For further details of previous submission see: Pegvaliase (Palynziq®) HTA ID: 20001
| Assessment Status | Assessment process complete |
| HTA ID | 21057 |
| Drug | Pegvaliase |
| Brand | Palynziq® |
| Indication | for the treatment of patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. |
| Assessment Process | |
| Full submission received from Applicant | 18/11/2021 |
| Preliminary review sent to Applicant | 21/03/2022 |
| NCPE assessment re-commenced | 22/04/2022 |
| Follow-up to preliminary review sent to Applicant | 02/06/2022 |
| NCPE assessment re-commenced | 24/06/2022 |
| Factual accuracy sent to Applicant | 08/08/2022 |
| NCPE assessment re-commenced | 16/08/2022 |
| NCPE assessment completed | 29/09/2022 |
| NCPE assessment outcome | The NCPE recommends that pegvalisae (Palynziq®) 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.