Health technology assessment plays an important role in market access for medical technologies in England. NICE's early value assessment (EVA) program in medical technology, launched in 2022, assesses mostly digital technologies at an early stage in evidence generation. The program recommends the most promising technologies for use in the NHS while further evidence is being generated. NICE focuses on clinical effectiveness, safety, cost, and cost-effectiveness of the technologies. In this White Paper, MTRC performed a review of five recent EVA assessments by NICE to present the evidence requirements for digital and diagnostic medical technologies in this particular HTA program. A review of five cases is followed by recommendations in relation to evidence generation for medical technologies, market access in England, and factors influencing the decision-making of NICE.

Medical technologies face several market access challenges in Europe, including reimbursement, funding (post-reimbursement approval by payers), and health technology assessment. To overcome some of these challenges, Med Tech companies need to develop clinical and economic evidence to support the value claims about medical technologies. MTRC helps medical technology companies reduce uncertainty about evidence requirements of key European reimbursement, funding, and HTA authorities and develop a clear plan to address key gaps with clinical and economic evidence. A White Paper "Evidence Gap Analysis for Medical Technologies in Europe – a Practical Example" presents the methodological approach or MTRC and a practical example of evidence gap analysis.

In December 2023, the reimbursement scheme for outpatient pathology services was updated for 2024. This scheme has been gradually introduced in Norway since 2022. It comprises fee-for-service reimbursement by the Norwegian Health Economics Administration (Helfo) using Pathology Activity Codes (APAT). Fourteen new reimbursement codes were introduced.

Between early September 2023 and mid-January 2024, four 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, 53 health apps are currently available in the DiGA Directory, and six health apps were delisted from the Directory.

On December 21, 2023, the Dutch Healthcare Authority (NZa) issued a draft release of the DRG package for 2025, including new procedure codes, new diagnosis codes, and several new DRGs. These changes concern gynecology, cardiology, gene therapy and other technology groups.

On January 3, 2024, the entity managing the DRG system in Switzerland, SwissDRG, announced that they will be accepting applications for changes in the DRG system from June 3, 2024, until July 15, 2024. The results of the DRG applications made in 2024 will be reflected in the 2026 version of SwissDRG.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 26990 of December 18, 2023, Tuscany Regional Healthcare has published assessments of three medical devices in the peripheral vascular, orthopedic, and dermatology areas.

NHS England defined a deadline for applications to the High Cost Device List (HCDL) changes to be implemented in the 2025/26 NHS Payment Scheme. The completed application form should be submitted via email by May 31, 2024.

On January 01, 2024, the Dutch Healthcare Institute (ZIN) published the updated list of medical procedures reimbursed under basic health insurance with restrictions or limitations. The procedures that were newly introduced to the list concern pulmonary, gynecology and ENT procedures, as well as genetic testing.

On January 1, 2024, changes in the Norwegian central health administration announced by the government in May 2023 came into force. The Directorate of Health expanded its responsibility in digitalization, the development of health care services, and public health. The Directorate of e-Health discontinued to be an independent body and merged with the Directorate of Health.

In December 2023, NHS England launched a consultation regarding proposed changes in the 2023/25 NHS Payment Scheme for the 2024/25 financial year. The key changes concerned the High Cost Device List, top-up payments for specialized services, and payment for radiotherapy. The deadline for submitting comments is January 26, 2024.

MTRC announces the start of the new service – evidence gap analysis for medical technologies in Europe. The service helps to establish the sufficiency of existing evidence to obtain reimbursement and endorsement by HTA organizations in Europe and offers recommendations for the generation of missing evidence. MTRC offers a fact-based, unbiased approach to determining clinical and economic evidence requirements, based on the benchmarking to the prevision reimbursement decisions of reimbursement authorities and HTA organizations. Recommendations are also based on an in-depth understanding of the reimbursement pathways in individual markets.