Pharmacy Prior Authorization Criteria

Qfitlia (fitusiran)

Indications for Prior Authorization

Qfitlia (fitusiran)

• For diagnosis of Prevention or to reduce the frequency of bleeding episodes
  Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.

Criteria

Qfitlia

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of one of the following:
• hemophilia A with or without factor VIII inhibitors
• hemophilia B with or without factor IX inhibitors
AND
• Drug will be used for prophylaxis to prevent or reduce the frequency of bleeding episodes
AND
• Patient is 12 years of age or older
AND
• Presence of antithrombin (AT) activity greater than 60 percent (%) as detected by an FDA -approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [A]
AND
• Prescribed by or in consultation with a hematologist/oncologist
AND
• One of the following: (applies to Hemophilia A only)
• For continuation of prior therapy
OR
• Trial and inadequate response, intolerance, or contraindication to Hemlibra (emicizumab-kxwh)

Qfitlia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Drug continues to be used for prophylaxis to prevent or reduce the frequency of bleeding episodes
AND
• Patient demonstrates positive clinical response to therapy (e.g., reduced bleeding episodes)

P & T Revisions

2025-04-30

References

1. Qfitlia Prescribing Information. Genzyme Corporation. Cambridge, MA. March 2025.

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End Notes

1. Measure antithrombin (AT) activity prior to initiation of Qfitlia. Do not initiate Qfitlia dosing if AT activity is less than 60%. Monitor AT activity using an FDA-cleared test [1].

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Revision History

• 2025-04-30: New Program

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