Clinical characteristics, healthcare resource use, and survival outcomes among patients with advanced NSCLC tested for KRAS mutations in France, the United Kingdom, and Switzerland.

Objective: To evaluate real-world patient characteristics, healthcare resource use (HRU), and clinical outcomes among patients with advanced or metastatic (A/M) non-small cell lung cancer (NSCLC) stratified by KRAS mutation status (KRAS G12C, KRAS non-G12C, and KRAS wild-type[WT]).

Methods: This retrospective chart review included adults with A/M NSCLC and known KRAS status who received second- or third-line non-targeted therapy (index therapy) in France, the UK, or Switzerland. Patient characteristics, HRU, and key clinical outcomes-including time to treatment discontinuation (TTD), progression-free survival (PFS), and overall survival (OS)-were analyzed using the Kaplan-Meier method and log-rank methods.

Oncology pharmacy practice: Key insights, challenges, and perspectives - A position paper from the French Society for Oncology Pharmacy (SFPO).

The role of hospital oncology pharmacists (HOP) in the care of cancer patients has evolved considerably. This evidence led the experts of the French Society for Oncology Pharmacy (SFPO) to write a position paper. The first part presents the key insights of oncology pharmacy services (technology aspects of anticancer drug preparation and clinical pharmacy services), training of HOPs and research activities (clinical trials, research in oncology pharmacy).

The correlation of liquid biopsy genomic data to radiomics in colon, pancreatic, lung and prostatic cancer patients.

Introduction: With the advances in artificial intelligence (AI) and precision medicine, radiomics has emerged as a promising tool in the field of oncology. Radiogenomics integrates radiomics with genomic data, potentially offering a non-invasive method for identifying biomarkers relevant to cancer therapy. Liquid biopsy (LB) has further revolutionized cancer diagnostics by detecting circulating tumor DNA (ctDNA), enabling real-time molecular profiling.

Baseline CT-derived tumor burden and liquid biopsy as biomarkers to predict survival in patients with metastatic solid cancer.

Purpose: The purpose of this study was to evaluate baseline tumor burden from liquid biopsy (LB) and computed tomography (CT) as prognostic biomarkers and whether their combination refines stratification in metastatic solid cancers.

Materials And Methods: This retrospective cohort study included 1065 patients. Eligible patients underwent LB and chest-abdomen-pelvis CT examination at baseline.

Healthcare resource utilization and costs in immunodeficient patients receiving subcutaneous Ig: Real-world evidence from France.

Background: Subcutaneous immunoglobulin (SCIg) replacement therapy is indicated for patients with hypogammaglobulinemia caused by primary (PID) and secondary immunodeficiencies (SID).

Objective: To compare healthcare resource utilization (HCRU) and related direct medical costs of patients in France treated with weekly conventional SCIg (cSCIg) vs monthly hyaluronidase-facilitated SCIg (fSCIg).

Methods: This retrospective study of Ig-naïve patients with PID or SID newly receiving a SCIg between 2016 and 2018, extracted from the French National Healthcare reimbursement database (SNDS), analyzed the SCIg-related HCRU and reimbursed costs generated from in-hospital (hospitalizations and SCIg doses) or at-home (nurse visits [NV] and pump provider visits [PPV], drug doses) SCIg administration.

Methodological expectations for demonstration of health product effectiveness by observational studies.

The issue of assessing the effectiveness of health technologies (drugs, devices, etc.) through observational studies is becoming increasingly important as registration and market access agencies consider them in their evaluation process. In this context, observational studies must be able to provide real demonstrations of a level of reliability comparable to those produced by the conventional randomized controlled trial (RCT) approach.

Thyroidectomy without radioiodine in patients with low-risk thyroid cancer: 5 years of follow-up of the prospective randomised ESTIMABL2 trial.

Background: ESTIMABL2, a multicentre randomised phase 3 trial in patients with low-risk differentiated thyroid cancer (ie, pT1am or pT1b, N0 [no evidence of regional nodal involvement] or Nx [involvement of regional lymph nodes that cannot be assessed in the absence of neck dissection]), showed the non-inferiority of a follow-up strategy without radioactive iodine (I) administration compared with a postoperative I administration at 3 years post-randomisation. Here, we report a pre-specified analysis after 5 years of follow-up.

Methods: Patients treated with total thyroidectomy with or without prophylactic neck lymph node dissection, without postoperative suspicious findings on neck ultrasonography, were randomly assigned to the no-radioiodine group or to the radioiodine group (1·1 GBq-30 mCi after recombinant human thyrotropin-stimulating hormone).

A Cost-Effectiveness Analysis of Gonadotropins Used for Ovarian Stimulation during Assisted Reproductive Technology Based on Data from the French Nationwide Claims Database (SNDS).

Objective: Various gonadotropins are used for ovarian stimulation (OS). This study investigated the cost-effectiveness of different gonadotropins based on real-world data from the French National Health Database (SNDS) over a 7-year follow-up of assisted reproductive technology (ART) treatments.

Design: Cost-effectiveness analysis of different gonadotropins based on real-world data from the SNDS was conducted.

[Real-life evaluation of the care pathway of patients eligible for axicabtagene ciloleucel treatment: Analysis of a multicenter retrospective cohort (IMPA-CT study)].

The arrival of CAR-T cell treatments in Europe in 2018 has considerably changed the clinical and logistical management of lymphoma patients. The aim of this study is to evaluate pathways of patients eligible for axicabtagene ciloleucel (axi-cel), particularly previously and afterwards of its administration, stages that are currently poorly documented in the literature. Ninety-eight patients from eleven French qualified centers eligible for axi-cel treatment between June 2020 and February 2021 were retrospectively included.

Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review.

Background: Artificial intelligence (AI)-based medical devices have garnered attention due to their ability to revolutionize medicine. Their health technology assessment framework is lacking.

Objective: This study aims to analyze the suitability of each health technology assessment (HTA) domain for the assessment of AI-based medical devices.

Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs.

Background: An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and accelerate access to innovative drugs.

Objective: This study analyzes the characteristics of oncology drug approvals through the EA process and its impact on real-life data for oncology patients.

Methods: The number and characteristics of EA demands concerning oncology drugs submitted to the National Health Authority (HAS, Haute Autorité de Santé) were reviewed until 31 December 2022.

Basal Insulinotherapy in Patients Living with Diabetes in France: The EF-BI Study.

Introduction: Second-generation basal insulins like glargine 300 U/mL (Gla-300) have a longer duration of action and less daily fluctuation and interday variability than first-generation ones, such as glargine 100 U/mL (Gla-100). The EF-BI study, a nationwide observational, retrospective study, was designed to compare persistence, acute care complications, and healthcare costs associated with the initiation of such basal insulins (BI) in a real-life setting in France.

Methods: This study was conducted using the French healthcare claims database (SNDS).

Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France.

Objectives: To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization.

Methods: A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use.

Organizational Impact of Immunotherapies in Advanced Cancers in France.

Purpose: In 2020, the French National Authority for Health () published a methodologic guide called organizational impact (OI) cartography to define and structure assessment of the OI of health technologies. As immunotherapies are associated with extended survival and improved quality of life in advanced cancer, we aimed to identify OIs that immunotherapies had on health care systems and professionals. To our knowledge, we suggest the first implementation for OI assessment on the basis of the cartography.

International Market Access Strategies for Artificial Intelligence-Based Medical Devices: Can We Standardize the Process to Faster Patient Access?

The reimbursement of artificial intelligence (AI)-based medical devices (MDs) is a complex and challenging issue, depending on national market access pathways. We aim to analyze these pathways and propose recommendations for standardized market access processes. In the USA, companies sell AI-based MDs to each health insurance provider separately.

Are current clinical studies on artificial intelligence-based medical devices comprehensive enough to support a full health technology assessment? A systematic review.

Introduction: Artificial Intelligence-based Medical Devices (AI-based MDs) are experiencing exponential growth in healthcare. This study aimed to investigate whether current studies assessing AI contain the information required for health technology assessment (HTA) by HTA bodies.

Methods: We conducted a systematic literature review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology to extract articles published between 2016 and 2021 related to the assessment of AI-based MDs.

ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer: a prospective randomized trial.

Background: Prophylactic central neck dissection in clinically low-risk cT1bT2N0 papillary thyroid carcinoma is controversial, due to a large number of conflicting retrospective studies, some showing an advantage in terms of locoregional recurrence, others showing no advantage. These previous studies all show high rates of excellent response. We aim to demonstrate the non-inferiority of thyroidectomy alone as compared to total thyroidectomy with prophylactic central neck dissection in conjunction with adjuvant RAI 30 mCi with rTSH stimulation in terms of excellent response at 1 year.

Assessment of Performance, Interpretability, and Explainability in Artificial Intelligence-Based Health Technologies: What Healthcare Stakeholders Need to Know.

This review aimed to specify different concepts that are essential to the development of medical devices (MDs) with artificial intelligence (AI) (AI-based MDs) and shed light on how algorithm performance, interpretability, and explainability are key assets. First, a literature review was performed to determine the key criteria needed for a health technology assessment of AI-based MDs in the existing guidelines. Then, we analyzed the existing assessment methodologies of the different criteria selected after the literature review.

A Phase II Redifferentiation Trial with Dabrafenib-Trametinib and 131I in Metastatic Radioactive Iodine Refractory BRAF p.V600E-Mutated Differentiated Thyroid Cancer.

Purpose: To evaluate the efficacy and safety of dabrafenib-trametinib-131I for the treatment of radioactive iodine refractory metastatic differentiated thyroid cancer (DTC) with a BRAF p.V600E mutation.

Patients And Methods: A prospective phase II trial including patients with RECIST progression within 18 months and no lesion > 3 cm.