OBJECTIVES:

Definition of success factors of achieving a benefit or a potential as the outcome of a Federal Joint Committee (German: Gemeinsamer Bundesausschuss, G-BA) benefit assessment according to §137h social code (SGB) V for high-risk medical devices in Germany.

METHODS:

Evaluation of resolutions and justifications for all §137h assessments publicly available on the G‑BA website by May 24^th, 2018. Evidence was screened on procedural level and analyzed by two individual reviewers. Data was extracted into an a priori developed extraction sheet and descriptively analyzed.

RESULTS:

Until late May 2018, the G‑BA recorded 20 procedures for medical devices under §137h assessment. Thereof 10 procedures were assigned the status consultation complete, 8 procedures showed the status assessment complete while two were completed without assessment. More than half of the procedures (11/20) met the §137h requirements whereas 8 procedures did not meet requirements mainly due to the circumstance that the medical device could not be classified as a medical device with high-risk class (4/8) or that the medical device did not represent a new theoretical‑scientific concept (3/8). In all procedures with completed G‑BA assessment, non‑comparative study design (evidence level III-IV, G‑BA rules of procedure) was predominant whereas randomized controlled trials or comparative cohort studies were available in three procedures. Overall, the G‑BA did not once assign a “benefit”, has assigned a “potential” for a benefit in two procedures - both of which showed comparative evidence - and did decide on “no potential” in six procedures. Arguments for why the G‑BA decided on “no potential” in those six procedures did vary.

CONCLUSIONS:

While limited by a small sample size, early findings suggest that §137h outcome is dependent on the evidence level of studies, with information on comparative treatments and providing data for patient-relevant endpoints also being a crucial success factor.