Time to access to novel anticancer drugs and the correlation with ESMO-Magnitude of Clinical Benefit Scale in Slovenia

Janžič, Urška; Knez, Lea; Janzic, Andrej; Čufer, Tanja

doi:10.1080/14737167.2019.1702879

Cited by 16 publications

(14 citation statements)

References 25 publications

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“…However, access to targeted therapies for NSCLC followed a slower pace, similarly to other Central and Eastern European (CEE) countries [7,8]. This is supported by recently published data reporting a lag time of 14 months between approval of new anticancer drugs by the European Medicines Agency and a positive national reimbursement decision in Slovenia [9]. Despite significant improvements, the benefits of targeted therapies are still restricted to a small proportion of patients with advanced NSCLC who harbor targetable driver mutations.…”

Section: Introductionmentioning

confidence: 99%

Immunotherapy for Metastatic Non-Small Cell Lung Cancer: Real-World Data from an Academic Central and Eastern European Center

et al. 2021

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BACKGROUND. Immunotherapy with immune checkpoint inhibitors (ICIs) recently became the standard treatment for advanced non-small cell lung cancer (NSCLC) patients. Here, we present the first results of a real-world observational study on the effectiveness of ICI monotherapy in advanced NSCLC patients treated at a single academic centre in a Central and Eastern European (CEE) country. METHODS. Overall, 66 consecutive advanced NSCLC patients treated with ICIs in everyday clinical practice, either with first-line pembrolizumab (26 patients) or second-line atezolizumab, nivolumab or pembrolizumab (40 patients), from August 2015 to November 2018, were included. All data were retrieved from a hospital lung cancer registry, where the data is collected prospectively. RESULTS. Included patients had a median age of 64 years, most were male (55 %), 6 % were in performance status ≥ 2, and 18 % had controlled CNS metastases at baseline. In first-line, the median progression-free survival (mPFS) was 9.3 months, while the median overall survival (mOS) was not reached. The 1-year OS was 62 %. In second-line, the mPFS and mOS were 3.5 months and 9.9 months, respectively, with a 1-year OS of 35 %. In the overall population, adverse events of any grade were recorded in 79 % of patients and of severe grade (3 -4) in 12 % of patients. CONCLUSION. The first real-world outcomes of NSCLC immunotherapy from a CEE country suggest comparable effectiveness to those observed in clinical trials and other real-world series, mainly coming from North America and Western European countries. Further data to inform on the real-world effectiveness of immunotherapy worldwide are needed. The Oncologist 2021;9999:• • Implications for Practice: Following the results from pivotal trials, immunotherapy became a standard treatment of advanced NSCLC. The real-world data on immunotherapy effectiveness in everyday clinical practice is still limited. This article presents the first data on the effectiveness of mono-immunotherapy with ICIs for patients with advanced NSCLC treated at a single academic centre in a CEE country. The survival rates and observed toxicity are comparable to those achieved in randomized clinical trials and other real-world series, coming mainly from North America and Western European countries. There is a pressing need to gather further data on the effectiveness of immunotherapy in everyday practice worldwide.

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Section: Introductionmentioning

confidence: 99%

Immunotherapy for Metastatic Non-Small Cell Lung Cancer: Real-World Data from an Academic Central and Eastern European Center

et al. 2021

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“…Researchers found that time to access is similar for drugs with or without substantial CAB. According to their conclusion, integrating the ESMO-MCBS into reimbursement deliberations could improve access to drugs with substantial clinical benefit (20). A similar analysis is planned in Hungary after our framework is routinely used.…”

Section: Discussionmentioning

confidence: 99%

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Dóczy¹,

Sódar²,

Hölgyesi

et al. 2022

Int J Technol Assess Health Care

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Objectives The reimbursement process for innovative health technologies in Hungary lacks any formalized assessment of clinical added benefit (CAB). The aim of this research is to present the development, retrospective testing, and implementation of a local assessment framework for determining the CAB of cancer treatments at the Department of Health Technology Assessment of the National Institute of Pharmacy and Nutrition in Hungary. Methods The assessment framework was drafted after screening existing methods and a retrospective comparison of local reimbursement dossiers to that of German and French methods. The Magnitude of Clinical Benefit Scale of the European Society for Medical Oncology was chosen to rate the extent of CAB in oncology, as part of a conclusion complemented by the assessment of endpoint relevance and the quality of evidence. Several rounds of retrospective assessments have been conducted involving all clinical assessors, iterated with semistructured discussions to consolidate divergence between assessors. External stakeholders were consulted to provide feedback on the framework. Results Retrospective assessments resulted in average more than 75 percent concordance between assessors on each element of the conclusion. Input from ten stakeholders was also incorporated; stakeholders were generally supportive, and they mostly commented on the concept, the elements of the framework, and its implementation. Conclusions The procedure is suitable for routine use in the decision-making process to describe the CAB of antineoplastic technologies in Hungary. Further extension of the framework is required to cover more disease areas for structured and comparable conclusions on CAB of innovative health technologies.

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“…A low correlation between time to access and clinical benefit of oncology drugs has additionally been observed in European healthcare systems. 19 , 20 Ferrario et al 19 found no correlation with ESMO‐MCBS scores when examining the time from European Medicines Agency (EMA) marketing authorization to first use of oncology drugs in Belgium, Estonia, Scotland, and Sweden. Furthermore, Janzic et al 20 found that the time from EMA marketing authorization to national reimbursement approval in Slovenia was equally long for oncology drugs with or without substantial clinical benefit, as measured by the ESMO‐MCBS.…”

Section: Discussionmentioning

confidence: 99%

“… 19 , 20 Ferrario et al 19 found no correlation with ESMO‐MCBS scores when examining the time from European Medicines Agency (EMA) marketing authorization to first use of oncology drugs in Belgium, Estonia, Scotland, and Sweden. Furthermore, Janzic et al 20 found that the time from EMA marketing authorization to national reimbursement approval in Slovenia was equally long for oncology drugs with or without substantial clinical benefit, as measured by the ESMO‐MCBS. These studies assessed a heterogenous range of the time period from regulatory approval to first use or reimbursement, which might be influenced by many processes or factors.…”

Section: Discussionmentioning

confidence: 99%

Examining the association between oncology drug clinical benefit and the time to public reimbursement

et al. 2021

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Background: We examined if oncology drug indications with high clinical benefit, as measured by the American Society of Clinical Oncology Value Framework (ASCO-VF) and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS), received public reimbursement status faster than those with lower clinical benefit from the time of pan-Canadian Oncology Drug Review (pCODR) recommendation.

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Time to access to novel anticancer drugs and the correlation with ESMO-Magnitude of Clinical Benefit Scale in Slovenia

Cited by 16 publications

References 25 publications

Immunotherapy for Metastatic Non-Small Cell Lung Cancer: Real-World Data from an Academic Central and Eastern European Center

Immunotherapy for Metastatic Non-Small Cell Lung Cancer: Real-World Data from an Academic Central and Eastern European Center

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Examining the association between oncology drug clinical benefit and the time to public reimbursement

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