| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. |
| Assessment Process | |
| Rapid review commissioned | 14/08/2018 |
| Rapid review completed | 29/08/2018 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 14/09/2018 |
| Pre-submission consultation with Applicant | 22/10/2018 |
| Full submission received from Applicant | 20/12/2018 |
| Preliminary review sent to Applicant | 14/06/2019 |
| NCPE assessment re-commenced | 10/07/2019 |
| Factual accuracy sent to Applicant | 31/07/2019 |
| NCPE assessment re-commenced | 09/08/2019 |
| NCPE assessment completed | 15/08/2019 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab (Keytruda®), prescribed in combination with platinum chemotherapy plus pemetrexed for the first line treatment of non-squamous NSCLC, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medial Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations – February 2021.
