Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®) for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes.
|NCPE Assessment Process||Complete|
|Rapid review commissioned||28/09/2018|
|Rapid review completed||08/11/2018|
|Rapid Review outcome||A Full Pharmacoeconomic Assessment is recommended|
|Full pharmacoeconomic assessment commissioned by HSE||14/11/2018|
|Pre-submission consultation with Applicant||15/01/2019|
|Submission received from Applicant||31/05/2019|
|HTA assessment commenced||04/09/2019|
|Preliminary review sent to Applicant||02/10/2019|
|NCPE assessment re-commenced||06/11/2019|
|Factual accuracy sent to Applicant||28/02/2020|
|NCPE assessment re-commenced||09/03/2020|
|NCPE assessment completed||16/04/2020|
|NCPE assessment outcome||The NCPE recommends that Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®) 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 Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations February 2021.