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, Bloemen et al. analyzed the procedures and methods used by health technology assessment (HTA) agencies in evaluating medical devices, focusing on the normative commitments of HTA practitioners. The authors revealed that existing drug-focused frameworks and practical constraints limit innovation, underscoring the need for a re-evaluation of HTA roles and institutional changes to support methodological advancements tailored for medical devices.

On November 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than January 1, 2025. Thirty-two new codes were added in the biochemistry, microbiology, clinical pharmacology, and immunology fields.

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, Tarricone et al. analyzed assessment frameworks for digital medical devices (DMDs) across the EU to identify prevailing regulatory and reimbursement approaches. The study categorized these frameworks into the following five clusters: integrated national systems combining regulation and reimbursement, decentralized or non-reimbursement-linked frameworks, institutional certification processes lacking standardization, preparatory systems, and countries with underdeveloped infrastructures. The authors emphasized the cross-country learning effects, expediting the harmonization of approaches to foster innovation and improve access to DMDs across the EU.

MTRC developed an analytical White Paper featuring an analysis of five HTAs and strategic recommendations regarding evidence generation for medical technologies in the Netherlands and factors influencing the decision-making of ZIN.

In December 2024, the Danish Board for Health Apps published information on how to apply for the health app evaluation, including the electronic form for the application to the Board of Health Apps, the assessment criteria, and details of the application process.

In late November 2024, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions recommending the transfer to standard care for two completed projects. The projects were dedicated to relieving the burden of emergency rooms and improving infection surveillance in nursing homes.

In December 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) launched a new agreement (Convention) allowing reimbursement for remote monitoring of patients with chronic heart failure. It will come into force on January 1, 2025. New codes (pseudonomenclature) with fees for packages of care will be used for reimbursement. The packages include monitoring of clinical parameters by patients at home (e.g., blood pressure measurement or pulmonary artery pressure measured by an implanted sensor) and transmission of data via a health app to the remote monitoring team at the hospital.

On November 22, 2024, the Danish Health Authority announced that it would change its organizational structure. This restructuring is expected to prepare the Danish Health Authority for Health Care Reform work and set a new framework for the work with public health. The organizational changes will take effect on January 1, 2025.

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 understand the potential scope of our support better. From the week of the 16th of December, we plan to work on 20 projects. Review the complete list of planned activities in this post.

In late November – early December 2024, the application period for 2026 ICD-10-GM (German modification of ICD-10 diagnosis codes), OPS (procedure codes), and DRG changes was opened by the Federal Institute for Drugs and Medical Devices (BfArM) and the Institute for Hospital Remuneration Systems (INeK), respectively.

On November 28, 2024, NHS England published a report summarising the Innovation Ecosystem Programme’s (IEP) findings and recommendations for the next steps. The IEP aimed to foster collaboration between the NHS and key stakeholders (industry, academia, and regulators) to streamline healthcare innovation. Recommendations are summarised in four areas: a) setting the direction, b) structures and tools for delivery, c) people, skills, and capabilities, and d) acceleration.

In November 2024, the annual update of the Swedish NordDRG system was published to come into force on January 1, 2025. No new DRGs were introduced. In 2025, to obtain DRG tariffs, cost-weights must be multiplied by a base rate of 88,061 SEK.