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TAGRISSO

TRANSPARENCY COMMITTEE OPINION
Opinions on drugs - Posted on Apr 03 2020

Reason for request

New indication

  • Key points

Favourable opinion for reimbursement as monotherapy in the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

  • What therapeutic improvement?

TAGRISSO provides a therapeutic improvement compared to other anti-EGFR TKIs in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations (EGFR).

  • Role in the care pathway?

In the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations, when the use of an anti-EGFR TKI isconsidered, osimertinib is the first-line treatment of choice due to demonstration of an improvement in overall survival compared to erlotinib and gefitinib with a safety profile judged to be acceptable.

The Committee reiterates that patients with EGFR mutations other than exon 19 deletion or exon 21 (L858R) activating mutations (in particular the T790M mutation for which osimertinib has an MA and a specific Committee opinion) were not assessed in the FLAURA study. Exons 19 or 21 mutations represent the majority of all EGFR mutations (85%)[1] [2]


Clinical Benefit

Substantial

The clinical benefit of TAGRISSO (osimertinib) is substantial in this MA indication extension.

 


Clinical Added Value

moderate

Considering:

  • the demonstration of the superiority of osimertinib compared to the anti-EGFR TKIs erlotinib or gefitinib in terms of:
    • progression-free survival evaluated by the investigator (median survival of 18.9 months in the osimertinib group vs 10.2 months in the comparator group; HR=0.46; 95% CI [0.37; 0.57]; p < 0.0001) and,
    • overall survival (median survival of 38.6 months in the osimertinib group vs 31.8 months in the comparator group; HR=0.799, CI05% [0.64; 0.99]; p= 0.0462),
  • the acceptable safety profile of osimertinib compared to the anti-EGFR TKIs erlotinib or gefitinib,
  • the absence of any formal conclusion that can be drawn based on the quality of life results,

the Committee considers that TAGRISSO (osimertinib) provides a moderate clinical added value (CAV III) compared to the anti-EGFR TKIs TARCEVA (erlotinib) and IRESSA (gefitinib) in the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. 

 


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