|Assessment Status||Assessment process complete|
|Drug||Pegylated liposomal irinotecan|
|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.|
|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.