Medical devices of
high risk class

Health technology assessment (HTA)

Assessment of new examination and treatment methods, which are mainly based on medical devices of high risk class. Section 137h of the 5th Book of the German Code of Social Law (Section 137h SGB V).

Health technology assessment: The NUB application procedure

When a hospital wants to have an NUB reimbursed by the German Institute for the Hospital Remuneration System (InEK), it triggers the HTA procedure by submitting an initial NUB application. In parallel to submission to the InEK, the hospital transmits information to the G-BA about its request for a benefit assessment. NUB stands for “New examination and treatment methods”. The assessment request, primarily to the InEK, is called an NUB application procedure. If the NUB essentially involves the use of high-risk class medical devices and embodies a new theoretical-scientific concept, the G-BA determines whether the benefit of the method has been proven or whether it at least shows “potential to be an alternative for a necessary treatment”. The outcome of the medical health assessment depends on whether the method might make patients get better faster or relieve them of suffering more than the previously available comparators. To this end, the G-BA commissions the German Institute for Quality and Efficiency in Health Care (IQWiG), an assessment technologies institute, to assess the body of scientific evidence that the hospital has submitted along with its NUB application for an HTA.

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Option for preliminary review before NUB application submission

Hospitals and medical device manufacturers can obtain advice from the G-BA as to whether their new examination and treatment method fulfills the prerequisites for a healthcare technology assessment in advance, i.e. before submitting an NUB application to the InEK. As part of its advisory services, the G-BA can issue a legally binding resolution to trigger the HTA process. These medical device advisory services are free of charge. This pre-submission review helps prevent superfluous medical technology assessments.

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Supplemental information and review of the prerequisites for a health technology assessment

  • After the hospital transmits the information to the G-BA, the procedure follows these steps: The G-BA runs a plausibility check and publishes the information provided on the G-BA website.
  • Publication by this means gives other hospitals and medical device manufacturers the opportunity to supply the G-BA with supplemental information and data.
  • Based thereupon, the G-BA decides if all prerequisites for a medical assessment have been met.

The criteria for a “new theoretical-scientific concept” and a “high-risk class medical device” are defined in the G-BA Rules of Procedure (VerfO).

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Health technology assessment outcomes and subsequent decision-making within the NUB application procedure

Insofar as the prerequisites for an HTA have been met, the G-BA then uses the information provided as a basis to determine whether the benefit of the method can be deemed proven or whether it shows potential to be an alternative for a necessary treatment. Hereby, the G-BA has three decision-making options:

  • Benefit has been sufficiently proved:
  • If benefit is proven, the G-BA then examines whether any quality assurance measures need to be put in place or whether the use of the method can be reimbursed by the statutory health insurers.
  • Benefit has not (yet) been proved, but has potential:
  • By contrast, if the benefit of the method has not been sufficiently proved, the G-BA decides on the conduct of an investigational trial whenever the method shows potential over the comparator. The objective is to use trials to gather the scientific evidence hitherto lacking for a conclusive assessment. Hospitals are obligated to participate in the trial insofar as they want to have the method reimbursed by the statutory health insurers.
  • Benefit has not been proved:
  • If the method does not show potential over the comparator, the G-BA decides about whether to exclude the method from the inpatient services portfolio. This particularly applies to methods deemed harmful or ineffective.

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IQWiG’s evidence review within a medical technology assessment

To determine whether the NUB might make patients get better faster or relieve them of suffering more than the comparator, the G-BA commissions the IQWiG to assess the body of scientific evidence provided by the hospital within a NUB application procedure.
In making their assessment, the IQWiG applies scientific benchmarks and carries out an HTA.
For this, the following challenges must be considered:

  • Clinical data requirements
  • The IQWiG will usually leverage positive results from randomized-controlled trials (RCT) on indications for a new method, which the hospital expects to prove has a potential benefit. The results must indicate that the method produces positive effects.
  • No automatic transferability of results of one indication to another
  • The potential deriving from the dossier on one indication must always refer to the indication for which the NUB application has been submitted. This is based on the assumption that the scientific evidence cannot be simply transferred to other indications.
  • Plausibility alone is not enough
  • As the law is explained on the IQWiG website: “A potential for the necessity of a method can, for example, arise from the fact that, because of its mode of action and the evidence so far available, it is associated with the expectation that it can replace other methods that are more elaborate and more invasive for patients or unsuccessful in certain patients.” Thus, the IQWiG concludes that just because the mode of action is plausible, does not mean that potential can be attributed to the method.
  • The burden of proof lies with the applicant
  • For assessment under Section 137h SGB V, the applicant hospital must prove that its method shows potential based on robust data. The IQWiG does not research the trial data on its own initiative.