Nivolumab (Opdivo®) as monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
|NCPE Assessment Process||Complete|
|Rapid review commissioned||09/07/2018|
|Rapid review completed||27/07/2018|
|Rapid Review outcome||A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||01/08/2018|
|Pre-submission consultation with Applicant||03/09/2018|
|Submission received from Applicant||30/11/2018|
|Preliminary review sent to Applicant||26/03/2019|
|NCPE assessment re-commenced||25/04/2019|
|Factual accuracy check sent to Applicant||10/09/2019|
|NCPE assessment re-commenced||17/09/2019|
|NCPE assesssment completed||13/10/2019|
|NCPE assessment outcome||The NCPE recommends that nivolumab 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.