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1.
Value Health ; 25(10): 1685-1695, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35537984

RESUMEN

OBJECTIVES: Several chemoimmunotherapy and targeted treatment regimens are approved as front-line therapies in chronic lymphocytic leukemia. We estimated for the 10-year cost-effectiveness of these treatment regimens and the economic burden of following the estimated risk-stratified 21 040 patients with chronic lymphocytic leukemia diagnosed in 2020 for 10 years. METHODS: A Markov model with 7 exclusive health states was specified over a 10-year time horizon. Treatment effectiveness inputs were obtained from a novel network meta-analysis on the progression-free survival, overall survival curves, and time to next treatment. Costs and utilities inputs were included for each health state for each treatment and discounted at 3.0%/year. Life-years (LYs) and quality-adjusted LYs (QALYs) for each treatment were determined. Using the lowest cost regimen as reference, the incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were estimated. The 10-year per-patient cost was determined by risk status and by initial treatment. RESULTS: Venetoclax-plus-obinutuzumab was the lowest cost regimen, hence the reference. Superior in effectiveness to all chemoimmunotherapies, it was cost saving. With the highest effectiveness gains at 6.26 LYs and 5.01 QALYs and despite being the most expensive regimen ($1 298 638 per patient), acalabrutinib-plus-obinutuzumab yielded the best ICER ($409 343/LY gained) and ICUR ($501 236/QALY gained). The remaining ICERs of targeted therapies ranged from $512 101/LY gained to $793 236/LY gained and the ICURs from $579 737/QALY gained to $869 300/QALY gained. The 10-year postdiagnosis low/high (venetoclax-plus-obinutuzumab/acalabrutinib-plus-obinutuzumab) economic burden ranges were $42 690 to $98 665 for low-risk, $141 339 to $326 660 for intermediate-risk, and $273 650 to $632 453 for high-risk patients. CONCLUSIONS: Compared with venetoclax-plus-obinutuzumab, chemoimmunotherapies are associated with less health benefits at higher cost. The targeted therapies achieve greater benefits at higher cost.


Asunto(s)
Leucemia Linfocítica Crónica de Células B , Benzamidas , Compuestos Bicíclicos Heterocíclicos con Puentes , Análisis Costo-Beneficio , Estrés Financiero , Humanos , Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Cadenas de Markov , Pirazinas , Años de Vida Ajustados por Calidad de Vida , Sulfonamidas
2.
Future Oncol ; 18(3): 363-373, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-34747185

RESUMEN

Aim: To estimate cost-savings from conversion to biosimilar pegfilgrastim-cbqv that could be reallocated to provide budget-neutral expanded access to AC (doxorubicin/cyclophosphamide) and TCH (docetaxel/carboplatin/trastuzumab) in breast cancer (BC) patients. Methods: Simulation modeling in panels of 20,000 BC and 5000 HER2+ (HER2+ BC) patients, varying treatment duration (one-six cycles) and conversion rates (10-100%), to estimate cost-savings and additional AC and TCH treatment that could be provided. Results: In 20,000 patients, cost-savings of $1,083 per-patient per-cycle translate to $21,652,064 (one cycle) to $129,912,397 (six cycles). Savings range from $5,413,016 to $32,478,097, respectively, in the 5000-patient HER2+ BC panel. Conclusion: Conversion to pegfilgrastim-cbqv could save up to $130 million and provide more than 220,000 additional cycles of antineoplastic treatment on a budget-neutral basis to BC patients.


Lay abstract Pegfilgrastim is used to prevent low white blood cell count in patients receiving chemotherapy. Comparable to a generic version of a drug, a biosimilar is a follow-on version of a biologic treatment. We calculated the savings from using biosimilar pegfilgrastim in a hypothetical group of 20,000 patients with breast cancer receiving chemotherapy with AC (doxorubicin/cyclophosphamide). We then computed the number of additional doses of AC chemotherapy that could be purchased with those savings. We did the same for a group of 5000 HER2+ breast cancer patients treated with TCH (docetaxel/carboplatin/trastuzumab). Using biosimilar pegfilgrastim could save $1,083 per patient per cycle. If all patients were treated with biosimilar pegfilgrastim over six cycles, $129.9 million could be saved in the AC group and $32.5 million in the TCH group. This could provide 220,468 additional AC doses and 6981 TCH doses. Biosimilar pegfilgrastim can generate significant savings. These savings can be used to provide additional patients with chemotherapy cost-free.


Asunto(s)
Biosimilares Farmacéuticos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Ahorro de Costo/estadística & datos numéricos , Filgrastim/uso terapéutico , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Polietilenglicoles/uso terapéutico , Anciano , Biosimilares Farmacéuticos/economía , Neoplasias de la Mama/economía , Simulación por Computador , Costos de los Medicamentos , Sustitución de Medicamentos/economía , Sustitución de Medicamentos/estadística & datos numéricos , Femenino , Filgrastim/economía , Humanos , Medicare/economía , Medicare/estadística & datos numéricos , Persona de Mediana Edad , Modelos Económicos , Polietilenglicoles/economía , Estados Unidos
3.
Future Oncol ; 18(19): 2381-2390, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35477322

RESUMEN

Aim: To determine the incidence of chemotherapy-induced febrile neutropenia (FN) and related outcomes after same-day pegfilgrastim in lung cancer. Materials & methods: This single-center, retrospective study evaluated electronic health records of patients with lung cancer treated between 2013-2018. The main end points were incidence of FN and grade 3/4 neutropenia after the first and across all chemotherapy cycles. Results: A total of 114 patients received same-day pegfilgrastim in 384 cycles. The incidence of FN and grade 3/4 neutropenia was 2.3 and 25% after the first chemotherapy cycle and 1.6 and 10.4% across all cycles, respectively. Conclusion: Same-day prophylactic pegfilgrastim in patients with lung cancer may be a suitable option, owing to its low incidence of FN and related outcomes.


Chemotherapy is intended to kill fast-growing cancer cells but can also kill immune cells that are needed to prevent infections. When too many immune cells are killed by chemotherapy, patients with cancer may experience febrile neutropenia, a serious condition that can lead to death in the most severe cases. To prevent this side effect of chemotherapy, a protein that helps certain immune cells to grow (pegfilgrastim) is administered on the day after chemotherapy. To avoid a second clinic visit the day after receiving chemotherapy, it has become common to administer pegfilgrastim on the same day as chemotherapy. Whether this approach is as effective and safe as next-day administration is currently unclear. This study from the University of Arizona Cancer Center showed that in patients with lung cancer who receive chemotherapy, administration of pegfilgrastim on the same day as chemotherapy is a safe, effective method to prevent febrile neutropenia.


Asunto(s)
Neutropenia Febril Inducida por Quimioterapia , Leucopenia , Neoplasias Pulmonares , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neutropenia Febril Inducida por Quimioterapia/epidemiología , Neutropenia Febril Inducida por Quimioterapia/etiología , Neutropenia Febril Inducida por Quimioterapia/prevención & control , Filgrastim , Factor Estimulante de Colonias de Granulocitos/efectos adversos , Humanos , Leucopenia/inducido químicamente , Neoplasias Pulmonares/complicaciones , Neoplasias Pulmonares/tratamiento farmacológico , Polietilenglicoles , Proteínas Recombinantes/efectos adversos , Estudios Retrospectivos
4.
Ann Hematol ; 100(10): 2501-2512, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34279676

RESUMEN

In this population-based study, we used the SEER database (1985-2015) to examine survival outcomes in chronic lymphocytic leukemia (CLL) patients followed up to the era of advanced treatments including targeted therapies. Data were extracted for patients 15 years or older with a primary diagnosis of CLL. A period analysis was performed to estimate 5- and 10-year relative survival rates for patients diagnosed during different calendar periods from 1985 to 2015. A mixture cure model was used to examine long-term survivors' proportions among patients diagnosed in 1985-2015 and for two cohorts diagnosed in 2000-2003, followed up to 2012 and 2004-2007, and followed up to 2015. Cox proportional hazard modeling was used for the two cohorts to estimate hazard ratios (HRs) of death adjusted for gender and age. The 5-year and 10-year age-adjusted relative survival rate ranged between 73.7 and 89.4% and from 51.6% to "not reached," respectively, for calendar periods of 1985-1989 to 2010-2014. The long-term survivor proportions varied by age and gender from 0 to 59%. The HRs (95%CI) for the 2004-2007 cohort in comparison to the 2000-2003 cohort were 0.58 (0.43-0.78), 0.58 (0.48-0.70), 0.57 (0.49-0.0.67), 0.68 (0.54-0.85), and 0.83 (0.68-1.02) for the age categories of 45-54, 55-64, 65-74, 75-84, and ≥ 85 years, respectively. Overall, relative survival improved significantly for CLL patients diagnosed between 1985 and 2015. These improvements were markedly better following the introduction of targeted therapies.


Asunto(s)
Leucemia Linfocítica Crónica de Células B/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Bases de Datos Factuales , Femenino , Humanos , Leucemia Linfocítica Crónica de Células B/terapia , Masculino , Persona de Mediana Edad , Programa de VERF , Análisis de Supervivencia , Estados Unidos/epidemiología , Adulto Joven
5.
Future Oncol ; 17(33): 4561-4570, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34382416

RESUMEN

Aim: To estimate the cost-savings from conversion to biosimilar pegfilgrastim-cbqv that can be reallocated to provide budget-neutral expanded access to FOLFIRINOX in patients with metastatic pancreatic cancer. Methods: Simulation modeling in a panel of 2500 FOLFIRINOX-treated patients, using varying treatment duration (1-12 cycles) and conversion rates (10-100%), to estimate cost-savings and additional FOLFIRINOX treatment that could be budget neutral. Results: In a 2500-patient panel at 100% conversion, savings of US$6,907.41 per converted patient over 12 cycles of prophylaxis translate to US$17.3 million and could provide 72,273 additional FOLFIRINOX doses or 6023 full 6-month regimens. Conclusion: Conversion to biosimilar CIN/FN prophylaxis can generate significant cost-savings and provide budget-neutral expanded access to FOLFIRINOX treatment for patients with metastatic pancreatic cancer.


Lay abstract Pegfilgrastim is used to prevent low white blood cell count in patients receiving chemotherapy. Comparable to a generic version of a drug, a biosimilar is a follow-on version of a biologic treatment. The authors calculated the savings from using biosimilar pegfilgrastim in a hypothetical group of 2500 patients with metastatic pancreatic cancer and then computed the number of additional doses of FOLFIRINOX chemotherapy that could be purchased with those savings. Using biosimilar pegfilgrastim for 12 cycles could save US$6,907.41 per patient. If all 2500 patients were treated with biosimilar pegfilgrastim, US$17.3 million could be saved. This could provide 72,273 additional FOLFIRINOX doses. Biosimilar pegfilgrastim can generate significant savings to purchase chemotherapy for additional patients cost-free.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/economía , Biosimilares Farmacéuticos/economía , Filgrastim/economía , Neoplasias Pancreáticas/tratamiento farmacológico , Polietilenglicoles/economía , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Simulación por Computador , Ahorro de Costo/estadística & datos numéricos , Análisis Costo-Beneficio , Costos de los Medicamentos , Filgrastim/uso terapéutico , Fluorouracilo/economía , Fluorouracilo/uso terapéutico , Accesibilidad a los Servicios de Salud/economía , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Humanos , Irinotecán/economía , Irinotecán/uso terapéutico , Leucovorina/economía , Leucovorina/uso terapéutico , Persona de Mediana Edad , Modelos Económicos , Oxaliplatino/economía , Oxaliplatino/uso terapéutico , Neoplasias Pancreáticas/economía , Neoplasias Pancreáticas/patología , Polietilenglicoles/uso terapéutico , Programa de VERF/estadística & datos numéricos
6.
Future Oncol ; 17(26): 3485-3497, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34241542

RESUMEN

Aim: To compare the incidence of febrile neutropenia and related outcomes of prophylactic same-day versus next-day pegfilgrastim/pegfilgrastim-cbqv in patients with lymphoma receiving cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone (CHOP)-like chemotherapy. Methods: Retrospective, real-world, single-institution study. Results: 93 patients received 460 cycles of CHOP-like chemotherapy. The incidence of febrile neutropenia and grade 3/4 chemotherapy-induced neutropenia was 5 and 16.5%, respectively. In 401 cycles pegfilgrastim was administered same-day versus 12 cycles next-day. Febrile neutropenia occurred in 17 cycles versus 0 cycles (p = 1.00) and grade 3/4 chemotherapy-induced neutropenia in 65 cycles (16.2%) versus 1 cycle (16.7%; p = 1.00) with same-day versus next-day pegfilgrastim administration, respectively. Conclusion: Pegfilgrastim may be safely administered on the same day as chemotherapy in patients with lymphoma receiving CHOP-like chemotherapy.


Lay abstract Aside from killing cancer cells, chemotherapy can also affect the growth of immune cells that normally prevent infections. Without enough of these immune cells in the blood, the patient's body cannot fight infections. This can lead to a serious condition called febrile neutropenia, and death in the most severe cases. Pegfilgrastim, a growth factor that helps important types of immune cells to grow, can prevent this side effect of chemotherapy. Usually, pegfilgrastim is administered the day after chemotherapy but there is a trend to administer it on the day of chemotherapy, but whether this is effective and safe is currently unclear. This study from the University of Arizona Cancer Center showed that administration of pegfilgrastim on the same day as chemotherapy is a safe, effective method of preventing febrile neutropenia in patients who receive standard-of-care chemotherapy to treat lymphoma.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neutropenia Febril Inducida por Quimioterapia/epidemiología , Linfoma/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Ciclofosfamida/administración & dosificación , Doxorrubicina/administración & dosificación , Femenino , Filgrastim/administración & dosificación , Estudios de Seguimiento , Factor Estimulante de Colonias de Granulocitos/administración & dosificación , Humanos , Linfoma/patología , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados no Aleatorios como Asunto , Polietilenglicoles/administración & dosificación , Prednisona/administración & dosificación , Pronóstico , Estudios Retrospectivos , Rituximab/administración & dosificación , Estados Unidos/epidemiología , Vincristina/administración & dosificación , Adulto Joven
7.
Clin Lymphoma Myeloma Leuk ; 24(3): 177-186, 2024 03.
Artículo en Inglés | MEDLINE | ID: mdl-37996264

RESUMEN

BACKGROUND: We sought to understand the clinical effectiveness associated with use of hypomethylating agents (HMAs) azacitidine (AZA) and decitabine (DEC) for patients with refractory anemia with excess blasts (RAEB; an established proxy for higher-risk myelodysplastic syndromes/neoplasms) in contemporary and representative real-world settings. PATIENTS AND METHODS: We used the Surveillance, Epidemiology and End Results (SEER)-Medicare database, a linkage of cancer registry and Medicare claims data, to identify patients aged ≥ 66 years diagnosed with RAEB, between 2009 and 2017 in the United States, and who received AZA or DEC as first-line therapy. Outcomes measured were overall survival (OS), event-free survival (EFS), and incidence of progression-related acute myeloid leukemia (AML). RESULTS: Of 973 eligible patients, 738 (75.8%) received AZA and 235 (24.2%) received DEC; 6.4% received hematopoietic cell transplantation during follow-up. In the overall population, median OS was 13.9 months (95% confidence interval [CI]: 12.9-15.0), median EFS was 5.2 months (95% CI: 4.9-5.7), and 38.0% of patients progressed to AML. Incidences of AML progression and death were 25.6% and 29.9%, respectively, at Year 1, and 34.3% and 44.8%, respectively, at Year 2. There were no significant differences in clinical benefits between AZA and DEC. CONCLUSION: Median OS with both HMAs remained significantly shorter than in the AZA-001 clinical trial, highlighting how patient outcomes vary between clinical and real-world settings. Further research is required to understand why these disparities exist.


Asunto(s)
Anemia Refractaria con Exceso de Blastos , Leucemia Mieloide Aguda , Humanos , Anciano , Estados Unidos/epidemiología , Anemia Refractaria con Exceso de Blastos/tratamiento farmacológico , Decitabina/farmacología , Decitabina/uso terapéutico , Antimetabolitos Antineoplásicos/farmacología , Antimetabolitos Antineoplásicos/uso terapéutico , Medicare , Azacitidina/uso terapéutico , Leucemia Mieloide Aguda/tratamiento farmacológico
8.
J Adv Pract Oncol ; 13(8): 796-811, 2022 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-36727017

RESUMEN

Background: Pegfilgrastim is recommended to be administered at least 24 hours following the completion of chemotherapy, yet some clinicians use a same-day administration protocol. In this meta-analysis, we compared the incidence of chemotherapy-induced (febrile) neutropenia (CIN/FN) as well as CIN/FN-related chemotherapy disruptions in cancer patients provided with pegfilgrastim same-day vs. next-day. Methods: Six databases were searched for comparative studies of same-day vs. next-day pegfilgrastim administration. Fixed or random-effects meta-analyses were conducted to estimate pooled odds ratios (ORs) and 95% confidence intervals (CIs). Results: Thirteen studies were included in this meta-analysis. The FN OR for same-day vs. next-day administration was 1.48 (95% CI = 1.06-2.08) across all cycles, attributable mainly to studies of high FN risk (OR = 2.46, 95% CI = 1.04-5.83) vs. intermediate FN risk regimens (OR = 1.41, 95% CI = 0.95-2.10), and breast cancer (OR = 3.15, 95% CI = 1.24-8.01) vs. non-Hodgkin lymphoma (NHL; OR = 1.48, 95% CI = 0.98-2.23) and gynecologic cancers (OR = 0.64, 95% CI = 0.11-3.85). Where available, ORs for first cycle of chemotherapy, grades 3 and/or 4 CIN, and chemotherapy dose delays or reductions were in line with these findings. Conclusion: In this independent study, same-day pegfilgrastim administration may or may not increase the likelihood of FN, grades 3 and/or 4 CIN, and chemotherapy dose reductions or delays; and this may be a function of the myelotoxicity of the regimens (elevated in high-risk but not intermediate-risk regimens) and tumor type (elevated in breast but not in NHL or gynecologic cancers). With due caution, same-day pegfilgrastim administration may be safe and beneficial in intermediate-risk regimens and selected tumor types.

9.
J Manag Care Spec Pharm ; 28(4): 390-400, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35332792

RESUMEN

BACKGROUND: Ibrutinib, acalabrutinib, and zanubrutinib have shown improvements in efficacy and safety over conventional chemoimmunotherapy in refractory or relapsed mantle cell lymphoma (R/R MCL). OBJECTIVE: To evaluate the comparative cost-effectiveness of the Bruton's tyrosine kinase inhibitors (BTKIs) and estimate the expected value of (partial) perfect information (EV[P]PI) in terms of net health benefits (NHBs) and net monetary benefits (NMBs) forgone. METHODS: Using a two-state Markov model (progression-free; progression or death), we estimated in base-case and probabilistic sensitivity analyses (PSAs) the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) of, respectively, progression-free survival (PFS) life-years (PFLYs) and PFS quality-adjusted LY (PFQALY) gained (g) against 3-year and 5-year time horizons. A willingness-to-pay threshold of $150,000/PFQALY was used to assess the probability of being cost-effective in the PSA. EVPI was calculated from the respective NHBs and NMBs. RESULTS: Compared with ibrutinib, acalabrutinib yielded a 3-year ICER of $90,571 (PSA = $88,588)/PFLYg and ICUR of $117,098 ($110,063)/PFQALYg, whereas zanubrutinib yielded a 3-year ICER of $58,422 ($58,907)/PFLYg and ICUR of $73,027 ($73,634)/PFQALYg. The corresponding 5-year estimates were ICER of $73,918 ($74,189)/PFLYg and ICUR of $90,512 ($90,844)/PFQALYg for acalabrutinib and ICER of $48,641 ($48,732)/PFLYg and ICUR of $61,612 ($63,727)/PFQALYg for zanubrutinib. Compared with zanubrutinib, treatment with acalabrutinib yielded a 3-year ICER of $144,633 ($134,964)/PFLYg and ICUR of $197,227 ($166,109)/PFQALYg; the corresponding 5-year estimates were $117,579 ($118,161)/PFLYg and $136,144 ($136,818)/PFQALYg. The EVPI/patient was an NHB of 0.036 PFQALYs and NMB of $3,602 forgone, resulting in a population EVPI of $134,766,957 forgone. The EVPPIs/patient for effectiveness were NHB of 0.015 PFQALYs and NMB of $1,479, with corresponding values of 0.032 and $3,187 for costs and 0.015 and $1,519 for health-related quality of life forgone. CONCLUSIONS: This early cost-effectiveness analysis based on phase I/II clinical trials of BTKIs in R/R MCL suggests an additional PFS benefit for second-generation BTKIs compared with ibrutinib. However, the relative uncertainty due to the lack of direct trial evidence may lead to an opportunity cost or lost health benefits if the current evidence is adopted to compare between these products. Additional evidence is needed to address the relative efficacy of the BTKIs. DISCLOSURES: A. McBride serves on speakers bureaus for Coherus BioSciences and Merck. He is now at Bristol-Myers Squibb in a position unrelated to this study. I. Abraham is joint equity owner in Matrix45. By company policy, owners and employees are prohibited from owning equity in client and sponsor organizations (except through mutual funds or other independently administered collective investment instruments), contracting independently with client and sponsor organizations, or receiving compensation independently from such organizations. Matrix45 provides similar services to biopharmaceutical, diagnostics, and medical device companies on a nonexclusivity basis. Of relevance to this article, Matrix45 has not provided any services to this study. I. Abraham is the quantitative methods editor of JAMA Dermatology and deputy editor-in-chief of the Journal of Medical Economics. The remaining authors have no relevant financial or nonfinancial interests to disclose.


Asunto(s)
Linfoma de Células del Manto , Adulto , Análisis Costo-Beneficio , Humanos , Linfoma de Células del Manto/tratamiento farmacológico , Masculino , Inhibidores de Proteínas Quinasas/uso terapéutico , Calidad de Vida , Estados Unidos
10.
Expert Opin Biol Ther ; 21(12): 1647-1653, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34693839

RESUMEN

BACKGROUND: Talimogene laherparepvec (T-VEC) improves overall survival (OS) in unresectable stage IIIB/C-IV melanoma T-VEC may have synergistic effects with CTLA-4 inhibitors In the absence of a trial comparing T-VEC and ipilimumab (T-VEC + IPI) to T-VEC, we applied a novel indirect comparison method using extrapolated OS curves to estimate OS outcomes in a simulated trial comparing both regimens in stage IIIB/C-IV unresectable melanoma. RESEARCH DESIGN AND METHODS: Two trials with extractable OS curves for a T-VEC versus T-VEC + IPI comparison were identified. Outcomes were adjusted for heterogeneity in prognostic factors using a calculated adjustment factor. T-VEC and adjusted/unadjusted T-VEC+IPI curves were plotted with 95% CIs. RESULTS: Unadjusted indirect OS comparison of T-VEC versus T-VEC + IPI revealed no significant difference up to 15 months. Extrapolation beyond 15 months showed significant survival benefits for T-VEC + IPI over T-VEC, confirmed in adjusted analyses. The expected OS percentage at 48 months is 32.0% (95% CI = 26.6-37.3) for T-VEC, 60.0% (95% CI = 46.2-69.1) for unadjusted, and 81.1% (95% CI = 72.3-85.9) for adjusted T-VEC + IPI. CONCLUSIONS: Our novel indirect comparison suggests that T-VEC + IPI may demonstrate a significantly improved OS versus T-VEC alone. Findings may portend a possible role for the addition of T-VEC to advanced melanoma treatment regimens in select patients as salvage therapy.


Asunto(s)
Melanoma , Viroterapia Oncolítica , Neoplasias Cutáneas , Productos Biológicos , Herpesvirus Humano 1 , Humanos , Ipilimumab/uso terapéutico , Melanoma/tratamiento farmacológico , Terapia Recuperativa , Neoplasias Cutáneas/tratamiento farmacológico
11.
Clin Lymphoma Myeloma Leuk ; 21(11): e820-e831, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34274291

RESUMEN

BACKGROUND: Multiple treatment options in first-line chronic lymphocytic leukemia (CLL) pose a challenge in identifying the best treatment. We performed novel network meta-analyses (NMA; 8 trials, 11 treatments) on the Kaplan-Meier curves to compare treatments for fludarabine-ineligible patients on progression-free survival (PFS), time-to-next-treatment (TTNT) and overall survival (OS). METHODS: Using the Guyot method of enhanced secondary analysis of digitized survival data and applying the fixed lognormal distribution model, we extracted the survival proportions and hazard ratios (HR) over 60 months of follow-up, including PFS comparisons by unmutated/mutated IGHV and del 17p. RESULTS: Acalabrutinib-plus-obinutuzumab was associated with higher 5-year PFS proportions than ibrutinib (HR = 0.42, 95% CrI = 0.25-0.63) but not acalabrutinib, ibrutinib-plus-obinutuzumab, ibrutinib-plus-rituximab or venetoclax-plus-obinutuzumab. In patients with un-mutated (but not with mutated) IGHV higher PFS proportions and favorable HRs were observed for acalabrutinib, acalabrutinib-plus-obinutuzumab, and ibrutinib-plus-obinutuzumab relative to ibrutinib; and targeted therapies were superior over chemoimmunotherapies in patients with del 17p. Targeted therapies containing ibrutinib or acalabrutinib regimens were associated with superior TTNT over venetoclax-plus-obinutuzumab and all chemoimmunotherapies. OS NMA generally found no difference between therapies except for some chemoimmunotherapies. CONCLUSIONS: Overall, only acalabrutinib-plus-obinutuzumab was associated with superior 5-year PFS gains over ibrutinib, which in turn was similar or superior in PFS benefit over other targeted therapies. Acalabrutinib and ibrutinib with obinutuzumab and acalabrutinib monotherapy were associated with greater 5-year TTNT benefits. Despite marked 5-year OS for many regimens, a differential 5-year OS benefit could not be ascertained.


Asunto(s)
Leucemia Linfocítica Crónica de Células B/tratamiento farmacológico , Leucemia Linfocítica Crónica de Células B/mortalidad , Humanos , Estimación de Kaplan-Meier , Metaanálisis en Red
12.
J Med Econ ; 24(sup1): 34-41, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34866529

RESUMEN

OBJECTIVES: To demonstrate how medical purchasing power parities (mPPP) may harmonize economic evaluations from different jurisdictions and enable comparisons across jurisdictions. METHODS: We describe the use of mPPPs and illustrate this with an example of economic evaluations of nab-paclitaxel with gemcitabine (Nab-P + Gem) versus gemcitabine monotherapy in the setting of metastatic pancreatic cancer. Following a literature search, we extracted data from cost-effectiveness studies on these treatments performed in various countries. mPPPs from the Organization for Economic Co-operation and Development were used to convert reported costs in the jurisdiction of origins to US dollars for the most current year using two possible pathways: (1) reported costs first adjusted by mPPP then adjusted by exchange index; and (2) reported costs first adjusted by exchange index then adjusted by mPPP. RESULTS: Despite many of the pharmaco-economic evaluations sharing similar assumptions and inputs, even after mPPP conversion, residual heterogeneity was attributable to perspectives, discount rate, outcomes, and costs, among others; including in studies conducted in the same jurisdiction. CONCLUSION: Despite the methodological challenges and heterogeneity within and across jurisdictions, we demonstrated that mPPP offers a way to compare economic evaluations across jurisdictions.


Asunto(s)
Neoplasias Pancreáticas , Análisis Costo-Beneficio , Humanos
13.
J Med Econ ; 23(12): 1466-1476, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33023360

RESUMEN

AIMS: In this pharmacoeconomic simulation, we: (1) modeled the cost-efficiency of converting patients from reference pegfilgrastim to biosimilar pegfilgrastim-cbqv for prophylaxis of chemotherapy-induced (febrile) neutropenia (CIN/FN) from the US payer perspective, (2) simulated how savings enable, on a budget-neutral basis, expanded access to pegfilgrastim-cbqv, and (3) estimated the number-needed-to-convert (NNC) to purchase one additional dose of pegfilgrastim-cbqv. METHODS: In a hypothetical panel of 20,000 patients, we modeled cost-savings utilizing: two reference formulations (pre-filled syringe [PFS] and on-body injector [OBI]), three medication cost inputs (average sales price [ASP], wholesale acquisition cost [WAC], and an age-proportionate blended ASP/WAC rate), administration cost for injection (PFS) and device application (OBI), conversion rates of 10-100%, and 1-6 cycles of prophylaxis. Cost-savings were used to estimate additional doses of pegfilgrastim-cbqv that could be purchased and the NNC to purchase one additional dose. RESULTS: Using ASP and 10% conversion from reference OBI to pegfilgrastim-cbqv, savings range from $326,744 (1 cycle) to $2.0M (6 cycles) which could provide 93-556 additional doses of pegfilgrastim-cbqv, respectively; the NNC to purchase one additional dose of pegfilgrastim-cbqv ranges from 21.6 (1 cycle) down to 3.6 patients (6 cycles). The WAC model saves $41.1M per cycle and $246.7M over 6 cycles at 100% conversion from reference PFS which could provide 9,709-58,253 additional pegfilgrastim-cbqv doses; the NNC ranges from 2.1 (1 cycle) to 0.3 (6 cycles). Using the blended ASP/WAC rate, converting 50% from reference OBI to pegfilgrastim-cbqv would save $10.2M per cycle and $60.9M over 6 cycles providing 2,638-15,829 additional doses of pegfilgrastim-cbqv; NNCs are 3.8 (1 cycle) and 0.6 patients (6 cycles). CONCLUSIONS: Converting 20,000 patients from reference to pegfilgrastim-cbqv over 6 cycles can generate savings up to $246.7M, enough to purchase up to 58,253 additional doses of pegfilgrastim-cbqv. This simulation provides economic justification for prophylaxis with biosimilar pegfilgrastim-cbqv.


Asunto(s)
Antineoplásicos , Biosimilares Farmacéuticos , Neutropenia , Filgrastim , Humanos , Neutropenia/inducido químicamente , Neutropenia/tratamiento farmacológico , Neutropenia/prevención & control , Polietilenglicoles
14.
Int J Clin Pharm ; 41(5): 1193-1201, 2019 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31377967

RESUMEN

Background A decade ago, clinical pharmacy was a new concept in hospital settings in Jordan, as evidenced in our 2006/2007 study. Changes in the perceptions, expectations, and experiences of physicians regarding the role of clinical pharmacists need to be investigated. Objective To document physicians' perceptions and expectations of, and experiences with, clinical pharmacists in hospital settings in 2017, and to assess differences in these areas between the 2017 and the 2006/2007 samples. Setting: The study was conducted at four hospitals in the north of Jordan. Method Physicians completed a self-administered questionnaire similar to the one used in our 2006/2007 study, which recorded demographics and assessed physicians' perceptions, expectations, and experiences regarding clinical pharmacists. Data of the 2017 sample were analyzed and compared descriptively to those of the 2006/2007 sample. Main outcome measure Physicians' perceptions, expectations, and experiences of pharmacists in hospital settings in 2017. Results Two hundred and ninety-five physicians completed the questionnaire. Physicians in the 2017 sample were most comfortable with pharmacists suggesting the use of prescription medications such as antibiotics (53.6%). Physicians in the 2017 cohort agreed with the eight expectations stated in the questionnaire. Physicians' experiences with clinical pharmacists improved in 2017 from 2006/2007 in all eight areas evaluated. Conclusion Physicians' perceptions, expectations, and experiences towards the professional role of pharmacists have changed over the past 10 years in Jordan.


Asunto(s)
Actitud del Personal de Salud , Farmacéuticos , Médicos , Adulto , Factores de Edad , Anciano , Estudios de Cohortes , Prescripciones de Medicamentos , Femenino , Humanos , Relaciones Interprofesionales , Jordania , Masculino , Persona de Mediana Edad , Servicio de Farmacia en Hospital , Rol Profesional , Estudios Prospectivos , Encuestas y Cuestionarios
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