Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece. A health economic model was used to project clinical and economic outcomes of patients receiving empagliflozin plus SoC compared with those receiving SoC alone over a lifetime horizon. CV and renal event rates were derived from patient level data from the EMPA-REG-OUTCOME® trial by fitting time-dependent parametric survival functions. 5000 individual patient profiles randomly sampled from the trial were simulated using a time-to-event approach. Model extrapolated outcomes included life years (LYs), quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER). Following a Greek third-party payer perspective, only direct medical costs related to drug acquisition as well as fatal and non-fatal diabetes-related complications were considered (€2016). Cost units and utility data were extracted from the literature and publicly available official sources. Sensitivity analyses explored the impact of changes in input data. Over a patient’s lifetime, empagliflozin was predicted to result in longer mean survival (14.01 LY vs. 11.87 LY with SoC) and reduced rate of clinical events accumulating 7.75 QALYs versus 6.83 QALYs on SoC alone at additional costs of €4235. The generated ICER of empagliflozin was €4633 per QALY gained. One-way sensitivity analysis confirmed empagliflozin’s cost-effective profile. At the defined willingness-to-pay threshold of €34,000 per QALY gained, probabilistic sensitivity analysis showed that empagliflozin was estimated to have a 100% probability of being cost-effective relative to SoC. Empagliflozin added to SoC was estimated to be a highly cost-effective treatment option for the treatment of T2DM in adults with increased CV disease risk in Greece.

Cost-Effectiveness of Empagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus at Increased Cardiovascular Risk in Greece.

It has been nearly 5 decades since Congress passed the 1971 National Cancer Act to strengthen the National Cancer Institute’s ability to eliminate the suffering from cancer.1 Most early efforts of the National Cancer Institute focused on development of cancer therapeutics. Later, Congress passed the 21st Century Cancer Access to Life-Saving Early Detection, Research and Treatment Act to increase the national research focus on prevention and early detection.2

Data from this period in US health care history suggest that the investments in prevention, screening, and treatment have together reduced cancer mortality by 27% over the past quarter of a century.3 The present era holds the promise to further reduce mortality with an explosion of scientific discoveries and new technologies based on knowledge about personal, lifestyle, genetic, and molecular disease factors.4-9 Although these recent advances have the potential to avoid cancer incidence,10 detect cancer earlier, and/or improve cancer survival, it has become increasingly complex to determine which intervention has the best value or the greatest improvement in health outcomes for the US population at the most reasonable and affordable costs.11,12

Economic evaluation provides data on several aspects of cancer care that can be used to address discussions about value and inform policies and guidelines.13,14 Cost-effectiveness analysis is the most common economic evaluation tool currently used to inform public health policy decisions, resource allocation, and investment decisions (eg, purchase of equipment or coverage of a specific drug). Although cost effectiveness does not capture all aspects of value to the system, payers, or consumers, it can be useful to assess whether investments in a new technology or drug extend life and at what added cost compared with current standard of care.

In this study, we review modern breast cancer prevention, screening, and treatment cost-effectiveness analyses. We focus on breast cancer because it is a common cancer, accounts for the largest proportion of cancer economic analyses,15 has seen major advances in technology and shifts in treatment paradigms, and has cost-effectiveness analyses research spanning prevention through treatment. The results of the review are intended to determine whether new technology and therapies have improved population breast cancer outcomes at reasonable ranges of economic value, highlight gaps in the field, and inform the design of future economic analyses conducted to inform decisions about the value and prioritization of investments in breast cancer prevention and control.

Systematic Review of the Cost Effectiveness of Breast Cancer Prevention, Screening, and Treatment Interventions

Venous thromboembolism (VTE), comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is a major healthcare concern that results in substantial morbidity and mortality with great economic burden for healthcare systems. Hence, the need for effective and efficient treatment of patients with VTE is important for both clinical and economic reasons. The objective of this study was to evaluate the cost effectiveness of rivaroxaban compared to standard of care (SoC) with enoxaparin followed by dose-adjusted vitamin-K antagonists for the treatment of DVT and PE in Greece. An existing Markov model was locally adapted from a third-party payer perspective to reflect the management and complications of DVT and PE in the course of 3-month cycles, up to death. The clinical inputs and utility values were extracted from published studies. Direct medical costs, obtained from local resources, were incorporated in the model and refer to year 2017. Both costs and outcomes were discounted at 3.5%. The incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) gained was calculated. Probabilistic sensitivity analysis (PSA) was carried out to deal with uncertainty. The base-case analysis showed that rivaroxaban in 3- and 6-month treatment duration for DVT and PE, respectively, as this is the common clinical practice in Greece, was associated with a 0.02 and 0.01 increment in QALYs compared to SoC, respectively. Rivaroxaban was associated with a reduced total cost in DVT (€85) but with an additional total cost in PE (€2) compared to SoC. Therefore, rivaroxaban was a dominant (less costly, more effective) and cost-effective (ICER: €177) alternative over SoC for the management of DVT and PE, respectively. PSA revealed that the probability of rivaroxaban being cost effective at a threshold of €34,000 per QALY gained was 99% and 81% for DVT and PE, respectively. Rivaroxaban may represent a cost-effective option relative to SoC for the management of DVT and PE in Greece.

Cost-Effectiveness Analysis of Rivaroxaban for Treatment of Deep Vein Thrombosis and Pulmonary Embolism in Greece

[Background]
Medical technology is increasing the number of available treatments for cancer. For advanced cancer an increasing number of treatments can result in an increasing treatment sequence. Treatments are given one after another in a cycle of treatment, failure and then another treatment. Newly added treatments may not replace existing treatments. The movement of existing treatments into later lines of therapy is displacement.
Displacement poses challenges for economic evaluation. This thesis addresses three questions.
1. Does the displacement of a treatment alter its cost-effectiveness?
2. If the cost-effectiveness becomes less favourable can any resulting societal welfare loss be corrected by changing the price?
3. Can the required price change be calculated in Australia?
[Methods]
A theoretical framework is developed for displacement in cancer treatment. The implications of decision-making criteria and information gaps are assessed. Real-world data is used to estimate the number of treatments and lines of therapy received by patients, and costs of care. A systematic review and meta-analysis of randomised controlled trials which reported treatment outcomes of multiple lines of therapy is undertaken. The cost-effectiveness of displacing treatments for breast cancer, colorectal cancer and non-small cell lung cancer are modelled.
[Results]
The displacement of a treatment may result in dynamic and allocative inefficiencies. Real-world data showed 13-18% of participants received four or more lines of therapy. The mean health services cost of cancer care was approximately $4 000 per month. Displacement resulted in decreased effectiveness, an increased toxicity per unit time and reduced treatment length.
In the modelling, there was an increase in the incremental cost-effectiveness ratio with displacement. After displacement, reducing the price of cancer treatments by 32% was required to restore cost-effectiveness.
[Conclusions]
There is the potential for displacement in Australia. Displacement results in an increasing incremental cost-effectiveness ratio of a treatment. This can be corrected with price changes in most circumstances.
The Australian real-world data did not record all the treatments that were received by patients. Therefore, it is not able to be used to calculate the price changes that are required with displacement.
The addition of new treatments in Australia should consider the impact of displacement on currently subsidised treatments. A failure to do this results in biased assessments of the benefits and costs of new treatments. It will likely underestimate the cost and overestimate the benefit. Therefore, the potential for displacement should be considered in cancer treatment funding to ensure equity and cost-effectiveness.

https://opus.lib.uts.edu.au/bitstream/10453/129408/2/02whole.pdf

Increasing complexity of cancer care : how displaced treatments impact efficiency, cost-effectiveness and equity

The objective of this study was to analyze medical costs and healthcare resource utilization (HRU) associated with everolimus-based therapy or chemotherapy among elderly women with hormone-receptor-positive, human-epidermal-growth-factor-receptor-2-negative (HR+/HER2−) metastatic breast cancer (mBC). Elderly women (≥65 years) with HR+/HER2− mBC who failed a non-steroidal-aromatase-inhibitor and subsequently began a new line of treatment with everolimus-based therapy or chemotherapy for mBC (index therapy) during July 20, 2012 to March 31, 2014 were identified from two large commercial claims databases. All-cause, BC-, and adverse event (AE)-related medical costs (2014 USD), and all-cause and AE-related HRU per patient per month (PPPM) were compared between patients treated with everolimus-based therapy and chemotherapy across their first four lines of therapy for mBC. Adjusted costs and HRU differences were estimated by pooling all lines and using multivariable models adjusted for differences in patient characteristics. In total, 925 elderly patients (mean age approximately 73 years) with HR+/HER2− mBC met the inclusion criteria; 230 received everolimus-based therapy (240 lines) and 737 received chemotherapy (939 lines). Compared with chemotherapy, everolimus-based therapy was associated with significantly lower total all-cause PPPM medical services costs (adjusted mean difference: $4007), driven by lower inpatient ($1994) and outpatient ($1402) costs; lower BC-related medical services costs ($3129), driven by both BC-related inpatient ($1883) and outpatient costs ($913); and lower AE-related medical services costs ($1873; all P < 0.01). Additionally, compared to patients treated with chemotherapy, patients treated with everolimus-based therapy had fewer all-cause outpatient visits (adjusted incidence rate ratio = 0.69), BC-related outpatient visits (0.66), other-medical-service visits (0.65), and AE-related HRU (0.59), which was driven by significantly fewer AE-related outpatient visits (0.56; all P < 0.01). Subgroup analyses comparing medical costs of everolimus-based therapy with capecitabine monotherapy showed consistent results overall. This retrospective claims database analysis of elderly women with HR+/HER2− mBC in the United States showed that everolimus-based therapy was associated with significantly lower all-cause, BC-related, and AE-related medical services costs and less use of healthcare resources compared with chemotherapy. Novartis.

Real-World Analysis of Medical Costs and Healthcare Resource Utilization in Elderly Women with HR+/HER2− Metastatic Breast Cancer Receiving Everolimus-Based Therapy or Chemotherapy

The objective of our study was to conduct a cost-effectiveness (CE) study of combined everolimus (EVE) and exemestane (EXE) versus the common clinical practice in Greece for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer (BC) progressing on nonsteroidal aromatase inhibitors (NSAI). The combinations of bevacizumab (BEV) plus paclitaxel (PACL) and BEV plus capecitabine (CAPE) were selected as comparators. A Markov model, consisting of three health states, was used to describe disease progression and evaluate the CE of the comparators from a third-party payer perspective over a lifetime horizon. Efficacy and safety data as well as utility values considered in the model were extracted from the relevant randomized Phase III clinical trials and other published studies. Direct medical costs referring to the year 2014 were incorporated in the model. A probabilistic sensitivity analysis was conducted to account for uncertainty and variation in the parameters of the model. Primary outcomes were patient survival (life-years), quality-adjusted life years (QALYs), total direct costs and incremental cost-effectiveness ratios (ICER). The discounted quality-adjusted survival of patients treated with EVE plus EXE was greater by 0.035 and 0.004 QALYs, compared to BEV plus PACL and BEV plus CAPE, respectively. EVE plus EXE was the least costly treatment in terms of drug acquisition, administration, and concomitant medications. The total lifetime cost per patient was estimated at €55,022, €67,980, and €62,822 for EVE plus EXE, BEV plus PACL, and BEV plus CAPE, respectively. The probabilistic analysis confirmed the deterministic results. Our results suggest that EVE plus EXE may be a dominant alternative relative to BEV plus PACL and BEV plus CAPE for the treatment of HR+/HER2- advanced BC patients failing initial therapy with NSAIs.

/pdf/everolimus-plus-exemestane-versus-bevacizumab-based-21i8xxe4w2.pdf

Everolimus plus exemestane versus bevacizumab-based chemotherapy for second-line treatment of hormone receptor-positive metastatic breast cancer in Greece: An economic evaluation study.

e17638 Background: Estrogen receptor positive (ER+) metastatic breast cancer patients progressing on nonsteroidal aromatase inhibitors are candidates for treatment with everolimus (EVE) plus exemes...

Economic evaluation of everolimus plus exemestane versus bevacizumab plus paclitaxel and bevacizumab plus capecitabine for the management of postmenopausal women with ER+ breast cancer.

The contribution of positron emission tomography/computed tomography (PET/CT) with 18F-fludeoxyglucose (FDG) in evaluating ovarian cancer recurrence even after a prolonged disease-free interval, and in therapy response is well-described. Calcifications observed in CT, although usually attributed to benign conditions, may actually represent active disease. Such an example of calcified formations is psammoma bodies. We present a case of 56-y. o. patient with ovarian cancer relapse at the supraclavicular area 18 years after complete response and disease-free interval. The patient received chemotherapy and underwent 18F-FDG-PET/CT for the evaluation of treatment response. Both CT corrected and uncorrected PET images showed hypermetabolism in the massively calcified lymph nodes in the neck, mediastinum, axilla and abdomen, indicative of active residual disease.

Hypermetabolic Calcified Lymph Nodes on 18Fludeoxyglucose-Positron Emission Tomography/Computed Tomography in a Case of Treated Ovarian Cancer Recurrence: Residual Disease or Benign Formation?

Vasiliki Rapti

Papers

Everolimus plus exemestane versus bevacizumab-based chemotherapy for second-line treatment of hormone receptor-positive metastatic breast cancer in Greece: An economic evaluation study.

Economic evaluation of everolimus plus exemestane versus bevacizumab plus paclitaxel and bevacizumab plus capecitabine for the management of postmenopausal women with ER+ breast cancer.

Hypermetabolic Calcified Lymph Nodes on 18Fludeoxyglucose-Positron Emission Tomography/Computed Tomography in a Case of Treated Ovarian Cancer Recurrence: Residual Disease or Benign Formation?