Tisagenlecleucel (Kymriah®) for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
|NCPE Assessment Process||Complete|
|Rapid review commissioned||19/09/2018|
|Rapid review completed||19/10/2018|
|Rapid Review outcome||A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tisagenlecleucel compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||22/10/2018|
|Pre-submission consultation with Applicant||06/11/2018|
|Submission received from Applicant||30/01/2019|
|Preliminary review sent to Applicant||11/04/2019|
|NCPE assessment re-commenced||10/05/2019|
|Factual accuracy sent to Applicant||23/07/2019|
|NCPE assessment re-commenced||01/08/2019|
|NCPE assessment completed||27/08/2019|
|NCPE assessment outcome||The NCPE recommends that tisagenlecleucel (Kymriah®) 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.