Molecular gene profile analysis (Oncotype DX) was evaluated within the "New Methods" framework starting in 2021. On August 26, 2024, the Decision Forum for "New Methods" recommended Oncotype DX to be introduced to predict the benefit of chemotherapy in postmenopausal patients with lymph node-positive, estrogen receptor-positive (ER+), human epidermal growth factor receptor-2 negative (HER2-) early-stage invasive breast cancer.

On July 31, 2024, NHS England and the National Institute for Health and Care Excellence (NICE) published a consultation document that proposes to increase the Budget Impact Test (BIT) threshold from £20 million to £40 million. The BIT applies during NICE's technology evaluation process. The deadline for comments submission is September 25, 2024.

On August 19, 2024, the Agenda for the meeting of the Board of Danish Regions was published. One of the themes to be discussed during the meeting was the Danish Regions consultation response regarding the Health Structure Commission's report. The meeting was held on August 22, 2024.

Our goal at MTRC is to inform the decision-making of our clients and to support their market access activities. Below is a snapshot of our planned activities for the next two weeks. This can help our existing and prospective clients to better understand the potential scope of our support. From the week of the 9th of September, we are planning to work on 18 projects. Review the full list of planned activities in this post.

On July 25, 2024, the National Institute for Health and Care Research (NIHR) launched a funding call within the HTA Programme concerning ambitious data-enabled trial proposals (or “e-trials”). Proposed interventions need to be mature enough to be tested on a national scale. The application deadline is November 27, 2024.

In mid-August 2024, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions recommending the transfer to standard care for another four completed projects. The projects were dedicated to the topics of support for families with a parent suffering from cancer, modeling routine risk screening in children, reducing problematic media use, promoting treatment motivation in people with computer game addiction and Internet addiction, and follow-up care for gestational diabetes.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2024. Five recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, peripheral vascular, neuromodulation, orthopedic, and spine devices.

NICE recently introduced a new centralized approach to prioritizing topics for its guidance and a decision-making body - a prioritization board. In July 2024, the decisions of the prioritization board were first published by NICE. Sixteen topics were prioritized, twenty were not prioritized, and one was withdrawn.

In early July 2024, Dutch Organization for Health Research and Development (ZonMw) awarded seventeen projects under the Efficiency Research program, including four projects on e-health, two projects on diagnostic imaging techniques, two projects in orthopedics, one project on abdominal surgery, one project in gynecology, and one project in the cardiovascular area.

On August 8, 2024, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 197 and 093 with changes to be implemented no later than October 4, 2024. Thirteen new procedure codes related to cardiovascular, endoscopy, gastrointestinal, interventional radiology, neurology, gynecology, orthopedics, spine, and robotic surgery areas, and four new diagnostic codes were introduced.

On August 3, 2024, the Ministry of Labor, Health, and Solidarity published an Order in the Official Journal of the French Republic modifying the national neonatal screening program using laboratory examinations. Starting November 1, 2024, all newborns will be screened for sickle cell disease. Other modifications include organizational changes and modifications related to the timing of blood sample collection.

In August 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) announced the national implementation of the first Integrated Care Program as part of the Intrafederal Plan: care and support for pregnant women, children, and their families during their first 1000 days. Four new INAMI-RIZIV pseudo-nomenclature codes with fees were introduced to cover the key activities within the program.