Oral semaglutide (Rybelsus®) 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.
|NCPE Assessment Process||Complete|
|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.