FDA approved dose of rivaroxaban for VTE prophylaxis is 10mg once daily. In the 2020 version of eCQMs rivaroxaban 2.5mg is acceptable. What criteria was used and is there data to support rivaroxaban 2.5mg twice a day for VTE prophylaxis?

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    • Deborah Hence
    • 6154308743
    • Saint Thomas Health
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      Thank you for your question. Prior to 2021 reporting year, patients who were given an oral factor Xa inhibitor, including Rivaroxaban 2.5mg, with a prior or present diagnosis of atrial fibrillation/VTE or hip or knee replacement surgery will meet the VTE numerator criteria. Beginning with the 2021 reporting year, Rivaroxaban and Betrixaban were added to the VTE Prophylaxis medication list, including Rivaroxaban 2.5mg. This is because the “FDA has approved Xarelto (Rivaroxaban) for the prevention of venous thromboembolism (VTE) in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding”. The value set “Rivaroxaban and Betrixaban for VTE Prophylaxis” (2.16.840.1.113762.1.4.1110.50) contains all eligible RxNorm codes for both medication categories. The frequency of medication is determined by the physician, based on patient conditions.

      In the 2020 reporting year, a chronic CAD patient prescribed a dose of Rivaroxaban of 2.5mg twice a day is will fail the measure if he/she had no atrial fibrillation/VTE or hip or knee replacement surgery. However, this case will pass the measure beginning in the 2021 reporting year due to FDA indication listed above.
      While we do not have clinical data on Xarelto’s usage comparison, please review the following research summary- “New Indication for Rivaroxaban Approved by FDA” (https://www.pharmacytimes.com/resource-centers/cardiovascular-health/new-indication-for-rivaroxaban-approved-by-fda).
      Show
      Thank you for your question. Prior to 2021 reporting year, patients who were given an oral factor Xa inhibitor, including Rivaroxaban 2.5mg, with a prior or present diagnosis of atrial fibrillation/VTE or hip or knee replacement surgery will meet the VTE numerator criteria. Beginning with the 2021 reporting year, Rivaroxaban and Betrixaban were added to the VTE Prophylaxis medication list, including Rivaroxaban 2.5mg. This is because the “FDA has approved Xarelto (Rivaroxaban) for the prevention of venous thromboembolism (VTE) in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding”. The value set “Rivaroxaban and Betrixaban for VTE Prophylaxis” (2.16.840.1.113762.1.4.1110.50) contains all eligible RxNorm codes for both medication categories. The frequency of medication is determined by the physician, based on patient conditions. In the 2020 reporting year, a chronic CAD patient prescribed a dose of Rivaroxaban of 2.5mg twice a day is will fail the measure if he/she had no atrial fibrillation/VTE or hip or knee replacement surgery. However, this case will pass the measure beginning in the 2021 reporting year due to FDA indication listed above. While we do not have clinical data on Xarelto’s usage comparison, please review the following research summary- “New Indication for Rivaroxaban Approved by FDA” ( https://www.pharmacytimes.com/resource-centers/cardiovascular-health/new-indication-for-rivaroxaban-approved-by-fda ).
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      Our Pharmacy has a question that may impact are VTE eCQMS
      Short description: eCQM VTE1 and VTE2 FDA approved dose for rivaroxaban (Xarelto) for VTE prophylaxis Description: The FDA approved dose for rivaroxaban (Xarelto) for VTE prophylaxis is 10mg once daily. This satisfies the criteria for VTE prophylaxis in VTE-1 and VTE-2. The FDA approved dose for rivaroxaban (Xarelto) for chronic CAD is 2.5mg po twice daily. Because it is half the dose of the VTE prophylaxis dose, it appears to be clinically insufficient for VTE prophylaxis. The Value Set for the 2020 version of eCQMs state that the rivaroxaban 2.5mg oral tablet is acceptable to satisfy the requirements for VTE prophylaxis. Since the 2.5mg bid dose is half the FDA approved dose of rivaroxaban (Xarelto) for VTE prophylaxis, what criteria did you use to make this determination? Do you have data that shows that rivaroxaban (Xarelto) 2.5mg twice a day is clinically equivalent to rivaroxaban (Xarelto) 10mg once daily for VTE prophylaxis as approved by the FDA?
      Show
      Our Pharmacy has a question that may impact are VTE eCQMS Short description: eCQM VTE1 and VTE2 FDA approved dose for rivaroxaban (Xarelto) for VTE prophylaxis Description: The FDA approved dose for rivaroxaban (Xarelto) for VTE prophylaxis is 10mg once daily. This satisfies the criteria for VTE prophylaxis in VTE-1 and VTE-2. The FDA approved dose for rivaroxaban (Xarelto) for chronic CAD is 2.5mg po twice daily. Because it is half the dose of the VTE prophylaxis dose, it appears to be clinically insufficient for VTE prophylaxis. The Value Set for the 2020 version of eCQMs state that the rivaroxaban 2.5mg oral tablet is acceptable to satisfy the requirements for VTE prophylaxis. Since the 2.5mg bid dose is half the FDA approved dose of rivaroxaban (Xarelto) for VTE prophylaxis, what criteria did you use to make this determination? Do you have data that shows that rivaroxaban (Xarelto) 2.5mg twice a day is clinically equivalent to rivaroxaban (Xarelto) 10mg once daily for VTE prophylaxis as approved by the FDA?

          Assignee:
          Joelencia Leflore
          Reporter:
          Deborah Hence (Inactive)
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