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Fratino, Pietro. "Sui Piani Terapeutici AIFA." PharmacoEconomics Italian Research Articles 10, no. 2 (2008): 119–21. http://dx.doi.org/10.1007/bf03320648.
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Dal Moro, Fabrizio. "Si Riporta il Comunicato AIFA." Urologia Journal 81, no. 4 (2014): 253. http://dx.doi.org/10.1177/039156031408100401.
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Montilla, Simona, Entela Xoxi, Pierluigi Russo, Americo Cicchetti, and Luca Pani. "MONITORING REGISTRIES AT ITALIAN MEDICINES AGENCY: FOSTERING ACCESS, GUARANTEEING SUSTAINABILITY." International Journal of Technology Assessment in Health Care 31, no. 4 (2015): 210–13. http://dx.doi.org/10.1017/s0266462315000446.
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Objectives: The AIFA (Agenzia Italiana del Farmaco—Italian Medicines Agency) Monitoring Registries track the eligibility of patients and the complete flow of treatments, guaranteeing appropriateness in use of pharmaceutical products, according to approved indications.Methods: This study describes the Italian pharmaceutical context and the aims and functioning of AIFA Monitoring Registries, focusing on the applications to the Managed Entry Agreements (MEAs) and HTA approaches.Results: The AIFA Monitoring Registries System has been operational in Italy since 2005. In 2012, the system became part of the NHS Information Technology system, aiming at enhancing appropriate use of pharmaceuticals and efficiency of the administrative activity. Currently, seventy-six medicines are monitored through the system, corresponding to fifty-eight therapeutic indications; individual treatments recorded are more than 515,000, for a population of approximately 505,000 patients. For each monitored product, patients eligible for treatment are registered in the specific therapeutic indication dynamic monitoring database to collect epidemiologic and clinical data, including data on the safety profile, and ex-post information missing at first evaluation stage.Conclusions: AIFA Monitoring Registries allow the evaluation of the pharmaceuticals’ performance in clinical practice and may promote innovation and quicker access to medicines at affordable prices, for the benefit of patients.
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Wisesa, Adithya Raidipa. "INOVASI ARTIFICIAL INTELLIGENCE SEBAGAI FINANCIAL ADVISOR KEMENTERIAN KEUANGAN." SWATANTRA 21, no. 1 (2023): 01. http://dx.doi.org/10.24853/swatantra.21.1.01-08.
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Era digital yang tengah kita masuki memicu perdebatan di kalangan profesional bisnis. Ada yang melihat perkembangan yang ada sebagai peluang dan ada yang memandangnya sebagai ancaman. Perkembangan Artificial Intelligence (AI) sangat pesat akhir-akhir ini. Kolaborasi antara kecerdasan manusia dengan kecepatan mesin menjadi sangat penting untuk memproses dan menganalisis secara terstruktur data yang besar dengan kecepatan. Pada penelitian ini menggunakan pendekatan kualitatif bersifat deskriptif dan pengumpulan data dilakukan dengan Studi literatur. Dalam inovasi ini DJPK telah mengembangkan dashboard Artificial Intelligence sebagai Financial Advisor (AIFA) yang dapat memberikan financial advice secara otomatis, real time, dan online kepada Pemda. Inisisasi pemanfaatan AI di pemerintahan merupakan upaya mewujudkan data-driven culture dalam pengambilan kebijakan. AIFA juga dapat mendukung terwujudnya Sistem Pemerintahan Berbasis Elektronik (SPBE) sebagaimana diamanatkan dalam Peraturan Presiden Nomor Nomor 95 Tahun 2018. AIFA dapat dimanfaatkan dalam rangka meningkatkan kualitas pengelolaan keuangan daerah melalui evaluasi kinerja APBD menggunakan pendekatan EDA, forecasting realisasi APBD dalam rangka perbaikan manajemen kas menggunakan exponential smoothing, dan fraud detection sebagai early warning system menggunakan Benford’s Law. Adanya perkembangan teknologi AIFA yang semakin canggih akan menjadi peluang bagi profesi akuntan untuk meningkatkan kapasitas profesi yang telah ada. Adanya otomatisasi pekerjaan repetitif dan clerical, tenaga dan waktu yang dimiliki akuntan dapat dialokasikan untuk pekerjaan yang lebih stratejik dan berdayaguna yaitu menjadi roda penggerak nilai
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Nisticò, Robert. "Agenzia Italiana del Farmaco (AIFA): Developments and Strategy in a Transitioning European HTA Landscape." Journal of Market Access & Health Policy 13, no. 1 (2025): 5. https://doi.org/10.3390/jmahp13010005.
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Prada, Mariangela, Matteo Ruggeri, Carmen Sansone, Dalila De Fazio, Alessia Tettamanti, and Matteo Mantovani. "Timeline of Authorization and Reimbursement for Oncology Drugs in Italy in the Last 3 Years." Medicine Access @ Point of Care 1 (January 2017): maapoc.0000007. http://dx.doi.org/10.5301/maapoc.0000007.
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Introduction The main purpose of this analysis was to quantify the time elapsed between the validation date of European Medicines Agency (EMA) centralized procedure and the first purchase of a product by at least 1 Italian health care structure, evaluating different variables that affect the process, the number of products approved by the Committee for Medicinal Products for Human Use (CHMP) that are available on the Italian market (July 2016), and the impact of the Cnn class for oncology drugs in Italy. Methods A panel of oncology products has been defined, which considered drugs approved by the EMA between January 2013 and December 2015, and authorized for the treatment of oncology diseases, excluding generics. Data were obtained via the EMA website by the Agenzia Italiana del Farmaco (AIFA; the Italian Medicine Agency) meeting reports, by official administrative acts of marketing authorization, and the date of the first purchase (first day of the first handling month). Results The mean time of EMA evaluation for the considered panel of medicines was about 441 days (standard deviation (SD) 108; range 266-770); the average approval time for AIFA was about 248 days (SD 131; range 85-688). Interestingly, the mean AIFA evaluation time decreased significantly from 264 days for products submitted to AIFA assessment in 2013-2014 to 219 days for products evaluated in 2015-2016. Focusing on the regional access, both the timing and the number of drugs available for patients were widely different from region to region. Discussion A reduction in the approval time in the last 2 years has been observed in Italy. However, several variables influence the efficiency of the process and need to be addressed to make the access to drugs timely and efficient.
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Cocciolo, Raffaella, Paola Turella, Daniela Pilunni, and Pierluigi Navarra. "The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines." Global and Regional Health Technology Assessment 12, no. 1 (2025): 1–6. https://doi.org/10.33393/grhta.2025.3259.
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Background: The duration of price&reimbursement (P&R) procedures is taken as a key performance indicator of Regulatory Agencies in Europe. In this study we have tested the hypothesis that the price of medicines may have negatively affected the duration of P&R negotiations in Italy in the period 2021-2023. Methods: Data were retrieved from the Intexo database, which included all medicines with EC approval within the period 2021-2023. Biosimilars, generics, gene therapies, Sars-Cov-2 vaccines and medicines with no negotiated price at the datalock of December 2023 were excluded from the analysis. The ex-factory price of the most expensive package was taken as the price of each reimbursed medicine, whereas the time between the publication of EC decision in the European GU and the publication of P&R AIFA decision in the Italian GU (gazette-to-gazette time) as well as the time between the submission of P&R dossier and the publication of AIFA decision in the Italian GU (AIFA negotiation time) were taken as the procedure duration. Results: Sixty-seven EC approved medicines completed the P&R procedure in Italy within the study period, and had a reimbursed price. The median and mean gazette-to-gazette times were 395 and 442.6 days, respectively, whereas the mean and median AIFA negotiation times were 389.5 and 434.7 days, respectively. The mean price was 10,942 euros. The analysis of correlation between the duration of procedure and the negotiated price showed that there is no correlation whatsoever between the length of procedures and the price of medicines. Conclusions: We can reasonably exclude that the price of medicines negatively affected the duration of P&R negotiation procedures.
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S. Gholap, Kaveri. "A Review on New Advancement in AIFA Guidelines." Biomedical Science and Clinical Research 4, no. 1 (2025): 01–09. https://doi.org/10.33140/bscr.04.01.01.
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Italy's pharmaceutical industry is governed and managed by the Italian Medicines Agency (AIFA). It publishes guidelines that offer thorough advice and rules for the creation, authorization, and post-marketing surveillance of pharmaceutical goods. These recommendations seek to promote patients' and healthcare providers' appropriate use of medications and medical equipment while also guaranteeing their efficacy, safety, and quality. Clinical trials, marketing authorization, pharmacovigilance, pricing, and reimbursement are only a few of the areas of pharmaceutical regulation that are covered by the AIFA standards. The recommendations seek to assure the availability of safe and effective medical products for the Italian people, foster innovation in the pharmaceutical business, and promote public health and safety by establishing defined standards and criteria.
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Di Tonno, Davide, Laura Martena, Manuela Taurisano, et al. "The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies." Epidemiologia 5, no. 1 (2024): 137–45. http://dx.doi.org/10.3390/epidemiologia5010009.
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Phase I clinical trials represent a critical point in drug development because the investigational medicinal product is being tested in humans for the first time. For this reason, it is essential to evaluate and identify the Maximum Tolerated Dose (MTD) and the safety of the new compound. To mitigate the possible risks associated with drug administration and treatment, the European Competent Authority issued various guidelines to provide provisions and harmonize risk management processes. In the UK and Italy, particular attention should be paid to the Medicines & Healthcare Products Regulatory Agency (MHRA) phase I accreditation scheme and the specific rules set by the Italian Drug Authority through the AIFA Determination no. 809/2015. Both reference documents are based on the concept of quality risk management while conducting phase I clinical studies. Moreover, the AIFA determination outlines specific requirements for those sites that want to conduct non-profit phase I clinical trials. Indeed, the document reports peculiar activities to the “Clinical Trial Quality Team”, which is a team that should support the clinical site researchers in designing, starting, performing, and closing non-profit phase I studies. In this paper, we provide a general overview of the main European guidelines concerning the management of risks during phase I trials, focusing on the main peculiarities of the schemes and rules set by the MHRA and AIFA.
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Singh, Ravinder, and Kuldeep Singh Nagla. "Error analysis of laser scanner for robust autonomous navigation of mobile robot in diverse illumination environment." World Journal of Engineering 15, no. 5 (2018): 626–32. http://dx.doi.org/10.1108/wje-08-2017-0228.
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Purpose Modern service robots are designed to work in a complex indoor environment, in which the robot has to interact with the objects in different ambient light intensities (day light, tube light, halogen light and dark ambiance). The variations in sudden ambient light intensities often cause an error in the sensory information of optical sensors like laser scanner, which reduce the reliability of the sensor in applications such as mapping, path planning and object detection of a mobile robot. Laser scanner is an optical sensor, so sensory information depends upon parameters like surface reflectivity, ambient light condition, texture of the targets, etc. The purposes of this research are to investigate and remove the effect of variation in ambient light conditions on the laser scanner to achieve robust autonomous mobile robot navigation. Design/methodology/approach The objective of this study is to analyze the effect of ambient light condition (dark ambiance, tube light and halogen bulb) on the accuracy of the laser scanner for the robust autonomous navigation of mobile robot in diverse illumination environments. A proposed AIFA (Adaptive Intensity Filter Algorithm) approach is designed in robot operating system (ROS) and implemented on a mobile robot fitted with laser scanner to reduce the effect of high-intensity ambiance illumination of the environment. Findings It has been experimentally found that the variation in the measured distance in dark is more consistent and accurate as compared to the sensory information taken in high-intensity tube light/halogen bulbs and in sunlight. The proposed AIFA approach is implement on a laser scanner fitted on a mobile robot which navigates in the high-intensity ambiance-illuminating complex environment. During autonomous navigation of mobile robot, while implementing the AIFA filter, the proportion of cession with the obstacles is reduce to 23 per cent lesser as compared to conventional approaches. Originality/value The proposed AIFA approach reduced the effect of the varying ambient light conditions in the sensory information of laser scanner for the applications such as autonomous navigation, path planning, mapping, etc. in diverse ambiance environment.
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Cagnazzo, Celeste, Oriana Nanni, Francesca Arizio, et al. "Phase I studies: a test bench for Italian clinical research." Tumori Journal 106, no. 4 (2019): 295–300. http://dx.doi.org/10.1177/0300891619868008.
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Background: The Agenzia Italiana del Farmaco (AIFA) Determination 809/2015 sets all the requirements that clinical units and laboratories must meet in order to conduct phase I studies. Requirements include buildings, equipment, personnel, emergency management, as well as quality requirements defined in a set of standard operating procedures. Methods: In September 2018, the Italian Association of Medical Oncology working group, Clinical Research Coordinator, created an anonymous survey addressed to 51 medical directors of oncologic/hematologic clinical phase I units and all medical directors of generic and transversal units located in Italy and listed at the AIFA website. Results: Questionnaires from 24 institutions were collected, 9 previously inspected by competent authorities. All surveyed structures are certified to conduct profit studies and 1 is authorized to include healthy volunteers; 15 units implemented a Clinical Trial Quality Team in order to conduct nonprofit studies. At the time of data collection, a total of 398 proposals for phase I trials have been received, more than 50% coming from 3 institutes. A total of 144 phase I studies were active, with a median of 2.5 (Q1–Q3=0–6) studies for each center and asymmetric distribution of proposals. Conclusion: The considerable number of proposals received from the interviewed centers indicates that Italy plays an important role in the international pharmaceutical scene, despite bureaucratic procedures that threaten exclusion from decision-making. The AIFA Determination will be an important opportunity to acquire a competitive working approach.
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Dri, Diego Alejandro, Carlotta Marianecci, Maria Carafa, Elisa Gaucci, and Donatella Gramaglia. "Surfactants, Nanomedicines and Nanocarriers: A Critical Evaluation on Clinical Trials." Pharmaceutics 13, no. 3 (2021): 381. http://dx.doi.org/10.3390/pharmaceutics13030381.
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Advances, perspectives and innovation in drug delivery have increased in recent years; however, there is limited information available regarding the actual presence of surfactants, nanomedicines and nanocarriers in investigational medicinal products submitted as part of a request for authorization of clinical trials, particularly for those authorized in the European Economic Area. We retrieve, analyze and report data available at the Clinical Trial Office of the Italian Medicines Agency (AIFA), increasing the transparency and availability of relevant information. An analysis of quality documentation submitted along with clinical trials authorized by the AIFA in 2018 was carried out, focusing on the key terms “surfactant”, “nanomedicine” and “nanocarrier”. Results suggest potential indications and inputs for further reflection and actions for regulators to actively and safely drive innovation from a regulatory perspective and to transpose upcoming evolution of clinical trials within a strong regulatory framework.
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Degli Esposti, Ezio, and Radovan Tomic. "Clinical and economic impact of aliskiren in uncontrolled hypertensive patients." Farmeconomia. Health economics and therapeutic pathways 13, no. 1 (2012): 15–23. http://dx.doi.org/10.7175/fe.v13i1.199.
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BACKGROUND: the majority of hypertensive patients do not achieve adequate blood pressure (BP) control and thus remain at risk of cardio-cerebrovascular events. Aliskiren, a novel antihypertensive drug acting as direct renin inhibitor, was authorized in Italy for the treatment of hypertension in patients who remain uncontrolled and at risk despite the use of at least two antihypertensive drugs. It was subject to an AIFA web-based monitoring registry. Results of the registry show a decrease of 20.8/9.2 mmHg in systolic/diastolic BP, within 6 months, when aliskiren is added to current therapy.OBJECTIVE: to evaluate the clinical and economic impact of such BP reduction in terms of avoidable cardio-cerebrovascular events.METHODS: an Excel-based Markov model compared aliskiren plus current antihypertensive treatment to current antihypertensive treatment alone over a 5-year horizon. Patients’ baseline characteristics and BP-reduction were taken from the AIFA registry and literature. Using Wilson and Anderson risk equations, the model simulated patient’s transitions from Pre-Event to Post-Event and Death, calculating the number of those who experience an event. Unit costs were assigned to treatments, events and follow-up. Sensitivity analyses considered: efficacy variability and societal costs of events.RESULTS: 2.47% of patients treated with aliskiren added-on to their antihypertensive therapy were expected to avoid an event. As observed in the AIFA registry, 19.8% of patients remained treated only with aliskiren whereas others reduced the number of antihypertensive treatments, leading to a 38.6% reduction of monthly concomitant antihypertensive treatment cost. Considering events and follow-up cost reduction, the per-patient annual incremental cost of aliskiren is calculated at € 187 and generates 0.042 QALYs over 5 years. The ICER was € 22,062 per QALY (€ 16,845 to € 30,771 for an efficacy range of ± 25%). Considering societal costs ICER was € 20,094 per QALY.Conclusions: AIFA registry real-world data confirmed aliskiren’s efficacy in uncontrolled hypertensive patients. Together with reaching their BP goals, patients consumed less medication from other antihypertensive drug classes and are expected to avoid cardio-cerebrovascular events. The ICER remained within acceptable thresholds, confirming that aliskiren represents a good investment in terms of health benefit.
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Zago, Alessandro, Alessandro Agostino Occhipinti, Matteo Bramuzzo, et al. "The Risks of Phosphate Enemas in Toddlers: A Life-Threatening Unawareness." Children 11, no. 3 (2024): 349. http://dx.doi.org/10.3390/children11030349.
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Background: While oral laxatives represent the first-line treatment of fecal impaction, enemas are frequently used in clinical practice in pediatric emergency departments (PEDs) and by family pediatricians (FPs). Objectives: Phosphate-containing enemas (PcEs) are commonly employed, even causing the risk of rare but lethal toxicity. We investigated pediatricians’ awareness of PcE risks. Methods: We conducted an online survey by sending a multiple-choice questionnaire to the referents of 51 PEDs and 101 FPs. We collected and compared the answers with recommendations reported by the Italian Drug Agency (AIFA) and the available literature about PcE administration. Results: Of the institutions and pediatricians receiving the questionnaire, 23 PEDs (45%) and 63 FP (62.3%) participated in the survey. Of PEDs, 95% and 33.0% of FPs treated fecal impaction with PcE. Moreover, 54% of PEDs and 86.0% of FPs did not provide treatment according to the AIFA recommendations for the daily dose. Conclusions: This study shows limited pediatricians’ awareness of the potential risks related to PcE.
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Belleudi, Valeria, Francesco Trotta, Luigi Pinnarelli, Marina Davoli, and Antonio Addis. "Neonatal outcomes following new reimbursement limitations on palivizumab in Italy." Archives of Disease in Childhood 103, no. 12 (2018): 1163–67. http://dx.doi.org/10.1136/archdischild-2018-315349.
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ObjectiveTo evaluate the impact of new reimbursement decisions for palivizumab treatment on respiratory syncytial virus (RSV) hospitalisations and the concomitant number of palivizumab prescriptions for infants aged <2 years.DesignWe compared the RSV hospitalisation rates in infants before and after implementation of new limitations during three RSV seasons 2014–2017.SettingPopulation aged <2 years at the beginning of each RSV seasons extracted from regional health systems (Lazio region, 2016, 5 898 124 inhabitants and 47 595 births).PatientsOut of 70 323 infants, 5895 (8.4%) premature babies (gestational age (GA) <37 weeks) were followed before-after Italian Medicines Agency (AIFA)-2016 limitations.InterventionIn 2016, AIFA, following the American Academy of Pediatrics guidelines, decided to limit coverage of palivizumab prophylaxis (GA ≤29 weeks).Main outcomes measuresTrend of hospitalisations by months and rate of RSV before-after new restrictions were analysed. Palivizumab prescriptions and costs for National Health Service (NHS) were considered.ResultsIn a population of 284 902 aged <2 years, the number of hospitalisations due to RSV infection was 1729. Following AIFA-2016 limitations, a reduction in the number of RSV infection-based hospitalisations from 6.3/1000 (95% CI 6.0 to 6.7) to 5.5/1000 (95% CI 5.0 to 5.9) was observed. Palivizumab showed a concomitant reduction of 48% in the number of prescriptions (saving €750 000 for the NHS). No differences of GA, age on admission or severity of RSV infection were observed.ConclusionsImplementation of the new palivizumab reimbursement criteria was not associated with an increase in the RSV hospitalisation rate for children aged <2 years despite a significant reduction in the number of palivizumab prescriptions.
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Macaulay, R., and G. Wang. "PMU89 NEW AIFA INNOVATION ALGORITHM: 2 YEAR REPORT CARD." Value in Health 23 (May 2020): S249. http://dx.doi.org/10.1016/j.jval.2020.04.855.
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Rivera Hernández, Melesio, Enrique Moreno Sánchez, and Mayra Patricia Pérez Román. "Habitabilidad urbana periférica al Aeropuerto Internacional Felipe Ángeles (AIFA)." REVISTA TRACE, no. 87 (April 23, 2025): 123–48. https://doi.org/10.22134/trace.87.2025.913.
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This paper focuses on the study of the conditions of urban habitability in the community of Xaltocan, State of Mexico, derived from its proximity, as of 2022, to the Felipe Ángeles International Airport (FAIA). The study considered three dimensions: physicalspatial, environmental and sociospatial; of these, specific elements were studied to identify the functionality and qualities of the town to reproduce, maintain and create traditions, customs, identities, as well as a sense of belonging; in a regional context in which an urban scenario of uncertainty prevails with respect to the mediumterm future. In performing the work one of the discoveries is that, the community has historically managed to build urban habitability and to have a robust social fabric in expectation of what is about to happen in its living space.
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Rahmawati, Sylvina. "PENGARUH TERAPI JAHE (ZINGIBERS OFFICINALE ROSC.) TERHADAP PENURUNAN NYERI DISMENORHOE DI AKADEMI KEBIDANAN AIFA HUSADA MADURA." JURNAL ILMIAH OBSGIN : Jurnal Ilmiah Ilmu Kebidanan & Kandungan P-ISSN : 1979-3340 e-ISSN : 2685-7987 10, no. 1 (2019): 26–32. http://dx.doi.org/10.36089/job.v1i1.71.
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Menstruation is a sign of reproductive period in women’s life. But for some women are not like that, there are various kinds of disorders and discomfort when menstruation, such as premenstrual syndrome, dismenorhoe. Based on preliminary studies in midwifery Academy Aifa Husada Madura on Maret 20th 2016 from 107 female students of semester 4 to 59 female students (55,1%) experienced dismenorhoe, and 48 female students (44,9%) did not experience dismenorhoe. The purpose of this study was to analyze the effect of ginger therapy toward the decreasing of dismenorhoe pain. The research methods are experiment (Experiment Research). The study design used One Group Pre-Post Test Design model and the sampling technique used accidental. Independent variable in this study was giving of ginger therapy and the dependent used variable in this study was reduction of pain scale dismenorhoe. The instrument used rating scale through observations of respondents before and after given ginger therapy. The samples were taken mostly the female students who experienced dismenorhoe in Midwifery Academy Aifa Husada Madura were 51 respondents. And the results were analyzed using wilconox test (α = 0,05). The result showed that some respondents befor giving ginger therapy were almost experiencing pain dismenorhoe were 47,1 %. While almost all respondents after given ginger therapy was experiencing of lowing pain dismenorhoe were 78,4%. Based on wicoxon statistic test found the significant value 0,00 and α = 0,05. Because of significant value < α values (0,00 < 0,05) means that Ho is rejected and Hi is accepted. So, there is the effect of ginger therapy toward the decreasing of dismenorhoe pain at Midwifery Academy Aifa Husada Madura The research should be used as a reference material as a herbal medicine to decrease dismenorhoe pain.
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Osmola, Malgorzata, Caroline Hemont, Nicolas Chapelle, et al. "Atrophic Gastritis and Autoimmunity: Results from a Prospective, Multicenter Study." Diagnostics 13, no. 9 (2023): 1599. http://dx.doi.org/10.3390/diagnostics13091599.
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Despite a global decrease, gastric cancer (GC) incidence appears to be increasing recently in young, particularly female, patients. The causal mechanism for this “new” type of GC is unknown, but a role for autoimmunity is suggested. A cascade of gastric precancerous lesions, beginning with chronic atrophic gastritis (CAG), precedes GC. To test the possible existence of autoimmunity in patients with CAG, we aimed to analyze the prevalence of several autoantibodies in patients with CAG as compared to control patients. Sera of 355 patients included in our previous prospective, multicenter study were tested for 19 autoantibodies (anti-nuclear antibodies, ANA, anti-parietal cell antibody, APCA, anti-intrinsic factor antibody, AIFA, and 16 myositis-associated antibodies). The results were compared between CAG patients (n = 154), including autoimmune gastritis patients (AIG, n = 45), non-autoimmune gastritis patients (NAIG, n = 109), and control patients (n = 201). ANA positivity was significantly higher in AIG than in NAIG or control patients (46.7%, 29%, and 27%, respectively, p = 0.04). Female gender was positively associated with ANA positivity (OR 0.51 (0.31–0.81), p = 0.005), while age and H. pylori infection status were not. Myositis-associated antibodies were found in 8.9% of AIG, 5.5% of NAIG, and 4.4% of control patients, without significant differences among the groups (p = 0.8). Higher APCA and AIFA positivity was confirmed in AIG, and was not associated with H. pylori infection, age, or gender in the multivariate analysis. ANA antibodies are significantly more prevalent in AIG than in control patients, but the clinical significance of this finding remains to be established. H. pylori infection does not affect autoantibody seropositivity (ANA, APCA, AIFA). The positivity of myositis-associated antibodies is not increased in patients with CAG as compared to control patients. Overall, our results do not support an overrepresentation of common autoantibodies in patients with CAG.
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Gargano, Ludmila, Isabela Freitas, Luila Henriques, et al. "PP128 A Transparent Methodology To Assess Innovativeness Of Health Technologies At Marketing Authorization Time." International Journal of Technology Assessment in Health Care 39, S1 (2023): S86. http://dx.doi.org/10.1017/s0266462323002404.
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IntroductionDefining drug innovation can be challenging and there is no consensus on what a truly “innovative” medicine is. The Italian Medicine Agency (AIFA) has established an approach to assess innovativeness based on therapeutic need, added therapeutic value, and quality of evidence. However, judgment can be subjective and may not be adequate for assessment at the time of marketing authorization, when only preliminary evidence – often from non-comparative or non-randomized trials – are available. We developed a transparent methodology for early assessment of innovativeness at the time of marketing authorization, based on AIFA guidelines.MethodsSince the perspective was the marketing authorization date, only data available at agency’s Medical Review or pivotal trial publications were considered. AIFA criteria were revisited, using oncology medicines approved in the last 10 years as a base case. Impact of preliminary evidence and inadequate study design was considered.ResultsEach assessment should refer to the first approved specific indication and predefined clinically relevant outcomes. When more than one study was presented, best methodological quality, larger sample and/or longer follow-up was selected. Four domains were established: Therapeutical need: existence and clinical benefits of alternative therapies; Clinical benefit added when compared to those alternatives; Suitability of study design considering adequate comparator group, relevant outcome assessed and randomization; Risk of bias. For each domain, clear and specific criteria were defined in consensus by a group of experts in health technology assessment (HTA) and were applied to all cancer drugs evaluated.ConclusionsEfficacy evidence available for marketing authorization are often based on preliminary data, arising from single randomized clinical trials or even non-comparative studies, which difficult early assessments of innovativeness. For this reason, transparent and reproducible methodologies can be useful not only to HTA bodies, but also for other key stakeholders in the pharmaceutical market, such as investors, researchers, doctors, and governments.
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Greco, D. "“Nota 100 AIFA”: indagine conoscitiva per medici di Medicina Generale e specialisti." Journal of AMD 27, no. 1 (2024): 30. http://dx.doi.org/10.36171/jamd24.27.1.5.
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La Consulta dei Presidenti Regionali AMD 2021-2023 ha promosso due survey parallele su Nota 100 Aifa, una indirizzata ai MMG, l’altra agli specialisti, volte a indagare l’utilizzo, il gradimento e eventuali vantaggi o criticità legati al suddetto provvedimento. A tale scopo abbiamo proposto un questionario online, composto da 23 quesiti specifici, cui hanno risposto 555 MMG e 332 specialisti. L’analisi dei risultati, mette in evidenza come un provvedimento teoricamente di portata epocale per il MMG, non abbia ancora raggiunto appieno lo scopo per cui era stato ideato e pertanto risulta ancora ampiamente sottoutilizzato. Nonostante siano già emersi tangibili benefici e un discreto apprezzamento da parte della classe medica, permangono ad oggi, a due anni dalla sua promulgazione, criticità, prevalentemente di tipo burocratico e formativo, che ne impediscono una applicazione completa e uniforme tale da potersi tradurre in un più ampia e produttiva collaborazione tra gli attori coinvolti e in un indiscutibile vantaggio per il paziente con diabete. PAROLE CHIAVE diabete mellito tipo 2; nota 100 AIFA; medico di medicina generale; specialista.
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Drago, Valentina, Tiziana Mele, Francesca Patarnello, Francesca Randon, Cristina Teruzzi, and Filippo Drago. "Assessment and value of drugs: report of the focus groups from the XXII National Conference on Pharmaceuticals." Global and Regional Health Technology Assessment 12, no. 1 (2025): 43–48. https://doi.org/10.33393/grhta.2025.3469.
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The XXII National Conference on Pharmaceuticals, held in Catania from 29 February to 1 March 2024, involved the participation of representatives from more than forty pharmaceutical industries, national authorities, academia, clinicians and clinical pharmacists. The 22nd edition represented a key forum for the analysis of value assessment of medicines, focusing on the impact of new European and National regulations, including the Italian Medicines Agency (AIFA) reform and the HTA regulation. This point of view summarizes insights from focus groups discussions that took place during the Conference, highlighting the pillar role of the new HTA regulation for homogenizing the evaluation across Europe, and the importance to strengthen the collaboration among the parties involved from an early phase, and implementing adaptive and flexible assessment, especially for orphan medicines. The re-evaluation of the innovativeness criteria and framework of the Pricing and Reimbursement (P&R) dossier are points raised among the different focus groups, especially for aligning these tools to the upcoming HTA regulation. The proposals emerged could be useful for AIFA, which is facing a reorganization aimed to optimizing the reimbursement process in Italy.
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Scaltriti, L., F. Giovanardi, G. Prati, et al. "AIFA anti-tumor drugs platform break: a good clinical management." Annals of Oncology 26 (October 2015): vi150. http://dx.doi.org/10.1093/annonc/mdv348.60.
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Vittoria, G., P. Berto, and S. Bakshi. "PRM82 - REAL WORLD EVIDENCE (RWE) FROM ITALIAN NHS-AIFA REGISTRIES." Value in Health 21 (October 2018): S369. http://dx.doi.org/10.1016/j.jval.2018.09.2203.
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Jaiswal, H., J. Rubinstein, R. V. F. Inumerable, and V. P. Wahal. "PMU79 Statistical Analyses of Variables Affecting AIFA Drug-Innovativeness Status." Value in Health 23 (December 2020): S616. http://dx.doi.org/10.1016/j.jval.2020.08.1291.
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Vittoria, Gabriele, Antonio Fascì, Matteo Ferrario, and Giovanni Giuliani. "PP138 Italian Medicines Agency Registries Distribution By Managed Entry Agreements And By Anatomical Therapeutic Area." International Journal of Technology Assessment in Health Care 33, S1 (2017): 135–36. http://dx.doi.org/10.1017/s0266462317002872.
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INTRODUCTION:In a budget constrained environment characterized by an increasing number of high-cost medicines, manufacturers need to demonstrate that their drugs can provide value-for-money. In this complex environment Managed Entry Agreements (MEAs) have been developed with the aim of sharing the risk between the National Health Service (NHS) and manufacturers (1). The objective of this analysis was to identify a correlation between Anatomical Therapeutic Chemical Classification (ATC) and different type of agreements assigned taking into consideration the distribution of Italian Medicines Agency registries by ATC and by kind of agreement negotiated (financial or performance based) (2).METHODS:This analysis takes into account all drugs under monitoring AIFA registries in place in Italy from 2006. For each registry included in the analysis it was collected the status of the registry (active, closed or incoming), the disease area that the registry covers and the monitored drugs with or without an associated Managed Entry Agreements. Considering the high weight of oncology drugs, a sub-analysis was done to investigate registries distribution for each specific form of cancer.RESULTS:The majority of drugs monitored are under a registry with no associated risk sharing agreement according to AIFA (60 percent). For what concerned monitored drugs with an associated agreement, performance-based agreement is the most diffused type of MEA. In terms of therapeutic area involved in the monitoring registries activity, oncology was the most common area. Financial based agreements characterize principally medicines used for Leukemia and Hepatitis C, whereas drugs administrated for Melanoma, Breast and Ovarian Cancer and Ophthalmology diseases follow performance based agreements.CONCLUSIONS:MEAs represent a way to guarantee a sustainable access for innovative medicines. It is proven that oncology products are most likely to have a MEA since they represent some of the most expensive drugs launched in recent years. From this study appear a correlation between the therapeutic disease area of the monitored drugs and MEA assigned by AIFA which is influenced also by other factors like budget impact, risk-benefit ratio and the presence of appropriate endpoints to evaluate the treatment response.
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Vittoria, Gabriele, Antonio Fascì, Matteo Ferrario, and Giovanni Giuliani. "VP116 Comparison Between Time To Off Treatment And Italian Medicines Agency Registries Treatment Duration." International Journal of Technology Assessment in Health Care 33, S1 (2017): 203–4. http://dx.doi.org/10.1017/s0266462317003737.
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INTRODUCTION:The Italian Medicines Agency Registry represents a tool that could be a precious source of information regarding the mean treatment duration of a drug in a real world context. Monitoring registries are applied at the national level after market authorization and are designed not only to apply the Managed Entry Agreements (MEAs) but also to collect Real World Data on drugs safety, effectiveness and real life utilization. The purpose of this analysis was to compare the treatment duration from clinical trials and the mean treatment duration calculated using data from monitoring registries (1).METHODS:For each drug included in the analysis it was collected the treatment duration from Time To Off Treatment curves for the experimental drug (eTTOT) from Phase III clinical trials and the mean treatment duration data calculated by using the number of cycles (converted in months of treatment) of all treated patients extracted from AIFA registries (TTAR). The mean ratios between the Time of Treatment of Italian Medicines Agency and Experimental arm time to off treatment were calculated to identify potential correlations. High level of correlation was expected if Time to Payment By Result /Time To Off Treatment ratio was close to 1 (±.2).RESULTS:Six Roche products or different indications of the same product were identified as candidates for the analysis from 2013 to 2016. The mean TTAR/eTTOT ratio observed in patients treated from 2013 to 2016 was .97 (±.10), meaning that the mean treatment duration calculated from AIFA Registries is strongly comparable with the treatment duration observed in clinical trials. In one case the TTAR is even more major than eTTOT.CONCLUSIONS:A high level of correlation between TTAR and eTTOT was found. Additional analyses considering different cohorts of patients over time could be useful to have a more precise estimate of real world drug utilization. Even though RCTs remain the gold standard for demonstrating clinical efficacy in restricted trial setting, Real World Evidence from AIFA registries can contribute to the evidence base needed for healthcare decisions.
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Monoson, L., MA Martin de Bustamante, and R. Beckerman. "Time to Reimbursement for Oncology Agents from EMA Marketing Authorization to AIFA Approval AS “C(NN)” Class versus. AIFA Approval AS “A” or “H” Class." Value in Health 17, no. 7 (2014): A740. http://dx.doi.org/10.1016/j.jval.2014.08.133.
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Vagnarelli, F., L. Brugiatelli, C. Lofiego, et al. "TAFAMIDIS FOR TREATMENT OF TRANSTHYRETIN CARDIAC AMYLOIDOSIS: A REAL WORLD EXPERIENCE." European Heart Journal Supplements 26, Supplement_2 (2024): ii3. http://dx.doi.org/10.1093/eurheartjsupp/suae036.006.
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Abstract Background A regional network for cardiac amyloidosis (CA) was created in 2019 with the aim of enhancing disease awareness among physicians and favoring appropriate access to innovative diagnostic tools/therapies. The network includes all 14 Cardiology Departments and outpatient clinics from 5 Local Health Units. Therapies for variant (ATTR–v) and wild–type (ATTR–wt) CA have recently become available in Italy. Selected centres with expertise in cardiomyopathies were identified to prescribe new modifying disease drugs. Tafamidis is the first medication approved for the treatment of ATTR–C. The landmark ATTRACT trial showed a reduction in cardiovascular mortality and cardiovascular–related hospitalization in patients treated with tafamidis compared to placebo. From October 2021 tafamidis can be prescribed in Italy according to AIFA criteria (only NYHA I/II patients eligible). The aim of our study is to present the experience of our Network in prescribing tafamidis and to compare the clinical baselibe characteristics of our population and the ATTRACT trial population. Methods Thanks to our network , 189 patients with ATTR–CA were referred to our Center. 58 ATTR patients were treated with tafamidis according to AIFA criteria, while 5 patients with variant–TTR and neuropathy received patisiran iv. The causes of exclusion from tafamidis therapy are shown in figure 1. We prospectively collected all the patientst treated with tafamidis from January 2022 until November 2023. All the data about clinical characteristics, laboratoy findings ECG, echo, bone scintigraphy and concomitant treatment were collected during routin follow–up visits anc compared to those of ATTRACT trial population. Results The main findings of our study are summarized in Table (fig,2) The age of our population was similar to that of the patients enrolled in the ATTR–ACT trial (75,94 ± 11.4 vs. 74,5±7.2, P = 0.21). Of note, our population does not include patients in NYHA class III as the AIFA prescriptive criteria exclude these patients from treatment in Italy. this implies a substantial difference in the distribution of the NYHA class compared to the attract population (p = 0.001). The outcome of our patient was excellent, the drug was well tolerated. Conclusions: Implementing specific clinical network provided excellent results, allowing a precise phenotype/genotype characterization and favoring appropriate access to specific disease–modifying drugs.
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Fogacci, Federica, Marina Giovannini, Elisa Grandi, et al. "Management of High-Risk Hypercholesterolemic Patients and PCSK9 Inhibitors Reimbursement Policies: Data from a Cohort of Italian Hypercholesterolemic Outpatients." Journal of Clinical Medicine 11, no. 16 (2022): 4701. http://dx.doi.org/10.3390/jcm11164701.
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Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective and safe lipid-lowering treatments (LLT). The primary endpoint of the study was to assess the prevalence of patients eligible for treatment with PCSK9 inhibitors in a real-life clinical setting in Italy before and after the recent enlargement of reimbursement criteria. For this study, we consecutively considered the clinical record forms of 6231 outpatients consecutively admitted at the Lipid Clinic of the University Hospital of Bologna (Italy). Patients were stratified according to whether they were allowed or not allowed to access to treatment with PCSK9 inhibitors based on national prescription criteria and reimbursement rules issued by the Italian Medicines Agency (AIFA). According to the indications of the European Medicines Agency (EMA), 986 patients were candidates to treatment with PCSK9 inhibitors. However, following the prescription criteria issued by AIFA, only 180 patients were allowed to access to PCSK9 inhibitors before reimbursement criteria enlargement while 322 (+14.4%) with the current ones. Based on our observations, low-cost tailored therapeutic interventions for individual patients can significantly reduce the number of patients potentially needing treatment with PCSK9 inhibitors among those who are not allowed to access to the treatment. The application of enlarged reimbursement criteria for PCSK9 inhibitors could mildly improve possibility to adequately manage high-risk hypercholesterolemic subjects in the setting of an outpatient lipid clinic.
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Buzzoni, Alessandro. "Aspetti del principio di costituzionalità in ambito sanitario regionale e direttive AIFA." Pratica Medica & Aspetti Legali 4, no. 3 (2010): 95–101. http://dx.doi.org/10.7175/pmeal.v4i3.349.
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Degli, Esposti L., A. Ghigi, C. Nappi, I. Tonello, and M. Andretta. "POSA239 Impact of AIFA Note 96 on Vitamin D Analogs' Prescriptive Appropriateness." Value in Health 25, no. 1 (2022): S155. http://dx.doi.org/10.1016/j.jval.2021.11.754.
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Rossini, E., D. Lidonnici, G. Casilli, C. Lucchetti, and F. Luccini. "HPR68 Retrospective Analysis of the Negotiation in AIFA for New Therapeutic Indications." Value in Health 25, no. 12 (2022): S244—S245. http://dx.doi.org/10.1016/j.jval.2022.09.1199.
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Sanitaria, Politica. "Collaborazioni Politica sanitaria Prescrivibilità e rimborsabilità degli SGLT2i. La nota 100 AIFA." Cardiologia Ambulatoriale 30, no. 4 (2023): 251–64. http://dx.doi.org/10.17473/1971-6818-2022-4-9.
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Avendo raccolto numerose istanze da parte dei nostri lettori ed avendo effettivamente constatato che alla luce dei recenti risultati di grandi trials clinici e delle modifiche delle Linee Guida internazionali e quindi in ultimo delle disposizioni di AIFA in merito alla prescrivibilità e rimborsabilità della classe di farmaci denominata chimicamente ‘Gliflozine’ e dal punto di vista farmacodinamico ‘SodioGlucosio Transferasi 2 inibitori (SGLT2i), abbiamo voluto riportare quali siano le regole prescrittive attuali in Italia. Potrebbero esserci modifiche a breve per il riconoscimento di alcune indicazioni a singole molecole. Si precisa che al momento in Italia sono in commercio 4 molecole appartenenti a questa classe di farmaci.
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Eandi, Mario, and Roberto Serra. "L’uso appropriato di antibiotici iniettivi a domicilio: criteri epidemiologici, clinici e farmacoeconomici." Farmeconomia. Health economics and therapeutic pathways 6, no. 1 (2005): 37–56. http://dx.doi.org/10.7175/fe.v6i1.819.
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Outpatient parenteral antibiotic therapy (OPAT) has become an increasingly used therapeutic modality during the last 20 years. Reasons for this rapid growth include OPAT’s many patient benefits as well as the development of new technologies and well-documented cost savings. Recently the Italian Drug Agency (AIFA) has revised the list of drug’s limitations and indications; particularly two notes about OPAT (n. 55- n.56) have been modified. These new notes can assume at least a double significance: if on the one hand they try to put a check on the overuse and misuse of OPAT, steering physicians towards a better utilization of parenteral antibiotics, on the other they allow to prescribe OPAT also in case of non-ordinary infections, promoting development of more structured OPAT programmes. Prescribing physicians should be aware of a number of aspects of OPAT which distinguish it from other forms of therapy: multiple factors must be taken into account, including the probable infecting organism, the pharmacodynamic and pharmacokinetic properties of candidate drugs, the capabilities of patients who will receive OPAT and of their caregivers. The Infectious Diseases Society of America (IDSA) Guidelines have been elaborated to help physicians thorough assessment of OPAT suitability, even if they need to be adapted to many variables in each treatment setting. Aim of the present study is to re-consider the main microbiologic, clinical and pharmacoeconomic criteria supporting the prescription of an outpatient parenteral antibiotic therapy after the publication of the new AIFA notes.
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Bechini, Angela, Fabrizio Chiesi, Barbara Giammarco, et al. "Electronic Package Leaflets for Vaccines: What Are People’s Perceptions in Italy?" Vaccines 10, no. 7 (2022): 1075. http://dx.doi.org/10.3390/vaccines10071075.
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In Italy, the paper package leaflet (PPL) is the official document that is approved by the Italian Medicines Agency (AIFA) for each medicine. PPLs of all medicines, including vaccines, are freely available online by accessing the AIFA website. To investigate people’s attitudes toward possible access to the PPLs of vaccines and the acceptability of switching to an electronic package leaflet (e-leaflet) in the future, we surveyed three target groups (pregnant women, young parents, and older people) in Italy, via an online survey. We collected 321 questionnaires from the cohorts, which comprised 104 pregnant women, 105 young parents, and 112 older people. The results indicate in all target groups that health care professionals (HCPs) do not usually offer the vaccine PPL during the vaccination session: only about 10.7% of respondents receive the PPL without asking for it, with pregnant women receiving it the most frequently. The acceptance rate for switching from a PPL to an e-leaflet is fairly high in all target groups (76.9% in pregnant women, 81.9% in young parents, and 66.1% in the elderly), especially if the option exists to request a paper print, to make sure that people with a low level of digital skills can access the PPL information as well. HCPs have an important role in ensuring access to the PPLs of vaccines. HCPs should be trained to inform their patients about the different options for accessing the PPLs (as well as online access) to increase their patients’ knowledge and satisfaction.
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Medaglia, Massimo, Giuliano Buzzetti, Marco Cossolo, Paola Deambrosis, and Giovanna Scroccaro. "The future of drugs distribution in the National Health System." Global and Regional Health Technology Assessment 11, no. 1 (2024): 17–21. http://dx.doi.org/10.33393/grhta.2024.2619.
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The distribution of drugs reimbursed by the NHS in Italy can be summarized in three forms: direct (DD), on behalf of (DPC) and affiliated. The following document presents the results of the discussion of a multidisciplinary experts’ panel, from different professional realities in the healthcare system, on alternative methods of drugs’ distribution. It was highlighted how regional autonomy has led to extremely innovative experiences but also to a lack of homogeneity regarding the access to pharmaceutical assistance across Italy. The main recommendations developed by the experts can be summarized as follows: To ensure decisions regarding prescription and classification, with respect to the healthcare delivery settings, with the consequent distribution model and purchasing processes, is AIFA’s responsibility. To evaluate the reclassification of drugs from class H to class A-PHT for drugs intended to be taken at patient’s home, in cases where close monitoring by specialistic structures is not necessary. To limit the inclusion of a drug in PHT to conditions of differential diagnostic complexity, need for recurrent patient’s referral to the healthcare facility, presence of AIFA monitoring register, settings of drugs’ administration (home hospitalization and home care). In the field of PHT drugs, AIFA should, with the support of a multidisciplinary technical table: Update the list periodically. Identify the drugs on the list for which DD is preferential, leaving the others in DPC. Evaluate the conditions to transfer some drugs to distribution under an agreement.
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Moretti, Giaele, Benedetta Dal Canto, Francesco Attanasio, Alma Martelli, and Francesca Ferrè. "How effective are prescriptive governance tools? Results from the application of AIFA notes." Global and Regional Health Technology Assessment 11, no. 1 (2024): 131–37. http://dx.doi.org/10.33393/grhta.2024.3027.
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Introduction: Prescription appropriateness is crucial for healthcare, balancing scientific evidence, optimal benefit/risk ratios and cost-effectiveness in alignment with the National Health System (NHS) sustainability. In Italy, various governance tools, including Notes AIFA, regulate drug reimbursements. This research aims to evaluate the impact of the introduction of Notes AIFA in curbing consumption and expenditures and assessing their lasting effects. We evaluate the effect generated by the Notes in terms of prescriptive appropriateness by assessing their effect on reducing overprescribing phenomena for drugs covered by the Notes. Note 96, focused on the prevention and treatment of vitamin D deficiency in adults, is used as a case study to evaluate the short- and long-term effectiveness of these tools on prescribing behaviors. Methods: Using a quasi-experimental approach, administrative data on pharmaceutical consumption in Tuscany over 60 months (22 pre- and 38 post-Note) were analyzed. Interrupted Time Series (ITS) analysis at regional, and local health authorities (LHAs), and primary care group practices (AFTs) was performed. Results and conclusions: The ITS analysis showed an immediate reduction in consumption rates and spending post-Note 96. This real-world study highlights short-term effectiveness and suggests a positive long-term impact, despite recognizing a physiological increase in consumption at the regional level. The findings emphasize that ongoing continual monitoring of its effectiveness is imperative to promptly identify failures in implementation and mitigate the risk of consumption escalation, potentially reverting to pre-intervention levels.
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Lavalle, Carlo, Marco Valerio Mariani, Agostino Piro, et al. "Five Years of Direct Oral Anticoagulants Use in Italy: Adverse Drug Reactions from the Italian National Pharmacovigilance Network." Journal of Clinical Medicine 11, no. 11 (2022): 3207. http://dx.doi.org/10.3390/jcm11113207.
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Background: Direct oral anticoagulants (DOACs) are the preferred anticoagulant drugs for the prevention of atrial fibrillation (AF)-related thromboembolic complications and for the treatment and the prevention of recurrences of venous thromboembolism (VTE). The evaluation of self-reported adverse drug reactions (ADRs) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision making. Objective: To assess the safety profile of DOACs by analyzing ADR rates in the real-world Italian scenario. Methods: Post-marketing surveillance data recorded by the National Pharmacovigilance Network were retrieved for the time period 2017–2021 from the AIFA online site. The following data were collected for each DOAC: total ADR number, serious ADR number, gastrointestinal (GI) ADR, intracranial hemorrhage events (ICH ADR), and more frequently reported ADR for the study year. The safety profile was expressed by the risk index (RI). Results: Rivaroxaban use was associated with consistent and stable low rates of serious ADR, GI ADR, and ICH ADR across the 5-year study period. Rivaroxaban and apixaban showed the lowest RI for serious ADR and GI ADR, while rivaroxaban use was associated with significantly lower ICH events as compared to apixaban. Dabigatran was related to the highest RIs for every ADR class, in particular GI ADRs. Conclusions: DOACs presented an acceptable safety profile in the current post-market analysis. However, rivaroxaban and apixaban were associated with more favorable safety profiles as compared to dabigatran, while rivaroxaban provoked statistically significantly fewer ICH events as compared to apixaban.
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Lavalle, Carlo, Luca Di Lullo, Antonio Bellasi, et al. "Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network." Cardiorenal Medicine 10, no. 4 (2020): 266–76. http://dx.doi.org/10.1159/000507046.
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Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.
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Malandrini, Francesco, Cesare Borroni, Michela Meregaglia, Massimiliano Sarra, and Oriana Ciani. "The role of patient-reported outcomes in reimbursement decisions and drug innovation in Italy." Global & Regional Health Technology Assessment 10 (February 9, 2023): 12–17. http://dx.doi.org/10.33393/grhta.2023.2514.
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The attention paid by regulatory authorities to patient-reported outcomes (PROs) and their related measures (PROMs) has progressively increased to allow for a more complete description of the patient’s health status. This work aimed at investigating the use of PROs/PROMs in relation to reimbursement agreement and innovativeness recognition by the Italian Medicines Agency (AIFA). The list of European Public Assessment Reports (EPARs), downloaded from the European Medicine Agency (EMA) website, was analyzed to identify drugs authorized between 2017 and 2021. The associations between the use of PROs/PROMs in the EPARs and the reimbursement and innovativeness status in Italy were explored through Chi2 test and logistic regression. In addition, each innovativeness report was analyzed to identify any further evidence about the consideration of PROs/PROM in the decision-making process. Of the 403 EPARs analyzed, 197 (48.9%) reported the use of PROs/PROMs. A subsample of 229 drugs with a reimbursement class (A, H, or C) officially assigned by AIFA was further investigated. Of them, 49.3% reported the use of PROs/PROMs. The Chi2 test revealed a statistically significant association between the use of PROs/PROMs and innovativeness (p = 0.001) and orphan status (p = 0.012). In the logistic regression, orphan status and availability of PROs/PROMs are significant predictors of the innovativeness status. However, of the 46 innovative drugs, only 9 (19.6%) explicitly reported a consideration of a PRO/PROM in their innovativeness reports. Robust instrument’s validation, reliable data collection and growing potential’s awareness are keys to increase the consideration of PROs at every step of the drug development process.
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Pompilio, Giuseppe, and Davide Integlia. "Cost per responder for methotrexate versus other therapies in patients with moderate-to-severe plaque psoriasis in Italy." Global & Regional Health Technology Assessment 9 (November 10, 2022): 138–45. http://dx.doi.org/10.33393/grhta.2022.2474.
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Objective: Conventional synthetic disease modifying antirheumatic drugs (csDMARDs) were recommended in 2019 as first line therapy from Italian Medicines Agency (AIFA) for the treatment of moderate to severe psoriasis. Updated local guidelines recommended methotrexate (MTX) as the drug of first choice. Nevertheless, MTX is reported by AIFA to be underused. Since no study evaluated jointly the first-line efficacy and costs of the most widely used biologic drugs (adalimumab, etanercept, secukinumab and ustekinumab) and methotrexate in Italy, a cost per responder (CPR) analysis was performed. Methods: A CPR model was developed based on efficacy data from a published Cochrane network meta-analysis.Drug costs included in the model were estimated based on average regional tender prices. The primary analysisassessed the CPR of both Psoriasis Area and Severity Index (PASI) 90 at weeks 12 and 52. A secondary analysis was conducted considering PASI 75. For methotrexate, both an average dosage of 13.4 mg, estimated by an expertpanel, and a dosage of 15 mg reported in European guidelines were considered. Results: At weeks 12 and 52, the costs per responder PASI 90 were lower for methotrexate 13.4 mg compared to the most widely used biologics in Italy, € 566.71 and € 2,455.72 respectively. Methotrexate also showed a lowest CPR both at 12 and 52 weeks, € 529.95 and € 2,296.47 respectively, in the secondary analysis. Conclusions: The analysis showed a lower cost per responder for methotrexate than for adalimumab, etanercept,secukinumab and ustekinumab. For healthcare budget holders, this means using the saved resources to treat more patients.
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Ciani, Oriana, Carlo Federici, Giulia Fornaro, and Carla Rognoni. "Value-based healthcare: Il nuovo approccio di AIFA alla determinazione multidimensionale del valore." Global & Regional Health Technology Assessment 7, no. 1 (2020): 9–13. http://dx.doi.org/10.33393/grhta.2020.2102.
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In this viewpoint, we discuss the approach promoted by the Italian Drug Agency (AIFA) to the assessment of the value of new pharmaceuticals in the Italian Healthcare Service. On top of traditionally acknowledged components, such as quality adjusted life years gained and net costs, the overall value framework might include other elements such as productivity and adherence, equity, severity of disease, reduction in uncertainty, spillover effects. There is a residual dimension in the value framework that may capture the option value or reduction in fear of contagion for infectious disease treatments. We debate measurement issues on these elements of value and discuss open issues from a methodological and policy standpoint.
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Cafiero, D., S. Giugliano, D. Putignano, and S. Lopatriello. "PNS94 The AIFA Assessment for Innovation Status: An Overview of 2017-2019 Reports." Value in Health 23 (December 2020): S657—S658. http://dx.doi.org/10.1016/j.jval.2020.08.1538.
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LAI, M. "F11-3 Combination therapy of ribavirin plus interferon aifa for chronic hepatitis C." International Hepatology Communications 3 (July 1995): S31. http://dx.doi.org/10.1016/0928-4346(95)90278-f.
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Moscatiello, Simona, and Giulio Marchesini. "Impatto delle incretine sulla gestione del paziente diabetico: dati del monitoraggio antidiabetici AIFA." L'Endocrinologo 13, no. 5 (2012): 210–15. http://dx.doi.org/10.1007/bf03345997.
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Candelora, L., L. Ruva, G. Lombardi, and D. Urbinati. "HPR84 Impact of AIFA Monitoring Registries Closure on Drugs’ Turnover Trends in Italy." Value in Health 26, no. 12 (2023): S268. http://dx.doi.org/10.1016/j.jval.2023.09.1402.
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Marchetti, Federico. "News Box - Il rapporto AIFA 2023 sulla prescrizione di antibiotici in età pediatrica." Medico e Bambino 44, no. 03 (2025): 149–52. https://doi.org/10.53126/meb44149.
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Alla ricerca continua di un’uniformità di utilizzo, razionale e ragionevole: troppe (e ingiustificate) le differenze regionali e individuali (e da sempre); c’è la novità di una App su 10 infezioni, possibile punto di riferimento.
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Yunus, Muhammad, and Zahrin F. Syahdinar. "Bearing Capacity Analysis of Bridge Foundation Based on Cone Penetration Test Data and Soil Parameters Data." Logic : Jurnal Rancang Bangun dan Teknologi 19, no. 3 (2019): 145. http://dx.doi.org/10.31940/logic.v19i3.1471.
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One that deserves the attention of planners in designing a bridge structure is the design of the substructure. This is due to the fact that the structure below determines the quality and service life of a bridge and at present many cases of bridge structure failures are caused by failures of the substructure in holding the load acting on the bridge The aim of this research to test the characteristics of the soil and calculate bearing capacity of the foundation based cone penetration testing data and soil parameters at the Aifa bridge construction field in Fafurwar District, Teluk Bintuni Regency, West Papua Province. From the results of testing the soil characteristics in the laboratory, the type of soil at point 1 is the type of good to bad graded sand soil (SW-SP) with a water content of 17.72%, specific gravity 2.98, liquid limit (LL) = 16,746% included in the non-plastic category. While the location of point 2 is obtained from good to bad graded sand soil type (SW-SP) with a water content of 28.52%, specific gravity 2.73, liquid limit (LL) = 16.746% including the non-plastic category. To analysis of the calculation of the bearing capacity of the foundation Aifa bridge using data from the sondir test results for point 1 was obtained allowable bearing capacity (Qall) is 4.610,44 kN and for point 2 was obtained allowable bearing capacity (Qall) is 3.598,43 kN. For calculating bearing capacity of the foundation using soil parameter data for point 1 was obtained bearing capacity allowable (Qall) is 2.209,93 kN and for point 2 was obtained allowable bearing capacity (Qall) is 655,41 kN
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Prada, Mariangela, Letizia Rossi, and Matteo Mantovani. "Time to reimbursement and negotiation condition in Italy for drugs approved by the European Medicines Agency during the period 2014-2019." AboutOpen 7, no. 1 (2020): 89–94. http://dx.doi.org/10.33393/abtpn.2020.2184.
Full textAbstract:
Introduction: The main purpose of this study was comparing median time (TTR, time to reimbursement) between the first Agenzia Italiana del Farmaco (AIFA) pricing and reimbursement (P&R) dossier’s evaluation and patient access in Italy and to observe the key P&R negotiation results for all new active substances approved by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use between January 2014 and December 2019. We analysed the different factors influencing TTR.
 Methods: A panel of medicines for human use approved by the EMA in the period 2014-2019 was considered. All information about authorisation and reimbursement in Italy, including timelines and results from the negotiation, were gathered through EMA and Italian Official Journal databases.
 Results: Of 213 new active substances approved from January 2014 to December 2019, 137 obtained reimbursement in Italy, with a median TTR of 7.6 months (228 days). Even if orphan designation, oncology indication, application of Managed Entry Agreements (MEAs; both outcome and financial based) or a discount did not show an impact on TTR, recognition of full innovativeness (n = 27; 20%) was associated with a reduction of 1 month in median TTR. Interestingly, drugs reimbursed with a lower price/daily defined dose showed a reduced TTR (−22%).
 Conclusions: Even if the lack of impact of some negotiation conditions was predictable (e.g. oncology indication or orphan status) or the application of a MEA helped to manage possible uncertainties, it did not lead to a quicker completion of the negotiation procedure. Likewise, full innovative drugs showed a shorter TTR underlying the AIFA commitment in recognising, promoting and rewarding innovation.