Position Ensure and further accelerate access to laboratory innovations

The diagnostics industry is an innovation driver of the first order. The inclusion of laboratory innovations in the standard care provided by statutory health insurance requires clear procedural rules, transparency regarding the consultation process and defined timeframes for decision-making. Participation opportunities for the industry, patient organizations and representatives from the scientific community must be improved.

A key quality feature of developed healthcare systems is that patients have rapid access to medical innovations. Despite a wide range of legal requirements aimed at achieving this goal, the situation in the field of laboratory diagnostics remains deficient. While innovations in the pharmaceutical sector can be reimbursed by statutory health insurance immediately after approval, the situation for IVDs is more complex and delayed. The safety, quality and performance of an IVD are verified by a complex conformity assessment procedure. After successful CE marking, the product can then be marketed throughout Europe. In Germany, a benefit assessment is also required before new laboratory services can be billed to the SHI system.

The evaluation committee of the KBV and GKV-Spitzenverband is responsible for the inclusion of new laboratory services in the EBM (uniform evaluation scale). Despite some improvements, the consultations there continue to be a "black box". Transparency about the decision-making processes and the people involved is desirable, not only for the industry, but also for patients and the insured. In the past, consultation periods often lasted several years. Legislators recognized this problem and responded with the SHI Care Reinforcement Act of 2015. The evaluation committee was obliged to include deadlines in its rules of procedure with regard to consultations and resolutions on the inclusion of new laboratory services and human genetic services in the EBM. Only under political pressure did the self-administration adopt new rules of procedure for the evaluation of laboratory diagnostic innovations. However, there are deficits in the details. For example, the consultation period of two years is too long for an innovative sector. There is also a lack of a regulation that would lead to immediate reimbursement if the self-administration does not make a decision within the deadline.

In 2011, the Joint Federal Committee (G-BA) introduced the testing of examination and treatment methods in accordance with Section 137e of the German Social Code, Book V (SGB V). To date, the trial regulation has hardly had any effect, as it was very complicated to implement. The aim of accelerating access to useful medical innovations for those insured by the statutory health insurance system (SHI) was largely missed. The Appointment Service and Care Act made selective improvements that led to shorter timeframes and a lower-risk calculation of cost sharing for the medical device industry.

Neither the basic idea of an innovation on trial nor the hope of accelerating the innovation evaluation process have yet been realized in practice. The trial regulation should therefore be further developed by the G-BA, possibly flanked by legal clarifications. The G-BA's budgetary reservations must not become a bottleneck for trials.

For the benefit assessment under the responsibility of the G-BA, a fundamental discussion is suggested on which assessment methods are appropriate for in vitro diagnostics. The concept of clinical benefit for IVDs differs fundamentally from that for medicinal products or therapeutic medical devices.

Science and industry turn inventions into marketable innovations - and patients benefit from them. It is difficult to understand why these groups in particular are left out of the evaluation of innovations by the evaluation committee or the G-BA. Their expertise should be included over and above the only rudimentary opportunities for participation (application and voting rights).

Laboratory diagnostics play a key role in personalized medicine, e.g. in cancer treatment. This is because it provides information on whether the use of a drug is promising in view of the patient's individual factors. The legislator has acted here and linked the reimbursement of the diagnostic agent to the reimbursement of the drug. This means that the necessary accompanying medical diagnostics for the drugs in question can be used promptly. This link does not exist in inpatient care. In this respect, there is a need for action to improve the reimbursement of concomitant diagnostics in the DRG flat rate system.

Did you know?

In 2003, the Federal Association of Guild Health Insurance Funds submitted an application to examine the introduction of the HPV test as a laboratory diagnostic method for the early detection of cervical cancer. In 2013, the legislator set dates and deadlines for the self-administration. It was not until 2020 - 17 years after the application was submitted - that the self-government regulated the details for implementing the screening program.

In a nutshell: The Association of the Diagnostics Industry (VDGH)

As a trade association, the German Diagnostics Industry Association (VDGH) represents the interests of more than 100 companies operating in Germany with a total turnover of 6.8 billion euros in 2022. They manufacture examination systems and reagents for the diagnosis of human diseases, which generate a turnover of more than 3.5 billion euros, as well as instruments, reagents, test systems and consumables for research in the life sciences, which generate a turnover of 3.3 billion euros.

www.vdgh.de