| Assessment Status | Assessment Process Complete |
| HTA ID | 20011 |
| Drug | Semaglutide |
| Brand | Rybelsus® |
| Indication | For the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise: (a) as monotherapy when metformin is considered inappropriate due to intolerance or contraindications. (b) in combination with other medicinal products for the treatment of diabetes. |
| Assessment Process | |
| Rapid review commissioned | 02/03/2020 |
| Rapid review completed | 30/03/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of oral semaglutide (Rybelsus®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 07/04/2020 |
| Pre-submission consultation with Applicant | 16/06/2020 |
| Full submission received from Applicant | 18/11/2020 |
| Preliminary review sent to Applicant | 21/12/2020 |
| NCPE assessment re-commenced | 29/01/2021 |
| Factual accuracy sent to Applicant | 04/02/2021 |
| NCPE assessment re-commenced | 11/02/2021 |
| NCPE assessment completed | 17/02/2021 |
| NCPE assessment outcome | The NCPE recommends that oral semaglutide should not be considered for reimbursement unless cost-effectiveness can be improved relative to existing therapy*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.