Daratumumab is indicated in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
|NCPE Assessment Process||Complete|
|Rapid review commissioned||02/06/2020|
|Rapid review completed||17/07/2020|
|Rapid Review outcome||A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of daratumumab compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||04/08/2020|
|Pre-submission consultation with Applicant||21/09/2020|
|Full HTA submission received from Applicant||12/03/2021|
|Preliminary review sent to Applicant||19/07/2021|
|NCPE assessment re-commenced||19/08/2021|
|Factual accuracy check sent to Applicant||04/10/2021|
|NCPE assessment re-commenced||11/10/2021|
|NCPE assessment completed||16/11/2021|
|NCPE assessment outcome||The NCPE recommend that daratumumab (Darzalex®) be considered for reimbursement if 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 June 2022.