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| Medical Drug Policy Name | Revised Criteria |
|---|---|
| Efgartigimod Alfa (Vyvgart®, Vyvgart® Hytrulo) “Notification” | For CIDP indication, adjusted standard of care trial and failure requirements to only allow for immunoglobulin (intravenous or subcutaneous) or plasma exchange therapy. For gMG indication, listed specific eculizumab biosimilars as additional eculizumab products not to be used concomitantly for clarity with no change to policy intent. Policy notification given 5/2/2025 for effective date 7/1/2025. |
| Interleukin-5 Antagonists “Notification” | For asthma initial criteria: Added required medical record documentation for eosinophil counts. Reformatted and added parameters for demonstration of inadequate asthma control despite adherence to asthma control therapy, with required medical record documentation. Adjusted formatting to create a separate criteria section with required medical record documentation added for current, adherent treatment with maximally tolerated conventional therapies for the past 3 months with both an inhaled corticosteroid regimen and a regimen containing a LABA, LTRA, LAMA, theophylline, or zileuton. Added requirement that patient will continue asthma control therapy in combination with the requested agent to align with FDA label as add-on maintenance treatment. For asthma continuation criteria: Adjusted formatting for demonstration of improvement or stabilization from baseline for clarity with no change to policy intent, and added requirement that patient is currently treated and compliant with asthma control therapy. Added specialist requirement and no presence of FDA labeled contraindications to both initial and continuation criteria for all indications. Policy notification given 5/2/2025 for effective date 7/1/2025. |
| Omalizumab (Xolair®) “Notification” | For asthma initial criteria: Adjusted formatting to create a separate criteria section with required medical record documentation added for current, adherent treatment with maximally tolerated conventional therapies for the past 3 months with both an inhaled corticosteroid regimen and a regimen containing a LABA, LTRA, LAMA, theophylline, or zileuton. Added parameters for demonstration of inadequate asthma control despite adherence to asthma control therapy, with required medical record documentation. Added requirement that patient will continue asthma control therapy in combination with the requested agent to align with FDA label as add-on maintenance treatment. For asthma continuation criteria: Adjusted formatting for demonstration of improvement or stabilization from baseline for clarity with no change to policy intent, and added requirement that patient is currently treated and compliant with asthma control therapy. For urticaria initial criteria: Added requirement of symptoms for at least 6 weeks with required medical record documentation. Added required dose reduction or discontinuation of medications known to cause/worsen urticaria, or that dose reduction/discontinuation is not clinically appropriate. Reformatted required trial of a second generation H1 antihistamine. For urticaria continuation criteria: Removed requirement of decreased rescue/controller medication utilization and exacerbation frequency. Adjusted formatting for demonstration of positive clinical response such as reduction in itch severity/hive count. Added requirement that dose is within FDA labeling and does not exceed 300 mg every 4 weeks. Added no presence of FDA labeled contraindications to both initial and continuation criteria for all indications. Other minor updates made throughout policy for clarity with no change to policy intent. Policy notification given 5/2/2025 for effective date 7/1/2025. |
| Tezepelumab-ekko (Tezspire®) “Notification” | For initial criteria: Added required medical record documentation for demonstration of inadequate asthma control despite adherence to asthma control therapy. Reformatted criteria for current, adherent treatment with maximally tolerated conventional therapies for clarity, and added zileuton as an option. Added required medical record documentation for current, adherent treatment with maximally tolerated conventional therapies. For continuation criteria: Added required medical record documentation for demonstration of improvement or stabilization from baseline, and adjusted formatting and improvement/stability parameters to include decreased utilization of rescue medications, decreased exacerbation frequency, or reduced reported asthma-related symptoms. Other minor updates made throughout policy for clarity with no change to policy intent. Policy notification given 5/2/2025 for effective date 7/1/2025. |
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