| Assessment Status | Assessment Process Complete |
| HTA ID | 19027 |
| Drug | Pembrolizumab |
| Brand | Keytruda® |
| Indication | In combination with axitinib (Inlyta®), is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. |
| Assessment Process | |
| Rapid review commissioned | 29/07/2019 |
| Rapid review completed | 23/08/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab in combination with axitinib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 28/08/2019 |
| Pre-submission consultation with Applicant | 16/09/2019 |
| Full submission received from Applicant | 07/05/2020 |
| Preliminary review sent to Applicant | 06/07/2020 |
| NCPE assessment re-commenced | 20/08/2020 |
| Factual accuracy sent to Applicant | 01/12/2020 |
| NCPE assessment re-commenced | 08/12/2020 |
| NCPE assessment completed | 21/12/2020 |
| NCPE assessment outcome | The NCPE recommends that pembrolizumab in combination with axitinib not be considered for reimbursement unless 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 Medicinal Goods) Act 2013.