[ A21-86] Osimertinib (NSCLC) - Benefit assessment according to §35a Social Code Book V

Last updated 01.10.2021

Project no.:
A21-86

Commission:
Commission awarded on 23.06.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Adjuvant treatment of adult patients with stage IB to IIIA non-small cell lung cancer (NSCLC) with exon 19 deletion or exon 21 substitution mutation (L858R) of the epidermal growth factor receptor (EGFR) after complete tumour resection

Result of dossier assessment:

  • Without prior adjuvant platinum-based chemotherapy: added benefit not proven.
  • Patients after prior adjuvant platinum-based chemotherapy or for whom this therapy it is not suitable: hint of considerable added benefit.

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

01.10.2021

Adjuvant treatment of NSCLC: Certain patients benefit from osimertinib.

Hint of considerable added benefit if adjuvant platinum-based chemotherapy has already been administered after complete tumour resection or is not suitable. ...

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

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