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Global & Regional Health Technology Assessment
Number of Followers: 1  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2284-2403 - ISSN (Online) 2283-5733
Published by AboutScience Srl Homepage  [4 journals]
  • Use of a maturity model for facilitating the introduction of CAR T-cell
           therapy—Results of the START CAR-T project

    • Authors: Stefania Bramanti, Matteo Carrabba, Alice Di Rocco, Elena Fabris, Luca Gastaldi, Paolo Locatelli, Maria Chiara Tisi
      Pages: 1 - 8
      Abstract: Introduction: Chimeric antigen receptor (CAR) T-cell therapies are novel immunotherapies for the treatment of hematologic malignancies. They are administered in specialized centers by a multidisciplinary team and require the careful coordination of all steps involved in manufacturing and using cellular therapies. The Maturity Model (MM) is a tool developed and used for assessing the effectiveness of a variety of activities. In healthcare, it may assist clinicians in the gradual improvement of patient management with CAR T-cell therapy and other complex treatments. Methods: The START CAR-T project was initiated to investigate the potential of a MM in the setting of CAR T-cell therapy. Four Italian clinics participated in the creation of a dedicated MM. Following the development and test of this MM, its validity and generalizability were further tested with a questionnaire submitted to 18 Italian centers. Results: The START CAR-T MM assessed the maturity level of clinical sites, with a focus on organization, process, and digital support. For each area, the model defined four maturity steps, and indicated the actions required to evolve from a basic to an advanced status. The application of the MM to 18 clinical sites provided a description of the maturity level of Italian centers with regard to the introduction of CAR T-cell therapy. Conclusion: The START CAR-T MM appears to be a useful and widely applicable tool. It may help centers optimize many aspects of CAR T-cell therapy and improve patient access to this novel treatment option.
      PubDate: 2022-01-08
      DOI: 10.33393/grhta.2022.2340
      Issue No: Vol. 9 (2022)
  • Cost analysis of extended half-life recombinant factor IX products in the
           treatment of haemophilia B in Italy: an update

    • Authors: Andrea Aiello, Maria E. Mancuso, Serena Leone, Letizia Rossi, Lorenzo Cioni, Cristina Teruzzi
      Pages: 9 - 13
      Abstract: Haemophilia B (HB) is a rare disease which may lead to chronic disabling arthropathy, resulting in a significant clinical, social and economic impact. In recent years, new extended half-life (EHL) factor IX concentrates produced by recombinant technology (rFIX) have been developed. They have shown significantly prolonged half-life as compared to other rFIX products and improved bleeding control when used as prophylaxis. To date, EHL rFIX products reimbursed in Italy are a recombinant coagulation factor IX produced with Fc technology (rFIXFc) and a recombinant fusion protein containing rFIX fused with recombinant albumin (rIX-FP). The results of extension studies with injection intervals with a median of almost every 14 days for the complete individualized interval prophylaxis (IP) group on rFIXFc and 21 days for a selected subgroup of patients on rIX-FP have recently been published.
      The aim of this analysis was to estimate the cost of prophylactic treatment with rFIXFc and rIX-FP in adult patients, in the light of new clinical evidence and current average prices in Italy.
      The cost of therapy was estimated on the basis of the results of extension studies, the average prices reported in regional drug tenders and assuming an average patient weight of 70 kg.
      The analysis estimated a cost per patient/year between €224,407 and €230,355 for rFIXFc and between €242,259 and €368,587 for rIX-FP. The sensitivity analysis confirmed the robustness of the results.
      The use of rFIXFc over rIX-FP proves to be the least expensive choice for the treatment of HB in Italy.
      PubDate: 2022-01-19
      DOI: 10.33393/grhta.2022.2331
      Issue No: Vol. 9 (2022)
  • A multicriteria decision analysis (MCDA) applied to three long-term
           prophylactic treatments for hereditary angioedema in Spain

    • Authors: Néboa Zozaya, Teresa Caballero, Teresa González-Quevedo, Pedro Gamboa Setien, M. Ángeles González, Ramón Jódar, José Luis Poveda-Andrés, Encarna Guillén-Navarro, Agustín Rivero Cuadrado, Álvaro Hidalgo-Vega
      Pages: 14 - 21
      Abstract: Introduction: Hereditary angioedema (HAE) is a rare genetic disease that impairs quality of life and could be life-threatening. The aim of this study was to apply a multicriteria decision analysis to assess the value of three long-term prophylactic (LTP) therapies for HAE in Spain. Methods: A multidisciplinary committee of 10 experts assessed the value of lanadelumab (subcutaneous use), C1-inhibitor (C1-INH; intravenous), and danazol (orally), using placebo as comparator. We followed the EVIDEM methodology that considers a set of 13 quantitative criteria. The overall estimated value of each intervention was obtained combining the weighting of each criterion with the scoring of each intervention in each criterion. We used two alternative weighting methods: hierarchical point allocation (HPA) and direct rating scale (DRS). A reevaluation of weightings and scores was performed. Results: Lanadelumab obtained higher mean scores than C1-INH and danazol in all criteria, except for the cost of the intervention and clinical practice guidelines. Under the HPA method, the estimated values were 0.51 (95% confidence interval [CI]: 0.44-0.58) for lanadelumab, 0.47 (95%CI: 0.41-0.53) for C1-INH, and 0.31 (95%CI: 0.24-0.39) for danazol. Similar results were obtained with the DRS method: 0.51 (95%CI: 0.42-0.60), 0.47 (95%CI: 0.40-0.54), and 0.27 (95%CI: 0.18-0.37), respectively. The comparative cost of the intervention was the only criterion that contributed negatively to the values of lanadelumab and C1-INH. For danazol, four criteria contributed negatively, mainly comparative safety. Conclusion: Lanadelumab was assessed as a high-value intervention, better than C1-INH and substantially better than danazol for LTP treatment of HAE.
      PubDate: 2022-01-25
      DOI: 10.33393/grhta.2022.2333
      Issue No: Vol. 9 (2022)
  • Budget Impact Analysis of afatinib for first-line treatment of Non-Small
           Cell Lung Cancer (NSCLC) patients with uncommon EGFR mutations

    • Authors: Giuseppe Pompilio, Alessandro Morabito, Diego L. Cortinovis, Davide Integlia
      Pages: 22 - 29
      Abstract: Background: The current clinical practice for patients affected by Non-Small Cell Lung Cancer (NSCLC) with uncommon mutation is based on afatinib and osimertinib, second and third generation of Tyrosine Kinase Inhibitor (TKI) respectively. For uncommon EGFR mutations, it is still unclear which EGFR TKI is most effective, since there are few dedicated prospective studies and Next Generation Sequencing (NGS) techniques trace an increasingly large and sometimes little-known population of EGFR mutations. Objective: To determine the economic impact associated to afatinib and osimertinib, a Budget Impact model considering a 3-year time horizon with two scenarios was developed: a first scenario, called AS IS, based on treatment with afatinib and osimertinib according to a distribution of market shares as emerged from clinical practice; a second suitable scenario, called TO BE, based on reviewed literature data, assuming for each year a 10%, 15% and 20% increase in afatinib use, respectively. Methods: Budget Impact analysis was conducted using a dynamic cohort model, in which the annual number of patients with NSCLC and uncommon mutations was equally distributed over 12 months. Progression-free survival (PFS) data for afatinib and osimertinib were extrapolated up to 36 months from published Kaplan Meier curves, and then the number of patients was estimated for each treatment. Results: The increase of 10% in afatinib use allowed a saving of drug acquisition costs for the Italian NHS, over the 3-year time horizon, of –€ 622,432. The univariate sensitivity analysis shows the market share of osimertinib to be the parameter significantly affecting the results achieved in the base case. Conclusions: The potential increase in the use of afatinib in patients with NSCLC and uncommon mutations leads to lower drug acquisition costs, lower Budget Impact and a saving of money for the Italian NHS.
      PubDate: 2022-01-31
      DOI: 10.33393/grhta.2022.2351
      Issue No: Vol. 9 (2022)
  • Erratum in: Cost per responder for upadacitinib vs abatacept in patients
           with moderate-to-severe Rheumatoid Arthritis in Italy

    • Authors: Roberto Caporali, Roberto Ravasio, Paola Raimondo, Fausto Salaffi
      Pages: 30 - 30
      Abstract: In the article “Cost per responder for upadacitinib vs abatacept in patients with moderate-to-severe Rheumatoid Arthritis in Italy”, (1) which appeared in Volume 8, Issue 1 of Global & Regional Health Technology Assessment, the values appearing in Fig. 5 C and D, inadvertently repeated the values reported in Fig. 5 A and B. Affected data have been corrected in the article now appearing online. The authors apologize for any inconvenience caused to the readers by these changes, which do not affect the final results of the study. The final version of this article is available online and includes a reference to this correction.
      PubDate: 2022-02-17
      DOI: 10.33393/grhta.2022.2383
      Issue No: Vol. 9, No. 1 (2022)
  • How reliable are ICER’s results published in current pharmacoeconomic
           literature' The controversial issue of price confidentiality

    • Authors: Pierluigi Russo
      Pages: 31 - 35
      Abstract: Pharmacoeconomic data are widely used along drug life cycle for supporting decision-making processes on research and development, pricing and reimbursement, and market access. In this context, the incremental cost-effectiveness ratio (ICER) is the gold standard of either cost-effectiveness analyses (CEAs) or cost-utility analyses (CUAs) of pharmaceuticals and health technologies. However, the widespread use of confidentiality clauses in the agreements between pharmaceutical companies and the payers may affect the reliability of ICER value based on transparent price. The aim of this article is to evaluate a case study and simulate the impact of price confidentiality and other managed-entry agreement conditions on the ICER value. The case study was conducted selecting a CEA submitted to the Health Economic Evaluations Office of the Italian Medicines Agency by the pharmaceutical company, which specifically compared two alternative options reimbursed by the Italian NHS using confidential managed-entry agreements. So, a real model was used to collect the output of ICERs generated by the simulation model, considering price inputs of alternative options ranging from the transparent prices to the confidential net price. The simulation showed that price confidentiality may affect the estimated value of the ICER of a new medicine and, consequently, its interpretation. From a different point of view, the published ICER values may also give a completely false economic evidence if non-disclosure agreements are not taken into account. A proposal for editors of pharmacoeconomic journals to improve reliability of CEA is also discussed.
      PubDate: 2022-02-25
      DOI: 10.33393/grhta.2022.2350
      Issue No: Vol. 9 (2022)
  • Distribution methods of ostomy and incontinence aids in the Italian
           healthcare setting: an evaluation questionnaire and social burden of
           direct distribution

    • Authors: Filippo Rumi, Francesca Orsini, Vincenzo Falabella, Pier Raffaele Spena, Americo Cicchetti
      Pages: 36 - 44
      Abstract: Background: The distribution of ostomy and incontinence devices takes place through different modalities according to the regional provisions in force. A first possibility is represented by direct distribution by the local health authorities. A second possibility consists of indirect distribution through affiliated retailers, typically pharmacies and authorized retailers of medical devices. A third form of distribution concerns home distribution. Methods: A survey has been administered to patients’ associations in order to investigate the degree of patients’ satisfaction with the distribution methods of medical devices necessary for the conditions associated with ostomy and incontinence and to provide an estimate of the indirect costs associated with distribution methods in the Italian healthcare context through the development of a budget impact model. Results: The distribution methods associated with a greater degree of satisfaction seem to be indirect and home distribution. Regarding the results of the budget impact mode, in our simulation, a diffusion of home distribution compared to direct and indirect distribution could lead to savings equal to 2,479,519 € over the three-year time horizon considered. Conclusion: The analysis conducted demonstrates how an increase in home distribution in the context of devices associated with people with ostomy or who practice self-catheterization can be associated with resource savings for the entire society (indirect costs avoided). The survey also demonstrates how this distribution method is associated with a good degree of satisfaction on the part of the users who use it.
      PubDate: 2022-03-01
      DOI: 10.33393/grhta.2022.2292
      Issue No: Vol. 9 (2022)
  • Cost-utility analysis of ceftolozane/tazobactam vs meropenem in patients
           with hospital-acquired pneumonia (HABP) or ventilator-associated pneumonia

    • Authors: Francesco Saverio Mennini, Martina Paoletti, Chiara Bini, Andrea Marcellusi, Marco Falcone, Massimo Andreoni
      Pages: 45 - 57
      Abstract: Objective: This study aims to evaluate the cost-effectiveness of ceftolozane/tazobactam compared to meropenem for the treatment of patients with hospital-acquired pneumonia (HABP) or ventilator-associated pneumonia (VABP) from the Italian National Health Service (NHS) and social perspective. Method: A decision tree and a Markov model were developed in order to forecast long-term and short-term disease effects respectively. A hypothetical target population of 1,000 HABP/VABP patients was followed for a lifetime time horizon. In the short-term decision tree, two different settings were developed in order to evaluate the value of empirical therapy compared with the start of treatment after confirmation of the antibiogram. Treated and cured patients enter the long-term Markov model following the mortality of the general population. Direct and indirect costs were considered accordingly with the analysis perspective. Results: The analysis showed that ceftolozane/tazobactam, in both treatment settings (empirical and confirmed), may be a cost-effective option compared to meropenem from the NHS and social perspective (ICER equal to € 1,913 and € 2,203 in the empirical treatment setting and € 6,163 and € 6,597 in the confirmed treatment setting for NHS and social perspective respectively). Conclusions: Introduction of ceftolozane/tazobactam within the Italian healthcare context can represent a valid therapeutic solution both from an economic and an efficacy profile point of view.
      PubDate: 2022-04-07
      DOI: 10.33393/grhta.2022.2287
      Issue No: Vol. 9 (2022)
  • Introduction of the telemonitoring device Turbo+ in the management of
           patients suffering from asthma in Italy: a budget impact analysis

    • Authors: Filippo Rumi, Michele Basile, Americo Cicchetti, Rosario Contiguglia, Antonella Pentassuglia, Alessandro Oliva, Gianenrico Senna, Marco Bonavia, Francesco Scarpelli, Marco Benvenuto
      Pages: 58 - 67
      Abstract: Introduction: Adherence to long-term asthma control drugs is one of the key factors in improving disease management among patients with asthma. Poor adherence to long-term therapies significantly compromises the effectiveness of treatment and represents a problem in controlling the disease in terms of quality of life and economic impact. A budget impact analysis has been developed taking into account that Turbo+ technology (electronic monitoring device) can increase adherence to therapy in patients suffering from asthma. Methods: Coherently with the budget impact model methodology, we developed two different scenarios. One represents the clinical practice assuming a constant market share of 0,99% for Turbo+ and the other one assumes an incremental market share of Turbo+ over the time horizon considered. An increase in adherence to therapy will likely correspond to a reduction of exacerbations and a lower rate of hospitalizations, thus generating savings in terms of use of health resources. Results: The differential analysis shows an incremental saving in terms of resources absorbed by the National Health Service (NHS) over the time horizon considered. In the first year the savings are equal to € 795,658.64 and in the fifth year they are equal to € 3,520,636.34 for a total of resources saved in 5 years of € 10,882,028.50. Conclusions. The model shows how the diffusion of the Turbo+ programme can lead to savings in terms of health resources consumed by the NHS. Further analyses with new real-world data on adherence in asthmatic patients could be useful in confirming the results of the present analysis.
      PubDate: 2022-04-19
      DOI: 10.33393/grhta.2022.2290
      Issue No: Vol. 9 (2022)
  • Analysis of the evolution of the price of oncology drugs after the loss of
           their patent and the marketing of generic medicines

    • Authors: José Manuel Martínez-Sesmero, Borja Smith, Julen Madurga
      Pages: 68 - 72
      Abstract: Background and research question: Loss of exclusivity of oncology drugs causes an important drop in their price due to the marketing of generic medicines. In this article we study how the price of certain oncology drugs evolves throughout time after the loss of their patent, both in terms of the notified price and at a level of the public tenders for the purchase of medicines. Methods: The variation in the price of oral oncology drugs was assessed from the public information provided by the Interministerial Medicinal Products Pricing Committee (Comisión Interministerial de Precios de los Medicamentos, CIPM) and the data from public tenders for the purchase of medicines. Results: The data show a significant drop in price of the medicines assessed after the expiry of their patent, both at a notified price level (70% of average drop in price in 2.6 years) and at the level of the public tenders (drops exceeding 90% in a year for the most innovative drugs). Discussion: The drop in the price of the oncology drugs after the expiry of their patent is seen in all the medicines assessed. The trends seen allow to predict the evolution of the price of another innovative medicine that is nearing the expiry of its patent (Lenalidomide), with an expected drop in price by 90% with respect to the current price of the innovative drug.
      PubDate: 2022-05-13
      DOI: 10.33393/grhta.2022.2366
      Issue No: Vol. 9 (2022)
  • The costs incurred by patients to get eligibility to PCSK9 treatment and
           one-year follow-up: the results of the PRIOR Study

    • Authors: Arianna Bertolani, Roberto Ravasio, Paola Raimondo, Claudio Jommi
      Pages: 73 - 81
      Abstract: Background. Several health care services are required to get eligibility to PCSK9-inhibitors medicines and the follow-up of patients being treated. The ultimate goal is making prescriptions appropriate and monitoring the effects of these drugs. Some recent papers (opinion / consensus documents) highlighted the necessity to make simpler this clinical pathway. Our paper illustrates the cost of this pathway incurred by patients (direct healthcare and non-healthcare costs, productivity losses by patients and their possible care-giver due to the time dedicated to healthcare services). Methods. The study relied on a retrospective data collection through a structured questionnaire administered to 240 patients, being on treatments with PCSK9-inhibiotrd drugs for at least one year. Patients were recruited in 4 Italian healthcare centres from June 2020 to July 2021. Results. Recruited patients are 64 years old on average. 64% of patients are males and 36% are actively employed and working. Mean cost incurred by patients amounts to € 926,1. Direct healthcare costs, direct non-healthcare costs and productivity losses equal to € 463,5 (50%), € 136,7 (15%) and € 325,9 (35%) respectively. Healthcare services fully covered by the National Health Service account for 56% of the total. Co-payments are applied to 26% of healthcare services, whereas patients pay the full price for 18% healthcare services. Discussion. Getting eligibility to PCSK9-inhibitors and managing patients’ follow-up generate important costs incurred by patients. Furthermore, these costs are very different across healthcare centres. We are fully aware that appropriateness of prescriptions and patients’ follow-up are very important. However, simplifying the clinical pathway would bring economic advantages and could make more homogenous the way this pathway is managed by healthcare centres.
      PubDate: 2022-07-18
      DOI: 10.33393/grhta.2022.2415
      Issue No: Vol. 9 (2022)
  • Cost-benefit analysis of ALK diagnosis vs. non-diagnosis in patients with
           advanced non–small cell lung cancer in Spain

    • Authors: Margarita Majem, Rosa Álvarez, Ana Laura Ortega, Lucía Ruiz de Alda, Rocío Gordo, J Francisco García, Yoana Ivanova-Markova, Almudena González-Domínguez, Raquel Sánchez San Cristóbal, Federico Rojo
      Pages: 82 - 90
      Abstract: Introduction: In recent years, target therapies to specific molecular alterations in advanced non–small cell lung cancer (NSCLC) have been identified and have shown superior efficacy compared to non-targeted treatments. Anaplastic lymphoma kinase (ALK) is one of the therapeutic targets; nevertheless, ALK diagnosis is not performed in all NSCLC patients in Spain. The objective of this study is to estimate in monetary terms the benefit for the Spanish society of ALK diagnosis in advanced NSCLC patients. Methods: A cost-benefit analysis of ALK diagnosis vs. non-diagnosis in advanced NSCLC patients was carried out from the Spanish social perspective, with a time horizon of 5 years. Costs, benefits and the cost-benefit ratio weremeasured. The analysis has considered the overall survival in advanced NSCLC patients treated with the ALKtyrosine kinase inhibitor (TKI) alectinib. The natural history of NSCLC was simulated using a Markov model. A 3% discount rate was applied to both costs and benefits. The result was tested using a deterministic sensitivity analysis. Results: The cost of ALK diagnosis vs. non-diagnosis in the base case would be €10.19 million, generating benefits of €11.71 million. The cost-benefit ratio would be €1.15. In the sensitivity analysis, the cost-benefit ratio could range from €0.89 to €2.10. Conclusions: The results justify the universal application of ALK diagnosis in advanced NSCLC, which generates a benefit for Spanish society that outweighs its costs and allows optimal treatment with targeted therapies for these patients.
      PubDate: 2022-09-12
      DOI: 10.33393/grhta.2022.2449
      Issue No: Vol. 9 (2022)
  • Budget Impact analysis of a new system of care in Parkinson’s
           disease patients

    • Authors: Chiara Bini, Francesco Saverio Mennini, Andrea Marcellusi, Martina Paoletti, Carlo Tomino
      Pages: 91 - 98
      Abstract: Objective: To estimate the economic impact of the introduction of a new care system based on apomorphine and Patient Support Program for motor fluctuations (“on-off” phenomena) in patients with Parkinson’s disease which are not sufficiently controlled by oral anti-Parkinson medication in Italy. Method: A Budget Impact model was developed to evaluate the new care system in patients with Parkinson’s disease over a 3-years’ time horizon. The comparator treatments included in the analysis were treatments based on apomorphine and levodopa + carbidopa. The analysis was conducted from a National Health Service (NHS) perspective. Costs included in the analysis were acquisition costs and device costs. A deterministic sensitivity analysis was carried out to evaluate the uncertainty of the parameters used. A break-even analysis was conducted to identify the minimum number of subjects that would need to be treated with the new care system to obtain a positive Budget Impact (World With – World Without = 0). Results: The analysis shows that the introduction of the new care system based on apomorphine could generate a cost saving incurred by the NHS of over € 5.7 million in 3 years. Break-even analysis shows that if it were possible to intercept with the new treatment at least 9 patients treated with apomorphine, there would not be an increase in costs for the NHS. Conclusion: The new care system would respond to the unmet needs of patients with Parkinson’s disease by generating a reduction in the expenditure incurred by NHS.
      PubDate: 2022-09-19
      DOI: 10.33393/grhta.2022.2413
      Issue No: Vol. 9 (2022)
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Heriot-Watt University
Edinburgh, EH14 4AS, UK
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