Oral dabigatran etexilate is indicated for the prevention of systemic thromboembolic events in patients with non-valvular atrial fibrillation (NVAF). Based on the RE-LY study we investigated the cost-effectiveness of dabigatran etexilate versus warfarin and versus others new oral anticoagulants (rivaroxaban and apixaban) in the Italian setting.
Infantile hemangioma (IH) is the most common childhood benign tumour. A recent phase II/III study has demonstrated the success of propranolol for involution of infantile hemangioma as well as a better efficacy and safety when indirectly compared with corticosteroids. The purpose of this study was to estimate the cost-utility of propranolol (Hemangiol), a new medicinal product and the first to be authorized for this specific paediatric indication, versus corticosteroids in the treatment of proliferating infantile hemangioma requiring systemic therapy.
Biosimilars of hemopoietic growth factors present an important saving opportunity in oncology. However, while pharmacologists are aware of their potential benefits, biosimilars are still under-used in Italy. Improved information and guided clinical experience may help to increase the clinical acceptance of these drugs. To this aim, a collaborative educational project was set between an Hospital Oncology Unit and the Local Health Care Authority in Pavia, Italy.
The hepatitis C virus (HCV) induces several pathological conditions worldwide with a substantial medical and economic burden. The objective of this study was to estimate the average annual cost incurred by the National Health Service (NHS) as well as society due to HCV in Italy.
Vinorelbine and Cisplatin is a standard treatment in non small cell lung cancer; oral Vinorelbine is registered in 45 countries. Pemetrexed and Cisplatin are recommended in front-line chemotherapy of non-squamous non small cell lung cancer (NS-NSCLC). An economic evaluation of oral Vinorelbine plus Cisplatin and Pemetrexed plus Cisplatin was implemented in NS-NSCLC patients, adopting specific costs and clinical settings reflecting the Italian practice.
Treatment options for chronic hepatitis B (CHB) are the direct inhibition of viral replication by continuous administration of nucleoside analogues (NUCs) or a finite 48-week course of peg-interferon (PEG). PEG can induce the off-therapy immune control of CHB leading to HBsAg loss/anti-HBs seroconversion, but with a low success rate. On the other hand life-long treatment with NUCs is expensive. Currently in Italy, around 67% of naïve patients receive treatment with NUCs. However, exploiting the early identification of PEG-non-responders by combined HBV-DNA and HBsAg quantification at week 12 (stopping-rule) is a new sequential therapeutic strategy that may benefit both patients and third payers. We measured the impact on the Italian National Health Service (NHS) budget of the strategy PEG-week-12-stopping-rule in the treatment of HBeAg-negative CHB.
The aim of the study is to compare the direct medical costs associated with colorectal cancer (CRC) in a population of patients treated at Policlinico Umberto I in Rome with the two most common chemotherapy regimens: Folfox vs Xelox. For the economic evaluation, a retrospective and observational cost minimization study has been conducted on CRC patients on chemotherapy treatment at Policlinico Umberto I in Rome, Lazio region. One-way sensitivity analysis was performed. The average cost per patient of the equipment required for treatment administration shows high resource consumption in the Folfox arm, whilst the Xelox arm, because of oral (capecitabine) and iv (oxaliplatin) administrations, does not incur such costs. When assuming a 6 month treatment period, an average saving of about 11.5% for the Policlinico Umberto I (Lazio Regional Health Service) is observed with Xelox compared to Folfox. The one-way sensitivity analysis confirmed the advantages of oral therapy in completing a therapeutic cycle (better compliance); moreover, when in the analysis the drug price was decreased by 5%, the Xelox arm provided benefits also in the medium/short term; the analysis also confirmed the robustness of the estimates, showing that drug price is the most important cost driver. This cost minimization analysis has shown cost savings when patients with CRC are treated, without compromising efficacy, with a chemotherapy scheme including oral drugs such as capecitabine, through savings in treatment administration. The huge costs associated with placement of central venous catheters and treatment of the related adverse events, as needed with Folfox (5-FU), in the long term offset capecitabine higher cost.
The expected benefits of biosimilar drugs (a lower price and a competition effect on originators’ price) offer an opportunity to contain the rising trend of the hospital pharmaceutical expenditure. This paper reviews the characteristics of biotechnological products and their regulatory features with the aim to evaluate if and how biosimilars are substituting the originators in the respective markets.
Multiple myeloma is a rare, incurable hematologic malignancy. It has a tendency to develop subsequent relapses, so affected patients are likely to undergo more than one line of treatment. Rather than evaluating the cost-effectiveness of individual therapeutic agents, it becomes therefore recommendable for decision-makers—from both a clinical and an economic perspective—identifying an optimal sequencing of such agents.
The UK National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of erlotinib (Roche) to submit evidence for the clinical and cost effectiveness of erlotinib as monotherapy for the maintenance treatment of patients with non-small cell lung cancer (NSCLC) and stable disease following previous treatment with four cycles of platinum containing therapy. The Liverpool Reviews and Implementation Group (LRiG) at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG) for this appraisal.
Lanreotide and octreotide are used to treat patients suffering from neuroendocrine tumors and acromegaly.
The National Institute for Health and Clinical Excellence (NICE) invited Boehringer Ingelheim GmbH, the manufacturer of dabigatran etexilate (DBG), to submit evidence on the clinical and cost effectiveness of this drug for the primary prevention of venous thromboembolism (VTE) in adult patients who have undergone total hip replacement (THR) or total knee replacement (TKR) surgery, as part of NICE’s single technology appraisal process. The comparators were enoxaparin and fondaparinux, as identified in the scope issued by NICE. The School of Health and Related Research at the University of Sheffield was commissioned to act as the Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and NICE’s subsequent decisions.
The aim of this study was to assess whether S-1 might represent a valuable therapeutic option for patients with advanced gastric cancer in comparison to other available therapies (5-FU, capecitabine), considering both costs and outcomes associated with the different therapeutic strategies. The perspective of the analysis was that of the Italian National Health Service (NHS).
To evaluate the cost-effectiveness of onabotulinumtoxinA versus placebo in patients with chronic migraine from the Italian National Health Service and a societal perspective.
The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dronedarone (Multaq®, Sanofi-Aventis Limited, UK) to submit evidence on the clinical and cost effectiveness of the anti-arrhythmic drug (AAD) for the treatment of atrial fibrillation (AF) and atrial flutter, as part of the Institute’s single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics, both at the University of York, were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and NICE’s subsequent decisions regarding the use of dronedarone within the UK NHS.
Atrial fibrillation (AF) is a chronically progressing arrhythmia and an independent risk factor for stroke, leading to a five-fold increased risk of stroke. The available options for stroke prophylaxis are anticoagulant oral drugs, which include warfarin, used in stroke for several decades, the new generation of anticoagulant drugs (Xa inhibitors and direct thrombin inhibitors), anti-platelet drugs, generally recommended for patients in whom anticoagulants are contra-indicated, and left atrial appendage closure technologies implanted via a catheter-based delivery system, including WatchmanTM.
According to WHO, seasonal influenza affects 5–15% of population. Its burden (hospitalizations and deaths) is particularly heavy on elderly people. The only effective means of combating influenza is vaccination, and adjuvanted vaccines optimize the immune response.
A recent meta-analysis pointed out that pegylated interferon α-2a is more effective than peginterferon α-2b in terms of rapid virological response (RVR) in the treatment of chronic hepatitis C (CHC). Considering the availability of triple therapy (TT—pegylated interferon, ribavirin and protease inhibitor) and the possibility to follow different treatment algorithms based on RVR achievement, verified after a 4 week lead-in period of dual therapy (DT—pegylated interferon and ribavirin), rational decisions, taking into account also economic implications, become particularly important, especially in a healthcare cost containment context.
The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of eltrombopag (GlaxoSmithKline) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of patients with chronic immune or idiopathic thrombocytopenic purpura (ITP), as part of the their Single Technology Appraisal (STA) process. The Aberdeen Technology Assessment Review (TAR) Group, commissioned to act as the evidence review group (ERG), critically reviewed and supplemented the submitted evidence. This paper describes the company submission, the ERG review and NICE’s subsequent decisions.
