| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20035 |
| Drug | Alpelisib |
| Brand | Piqray® |
| Indication | Is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2 -negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. |
| Assessment Process | |
| Rapid review commissioned | 22/07/2020 |
| Rapid review completed | 03/09/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of alpelisib (Piqray®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 30/09/2020 |
| Pre-submission consultation with Applicant | 17/11/2020 |
| Full submission received from Applicant | 18/02/2021 |
| Preliminary review sent to Applicant | 30/08/2021 |
| NCPE assessment re-commenced | 28/09/2021 |
| Follow-up to preliminary review sent to Applicant | 05/10/2021 |
| NCPE assessment re-commenced | 13/10/2021 |
| Factual accuracy sent to Applicant | 19/11/2021 |
| NCPE assessment re-commenced | 29/11/2021 |
| NCPE assessment completed | 21/12/2021 |
| NCPE assessment outcome | The NCPE recommends that alpelisib not be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
