Alpelisib (Piqray®). HTA ID: 20035

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*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.