Ribociclib (Kisqali®) in combination with an aromatase inhibitor (AI) is indicated for the treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine based therapy.
| Rapid Review Process | Complete |
| Rapid review received | 04/09/2017 |
| Rapid review completed | 19/09/2017 |
| Rapid Review outcome | Full pharmacoeconomic assessment recommended |
| Full pharmacoeconomic assessment commissioned by the HSE | 25/09/2017 |
| Pre-submission consultation with applicant | 23/10/2017 |
| Submission received from applicant | 07/02/2018 |
| Preliminary review part I sent to applicant | 25/04/2018 |
| Preliminary review part II sent to applicant | 22/05/2018 |
| Applicant response to preliminary review part I | 25/05/2018 |
| Applicant response to preliminary review part II | 10/06/2018 |
| NCPE assessment re-commenced | 11/06/2018 |
| Preliminary review part II sent to the applicant | 11/07/2018 |
| NCPE assessment re-commenced | 20/07/2018 |
| Factual Accuracy sent to the applicant | 27/07/2018 |
| NCPE assessment re-commenced | 03/08/2018 |
| NCPE assessment completed | 13/08/2018 |
| NCPE Assessment Outcome | Following NCPE assessment of the company submission, the NCPE recommends that ribociclib (in combination with an aromatase inhibitor) for the treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic BC as initial endocrine-based therapy, 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. |
The HSE has approved reimbursement following confidential price negotiations; February 2019