Oral semaglutide (Rybelsus®) for the treatment of adults with insufficiently controlled type 2 diabetes mellitus

Zorginstituut Nederland has completed its assessment, using the parallel procedure CBG-ZIN, whether oral semaglutide (Rybelsus®) is interchangeable with a product that is included in the medication reimbursement system (GVS). The Zorginstituut's advice is to include oral semaglutide (Rybelsus®) in Appendix 1B and Appendix 2 of the Health Insurance Regulation and to impose additional conditions.

Registered indication

Semaglutide (Rybelsus®) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise:

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;
  • in combination with other medicinal products for the treatment of diabetes.

The product is already available as an injection fluid (Ozempic®). This assessment is related to the first oral formulation of a GLP-1 receptor agonist (Rybelsus®). The product is available in 3 mg, 7 mg, and 14 mg tablets.

Assessment

Rybelsus® (oral semaglutide) is not interchangeable with Ozempic® (subcutaneous semaglutide) and the other subcutaneous GLP-1 receptor agonists included in the GVS, due to a difference in the route of administration. On the basis of the criteria for interchangeability, semaglutide (Rybelsus®) is also not interchangeable with the other oral blood glucose reducing medicinal products included in the GVS and registered for use in diabetes mellitus type 2.

Zorginstituut's advice

On the basis of the criteria for interchangeability, oral semaglutide (Rybelsus®) is not eligible for inclusion on appendix 1A. Zorginstituut Nederland advices including semaglutide (Rybelsus®) on appendix 1B and appendix 2 of the Health Insurance Regulation.

Appendix 2 conditions

Zorginstituut Nederland advises imposing the following appendix 2 conditions for oral semaglutide (Rybelsus®):

  • Exclusively for insured persons with diabetes mellitus type 2 and a body mass index (BMI) ≥ 30 kg/m² whose blood glucose values cannot be adequately regulated with the combination of metformin and a sulfonylurea derivative in the maximum tolerable dosages and who does not use insulin, or
  • as an addition to metformin and basal insulin (NPH insulin/long acting analogue insulin) in an insured person with type 2 diabetes mellitus and a BMI ≥ 30 kg/m2 whose blood glucose values are insufficiently controlled after ≥ 3 months of treatment with optimal titrated basal insulin in combination with metformin (whether or not with a sulfonylurea derivative) in a maximum tolerable dosage.

Parallel Procedure CBG-ZIN pilot

The Medicines Evaluation Board (CBG) and the National Health Care Institute (ZIN) have joined forces to shorten the time from authorisation up to the moment that innovative medicines are reimbursed in the "CBG-ZIN Parallel Procedures pilot". In this pilot, the reimbursement process starts while the registration process has not yet been completed. Medicinal products that go through these parallel procedures, rather than the current sequential procedures, will become available to the patient more quickly.

The EMA registration of oral semaglutide (Rybelsus®) was published on the EMA website on 27 May 2020. This is normally the time when a reimbursement dossier can be submitted. Due to the parallel procedure, the Zorginstituut can now rule on the reimbursement immediately after registration.