| Assessment Status | Assessment process complete |
| HTA ID | 20028 |
| Drug | Pegylated liposomal irinotecan |
| Brand | Onivyde® |
| Indication | For the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in adult patients who have progressed following gemcitabine based therapy. |
| Assessment Process | |
| Rapid review commissioned | 13/06/2017 |
| Rapid review completed | 13/07/2017 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended.
The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven. |
| Rapid review re-commissioned | 15/06/2020 |
| Rapid review completed | 14/07/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegylated liposomal irinotecan compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 14/07/2020 |
| Pre-submission consultation with Applicant | 07/09/2020 |
| Full submission received from Applicant | 04/03/2021 |
| Preliminary review sent to Applicant | 02/09/2021 |
| NCPE assessment re-commenced | 04/10/2021 |
| Factual accuracy sent to applicant | 20/10/2021 |
| NCPE assessment re-commenced | 29/10/2021 |
| NCPE assessment completed | 12/11/2021 |
| NCPE assessment outcome | The NCPE recommends that peg-IRI + 5FU + LV not be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.