Farmeconomia. Health economics and therapeutic pathways
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Analysis of Market Access Agreements in Turkey
Full text linkBACKGROUND: Reimbursement agencies are increasingly adopting innovative reimbursement approaches for new and expensive technologies. Social Security Institution (SSI), Turkey`s reimbursement agency, established the Alternative Reimbursement Commission (ARC) on February 10, 2016. This study aimed to understand the implementations of market access agreements in recent years in Turkey.METHODS: Decisions of the Health Services Pricing Commission published in the official gazette , and information from the Turkey Pharmaceuticals and Medical Devices Agency, the Abroad Drug List, Health Implementation Communique published by SSI with additional lists, such as the Annex-4A List of Reimbursed Medicines and the Annex-4C Abroad Drug Price List, were used. The data was transferred to Windows Office Excel files, and a descriptive analysis was conducted and evaluated by two market access experts.RESULTS: There were 57 drugs included in the coverage of reimbursement with alternative reimbursement since the application was started in Turkey. 35 of them were added to Annex-4A and 22 of them to Annex-4C. Furthermore, 45.6% of the drugs had an Anatomic Therapeutic Chemical Classification (ATC) code of l-antineoplastic and immunomodulating agents, 28% were orphan drugs, 44 of them had a confidential discount rate, and financial-based agreement models were preferred for nearly all agreements.CONCLUSIONS: Turkey has been implementing market access agreements since mid-2016. In the past 3 years, 57 drugs have been covered for reimbursement under the new implementation. Further analysis should be conducted to understand the decision-making process involved
Real-life Diagnostic and Therapeutic Approach to CLL: A New Proposal from an Expert Panel in Tuscany Region
Full text linkBACKGROUND: In the last years genomic and somatic alterations have shown to play a pivotal role in the pathogenesis of chronic lymphocytic leukemia (CLL) and new prognostic factors have been identified accordingly.AIM: To describe a real-life diagnostic and therapeutic approach to CLL that takes into account the role of genomic and somatic prognostic factors in the risk stratification of developing progressive disease, and treatment decision.METHODS: This new proposal has been developed and validated by ten key opinion leaders from Tuscany Region during two Expert Meetings. The approach suggested comes from their experience in daily clinical practice and is supported by guidelines recommendations, clinical trials results, and drugs prescribing conditions in Italy.RESULTS: Beside TP53 deletion or mutated status, the Expert Panel highlighted the importance of the IGHV mutation status characterization, since the diagnosis, in order to identify patients who will have a more aggressive progression. Furthermore, just before starting treatment, to obtain useful prognostic information and indication in the selection of the therapy, they recommend cytogenetic analysis for the detection of del(11q), trisomy 12, del(13q), del(17p), conventional karyotyping of stimulated CLL cells, TP53 sequencing, and molecular genetic analysis to detect IGHV mutation status.CONCLUSIONS: The Expert Panel recognized the limitations associated with traditional staging systems in identifying patients who will have a more aggressive disease course and predicting response to treatment and suggested a real-life diagnostic and therapeutic approach to CLL to update the current patient management in light of recent advances that have improved understanding of CLL
Clinical and Economic Rationale for the Early use of SGLT2 Inhibitors in Patients with Type 2 Diabetes
Full text linkType 2 diabetes (T2D) is a chronic disease associated with a high epidemiological and economic burden. It is associated with a high risk of developing both macrovascular and microvascular complications and cardiovascular diseases represent the main cause of mortality and morbidity in T2D patients. The economic impact of diabetes is primarily due to the cost and duration of treatment and secondary complications of diabetes and associated costs. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are an effective therapy for providing a long-term improvement of glucose control, thus contributing to the long-term prevention of diabetic (particularly microvascular) complications. Furthermore, SGLT-2 inhibitors seem to lead to significant reductions in hospital admissions due to heart failure and progression of renal disease, regardless of baseline atherosclerotic risk category or history of heart failure. Evidence from randomized controlled trials, observational and pharmacoeconomic studies suggest that SGLT2 inhibitors should be considered not only in patients with established cardiovascular disease and incipient nephropathy but also in earlier stages of T2D in order to prevent the first onset of cardiovascular and renal complications and contain the cost of illness
Corrigendum: An Integrated Management Model of Patients With Atrial Fibrillation: The Experience of the Local Health Unit Tuscany North-West/2
Full text linkThere was an error in the Figure 5 at page 11 in this Supplement by Casolo et al. [Farmeconomia. Health economics and therapeutic pathways 2019; 20(Suppl 1): 3-16; https://doi.org/10.7175/fe.v20i1S.1454]. The online version has been corrected on April 21, 2020
Funding Innovation Thanks to Anti-TNF-α Biosimilars Uptake: The Economic Impact in Italy
Full text linkINTRODUCTION: Anti-TNF-α biosimilars (ATB) hold the promise of reducing costs leading in improving access to bio-logical therapies. There is limited insight into how the savings generated by biosimilars may translate into patient benefit in other disease areas.AIMS: To assess the economic savings for Italian National Health System (NHS) due to the expansion of ATB market, together with a reduction in their price and to illustrate how this potential savings can be used by NHS to fund orphan drugs.METHODS: Trend of IMS Health monthly sell-in units (August 2016-December 2019) were used to estimate the current biologic and biosimilar market for rheumatic and inflammatory bowel disease in Italy and its evolution up to 2022. The scenario for 2019-2020 was compared with the future evolution (2021-2022) assuming an increasing uptake of biosimilars in the Italian market. Finally, it was estimated how these savings can potentially fund the treatment of orphan drugs, without increasing the Italian NHS budget.RESULTS: Italian biologic and biosimilar market remains stable in the next years (about 4 million units both in the current scenario and in the future evolution market) with a slight decreasing of less than 2%. However, according to our assump-tions, ATB market is expected to increase of about 33% in the next two years, covering 67% of the total Italian market, mostly due to biosimilar etanercept. Total savings due to biosimilars increases from € 96 million in 2019 to € 161 million in 2022 corresponding to a mean annual savings of about € 130 million. Such savings would permit funding 17.4% of the actual orphan drugs market corresponding to 2,600-4,800 new patients.CONCLUSIONS: The introduction of biosimilars in a range of rheumatic, dermatological and inflammatory bowel disease can be an opportunity to increase patient access to innovative treatments. Potential savings due to biosimilars uptake could lead to a re-allocation of economic resources to fund innovative therapies
The Economic Burden of Different Multiple Sclerosis Courses: Analysis from Italian Administrative and Clinical Databases
No full textINTRODUCTION: Poor specific economic information are available for the different Multiple Sclerosis (MS) courses: relapsing remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS). This study aims to fill this gap.METHODS: A cost of illness study was conducted. Clinical information of patients treated in a major MS Center located in Lombardy, in the period 2004-2010, were linked with administrative data of Lombardy Healthcare System. We assessed the mean cost per patient-year and its association with different MS characteristics.RESULTS: The study identified 869 patients (83.9% RRMS, 8.5% SPMS, 7.2% PPMS). RRMS reported the highest cost per patient-year with a mean of € 5,623 in Expanded Disability Status Scale (EDSS) 0-3, € 8,675 in EDSS 3.5-6.5, and € 7,451 in EDSS 7-9. The PPMS patients reported the lower annual mean cost per patient in all EDSS categories. The mul-tivariate analysis reported a significant association between cost per patient-year and EDSS categories, relapse and use of Disease Modifying Therapies but not to MS courses, age and sex.CONCLUSION: This study provides a complete picture of MS courses direct costs at the different disability levels. The results can help to better understand the burden of each MS courses and the cost-effectiveness of different interventions
Corrigendum: Treatments of Advanced Non‑Small Cell Lung Cancer (NSCLC) in an Italian Center: Drug Utilization and the Treatment Costs of Innovative Drugs
Full text linkThere was an error in Discussion section at page 36 in this article by Piantedosi et al. [Farmeconomia. Health economics and therapeutic pathways 2019; 20(1): 27-41; https://doi.org/10.7175/fe.v20i1.1376]. The online version has been corrected on June 5, 201
Cost-Effectiveness Analysis of Dimethyl Fumarate in the Treatment of Relapsing Remitting Multiple Sclerosis: An Italian Societal Perspective
Full text linkBACKGROUND: Delayed-release dimethyl fumarate (also known as gastro-resistant dimethyl fumarate, hereafter dimethyl fumarate) is an oral disease-modifying therapy used for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS), an autoimmune chronic inflammatory condition of the central nervous system.OBJECTIVE: The objective of this economic analysis was to compare cost-effectiveness of dimethyl fumarate with the alternatives used as first-line treatment of RRMS in Italy.METHODS: The analysis was conducted from the Italian societal perspective. Health outcomes and costs were evaluated over a 50-year time horizon (equivalent to a lifetime horizon). Both health outcomes and costs were discounted at 3.5%. The cost-effectiveness analysis was conducted by adapting a Markov model, already used in previous similar economic analyses conducted in RRMS, to the Italian context. The Markov model estimated the clinical and economic consequences of treating RRMS patients with the following therapeutic options: dimethyl fumarate; interferon (IFN) beta-1a subcutaneous (SC) at two different doses, 22 mcg and 44 mcg; IFN beta-1b SC; glatiramer acetate (GA) SC 20 mg; oral teriflunomide. Clinical efficacy data were retrieved from an elaboration of an already published mixed treatment comparison (MTC). Both direct and indirect costs (disability, treatment acquisition, administration, monitoring, relapses, adverse events) were included in the analysis. One-way and probabilistic sensitivity analyses were carried out and cost-effectiveness acceptability curves generated.RESULTS: In the base-case analysis, dimethyl fumarate was more efficacious than alternatives, in terms of both survival (19.634 vs. 19.440-19.600 life years for alternatives), and quality-of-life-adjusted survival (6.526 vs. 5.143- 6.189 QALYs for alternatives). The total lifetime cost per patient treated with dimethyl fumarate (€ 954,286) was lower than that of the other DMTs included in the analysis. Therefore, dimethyl fumarate was dominant compared with all analyzed alternatives. Dimethyl fumarate was also the therapeutic option with the highest benefit on disease burden. In fact, costs of disability management were lower than those of all the other first-line drugs included in the analysis. The results of one-way deterministic sensitivity analysis and probabilistic sensitivity analysis confirmed the reliability of base-case results.CONCLUSIONS: The results of the cost-effectiveness analysis confirm that dimethyl fumarate is an optimal first-line treatment for RRMS in Italy, compared with the other first-line alternatives included in the economic analysis, when evaluated from the societal perspective
Developing a Model for the Establishment of Pre-Hospital Emergency Medicine Bases in the Northern Provinces of Iran
Full text linkBACKGROUND: The faster and more accurately Pre-Hospital Emergency Medicine as the first line of care and treatment is done, the less the mortality and disability rates are.AIM: The present study is an attempt to design a model for the establishment of pre-hospital emergency bases in the northern provinces of Iran.METHODS: This quantitative-qualitative (mixed-method) research was conducted in two parts: First, using the literature review, interviews with experts in the field, and a comparative study, the most important factors affecting the establishment were extracted. Second, the obtained data were employed to formulate the development model and to design the questionnaire. The required data for factor analysis were collected through a questionnaire distributed among 200 operational personnel in January 2018. The results were analyzed using confirmatory factor analysis and multiple regression.RESULTS: Five components were identified after the exploratory factor analysis and Varimax with an eigenvalue larger than 1. The effect coefficients calculated for human resources components, service speed, and information and communication system were 0.935, 0.765 and 0.752, respectively. The obtained goodness of fit was very close to one, indicating the one-dimensional strength of the model. The highest parameter estimation in this model was allocated to the human component as 0.935, which has a significant correlation with other components.CONCLUSIONS: In order to reduce the response time, more attention should be paid to the allocation of budget and organizational roles, education, participation from government departments, establishment of an independent medical emergency organization, and appropriate accessibility to reduce the rates of mortality and morbidity
Erratum: Effectiveness of Long-Acting Injectable Antipsychotics in Schizophrenia: A Literature Review and Bayesian Meta-Analysis Informing Economic Considerations
Full text linkThere was an error in the relapse rate reduction reported in Figure 2 in this article by Zaniolo et al. [Farmeconomia. Health economics and therapeutic pathways 2019; 20: 13-24; https://doi.org/10.7175/fe.v20i1.1393]. The online version has been corrected on 13 February 2019