NUB method assessments in Germany

In Germany, the G-BA not only conducts HTAs but also assesses methods to determine whether they offer a benefit.

While pharmaceutical products are undergoing an early benefit assessment based on the AMNOG legislation, non-drug interventions are assessed as methods. Specifically, the G-BA evaluates and tests new diagnostic and treatment methods (“Neue Untersuchungs- und Behandlungsmethoden”, NUB). These methods are, for example, operations, procedures for the early detection of an illness, remedies, and psychotherapies.

Since July 2021, the G-BA website now includes overview tables of all method assessments.

Process of method assessments

1. The G-BA, physicians, hospitals, SHI funds or patient organizations can request the assessment of a new method.
2. If the request was accepted, the G-BA publishes the assessment topic. It also contacts clinical experts, manufacturers of devices, and patient groups to offer them a chance for commenting.
3. Then, the G-BA itself or IQWiG, on behalf of the G-BA, assesses whether a method has a benefit and there is a medical need. This is based on all available studies in the relevant indication and patient population. The assessment focuses on the use of the method, both in hospitals and in the outpatient sector.
   • If no benefit was seen (yet), the IQWiG then determines if there is the potential of showing a benefit in the future.
   • In that case, the G-BA will have to conduct studies that will provide an answer on the benefit with sufficient certainty in the future.
   • For this situation, the IQWiG defines criteria for specific studies, so-called testing studies (“Erprobungsstudien”), that will be able to demonstrate the benefit.
4. In the next step, the G-BA or IQWiG assesses whether the method is economical and needed in the health care context. This is conducted separately for the inpatient and outpatient sector.
5. When this assessment is concluded, the G-BA publishes the draft decision. Clinical experts, manufacturers of medical devices, and patient organizations etc. have another chance for commenting.
6. Lastly, the final decision is published. There are 4 possible conclusions:
   • The method should be reimbursed
   • The method should be excluded
   • The assessment will be suspended for a defined time
   • Testing studies will need to be conducted (see also step 3)

Method assessments used to take around 3 years. In 2020, the G-BA introduced new legislation to reduce this time to 2 years.

Diagnostic and treatment methods

The assessment of diagnostic and treatment methods follows the legislation of §135 SGB for outpatient procedures and § 137c SGB V for inpatient procedures. In addition, § 137e SGB V covers assessments requiring testing studies.

Diagnostic and treatment methods using high-risk medical devices

The G-BA handles method assessments of “high-risk” medical devices as a separate category. The legal basis for these assessments is covered in §137h SGB V.

These NUB assessments are entirely based on the data provided by the hospitals.