OBJECTIVES

Within the scope of the German Health Technology Assessment (HTA) process, both the Federal Joint Committee (G-BA) and the pharmaceutical manufacturers can initiate a renewed benefit assessment in accordance with the social code book five, section §35a, based on new scientific findings according to §13 and §14 in chapter 5 of the G-BA rules of procedure (VerfO). The objective of this project is to define factors that can lead to a renewed benefit assessment and to analysed whether the G-BA or the pharmaceutical manufacturer tends to be the initiator of a reassessment.

METHODS

Resolutions and justifications for all §35a benefit assessments publicly available on the G-BA website by April 4^th, 2019 were evaluated. Evidence was screened on procedural level and analysed descriptively by two individual reviewers. Data was extracted into an a priori developed extraction sheet.

RESULTS

Until early April 2019, there were 16 renewed §35a benefit assessments. Thereof four assessments were initiated by the G-BA, while twelve assessments were initiated by pharmaceutical manufacturers. The factors for reassessments initiated by the G-BA were 1) restriction of the area of application by the European Medicines Agency (EMA) (n=3) and 2) new clinical trials (n=1). Pharmaceutical manufacturers-initiated reassessments because of 1) new clinical trials (n=8), 2) longer study durations (n=4) and 3) changes in the determination of the appropriate comparative therapy (n=1). In approx. 1/3 of renewed benefit assessments this led to an improvement in the additional benefit, which is exclusively a matter of procedures according to §14 VerfO.

CONCLUSIONS

Renewed benefit assessments are primarily initiated by pharmaceutical manufacturers and in contrast to fixed-term resolutions of the G-BA, which are mainly based on unanswered questions at the time of the assessment, a renewed assessment is based on information which only becomes known after the HTA process has been completed.