with confirmed, symptomatic COVID-19, from the perspective of a third-party payer: (1) treatment with a 10-day course of fluvoxamine (100mg twice daily); (2) current standard-of-care; (3) molnupiravir 5-day course. We used a time horizon of 28 days. Results Administration of fluvoxamine to symptomatic outpatients with COVID-19 at high-risk of developing progression to severe COVID-19 complications is substantially cost-saving in the US, in the amount of $232 per eligible patient, and saves an average of 0.15 hospital days per patient treated is likely to be similarly beneficial in other settings. Fluvoxamine is cost saving in locations where total hospital costs are >$738. Molnupiravir had an additional cost to the healthcare system of $404 per patient treated. Conclusions Fluvoxamine is cost-saving for COVID-19 outpatient therapy.

Prolonged Administration of Azacitidine with or without Entinostat Increases Rate of Hematologic Normalization for Myelodysplastic Syndrome and Acute Myeloid Leukemia with Myelodysplasia-Related Changes: Results of the US Leukemia Intergroup Trial E1905

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 601-601 ◽  
Author(s):  
Thomas Prebet ◽  
Steven D. Gore ◽  
Zhuoxin Sun ◽  
Peter L. Greenberg ◽  
Mark Juckett ◽  
...  
Keyword(s):  
High Risk ◽  
Phase Ii ◽  
Histone Deacetylase Inhibitors ◽  
Response Rate ◽  
Median Number ◽  
Primary Objective ◽  
Prolonged Administration ◽  
Current Standard ◽  
The Us

Abstract Abstract 601 Background: The current standard of treatment for high risk myelodysplastic syndromes (MDS) is azacitidine (AZA) administered 75mg/m2/d days 1 – 7 (525 mg/m2/cycle) each 4 weeks. This approach improves survival; however, many AZA-treated patients (pts) continue to require blood products. The US registration trial (CALGB9221 trial; Silverman JCO 2002 and JCO 2006) showed a trilineage response rate (CR plus PR plus trilineage hematologic improvement [TL], IWG 2000) of 15%. Histone deacetylase inhibitors (HDACi) synergize with azanucleosides in vitro to re-express genes silenced through promoter methylation. In a previous phase I pilot study (J0443 study, NCT00101179), we showed that the combination of AZA and the orally bioavailable HDACi entinostat (MS-275) was effective and tolerable for pts with MDS and AML with myelodysplasia-related changes. The recommended Phase II schedule was AZA 50 mg/m2/d s.c. for 10 days (500 mg/m2/cycle) and entinostat 4 mg/m2/d PO on day 3 and day 10 of AZA on a 28 days cycle basis. Methods: E1905 US Leukemia Intergroup study (NCT00313586) is a phase II 1:1 randomized trial of AZA (50 * 10)+ entinostat (arm B) vs AZA (50 * 10) alone (arm A). Following six cycles of treatment, pts with documented clinical response (IWG 2000: CR, PR or TL) continued for the lesser of a total of 24 cycles or disease progression. The primary objective was to determine whether either arm significantly increased the rate of hematologic normalization (HN: CR + PR + TL) compared to CALGB9221 results (i.e. 15% to 30%). Patients were stratified according to the type of disease (i.e. MDS low risk vs MDS high risk vs CMML vs AML). Results: 150 pts were accrued and 136 analyzed (13 ineligible; 1 death before treatment), including 88 MDS, 5 CMML and 43 AML. Median age was 72 years. Poor risk cytogenetics were found in 31% of the patients. IPSS Int-2/High risk patients represented 72% (n=63) of the MDS cohort. There was no difference in pts characteristics between the 2 arms. The median number of administered cycles was 6 (range: 1–24). Toxicities in both arms were acceptable with a trend to an increase in grade IV platelet adverse events in Arm B (63% vs 46%, p=0.07) and grade III-IV fatigue in arm B (23% vs 13%, p=0.13). Overall HN rate was 28%: 10% CR, 8% PR and 10% TL. The HN rates by arm were A: 31% (12/9/10); B 24% (7/7/10) (p=NS). Non-trilineage hematologic improvement was achieved in an additional 12% of pts in arm A and 19% of pts in arm B; thus, total hematologic response was 43% and 44%. The median time to best response was 6 months in both arms (range: 1–14); median duration of response was 11 months (range: 1–18) in arm A and 10 months in arm B (range: 2–19, p=NS). With a median follow-up of 17 months, median overall survival was 18 months in arm A and 13 months in arm B (p=0.15). Conclusions: The rate of hematologic normalization in response to AZA 50 mg/m2/day * 10 in Arm A was twice that observed in C9221. The addition of entinostat examined in E1905 did not improve the response rate. Confirmation of improved response following prolonged administration of lower daily doses of AZA will require direct comparison to the currently approved dose regimen. Disclosures: Gore: Celgene: Consultancy, Research Funding, stock options; Syndax: Consultancy.

scholarly journals Use of a scoring strategy to determine clinical risk of progression and risk group-specific treatment adherence in subjects with latent tuberculosis infection

2017 ◽  
Author(s):  
Michael Scolarici ◽  
Ken Dekitani ◽  
Ling Chen ◽  
Marcia Sokol-Anderson ◽  
Daniel F Hoft ◽  
...  
Keyword(s):  
High Risk ◽  
Latent Tuberculosis Infection ◽  
Latent Tuberculosis ◽  
Standard Of Care ◽  
Treatment Completion ◽  
Risk Groups ◽  
Tuberculosis Infection ◽  
Current Standard ◽  
Clinical Risk ◽  
The Us

ABSTRACTBackgroundAnnual incidence of active tuberculosis (TB) cases has plateaued in the US from 2013-2015. Most cases are from reactivation of latent tuberculosis infection (LTBI). A likely contributor is suboptimal LTBI treatment completion rates in subjects at high risk of developing active TB. It is unknown whether these patients are adequately identified and treated under current standard of care.MethodsIn this study, we sought to retrospectively assess the utility of an online risk calculator (tstin3d.com) in determining probability of LTBI and defining the characteristics and treatment outcomes of Low: 0-<10%, Intermediate: 10-<50% and High: 50-100% risk groups of asymptomatic subjects with LTBI seen between 2010-2015.Results51(41%), 46 (37%) and 28 (22%) subjects were in Low, Intermediate and High risk groups respectively. Tstin3d.com was useful in determining the probability of LTBI in tuberculin skin test positive US born subjects. Of 114 subjects with available treatment information, overall completion rate was 61% and rates of completion in Low (60%), Intermediate (63%) and High (57%) risk groups were equivalent. 75% subjects in the 3HP group completed treatment compared to 58% in the INH group. Provider documentation of important clinical risk factors was often incomplete. Logistic regression analysis showed no clear trends of treatment completion being associated with assessment of a risk factor.ConclusionThese findings suggest tstin3d.com could be utilized in the US setting for risk stratification of patients with LTBI and select treatment based on risk. Current standard of care practice leads to subjects in all groups finishing treatment at equivalent rates.

A multilayer polyurethane foam dressing for pressure ulcer prevention in older hip fracture patients: an economic evaluation

2020 ◽  
Vol 29 (2) ◽  
pp. 120-127
Author(s):  
Cristiana Forni ◽  
Richard Searle
Keyword(s):  
Economic Evaluation ◽  
Cost Saving ◽  
Polyurethane Foam ◽  
Negative Impact ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Decision Analytic Model ◽  
Effective Strategy ◽  
Cost Effective Strategy ◽  
The Us

Objective: Hospital-acquired pressure ulcers (PU) have a substantial negative impact on patients and continue to impose a cost burden on hospital providers. Since the incidence of fragility fracture is growing, driven by the increase in the older population, it is expected that the overall incidence of associated complications will also increase accordingly. The aim of this economic evaluation was to determine whether the use of a multilayer, silicone-adhesive polyurethane foam dressing (ALLEVYN LIFE, Smith & Nephew, UK) alongside standard prevention (SP) for the prevention of PUs in older patients with hip fractures is a cost-effective strategy, compared with SP alone. Method: A decision-analytic model was constructed to determine the incremental cost and effectiveness of the foam dressing strategy from the perspectives of the Italian and US hospital systems. We also performed one-way and probabilistic sensitivity analyses. Results: The foam dressing intervention was found to be cost saving and more effective than SP in both Italy and the US. Switching to foam dressing and standard prevention would result in an expected cost saving of €733 per patient in Italy and $840 per patient in the US, reducing the per-patient cost of treating PUs by 37-69% and 36–68%, respectively. The one-way and probabilistic sensitivity analyses demonstrate that the strategy remains dominant over a range of values of the input variables. Conclusion: The foam dressing intervention is likely to be a cost-effective strategy compared with standard prevention alone.

A Cost-Effectiveness Evaluation of Hospital Discharge Counseling by Pharmacists

2011 ◽  
Vol 25 (2) ◽  
pp. 201-208 ◽  
Author(s):  
Chanadda Chinthammit ◽  
Edward P. Armstrong ◽  
Terri L. Warholak
Keyword(s):  
Cost Effectiveness ◽  
High Risk ◽  
Cost Saving ◽  
Hospital Discharge ◽  
Cost Effective ◽  
Drug Event ◽  
Decision Analytic Model ◽  
System Perspective ◽  
Pharmacist Counseling ◽  
The Cost

Objectives: This study estimated the cost-effectiveness of pharmacist discharge counseling on medication-related morbidity in both the high-risk elderly and general US population. Methods: A cost-effectiveness decision analytic model was developed using a health care system perspective based on published clinical trials. Costs included direct medical costs, and the effectiveness unit was patients discharged without suffering a subsequent adverse drug event. A systematic review of published studies was conducted to estimate variable probabilities in the cost-effectiveness model. To test the robustness of the results, a second-order probabilistic sensitivity analysis (Monte Carlo simulation) was used to run 10 000 cases through the model sampling across all distributions simultaneously. Results: Pharmacist counseling at hospital discharge provided a small, but statistically significant, clinical improvement at a similar overall cost. Pharmacist counseling was cost saving in approximately 48% of scenarios and in the remaining scenarios had a low willingness-to-pay threshold for all scenarios being cost-effective. In addition, discharge counseling was more cost-effective in the high-risk elderly population compared to the general population. Conclusion: This cost-effectiveness analysis suggests that discharge counseling by pharmacists is quite cost-effective and estimated to be cost saving in over 48% of cases. High-risk elderly patients appear to especially benefit from these pharmacist services.

Budget impact (BI) analysis of cemiplimab-rwlc for advanced basal cell carcinoma (BCC) after hedgehog inhibitor (HHI) therapy in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18830-e18830
Author(s):  
Eleanor Paul ◽  
Chieh-I Chen ◽  
Zahra Chowdhury ◽  
Yingxin Xu ◽  
Gerasimos Konidaris ◽  
...  
Keyword(s):  
Healthcare System ◽  
Eligible Patient ◽  
Locally Advanced ◽  
The United States ◽  
Best Supportive Care ◽  
Decision Analytic Model ◽  
Published Data ◽  
Reference Case ◽  
Market Shares ◽  
The Us

e18830 Background: A small proportion of patients (pts) with BCC develop advanced disease (locally advanced [la] and metastatic [m] BCC). Until recently, there was no standard treatment regimen for advanced BCC following progression on or intolerance to HHIs. Some pts received systemic therapy (ST), but most received best supportive care (BSC). Cemiplimab-rwlc is the first immunotherapy indicated in the US, fully for pts with laBCC and accelerated for mBCC, post HHIs or for whom HHIs are not appropriate. This study estimated the BI of introducing cemiplimab-rwlc in the US from a healthcare payer’s perspective. Methods: A decision analytic model was developed to estimate the BI of introducing cemiplimab-rwlc to a US healthcare system over 3 years for advanced BCC treatment following HHIs. Published data were used to estimate eligible patient population size. Reference case market shares for platinum chemotherapy (CT; 4%), nivolumab (3%), pembrolizumab (2%), vismodegib (1%), sonidegib (1%), and BSC (89%) were based on market research, as were predicted uptake of cemiplimab-rwlc and changes in market distribution of STs and BSC post-cemiplimab-rwlc launch, with most pts moving from BSC. Treatment costs were sourced from the ProspectoRx drug pricing database. Total costs (2020 US dollars [$]) to the healthcare system included costs related to treatment, disease monitoring, and mitigation of Grade 3–4 adverse events. Results: In a hypothetical US healthcare plan of 1,000,000 members, ̃32 pts per year with advanced BCC would be eligible for cemiplimab-rwlc, resulting in an average additional cost of cemiplimab-rwlc introduction of $0.12 per member per month (PMPM) over 3 years. The proportion of pts receiving ST rather than BSC was estimated to increase from 11% in 2020, prior to cemiplimab-rwlc approval, to 50% in 2023. Cemiplimab-rwlc market share is projected to increase by 41% by year 3 taking shares from BSC (–39%), HHIs (–1%), and CT (–1%). Given the large proportion of pts who currently receive BSC, the availability of cemiplimab-rwlc is expected to increase payers’ 3-year budget from $978,955 to $5,487,507 post-launch. A one-way sensitivity analysis showed that BI estimates were most sensitive to estimation of the size of the eligible population (health plan population [±20%], proportion of pts with advanced BCC [±20%], and those eligible for treatment post-HHI [±19%]), cemiplimab-rwlc treatment duration (±17%), and the cost of cemiplimab-rwlc (±17%). Changes to all other inputs had a < 5% impact. Conclusions: The introduction of cemiplimab-rwlc had a minimal BI on the average PMPM cost. Modest incremental BI is directly attributable to the projected uptake of cemiplimab-rwlc in a market where pts previously received no ST. These analyses provide new insights in the management of advanced BCC noting limited available evidence for post-HHI treatment.

scholarly journals What Is New in the Treatment of Smoldering Multiple Myeloma?

2021 ◽  
Vol 10 (3) ◽  
pp. 421
Author(s):  
Niccolo’ Bolli ◽  
Nicola Sgherza ◽  
Paola Curci ◽  
Rita Rizzi ◽  
Vanda Strafella ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
High Risk ◽  
Early Treatment ◽  
Individual Case ◽  
Symptomatic Disease ◽  
Plasma Cell Neoplasm ◽  
Smoldering Multiple Myeloma ◽  
Wide Range ◽  
Critical Issues

Smoldering multiple myeloma (SMM), an asymptomatic plasma cell neoplasm, is currently diagnosed according to the updated IMWG criteria, which reflect an intermediate tumor mass between monoclonal gammopathy of undetermined significance (MGUS) and active MM. However, SMM is a heterogeneous entity and individual case may go from an “MGUS-like” behavior to “early MM” with rapid transformation into symptomatic disease. This wide range of clinical outcomes poses challenges for prognostication and management of individual patients. However, initial studies showed a benefit in terms of progression or even survival for early treatment of high-risk SMM patients. While outside of clinical trials the conventional approach to SMM generally remains that of close observation, these studies raised the question of whether early treatment should be offered in high-risk patients, prompting evaluation of several different therapeutic approaches with different goals. While delay of progression to MM with a non-toxic treatment is clearly achievable by early treatment, a convincing survival benefit still needs to be proven by independent studies. Furthermore, if SMM is to be considered less biologically complex than MM, early treatment may offer the chance of cure that is currently not within reach of any active MM treatment. In this paper, we present updated results of completed or ongoing clinical trials in SMM treatment, highlighting areas of uncertainty and critical issues that will need to be addressed in the near future before the “watch and wait” paradigm in SMM is abandoned in favor of early treatment.

scholarly journals 1381. Rotavirus Gastroenteritis among older adults: discussion based on a systematic literature review

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S700-S701
Author(s):  
Cristina Carias ◽  
Susanne Hartwig ◽  
M Nabi Kanibir ◽  
Ya-Ting Chen
Keyword(s):  
Older Adults ◽  
High Risk ◽  
Acute Gastroenteritis ◽  
Rate Ratio ◽  
Rotavirus Gastroenteritis ◽  
Incident Rate Ratio ◽  
The Us ◽  
Incident Rate ◽  
The Uk ◽  
Retrospective Database

Abstract Background While the burden of Rotavirus Gastroenteritis (RGE) is well recognized in young children, it is less so in older adults. However, older adults are also at high-risk of Acute Gastroenteritis (AGE) severe outcomes. In this review, we thus aimed to comprehensively assess RGE burden and vaccination impact in older individuals. Methods We performed a systematic literature review with PubMed and Scopus, from 2000 to 2019, using MESH and free-range terms. We included only studies that reported the incidence, and/or RV vaccination impact, in adults aged 60 and above and using regional specific data-sources. Results We analyzed 11 manuscripts for individuals aged 60 and above (Figure 1). Studies spanned Australia, Sweden, Netherlands, Canada (2), Germany (2), UK (2), and the US (2). Yearly inpatient RV incidence varied between 1.6 per 100,000 in Australia for those 65+ (retrospective database analyses, pre-vaccine); and 26 per 100,000 for those 85+ in Canada (modeling estimates for 2006-10, pre-vaccine). The incidence rate ratio for inpatient RGE between the post and pre-vaccine periods for those 65+ was 0.57 [95% CI: 0.10 – 3.15] in Canada, but 2.24 [95%CI: 1.78-2.83] in Australia, which may be due to increased testing for RV in the elderly post-vaccine. Reductions in the post-vaccination burden of RV and AGE among 60+ were reported in the UK (2 studies), and the US (2 studies) via retrospective database analyses In the UK, post-vaccine reductions in AGE health care-utilization were reported in the Emergency Department (21%), and outpatient centers (walk-in centers: 47%; general practice consultations: 36%). Retrospective database analyses documenting the incident rate ratio (IRR) of Rotavirus Gastroenteritis (RGE) and Acute Gastroenteritis (AGE) in older adults between the pre and post-vaccine period. Retrospective database analyses documenting the incident rate ratio (IRR) of Rotavirus Gastroenteritis (RGE) and Acute Gastroenteritis (AGE) in older adults between the pre and post-vaccine period. Conclusion While the burden of RGE mainly falls on young children, it also affects older adults. Retrospective database analyses reveal that, likely due to indirect vaccination benefits, increases in RV vaccination coverage have had an impact on lowering RGE, and AGE cases and healthcare utilization in older adults, a group at high-risk of severe outcomes for AGE. Disclosures Cristina Carias, PhD, Merck (Employee, Shareholder) Susanne Hartwig, n/a, MSD Vaccins (Employee) M.Nabi Kanibir, MD, Merck/MSD (Employee, Shareholder) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder)

Improved Outcomes Amongst High Risk Lung Transplant Patients at High Volume Centers: A Case for Regionalization in the US

2015 ◽  
Vol 34 (4) ◽  
pp. S243
Author(s):  
J.C. Grimm ◽  
J. Magruder ◽  
A. Kilic ◽  
V. Valero ◽  
S.P. Dungan ◽  
...  
Keyword(s):  
High Risk ◽  
Lung Transplant ◽  
High Volume ◽  
Transplant Patients ◽  
Improved Outcomes ◽  
The Us

scholarly journals Geographic Variation of High-Risk Opioid Use and Risk of Overdose Among Disabled Medicare Beneficiaries in the US from 2011 to 2015

2018 ◽  
Vol 21 ◽  
pp. S2
Author(s):  
W Lo-Ciganic ◽  
WF Gellad ◽  
L Zhou ◽  
JM Donohue ◽  
A Roubal ◽  
...  
Keyword(s):  
High Risk ◽  
Geographic Variation ◽  
Medicare Beneficiaries ◽  
Opioid Use ◽  
The Us

Legal Reactivity: Correctional Health Care Certifications as Responses to Litigation

2021 ◽  
pp. 1-33
Author(s):  
Spencer Headworth ◽  
Callie Zaborenko
Keyword(s):  
Health Care ◽  
Third Party ◽  
Lower Court ◽  
Correctional Health Care ◽  
Right To Health Care ◽  
Correctional Health ◽  
The Us ◽  
Us Supreme Court ◽  
Wait And See ◽  
Constitutional Right

In 1976, the US Supreme Court established that incarcerated people have a constitutional right to health care, ratifying lower court decisions. Corresponding professionalization and standardization initiatives included the advent of third-party certifications of individual correctional health care (CHC) practitioners. Drawing on historical evidence about CHC reforms and contemporary data on certifications, incarcerated people’s lawsuits, and incarcerated people’s mortality rates, this study assesses relationships between certifications and key outcomes of incarceration. We find that corrections actors tend to adopt certifications when directly threatened by elevated rates of litigation in their states. This finding suggests that corrections actors are legally reactive, responding to filed lawsuits’ salient threat, rather than legally proactive, attempting to manage risk through anticipatory certification adoption. While early standardization and professionalization interventions reflected the legally proactive logic, our results indicate that contemporary corrections actors tend to “wait and see” about legal liability. Barriers to settlements or court rulings favoring incarcerated people—particularly the Prison Litigation Reform Act—help explain this tendency. Lawsuits’ observed influence on standardization and professionalization offer some support for litigation’s capacity to impel changes; litigation’s failure to predict mortality, however, gives pause regarding this capacity’s extent.

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