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Article ; Online: Variation in Medicaid and commercial coverage of cell and gene therapies.

Beinfeld, Molly T / Rucker, Julia A / Jenkins, Nola B / de Breed, Lucas A / Chambers, James D

Health policy OPEN

2023 Volume 5, Page(s) 100103

Abstract: Growth in the availability of cell and gene therapies (CGTs) promises significant innovation in the treatment of serious diseases, but the high cost and one-time administration of CGTs has also raised concern about strain on health plan budgets and ... ...

Abstract	Growth in the availability of cell and gene therapies (CGTs) promises significant innovation in the treatment of serious diseases, but the high cost and one-time administration of CGTs has also raised concern about strain on health plan budgets and inequity in access. We used coverage information from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database for 18 large commercial health plans in the US and information from state Medicaid websites to examine variation in coverage of 11 CGTs in August 2021. We found that US commercial and Medicaid health plans imposed restrictions in 53.5 % and 68.3 % of their coverage policies for the 11 included CGTs, respectively. In addition, we identified significant variation in access to CGTs across commercial plans and across Medicaid plans. Coverage restrictions for certain CGTs were more common than others; clinical requirements were often (but not always) consistent with the inclusion criteria for the clinical trial central to the drug's approval. We conclude that there is variation in access to CGTs, creating differential patient access.
Language	English
Publishing date	2023-10-13
Publishing country	Netherlands
Document type	Journal Article
ISSN	2590-2296
ISSN (online)	2590-2296
DOI	10.1016/j.hpopen.2023.100103
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Oral treatments for outpatient COVID-19: Effectiveness and value.

Beinfeld, Molly / Yeung, Kai / Whittington, Melanie D / Mohammed, Rasheed / Nhan, Emily / Pearson, Steven D

Journal of managed care & specialty pharmacy

2022 Volume 28, Issue 8, Page(s) 903–909

Abstract: DISCLOSURES: ...

Abstract	DISCLOSURES:
MeSH term(s)	COVID-19 ; Cost-Benefit Analysis ; Humans ; Massachusetts ; Outpatients ; Treatment Outcome
Language	English
Publishing date	2022-07-20
Publishing country	United States
Document type	Journal Article
ISSN	2376-1032
ISSN (online)	2376-1032
DOI	10.18553/jmcp.2022.28.8.903
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Mavacamten for hypertrophic cardiomyopathy: effectiveness and value.

Beinfeld, Molly / Wasfy, Jason H / Walton, Surrey / Sarker, Jyotirmoy / Nhan, Emily / Rind, David M / Pearson, Steven D

Journal of managed care & specialty pharmacy

2022 Volume 28, Issue 3, Page(s) 369–375

Abstract: DISCLOSURES: ...

Abstract	DISCLOSURES:
MeSH term(s)	Benzylamines ; Cardiomyopathy, Hypertrophic ; Cost-Benefit Analysis ; Humans ; United States ; Uracil/analogs & derivatives
Chemical Substances	Benzylamines ; MYK-461 ; Uracil (56HH86ZVCT)
Language	English
Publishing date	2022-02-21
Publishing country	United States
Document type	Journal Article
ISSN	2376-1032
ISSN (online)	2376-1032
DOI	10.18553/jmcp.2022.28.3.369
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Anti B-cell maturation antigen CAR T-cell and antibody drug conjugate therapy for heavily pretreated relapsed and refractory multiple myeloma.

Beinfeld, Molly / Lee, Sei / McQueen, Brett / Fluetsch, Noemi / Pearson, Steven D / Ollendorf, Daniel A

Journal of managed care & specialty pharmacy

2021 Volume 27, Issue 9, Page(s) 1315–1320

Abstract: DISCLOSURES: ...

Abstract	DISCLOSURES:
MeSH term(s)	B-Cell Maturation Antigen/economics ; Cost-Benefit Analysis ; Drug Costs ; Humans ; Immunoconjugates/economics ; Immunotherapy, Adoptive/economics ; Multiple Myeloma/drug therapy ; Receptors, Chimeric Antigen ; Recurrence ; Treatment Outcome
Chemical Substances	B-Cell Maturation Antigen ; Immunoconjugates ; Receptors, Chimeric Antigen
Language	English
Publishing date	2021-08-29
Publishing country	United States
Document type	Journal Article
ISSN	2376-1032
ISSN (online)	2376-1032
DOI	10.18553/jmcp.2021.27.9.1315
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: The effectiveness and value of nadofaragene firadenovec, oportuzumab monatox, and pembrolizumab for BCG-unresponsive non-muscle-invasive bladder cancer.

Beinfeld, Molly / Atlas, Steven J / Touchette, Daniel / McKenna, Avery / Rind, David / Pearson, Steven D

Journal of managed care & specialty pharmacy

2021 Volume 27, Issue 6, Page(s) 797–804

Abstract: ... ...

Abstract	DISCLOSURES
MeSH term(s)	Antibodies, Monoclonal, Humanized/economics ; Antineoplastic Agents, Immunological/economics ; BCG Vaccine ; Cost-Benefit Analysis ; Drug Costs ; Genetic Therapy ; Humans ; Models, Economic ; Treatment Outcome ; Urinary Bladder Neoplasms/drug therapy ; Urinary Bladder Neoplasms/physiopathology
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antineoplastic Agents, Immunological ; BCG Vaccine ; pembrolizumab (DPT0O3T46P)
Language	English
Publishing date	2021-05-20
Publishing country	United States
Document type	Journal Article
ISSN	2376-1032
ISSN (online)	2376-1032
DOI	10.18553/jmcp.2021.27.6.797
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Variation in Medicaid and commercial coverage of cell and gene therapies

Molly T. Beinfeld / Julia A. Rucker / Nola B. Jenkins / Lucas A. de Breed / James D. Chambers

Health Policy Open, Vol 5, Iss , Pp 100103- (2023)

2023

Abstract	Growth in the availability of cell and gene therapies (CGTs) promises significant innovation in the treatment of serious diseases, but the high cost and one-time administration of CGTs has also raised concern about strain on health plan budgets and inequity in access. We used coverage information from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database for 18 large commercial health plans in the US and information from state Medicaid websites to examine variation in coverage of 11 CGTs in August 2021. We found that US commercial and Medicaid health plans imposed restrictions in 53.5 % and 68.3 % of their coverage policies for the 11 included CGTs, respectively. In addition, we identified significant variation in access to CGTs across commercial plans and across Medicaid plans. Coverage restrictions for certain CGTs were more common than others; clinical requirements were often (but not always) consistent with the inclusion criteria for the clinical trial central to the drug’s approval. We conclude that there is variation in access to CGTs, creating differential patient access.
Keywords	Genetic therapy ; Insurance ; Medicaid ; Health policy ; Health care economics ; Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2023-12-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Cost-Effectiveness of Nadofaragene Firadenovec and Pembrolizumab in Bacillus Calmette-Guérin Immunotherapy Unresponsive Non-Muscle Invasive Bladder Cancer.

Joshi, Mrinmayee / Atlas, Steven J / Beinfeld, Molly / Chapman, Richard H / Rind, David M / Pearson, Steven D / Touchette, Daniel R

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2022 Volume 26, Issue 6, Page(s) 823–832

Abstract: Objectives: Nadofaragene firadenovec is a gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) undergoing Food and Drug Administration review. Pembrolizumab is approved for treating patients with BCG- ... ...

Abstract	Objectives: Nadofaragene firadenovec is a gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) undergoing Food and Drug Administration review. Pembrolizumab is approved for treating patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS). We evaluated the cost-effectiveness of these treatments compared with a hypothetical therapeutic alternative, at a willingness-to-pay threshold of $150 000 per quality-adjusted life-year (QALY) gained, in CIS and non-CIS BCG-unresponsive NMIBC populations. Methods: We developed a Markov cohort simulation model with a 3-month cycle length and lifetime horizon to estimate the total costs, QALYs, and cost per additional QALY from the health sector perspective. Clinical inputs were informed by results of single-arm clinical trials evaluating the treatments, and systematic literature reviews were conducted to obtain other model inputs. Sensitivity analyses were conducted to assess uncertainty in model results. Results: Nadofaragene firadenovec, at a placeholder price 10% higher than the price of pembrolizumab, had an incremental cost-effectiveness ratio of $263 000 and $145 000 per QALY gained in CIS and non-CIS populations, respectively. Pembrolizumab had an incremental cost-effectiveness ratio of $168 000 per QALY gained for CIS. A 5.4% reduction in pembrolizumab's price would make it cost-effective. The model was sensitive to many inputs, especially to the probabilities of disease progression, initial treatment response and durability, and drug price. Conclusions: The cost-effectiveness of nadofaragene firadenovec will depend upon its price. Pembrolizumab, although not cost-effective in our base-case analysis, is an important alternative in this population with an unmet medical need. Comparative trials of these treatments are warranted to better estimate cost-effectiveness.
MeSH term(s)	Humans ; BCG Vaccine/therapeutic use ; Cost-Benefit Analysis ; Non-Muscle Invasive Bladder Neoplasms ; Urinary Bladder Neoplasms/drug therapy ; Antineoplastic Agents/therapeutic use ; Immunotherapy ; Quality-Adjusted Life Years
Chemical Substances	pembrolizumab (DPT0O3T46P) ; BCG Vaccine ; Antineoplastic Agents
Language	English
Publishing date	2022-12-16
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2022.12.005
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Diagnostic imaging costs: are they driving up the costs of hospital care?

Beinfeld, Molly T / Gazelle, G Scott

Radiology

2005 Volume 235, Issue 3, Page(s) 934–939

Abstract: Purpose: To retrospectively determine how changes in utilization of computed tomography (CT), magnetic resonance (MR) imaging, and other imaging technologies between 1996 and 2002 influenced costs of inpatient hospital care at one large academic medical ...

Abstract	Purpose: To retrospectively determine how changes in utilization of computed tomography (CT), magnetic resonance (MR) imaging, and other imaging technologies between 1996 and 2002 influenced costs of inpatient hospital care at one large academic medical center. Materials and methods: Institutional review board did not require its approval or patient informed consent for studies with use of billing data. Patient anonymity was protected by removal of potentially identifying information. Data on hospital costs for 17 139 patients admitted to Massachusetts General Hospital, Boston, Mass, between 1996 and 2002 were downloaded from hospital cost-accounting system; sample was restricted to inpatients with diagnoses in diagnosis-related groups 014-015 (Stroke and TIA [transient ischemic attack]), 164-167 (Appendectomy), 082 (Lung Cancer), 182-183 (Upper Gastrointestinal Conditions), 148-149 (Colon Cancer), and 243 (Back Problems). For each patient, data on demographics, all products and services used, and costs associated with each product or service were obtained. By using institutional codes, we calculated costs of CT, MR imaging, and total imaging relative to total hospital costs. Statistical analyses were performed with Student t test and multiple linear regression analysis. Results: Between 1996 and 2002, number of inpatient CT and MR images obtained at the hospital more than doubled. In 2002, hospital costs were 155% those of 1996 levels; inpatient imaging costs were 151% those of 1996 levels. Total costs increased an average of 7.8% per year; imaging costs increased 8.3% per year. Although highly variable over the study period, as a percentage of total imaging costs, CT and MR imaging costs appeared to remain stable relative to costs of other imaging modalities. Conclusion: Despite substantial increases in utilization of inpatient CT, MR imaging, and other imaging technologies, diagnostic imaging costs increased at approximately same rate as did total costs for inpatients with several diagnoses. CT and MR imaging do not appear to be driving the cost increases seen between 1996 and 2002.
MeSH term(s)	Costs and Cost Analysis ; Hospitalization/economics ; Humans ; Magnetic Resonance Imaging/economics ; Magnetic Resonance Imaging/utilization ; Retrospective Studies ; Tomography, X-Ray Computed/economics ; Tomography, X-Ray Computed/utilization
Language	English
Publishing date	2005-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	80324-8
ISSN	1527-1315 ; 0033-8419
ISSN (online)	1527-1315
ISSN	0033-8419
DOI	10.1148/radiol.2353040473
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Article: Cost-effectiveness of whole-body CT screening.

Beinfeld, Molly T / Wittenberg, Eve / Gazelle, G Scott

Radiology

2005 Volume 234, Issue 2, Page(s) 415–422

Abstract: Purpose: To make preliminary estimates of the effectiveness (in life-years) and cost-effectiveness (in costs per life-year) of whole-body computed tomographic (CT) screening.: Materials and methods: Costs and effectiveness (in life-years) of onetime ... ...

Abstract	Purpose: To make preliminary estimates of the effectiveness (in life-years) and cost-effectiveness (in costs per life-year) of whole-body computed tomographic (CT) screening. Materials and methods: Costs and effectiveness (in life-years) of onetime whole-body CT screening relative to those of no screening were calculated by using a decision-analytic model. It was assumed that any benefits from screening were due to earlier detection of disease and improvement in survival relative to survival with routine care. Eight conditions were included in the model: ovarian, pancreatic, lung, liver, kidney, and colon cancer; abdominal aortic aneurysm; and coronary artery disease. Costs of the screening examination, follow-up tests, and patient care were estimated. The base-case analysis was performed for a hypothetical cohort of 500 000 self-referred asymptomatic 50-year-old men. For sensitivity analyses, the age and sex of the cohort were varied. Results were expressed in 2001 U.S. dollars per life-year gained. Results: Compared with routine care, whole-body CT screening provided minimal gains in life expectancy (0.016 6 years or 6 days) at an average additional cost of 2513 dollars per patient, or an incremental cost-effectiveness ratio of 151 000 dollars per life-year gained. Most patients (90.8%) had at least one positive finding, but only 2.0% had disease; work-up in patients with a false-positive result of screening accounted for 32.3% of total costs (1720 dollars of 5332 dollars). Results were sensitive to the prevalence of disease, the effect of screening on stage of disease at diagnosis, the specificity of screening, and the costs of follow-up for false-positive findings. Conclusion: Even with assumptions favorable to whole-body CT, implementation of onetime screening would not be cost-effective compared with currently funded medical interventions; follow-up for false-positive findings would add a substantial financial burden to the health care system.
MeSH term(s)	Cost-Benefit Analysis ; Costs and Cost Analysis ; False Positive Reactions ; Female ; Follow-Up Studies ; Humans ; Models, Theoretical ; Neoplasms/diagnostic imaging ; Sensitivity and Specificity ; Tomography, X-Ray Computed/economics ; Tomography, X-Ray Computed/methods
Language	English
Publishing date	2005-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80324-8
ISSN	1527-1315 ; 0033-8419
ISSN (online)	1527-1315
ISSN	0033-8419
DOI	10.1148/radiol.2342032061
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Article: Hospital costs of uterine artery embolization and hysterectomy for uterine fibroid tumors.

Beinfeld, Molly T / Bosch, Johanna L / Gazelle, G Scott

Academic radiology

2002 Volume 9, Issue 11, Page(s) 1300–1304

Abstract: Rationale and objectives: The purpose of this study was to compare the total actual hospital costs of uterine artery embolization (UAE) and hysterectomy for treatment of uterine fibroid tumors and to evaluate factors that might influence cost.: ... ...

Abstract	Rationale and objectives: The purpose of this study was to compare the total actual hospital costs of uterine artery embolization (UAE) and hysterectomy for treatment of uterine fibroid tumors and to evaluate factors that might influence cost. Materials and methods: Total actual hospital costs were collected from the institution's cost accounting system on patients who underwent UAE (n = 57) or hysterectomy (n = 300) for uterine fibroids between 1998 and 2001. Electronic medical records were reviewed to collect clinical information. Standard statistical techniques were used to determine which factors influenced hospital costs. Results: The mean total actual hospital costs of UAE were significantly higher than hysterectomy ($8,223 vs $6,046, P < .0001), but the mean length of stay was shorter (0.95 vs 2.6 days, P < .0001). In linear regression analyses, complications were predictive of increased costs of UAE; length of stay, complications, and laparoscopic hysterectomy were predictive of increased costs of hysterectomy. Conclusion: Hospital costs of UAE were higher than hysterectomy for the treatment of uterine fibroids, but the hospital stays were shorter.
MeSH term(s)	Adult ; Arteries ; Embolization, Therapeutic/adverse effects ; Embolization, Therapeutic/economics ; Female ; Health Care Costs ; Hospital Costs ; Humans ; Hysterectomy/adverse effects ; Hysterectomy/economics ; Leiomyoma/surgery ; Leiomyoma/therapy ; Length of Stay/economics ; Middle Aged ; Uterine Neoplasms/surgery ; Uterine Neoplasms/therapy ; Uterus/blood supply ; Uterus/surgery
Language	English
Publishing date	2002-11-25
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	1355509-1
ISSN	1076-6332
ISSN	1076-6332
DOI	10.1016/s1076-6332(03)80563-9
Database	MEDical Literature Analysis and Retrieval System OnLINE

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