Pegylated liposomal irinotecan (Onivyde®). HTA ID: 20028

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.

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