A Juarez-Garcia

Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation

BackgroundNew immuno-oncology (I-O) therapies that harness the immune system to fight cancer call for a re-examination of the traditional parametric techniques used to model survival from clinical trial data. More flexible approaches are needed to capture the characteristic I-O pattern of delayed treatment effects and, for a subset of patients, the plateau of long-term survival.ObjectivesUsing a systematic approach to data management and analysis, the study assessed the applicability of traditional and flexible approaches and, as a test case of flexible methods, investigated the suitability of restricted cubic splines (RCS) to model progression-free survival (PFS) in I-O therapy.MethodsThe goodness of fit of each survival function was tested on data from the CheckMate 067 trial of monotherapy versus combination therapy (nivolumab/ipilimumab) in metastatic melanoma using visual inspection and statistical tests. Extrapolations were validated using long-term data for ipilimumab.ResultsModelled PFS estimates using traditional methods did not provide a good fit to the Kaplan–Meier (K–M) curve. RCS estimates fit the K–M curves well, particularly for the plateau phase. RCS with six knots provided the best overall fit, but RCS with one knot performed best at the plateau phase and was preferred on the grounds of parsimony.ConclusionsRCS models represent a valuable addition to the range of flexible approaches available to model survival when assessing the effectiveness and cost-effectiveness of I-O therapy. A systematic approach to data analysis is recommended to compare the suitability of different approaches for different diseases and treatment regimens.

Patrones de Tratamiento y Costo de Atención del Cáncer de Mama Avanzado Con Falla a Antraciclinas y Taxanos en 3 Hospitales Públicos de México

OBJECTIVES In Mexico, breast cancer is the second leading cause of cancer mortality among females. For patients with advanced breast cancer (ABC) resistant to anthracyclines and taxanes (AT), there are limited treatment options. There is a scarcity of data regarding clinical management of this population and treatment costs at this stage of the disease. The objective of this study was to describe the treatment patterns of care for metastatic breast cancer after AT and the associated cost from the point-of-view of the Mexican Public Health Care Sector. METHODS Between January 1, 2004 and December 31, 2007, a retrospective cohort of adult female ABC patients resistant to AT was developed by reviewing and extracting key data from medical charts. We conducted a retrospective, transversal and descriptive analysis of the patient data. Target population data files were obtained from 414 patients from 3 public hospitals in México. RESULTS Capecitabine, vinorelbine and cyclophosphamide were the most commonly prescribed agents, however clinical drug therapy management of the disease was different within and among the three hospitals included in the study. This difference translated into a disparity of prescription costs, ranging from an average of

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

122.22 pesos/patient/month (cyclophosphamide, IC 95%

PDB19 BUDGET IMPACT ANALYSIS OF SAXAGLIPTIN FOR THE TREATMENT OF TYPE 2 DIABETES IN MEXICAN POPULATION AT PEMEX

94.43-

Apixaban In Patients With Atrial Fibrillation: Patient Characteristics Of The Latin America Cohort From A Multinational Clinical Trial

150.01) to

Cost-Effectiveness of Apixaban Versus Other New Oral Anticoagulants And Warfarin for Stroke Prevention In Atrial Fibrillation In Venezuela.

37,835.53 pesos/patient/month (capecitabine+trastuzumab IC 95%

Diferenciación en la Evaluación Económica Tradicional para Medicamentos que se Utilizan en Fases Terminales, Recomendaciones Recientes del Reino Unido y su Consideración para México y otros Países

34,953.18-

I-O Optimise: Developing A Unique Multinational Real-World Evidence-Based Research Platform In Oncology

40,717.88) for the first treatment after AT. CONCLUSIONS The results highlight a lack of standardized care for patients and suggest that differences in treatment patterns are not only a reflection of scarcity of scientific data and diversity of prescription preferences among physicians but also of economic restrictions. Ultimately, there is a clear unmet medical need to be addressed through evidence-based medicine alternatives that support efficacy and cost effectiveness treatments.

Real-World Treatment Patterns and Costs of Care Among Brentuximab Vendotin-Treated Patients with Hodgkin Lymphoma in The United States

Background Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. Materials and methods This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). Results The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Conclusion Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

Cost-Efficacy Analysis Of Ipilumumab In Peru

of risk factors, and smoking status. Patients with ≥4 risk factors account for 71.7% of current glycemic control group, while this value reached 84.3% in the uncontrolled group (P < 0.0001). CONCLUSIONS: In one out of seven patients with DM2 and poor glycemic control, none action to intensify treatment has been taken during the past 2 years. Patients without current glycemic control have more than two times higher clinical inertia than the controlled ones. Intensifi cation of treatment is twice as common in patients currently uncontrolled (85.1% vs. 44.9%).