| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25006 |
| Drug | Amivantamab in combination with lazertinib |
| Brand | Rybrevant® in combination with Lazcluze® |
| Indication | Amivantamab in combination with lazertinib is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. |
| Assessment Process | |
| Rapid review commissioned | 28/01/2025 |
| Rapid review completed | 05/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of amivantamab in combination with lazertinib compared with the current standard of care. |
| Full HTA commissioned by the HSE | 26/03/2025 |
| Pre-submission consultation with Applicant | 30/04/2025 |
| Full submission received from Applicant | 01/08/2025 |
| Preliminary review sent to Applicant | 19/02/2026 |
| NCPE assessment re-commenced | 20/03/2026 |
| Factual accuracy sent to Applicant | 24/04/2026 |
| NCPE assessment re-commenced | 01/05/2026 |
| NCPE assessment completed | 27/05/2026 |
| NCPE assessment outcome | The NCPE recommends that amivantamab in combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments* |
*Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013. Further information on this process may be found here