GVS assessment of rivaroxaban (Xarelto®) for the treatment of VTE and prevention of VTE recurrence in children

Zorginstituut Nederland has completed its assessment whether rivaroxaban (Xarelto®) 1 mg/ml suspension can be included in the Medication Reimbursement System (GVS). Additionally, the minister of Medical Care asked for changes to the further conditions for rivaroxaban 15 mg and 20 mg tablets. The Zorginstituut's advice is to include rivaroxaban suspension 1 mg/ml on List 1B of the GVS. Rivaroxaban in doses of 15 mg and 20 mg has already been included on List 1A with further conditions for adults. Based on the considerations mentioned in the report, the Zorginstituut advises to modify the List 2 conditions for rivaroxaban by adding the condition for children, as set out below. 

Registered indication

Rivaroxaban (Xarelto®) is used in the treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in full-term neonates, infants and toddlers, children and adolescents aged less than 18 after at least 5 days of initial parenteral anticoagulation treatment. For the 15 mg tablets, it is stated that the paediatric patient’s weight must be 30 kg to 50 kg, and for the 20 mg tablets at least 50 kg.

Assessment

Based on the data in the report, the Zorginstituut has concluded that rivaroxaban has therapeutic added value when treating VTE in children compared to the standard treatment (low molecular weight heparin and vitamin K antagonists).

Zorginstituut's advice

Rivaroxaban in doses of 15 mg and 20 mg has already been included on List 1A with further conditions for adults. Based on the considerations mentioned in the report, the Zorginstituut advises the Minister for Medical Care to modify the List 2 conditions for rivaroxaban by adding the condition for children, as set out below. Extension with these further conditions will involve additional costs. The Zorginstituutis aware that there is currently a financial arrangement for rivaroxaban.

Because dabigatran, apixaban and edoxaban are not licensed for children, the Zorginstituutadvises to not change the conditions for these drugs, which rivaroxaban is clustered with.

Rivaroxaban suspension 1 mg/ml has not yet been included in the GVS. The licensed indication for this formulation is only limited to use in children. Based on the cluster criteria, the Zorginstituutadvises that rivaroxaban suspension 1 mg/ml should be included on List 1B.

Conditions for rivaroxaban

Extension of further conditions for rivaroxaban 15 mg and 20 mg for VTE, for insured persons of 18 or older:

  • who are reliant on this medicine for the prevention of venous thromboembolism after elective knee or hip replacement surgery, 
  • have non-valvular atrial fibrillation and one or more risk factors and are using this medicine to prevent cerebrovascular accidents or systemic embolism in accordance with the introduction guide accepted by the relevant physicians association in the Netherlands, 
  • are reliant on this medicine in combination with acetylsalicylic acid and clopidogrel for preventive treatment of an acute coronary syndrome with elevated cardiac biomarkers and who have not had a stroke or TIA, or 
  • are reliant on this medicine to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) and to prevent recurrent DVT and PE, 
  • are reliant on this medicine in combination with acetylsalicylic acid for preventing atherothrombotic events in patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are at high risk of ischaemic events.

Or, for insured full-term neonates, infants and toddlers, children and adolescents aged less than 18:

  • who are reliant on this medicine for the treatment of venous thromboembolism (VTE) and the prevention of VTE recurrence after at least 5 days of initial parenteral anticoagulation treatment.

Further condition for rivaroxaban suspension 1 mg/ml

For insured full-term neonates, infants and toddlers, children and adolescents aged less than 18:

  • who are reliant on this medicine for the treatment of venous thromboembolism (VTE) and the prevention of VTE recurrence after at least 5 days of initial parenteral anticoagulation treatment.

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.