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News and blog posts

23
Feb 2024

Publication Digest: Digital health applications from a government-regulated directory of reimbursable health apps in Germany – a systematic review for evidence and bias

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Dittrich et al. conducted a systematic review to assess the evidence quality and manufacturers' approaches regarding digital health applications (DiGA) in Germany following the Digital Healthcare Act. The results revealed evidence-related gaps, such as the relatively low quality of most of the available studies for inclusion in the DiGA directory with high potential for bias and limited external generalizability. The authors highlighted the need for addressing found evidence gaps and further studies of higher quality to improve the evidence base concerning the benefits of prescribable apps.
22
Feb 2024

NHS Cancer Programme Innovation Open Call 3 announced in England

On January 26, 2024, NHS England announced the third round of the Innovation Open Call, funded by the NHS Cancer Programme. All types of late-stage innovations aimed at early detection and diagnosis of cancer are eligible, including medical devices, in-vitro diagnostics, digital health solutions, and AI. Awarded projects will be 100% funded up to the total value of £4 million to produce and evaluate evidence in a real-world setting, supporting adoption and spread by providers, commissioners, and regulators. The application submission will be open on April 8, 2024.
20
Feb 2024

Three more health apps obtained reimbursement in Germany

Between mid-January 2024 and mid-February 2024, three more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, 56 health apps are currently available in the DiGA Directory, and six health apps were delisted from the Directory.
19
Feb 2024

Publication Digest: Utilization of innovative medical technologies in German inpatient care: does evidence matter?

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Eckhardt et al. investigated the evolution of clinical evidence and the utilization of 25 innovative technologies in German inpatient care. Through systematic searches and empirical analysis, the authors revealed that the body of clinical evidence per technology often consisted mainly of non-comparative studies, and its robustness increased over time for many but not all technologies. The results highlighted the need for strengthened market approval standards, HTA pathways, and approaches like coverage with evidence development to ensure informed reimbursement decisions.
19
Feb 2024

Five-year implementation strategy for Hybrid closed loop technologies in England

On January 22, 2024, NHS England published a 5-year implementation strategy for Hybrid closed loop (HCL) technologies following the NICE technology appraisal (TA943) publication. As a rule, commissioners and providers must implement TA recommendations within three months. However, an agreed five-year implementation will allow NHS to build specialist competencies and cost-effective procurement. NHS England will fund integrated care boards to reimburse the use of HCL systems
16
Feb 2024

Publication Digest: Evolving Use of Health Technology Assessment in Medical Device Procurement-Global Systematic Review: An ISPOR Special Interest Group Report

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Cangelosi et al. conducted a systematic review to assess how data from health technology assessments (HTAs) informs procurement decisions for medical devices. By synthesizing evidence from 11 relevant studies, the authors aimed to identify the criteria used in purchasing decisions, highlighting the minimal evidence of HTA influencing procurement. The authors emphasized the unmet need for enhanced transparency, incentivization for publishing procurement-related work, and further research to strengthen the connection between HTA and procurement, ultimately aiming to optimize resource allocation and expand access to innovative medical technologies within healthcare systems.
16
Feb 2024

Recommendations about add-on reimbursement for medical devices in France in January 2024

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in January 2024. Twelve recommendations were published concerning the registration of medical devices or modification of registration conditions with the extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, peripheral vascular, interventional radiology, neurovascular, ophthalmology, men’s health, and endoscopy devices, as well as medical aids.
15
Feb 2024

Med Tech-related technology assessments and clinical guidelines from NICE in January 2024

In January 2024, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (intravascular lithotripsy in peripheral arterial disease, temperature control after cardiac arrest, and pharyngeal electrical stimulation for neurogenic dysphagia) and one new Diagnostics Guidance (AI-derived software to help clinical decision making in stroke). Furthermore, one Diagnostics Guidance and five clinical guidelines were updated.
13
Feb 2024

Publication Digest: Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks-evidence from Germany

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Groene et al. conducted a comprehensive evaluation of Germany's pioneering policy to include digital health applications in the statutory health insurance system, aiming to assess its impact, highlight challenges, and propose prospective policy options. Through analysis of publicly available data from the Federal Institute for Drugs and Medical Devices and empirical findings published by academic institutions and sickness funds, the authors delineated areas for improvement, such as low prescription rates and temporary reimbursement of applications that lack proven benefit. The authors advocated for value-based pricing and increased budget authority for insurance organizations to foster innovation while ensuring optimal resource allocation in healthcare.