Talazoparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer.
|NCPE Assessment Process||Complete|
|Rapid review commissioned||19/08/2019|
|Rapid review completed||03/09/2019|
|Rapid Review outcome||A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of talazoparib compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||09/09/2019|
|Pre-submission consultation with Applicant||02/12/2019|
|Initial submission received from Applicant||02/03/2020|
|Complete submission received from Applicant||06/03/2020|
|Preliminary review sent to Applicant||24/04/2020|
|NCPE assessment re-commenced||05/06/2020|
|Factual accuracy sent to Applicant||14/08/2020|
|NCPE assessment re-commenced||21/08/2020|
|NCPE assessment completed||18/09/2020|
|NCPE assessment outcome||The NCPE recommends that talazoparib (Talzenna®) 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.