NSCLC molecular testing in Central and Eastern European countries

Ryška, Aleš; Berzinec, Peter; Brčić, Luka; Čufer, Tanja; Dziadziuszko, Rafał; Gottfried, Maya; Kovalszky, Ilona; Olszewski, Włodzimierz; Öz, Büğe; Tı́már, József

doi:10.1186/s12885-018-4023-4

Cited by 30 publications

(48 citation statements)

References 32 publications

(41 reference statements)

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“…Our study included both a higher percentage of patients who received EGFR biomarker mutation testing (NSQ: 80.2%; SQ: 26.2%), and of presence of EGFR mutation (NSQ: 31.1%; SQ: 10.2%) than reported in literature, indicating a potential selection bias of patients with better outcomes and lower total costs. 18 The increasing use of EGFR mutation tests and treatment with tyrosine-kinase inhibitors (TKIs) may also lead to higher treatment costs than found in our sample.…”

Section: Discussionmentioning

confidence: 79%

<p>Costs and Cost Drivers Associated with Non-Small-Cell Lung Cancer Patients Who Received Two or More Lines of Therapy in Europe</p>

Verleger¹,

Penrod²,

Daumont³

et al. 2020

CEOR

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Purpose: Advanced non-small-cell lung cancer (aNSCLC; stage IIIB/IV) presents a substantial clinical burden to society; reliable estimates of its economic burden are lacking. Therefore, this study aimed to quantify real-world health care resource utilization (HCRU) and costs of patients with squamous (SQ) and non-SQ (NSQ) aNSCLC who received two or more lines of treatment (2L+) in Europe, and to describe cost-predictors. Methods: The LENS (Leading the Evaluation of Non-squamous and Squamous NSCLC) retrospective chart review study collected data from 2L+ patients with aNSCLC diagnosed between 07/2009 and 08/2011 (wave 1) or 07/2010 and 09/2012 (wave 2) in France, Germany, Italy, Spain, England, the Netherlands, and Sweden. Patients were followed from diagnosis through most recent visit/death. A weighted average of countryspecific unit costs (2018 Euro) was applied to systemic anti-cancer therapy usage and HCRU (hospital/emergency department visit, surgery, radiotherapy, ancillary care, biomarker testing) to determine the total cost from aNSCLC diagnosis to death. Generalized linear models (gamma distribution, log link) were used to assess clinical and demographic predictors. Results: Of 973 2L+ aNSCLC patients, median overall survival (OS) was 1.5 years from advanced diagnosis (range: 0.2-5.3; median OS: 1.4 [SQ], 1.6 [NSQ]), 79.0% died during follow-up. Weighted mean total per-patient costs were €21,273, ranging from €17,761 (England) to €30,854 (Sweden), and €15,446 (SQ) to €26,477 (NSQ). Systemic drug costs comprised 77.4% of total costs. Insurance status, presence of epidermal growth factor receptor (EGFR) mutation, SQ histology, age, alcohol abuse, and year of diagnosis were significant predictors for lower total costs per patient-month, Eastern Cooperative Oncology Group performance status (ECOG PS) ≥1 and country for higher costs. Conclusion: In the era pre-immunotherapy, HCRU and costs were substantial in aNSCLC 2L+ patients, with most of the costs accrued prior to start of 2L. NSQ patients incurred significantly higher total costs than SQ patients in all participating countries.

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Section: Discussionmentioning

confidence: 79%

<p>Costs and Cost Drivers Associated with Non-Small-Cell Lung Cancer Patients Who Received Two or More Lines of Therapy in Europe</p>

Verleger¹,

Penrod²,

Daumont³

et al. 2020

CEOR

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“…In 2015, the American Medical Association introduced specific NGS panel codes, and we calculated the overall reimbursement rate by dividing the total sum of obtained payments through the total sum of charges using CMS values as a reference. For comparison of our reimbursement rates with local, national, and international rates, we reviewed reimbursement data from selected publications [28][29][30][31][32][33][34][35][36].…”

Section: Economic Analysismentioning

confidence: 99%

“…4C). Notably, these comparison data are obtained in nonorphan disease settings and include multisite studies including large community centers or even national initiatives [28][29][30][31][32][33][34][35][36]. Nonetheless, obtaining reimbursement requires carefully designed workflows to account for prior authorization, policy tailoring, and appeals processes [45][46][47].…”

Section: Assessment Of Financial Sustainabilitymentioning

confidence: 99%

Clinically Integrated Molecular Diagnostics in Adenoid Cystic Carcinoma

Thierauf

Ramamurthy

et al. 2019

The Oncologist

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Background Adenoid cystic carcinoma (ACC) is an aggressive salivary gland malignancy without effective systemic therapies. Delineation of molecular profiles in ACC has led to an increased number of biomarker‐stratified clinical trials; however, the clinical utility and U.S.‐centric financial sustainability of integrated next‐generation sequencing (NGS) in routine practice has, to our knowledge, not been assessed. Materials and Methods In our practice, NGS genotyping was implemented at the discretion of the primary clinician. We combined NGS‐based mutation and fusion detection, with MYB break‐apart fluorescent in situ hybridization (FISH) and MYB immunohistochemistry. Utility was defined as the fraction of patients with tumors harboring alterations that are potentially amenable to targeted therapies. Financial sustainability was assessed using the fraction of global reimbursement. Results Among 181 consecutive ACC cases (2011–2018), prospective genotyping was performed in 11% (n = 20/181; n = 8 nonresectable). Testing identified 5/20 (25%) NOTCH1 aberrations, 6/20 (30%) MYB‐NFIB fusions (all confirmed by FISH), and 2/20 (10%) MYBL1‐NFIB fusions. Overall, these three alterations (MYB/MYBL1/NOTCH1) made up 65% of patients, and this subset had a more aggressive course with significantly shorter progression‐free survival. In 75% (n = 6/8) of nonresectable patients, we detected potentially actionable alterations. Financial analysis of the global charges, including NGS codes, indicated 63% reimbursement, which is in line with national (U.S.‐based) and international levels of reimbursement. Conclusion Prospective routine clinical genotyping in ACC can identify clinically relevant subsets of patients and is approaching financial sustainability. Demonstrating clinical utility and financial sustainability in an orphan disease (ACC) requires a multiyear and multidimensional program. Implications for Practice Delineation of molecular profiles in adenoid cystic carcinoma (ACC) has been accomplished in the research setting; however, the ability to identify relevant patient subsets in clinical practice has not been assessed. This work presents an approach to perform integrated molecular genotyping of patients with ACC with nonresectable, recurrent, or systemic disease. It was determined that 75% of nonresectable patients harbor potentially actionable alterations and that 63% of charges are reimbursed. This report outlines that orphan diseases such as ACC require a multiyear, multidimensional program to demonstrate utility in clinical practice.

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“…An international strategy should be considered to give support to countries where molecular pathology is performed so far only in minimal extent, in order to face the scenario of increasing technological complexity and hardware requirements [25].…”

Section: Importance Of Interpreting Somatic Alterations In Cancer In mentioning

confidence: 99%

The leading role of pathology in assessing the somatic molecular alterations of cancer: Position Paper of the European Society of Pathology

et al. 2020

Self Cite

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Molecular pathology is an essential part of pathology complementing conventional morphological tools to obtain a correct integrated diagnosis with appropriate assessment of prognosis and prediction of response to therapy, particularly in cancer. There is a concern about the situation of molecular pathology in some areas of Europe, namely, regarding the central role of pathologists in assessing somatic genomic alterations in cancer. In some countries, there are attempts that other laboratory medicine specialists perform the molecular analysis of somatic alterations in cancer, particularly now when next generation sequencing (NGS) is incorporated into clinical practice. In this scenario, pathologists may play just the role of "tissue providers," and other specialists may take the lead in molecular analysis. Geneticists and laboratory medicine specialists have all background and skills to perform genetic analysis of germline alterations in hereditary disorders, including familial forms of cancers. However, interpretation of somatic alterations of cancer belongs to the specific scientific domain of pathology. Pathologists are necessary to guarantee the quality of the results, for several reasons: (1) The identified molecular alterations should be interpreted in the appropriate morphologic context, since most of them are context-specific; (2) pre-analytical issues must be taken into consideration; (3) it is crucial to check the proportion of tumor cells in the sample subjected to analysis and presence of inflammatory infiltrate and necrosis should be monitored; and 4) the role of pathologists is crucial to select the most appropriate methods and to control the turnaround time in which the molecular results are delivered in the context of an integrated diagnosis. Obviously, there is the possibility of having core facilities for NGS in a hospital to perform the sequence analysis that are open to other specialties (microbiologists, geneticists), but also in this scenario, pathologists should have the lead in assessing somatic alterations of cancer. In this article, we emphasize the importance of interpreting somatic molecular alterations of the tumors in the context of morphology. In this Position Paper of the European Society of Pathology, we strongly support a central role of pathology departments in the process of analysis and interpretation of somatic molecular alterations in cancer.

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NSCLC molecular testing in Central and Eastern European countries

Cited by 30 publications

References 32 publications

<p>Costs and Cost Drivers Associated with Non-Small-Cell Lung Cancer Patients Who Received Two or More Lines of Therapy in Europe</p>

<p>Costs and Cost Drivers Associated with Non-Small-Cell Lung Cancer Patients Who Received Two or More Lines of Therapy in Europe</p>

Clinically Integrated Molecular Diagnostics in Adenoid Cystic Carcinoma

The leading role of pathology in assessing the somatic molecular alterations of cancer: Position Paper of the European Society of Pathology

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