Economic benefits of adaptive abiraterone therapy for advanced prostate cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18343-e18343
Author(s):  
Neil Thomas Mason ◽  
Jason M Burkett ◽  
Ryan Nelson ◽  
Julio M. Pow-Sang ◽  
Robert A Gatenby ◽  
...  

e18343 Background: We recently completed a study showing that adaptive abiraterone therapy (AT) led to more than a doubling of the time to radiographic progression (TTP) compared to continuous therapy (CT) in patients with metastatic castration resistant prostate cancer (mCRPC), [Nat Commun. 2017; 1816]. This study compared the cost of care in the AT cohort versus the standard of care CT cohort. Methods: We conducted a retrospective economic analysis of mCRPC patients receiving intermittent AT compared to patients receiving CT abiraterone. The study followed the adaptive therapy trial protocol (NCT02415621). The primary endpoints were costs of care per patient per year and cost per treatment month. We used itemized billing data and standardized to Medicare reimbursement rates to determine the pharmacy, lab, and imaging costs. Results: Patients receiving adaptive abiraterone therapy (N = 15) had a mean annual cost of care of $80,668 compared to a mean annual cost of care of $132,631 for CT patients. The cost of treatment per month was $6,713 for the AT versus $11,088 for the CT. The economic benefits persisted even after taking into account the cost of abiraterone (Table). Conclusions: The reduction in cost of care in patients with mCRPC with nearly an additional year of TTP from adaptive abiraterone therapy demonstrates the potential value of novel precision medicine approaches. If confirmed by other, larger scale studies, AT may provide significant economic value from far more effective therapy. [Table: see text]

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Tamara Dangouloff ◽  
Camille Botty ◽  
Charlotte Beaudart ◽  
Laurent Servais ◽  
Mickaël Hiligsmann

Abstract Background Spinal muscular atrophy (SMA) is a rare and devastating condition for which new disease-modifying treatments have recently been approved. Given the increasing importance of economic considerations in healthcare decision-making, this review summarizes the studies assessing the cost of SMA and economic evaluations of treatments. A systematic review of the literature in PubMed and Scopus up to 15 September 2020 was conducted according to PRISMA guidelines. Results Nine studies reporting the annual cost of care of patients with SMA and six evaluations of the cost-effectiveness of SMA treatments were identified. The average annual cost of SMA1, the most frequent and severe form in which symptoms appear before the age of 6 months were similar according to the different studies, ranged from $75,047 to $196,429 per year. The yearly costs for the forms of the later-onset form, called SMA2, SMA3, and SMA4, which were usually pooled in estimates of healthcare costs, were more variable, ranging from $27,157 to $82,474. The evaluations of cost-effectiveness of treatment compared nusinersen treatment against standard of care (n = 3), two treatments (nusinersen and onasemnogene abeparvovec) against each other and no drug treatment (n = 1), nusinersen versus onasemnogene abeparvovec (n = 1), and standard of care versus nusinersen with and without newborn screening (n = 1). The incremental cost-effectiveness ratio (ICER) of nusinersen compared to standard of care in SMA1 ranged from $210,095 to $1,150,455 per quality-adjusted life years (QALY) gained and that for onasemnogene abeparvovec ranged from $32,464 to $251,403. For pre-symptomatic patients, the ICER value ranged from $206,409 to $735,519. The ICERs for later-onset forms of SMA (2, 3 and 4) were more diverse ranging from $275,943 to $8,438,049. Conclusion This review confirms the substantial cost burden of standard of care for SMA patients and the high cost-effectiveness ratios of the approved drugs at the current price when delivered in post-symptomatic patients. Since few studies have been conducted so far, there is a need for further prospective and independent economic studies in pre- and post-symptomatic patients.


2017 ◽  
Vol 35 (7_suppl) ◽  
pp. 93-93
Author(s):  
Neil Thomas Mason ◽  
Nikhil I. Khushalani ◽  
Scott Joseph Antonia ◽  
Howard L. McLeod

93 Background: Recently approved PD-1 inhibitors such as nivolumab have demonstrated clear efficacy in metastatic melanoma and other cancers, but also come at a high cost and with the potential for severe side effects. However, most of the data available comes from clinical trials rather than patients treated in clinical practice as standard-of-care. This study reports the incidence of severe toxicities in a number of cancer types and estimates the per patient cost of managing these toxicities. Methods: Patients with metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, and Hodgkin’s lymphoma treated with nivolumab between January 1, 2014 through April 30, 2016 were identified at Moffitt Cancer Center (N=74). Toxicities occurring during treatment or within 2 months of stopping treatment were identified by a chart review and each toxicity graded using the CTCAE 4.0 criteria. A cost of care analysis was performed to estimate the cost of serious toxicities (Grade 3-5) compared to a control group who experienced no or minor adverse events (Grade 0-2). Billing data was used to estimate the mean cost of care for each group. Costs were subcategorized by service line, e.g., pharmacy costs, radiology, laboratory services. Results: The most common severe toxicities were anemia, dyspnea, renal failure, colitis, fatigue, and pneumonitis (Table 1). The average cost of care for patients experiencing grade 3-5 toxicities was $2,036 higher than those without toxicity. Conclusions: The incidence of toxicity in our population was similar to that reported in clinical trials. Costs were higher for patients with toxicities, driven by additional outpatient care (19% higher cost per patient) as well as additional pharmacy costs (22% higher per patient). Though small in comparison to the cost of nivolumab, over $6,000 per dose, these costs should not be dismissed, particularly when performing cost effectiveness and value research. [Table: see text]


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Ella Damiano ◽  
Regan Theiler

Objective. Innovative models of prenatal care are needed to improve pregnancy outcomes and lower the cost of care. We sought to increase the value of traditional prenatal care by using a new model (PodCare) featuring a standardized visit schedule and coordination of care within small interdisciplinary teams in an academic setting. Methods. Prenatal providers and clinic staff were divided into four “Pods”. Testing and counseling topics were assigned to visits based on gestational age. Interdisciplinary weekly Pod meetings provided coordination of care. A retrospective chart review was performed. The primary endpoints were the number of prenatal care visits and number of providers seen. Results. After PodCare implementation, more patients choose care with the low-risk physician team (42% compared to 26%). Study subjects included 85 women in 2013 and 165 women in 2014. The median number of visits decreased from 13 to 10 (p < 0.00004) and the median number of providers seen decreased from 7 to 5 (p < 0.0000008). Conclusion. PodCare increased the value of individual prenatal care by decreasing the number of visits, increasing continuity, and providing care coordination. The model provides a robust experience in interdisciplinary care. The PodCare model may be successful at other academic institutions.


Author(s):  
Julia Gonzalez ◽  
Diana Carolina Andrade ◽  
JianLi Niu

Abstract Background Acute bacterial skin and skin structure infections (ABSSSIs) are common infectious diseases that cause a significant economic burden on the healthcare system. This study aimed to compare the cost-effectiveness of dalbavancin vs standard of care (SoC) in the treatment of ABSSSI in a community-based healthcare system. Methods This was a retrospective study of adult patients with ABSSSI treated with dalbavancin or SoC during a 27-month period. Patients were matched based on age and body mass index. The primary outcome was average net cost of care to the healthcare system per patient, calculated as the difference between reimbursement payments and the total cost to provide care to the patient. The secondary outcome was proportion of cases successfully treated, defined as no ABSSSI-related readmission within 30 days after the initiation of treatment. Results Of the 418 matched patients, 209 received SoC and 209 received dalbavancin. The average total cost of care per patient was greater with dalbavancin vs SoC ($4770 vs $2709, P &lt; .0001). The average reimbursement per patient was $3084 with dalbavancin vs $2633 SoC (P = .527). The net cost, calculated as revenue minus total cost, was $1685 with dalbavancin vs $75 with SoC (P = .013). The overall treatment success rate was 74% with dalbavancin vs 85% with SoC (P = .004). Conclusions Dalbavancin was more costly than SoC for the treatment of ABSSSI, with a higher 30-day readmission rate. Dalbavancin does not offer an economic or efficacy advantage.


2018 ◽  
Vol 16 (1) ◽  
pp. 145-145
Author(s):  
Michel L. Peters ◽  
Claudine de Meijer ◽  
Dirk Wyndaele ◽  
Walter Noordzij ◽  
Annemarie M. Leliveld-Kors ◽  
...  

2012 ◽  
Vol 10 (12) ◽  
pp. 1505-1512 ◽  
Author(s):  
Ravi A. Madan ◽  
Thomas Schwaab ◽  
James L. Gulley

Sipuleucel-T is a therapeutic cancer vaccine that has shown improved survival in men with metastatic castration-resistant prostate cancer. As a first-in-class agent, it has been met with both fan-fare and controversy. A broad review of immune-based therapies may reveal the delayed clinical impact of sipuleucel-T to be a class effect. As new strategies of immune-based therapy are developed, their effects can be optimized through better understanding of how they affect disease differently from more standard therapeutics. Furthermore, combination therapy with agents that can either work synergistically with immune-activating therapies or deplete immune-regulating cells may result in more vigorous immune responses and improved clinical outcomes. In addition, therapeutic vaccines may be ideal candidates to safely combine with standard-of-care therapies because of their nonoverlapping toxicity profile. The ultimate role of immunotherapy may not be to supplant standard therapies, but rather to work in concert with them to maximize clinical benefit for patients.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 135-135 ◽  
Author(s):  
E. Y. Yu ◽  
F. E. Nathan ◽  
C. S. Higano

135 Background: Many patients with biochemical relapse after definitive therapy for prostate cancer receive androgen deprivation therapy. Although most patients experience a decline in PSA, PSA eventually rises despite a castrate level of testosterone. Many of these patients have non-metastatic disease and do not develop metastases for a median of 30 mos (Smith MR. JCO, 2005). However, there is no standard therapy for asymptomatic patients with non-metastatic CRPC. ENTHUSE M0 (Study 15) is an ongoing global phase III study comparing zibotentan 10 mg (an oral specific endothelin A receptor antagonist) vs placebo in non-metastatic CRPC patients. Co-primary endpoints are overall survival and progression-free survival; secondary endpoints are safety, PSA, quality of life, and time to symptomatic progression. Eligible patients are screened for metastases by bone and CT/MRI scan and other parameters. An unexpectedly high number of patients failed screening, prompting this analysis. Methods: All patients who were screened were included in the analysis. Reasons for exclusion were recorded. Results: As of June 3, 2010, 1,756 patients completed screening. Of these patients, 960 (55%) were randomized and 796 (45%) failed screening. The leading causes of screen failures are listed in the table. Exclusion rates by investigator specialty and country will be reported. Conclusions: As 30% of patients had metastatic disease on screening and were excluded, these data suggest that the frequency of asymptomatic metastases is high in men thought to have non-metastatic CRPC. These findings stress the value of periodic staging studies in men progressing from hormone sensitive to non-metastatic CRPC as metastatic CRPC patients may benefit from standard treatments or research treatments on other protocols. [Table: see text] [Table: see text]


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 133-133
Author(s):  
A. L. Harzstark ◽  
T. M. Beer ◽  
V. K. Weinberg ◽  
C. S. Higano ◽  
L. T. Nordquist ◽  
...  

133 Background: Docetaxel remains the standard of care for patients (pts) with mCRPC. However, the optimal duration of chemotherapy (Ch) is not known. Providing Ch holidays is often undertaken, but is not well characterized. A randomized phase II trial was undertaken to test two ICh regimens. Methods: Pts with Ch naive mCRPC and KPS > 60% were eligible. Pts were treated with “induction” docetaxel 75 mg/m2 q3 weeks, and prednisone 5 mg po bid. After 6 cycles, responding pts (PSAWG1 criteria) stopped Ch and were randomized to observation (Obs) or to GM-CSF, 250 mcg/m2 sq daily for 14 days out of every 28 day cycle. Pts were followed with monthly PSA and imaging every 2 cycles until progressive disease (PD) by PSAWG1 criteria, at which point they resumed treatment with Ch, again for 6 cycles, followed by the same “off Ch” regimen. The primary endpoint was the time to PD while on Ch (time to Ch resistance.) Results: Of 97enrolled pts to date, 94 are evaluable (3 are still undergoing induction). 69 pts completed induction (25 did not due to PD, adverse events (AE), or MD choice), of which 27 had PD after 6 cycles. Thus, 42/94 evaluable pts (45%) were eligible for randomization. Of these, 21 pts underwent Obs and 21 received GM-CSF. To date, 23/42 (55%) pts who underwent a Ch holiday restarted Ch, all for PSA PD. 8/23 (35%) had a response to Ch re-initiation. (15 pts did not re-start Ch because of AE, other therapy being started, or patient choice, and 4 pts are still undergoing either Obs or GM-CSF.) Obs pts were “off Ch” for a median of 2 months (range 2-4), compared with 3 months (range 2-8) for GM-CSF pts. Conclusions: While feasible, only 45% of pts met criteria for ICh. 35% of pts responded to Ch re-initiation. Insufficient data exist to assess the impact of GM-CSF on time off Ch or time to Ch resistance. No significant financial relationships to disclose.


2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS390-TPS390
Author(s):  
Bertrand F. Tombal ◽  
Yohann Loriot ◽  
Fred Saad ◽  
Raymond S. McDermott ◽  
Sandrine Marreaud ◽  
...  

TPS390 Background: α-emitting radiopharmaceutical Ra-223 reduces the risk of death by 30% vs placebo in phase 3 ALSYMPCA (Parker et al. NEJM 2013). Ra-223’s favourable safety profile and lack of significant toxicity support combining it with other agents. The ALSYMPCA trial was developed to add Ra-223 on the contemporary standard of care that did not include last generation AR pathway inhibitors enzalutamide, one of the modern reference treatments for asymptomatic or moderately symptomatic metastatic CRPC (Gillessen et al. Eur Urol. 2017). In addition Ra-223 is registered in symptomatic prostate cancer (PCa), a very late stage of modern patient disease. There is thus a good rationale to combine Ra-223 to modern AR pathway inhibitors and to initiate the treatment in asymptomatic or moderately symptomatic patients. Methods: The EORTC 1333-GUCG study will run in 51 sites (21 activated) across 7 European countries, 4 sites in US and 12 sites in Canada. The study is an intergroup initiative between EORTC (Coordinating Group), UNICANCER; Cancer Trials Ireland (Ireland), ACCRU (The United States), and CUOG (Canada). A total of 560 patients will be randomized in a 1:1 ratio to receive enzalutamide 160 mg q.d. p.o. or enzalutamide at the same dose and Ra223 at 55 kBq/kg i.v. monthly for 6 months. Patients will be stratified by country, pain (BPI 0-1 vs BPI 2-3), prior docetaxel use (no vs yes) and use of bone targeting agents (no vs yes). The main inclusion criteria require asymptomatic or mildly symptomatic (defined as no opioids and BPI-SF question 3 < 4), metastatic to bone with ≥ 2 bone metastases with or without additional lymph node metastases. Visceral metastases are not allowed. The primary endpoint is radiological progression-free survival (rPFS1), according to PCWG3. Secondary endpoints include: overall survival, PCa specific survival, 1st symptomatic skeletal event (SSE), time to initiation of next systemic anti-neoplastic therapy, time to pain progression, health-related quality of life (EQ-5D-5L and BPI). Clinical trial information: NCT02194842.


2011 ◽  
Vol 71-78 ◽  
pp. 2763-2766 ◽  
Author(s):  
Bing Yan

Green roofs are a passive cooling technique that stop incoming solar radiation from reaching the building structure below. Many studies have been conducted over the past 10 years to consider the potential building energy benefits of green roofs and shown that they can offer benefits in winter heating reduction as well as summer cooling.With review and summarized the description of its functional traits in our country, this paper discuss the necessity to carry out the research on the functional traits of green roofs, and gave some suggestions about how to do this.At last, we propose the estimate method for the cost of green roofs construction project and green roof’s economic value and ecological benefit.


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