Apalutamide (Erleada®) is indicated for the treatment of non-metastatic castration resistant prostate cancer (nmCRPC) at high risk of developing metastatic disease.
|NCPE Assessment Process||Ongoing|
|Rapid review received||30/01/2019|
|Rapid review completed||27/02/2019|
|Rapid Review outcome||A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of apalutamide in combination with ADT compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||06/03/2019|
|Pre-submission consultation with Applicant||28/05/2019|
|Initial submission received from Applicant||20/11/2019|
|Complete submission received from Applicant||12/12/2019|
|Preliminary review sent to Applicant||10/04/2020|
|NCPE assessment re-commenced||04/06/2020|
|Factual accuracy check sent to Applicant||01/07/2020|
|NCPE assessment re-commenced||09/07/2020|
|NCPE assessment completed||04/08/2020|
|NCPE assessment outcome||The NCPE recommend that apalutamide (Erleada®) 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.