[A22-84] Review of the final study protocol and statistical analysis plan on routine practice data collection for onasemnogene abeparvovec - Third addendum to Commission A20-61

Last updated 24.10.2022

Project no.:
A22-84

Commission:
Commission awarded on 02.08.2022 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Muscles, bones and joints

Note:

Routine practice data collection (RPDC): Review of the study protocol and statistical analysis plan

In the case of new drugs that have entered the health care system via a special marketing authorization or as a drug for the treatment of a rare disease, the study data at the time of marketing authorization are usually not very informative for the early benefit assessment. As in the present case, the G-BA can require the pharmaceutical company to collect routine practice data, including the associated analysis, for the benefit assessment. The pharmaceutical company has to submit a study protocol and a statistical analysis plan for the RPDC. IQWiG reviews these documents on behalf of the G-BA.

Federal Joint Committee (G-BA)

2022-10-20 A G-BA decision was published.

G-BA documents on this decision

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