Clinical Impact and Cost-Effectiveness of an Education Program for PD Patients: A Randomized Controlled Trial

Introduction: Randomized clinical trials showed that bortezomib, in addition to conventional chemotherapy, improves survival and disease progression in multiple myeloma (MM) patients not eligible for stem cell transplantation. The aim of this retrospective population-based cohort study is the evaluation of both clinical and economic profile of bortezomib-based versus conventional chemotherapy in daily clinical practice. Methods: Healthcare utilization databases of six Italian regions were used to identify adult patients with non-transplant MM, who started a first-line therapy with bortezomib-based or conventional chemotherapy. Patients were matched by propensity score and were followed from treatment start until death, lost to follow-up or study end-point. Overall survival (OS) and restricted mean survival time (RMST) were estimated using the Kaplan–Meier method. Association between first-line treatment and risk of death was estimated by a conditional Cox proportional regression model. Average mean cumulative costs were estimated and compared between groups. Results: In the period 2010–2016, 3509 non-transplant MM patients met the inclusion criteria, of which 1157 treated with bortezomib-based therapy were matched to 1826 treated with conventional chemotherapy. Median OS and RMST were 33.9 and 27.9 months, and 42.9 and 38.4 months, respectively, in the two treatment arms. Overall, these values corresponded to a HR of death of 0.79 (95% CI 0.71–0.89) over a time horizon of 84 months. Average cumulative cost were 83,839 € and 54,499 €, respectively, corresponding to an incremental cost-effectiveness ratio of 54,333 € per year of life gained, a cost coherent with the willingness-to-pay thresholds frequently adopted from Western countries. Conclusions: These data suggested that, in a large cohort of non-transplant MM patients treated outside the experimental setting, first-line treatment with bortezomib-based therapy was associated with a favourable effectiveness and cost-effectiveness profile.

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“…Non-parametric bootstrap method based on 1000 re-samples 20 was used to explore the uncertainty in the cost-effectiveness estimates. 21 …”

Section: Methodsmentioning

confidence: 99%

Bortezomib-based therapy in non-transplant multiple myeloma patients: a retrospective cohort study from the FABIO project

Franchi

Vener

Garau

et al. 2021

Therapeutic Advances in Hematology

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“…Thus, the ICER represents the additional healthcare expenditure for gaining one year of life due to the treatment with trastuzumab. The non-parametric bootstrap method based on 1000 re-samples [ 26 ] was used to explore the uncertainty in the cost-effectiveness estimates [ 27 ].…”

Section: Methodsmentioning

confidence: 99%

Effectiveness and Healthcare Cost of Adding Trastuzumab to Standard Chemotherapy for First-Line Treatment of Metastatic Gastric Cancer: A Population-Based Cohort Study

Franchi

Tritto

Torroni

et al. 2020

Cancers

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A randomized clinical trial showed that trastuzumab, added to traditional chemotherapy, significantly improved overall survival in human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic gastric cancer patients. This population-based study aimed at evaluating both the clinical and economic impact of trastuzumab in a real-world setting. By using the healthcare utilization databases of Lombardy, Italy, a cohort of patients newly diagnosed with metastatic gastric cancer during the period 2011–2016 was selected. Among these, patients initially treated with either trastuzumab-based chemotherapy or standard chemotherapy alone were followed up until death, migration in other regions or June 2018. Overall survival and average cumulative costs were estimated and compared between the two treatment arms. Among the 1198 metastatic gastric cancer patients who started therapy within six months after metastasis detection, 87 were initially treated with trastuzumab-based chemotherapy and 1111 with standard chemotherapy. Median overall survival and restricted mean survival were 10.2 and 7.4 months, and 14.9 and 11.4 months, respectively, in the two treatment arms. The adjusted hazard ratio of death was 0.73 (95% CI 0.57–0.93). The average per capita cumulative healthcare costs were, respectively, EUR 39,337 and 26,504, corresponding to an incremental cost-effectiveness ratio of EUR 43,998 for each year of survival gained. Our study shows that adding trastuzumab to conventional chemotherapy is effective and cost-effective.

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“…The ICER is the healthcare expenditure expected to be saved (or added, depending on the sign) for gaining one month of life due to starting therapy with a biological drug. A non-parametric bootstrap method based on 1000 re-samples [23] was used to explore the uncertainty in the cost-effectiveness estimates [24].…”

Section: Statistical Analysesmentioning

confidence: 99%

Effectiveness and Costs Associated to Adding Cetuximab or Bevacizumab to Chemotherapy as Initial Treatment in Metastatic Colorectal Cancer: Results from the Observational FABIO Project

Franchi

Garau²,

Kirchmayer

et al. 2020

Cancers

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Evidence available on the effectiveness and costs of biological therapies for the initial treatment of metastatic colorectal cancer (mCRC) is scarce and contrasting. We conducted a population-based cohort investigation for assessing overall survival and costs associated with their use in a real-world setting. Healthcare utilization databases were used to select patients newly diagnosed with mCRC between 2010 and 2016. Those initially treated with biological therapy (bevacizumab or cetuximab) added to chemotherapy were propensity-score-matched to those treated with standard chemotherapy alone, and were followed up to June 30th, 2018. Kaplan–Meier survival estimates, restricted mean survival time (RMST) and cumulative costs were compared between the two treatment arms. The study cohort included 1896 mCRC patients treated with biological therapy matched to 5678 patients treated with chemotherapy alone. Median overall survival was 21.8 and 20.2 months, respectively. After 84 months of follow-up, RMSTs were 30.9 and 31.9 months (p = 0.193), indicating no differences between the average survival time between treatment arms. Patients treated with biological therapy were associated with higher costs. Cumulative per capita costs were €59,663 and €44,399, respectively. In our study, first-line biological therapy did not improve long-term overall survival and was associated with higher costs as compared to standard chemotherapy.

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Clinical Impact and Cost-Effectiveness of an Education Program for PD Patients: A Randomized Controlled Trial

Cited by 18 publications

References 24 publications

Bortezomib-based therapy in non-transplant multiple myeloma patients: a retrospective cohort study from the FABIO project

Bortezomib-based therapy in non-transplant multiple myeloma patients: a retrospective cohort study from the FABIO project

Effectiveness and Healthcare Cost of Adding Trastuzumab to Standard Chemotherapy for First-Line Treatment of Metastatic Gastric Cancer: A Population-Based Cohort Study

Effectiveness and Costs Associated to Adding Cetuximab or Bevacizumab to Chemotherapy as Initial Treatment in Metastatic Colorectal Cancer: Results from the Observational FABIO Project

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