| Medical Drug Policy Name | Revised Criteria |
|---|---|
| Complement C5 Inhibitors “Notification” (PDF) | Original medical policy criteria issued. Consolidated “Crovalimab-akkz (PiaSky)”, “Eculizumab (Soliris) and Eculizumab Biosimilars”, and “Ravulizumab-cwvz (Ultomiris)” medical policies into the following “Complement C5 Inhibitors” medical policy. For PNH: Applied consistent diagnostic requirements of flow cytometry, LDH level, and PNH signs/symptoms. For eculizumab products for treatment of PNH, added requirement for trial of Fabhalta in addition to Empaveli and Ultomiris. For aHUS: Added differential diagnosis demonstrating complement-mediated HUS, and requirement of ADAMTS13 activity level greater than 5%. For NMOSD: Added requirement of at least one attack or relapse in the last 12 months prior to treatment and rule out of alternative diagnoses. For eculizumab products, added requirement for trial and failure of preferred eculizumab biosimilar Epysqli (eculizumab-aagh), and adjusted non-preferred eculizumab products to include Soliris (eculizumab) and Bkemv (eculizumab-aeeb); updated trial and failure criteria to also allow for presence of a documented serious adverse event requiring medical intervention from the preferred eculizumab biosimilar product that is not anticipated with the requested non-preferred eculizumab product, with required submission of an FDA MedWatch Adverse Event Reporting Form. Added requirement to be prescribed by or in consultation with a specialist. Policy notification given 11/1/2025 for effective date 1/1/2026. |
| Esketamine (Spravato®) Nasal Spray “Notification” (PDF) | Added requirement that the requested product be administered to the individual patient for whom it has been specifically prescribed and ordered, and within 14 days after receipt by the REMS-certified treatment facility. Minor adjustments made to dosing table and coding description for clarity according to FDA label. Policy notification given 11/1/2025 for effective date 1/1/2026. |
| Gonadotropin Releasing Hormone Therapy “Notification” (PDF) | For GID/GD/gender incongruence indications, added requirement that the patient has sex trait modification coverage. Added the following benefits limitation statement within policy: “Drugs used for sex trait modification for gender affirming care may be specifically excluded under some health benefit plans. Please refer to the Member’s Benefit Booklet for availability of benefits.” Other minor adjustments made throughout policy for clarity. Policy notification given 11/1/2025 for effective date 1/1/2026. |
| Inebilizumab-cdon (Uplizna®) “Notification” (PDF) | For NMOSD indication, added requirement of at least one attack or relapse in the last 12 months prior to treatment with an immunotherapy/complement inhibitor for NMOSD, and no other alternative diagnoses to explain or cause the current disease symptoms; adjusted list of drugs not to be used in combination for clarity; adjusted continuation criteria verbiage for clarity. For IgG4-RD indication, added requirement of no other alternative diagnoses to explain or cause the current disease symptoms. For all indications, added requirement to be prescribed by or in consultation with a specialist. Other minor updates made throughout policy for clarity. Policy notification given 11/1/2025 for effective date 1/1/2026. |
| Neonatal Fc Receptor (FcRn) Blockers “Notification” (PDF) | Original medical policy criteria issued. Consolidated “Efgartigimod Alfa (Vyvgart, Vyvgart Hytrulo)”, “Nipocalimab-aahu (Imaavy)”, and Rozanolixizumab-noli (Rystiggo)” medical policies into the following “Neonatal Fc Receptor (FcRn) Blockers” medical policy. For Vyvgart and Vyvgart Hytrulo, added to initial and continuation criteria the requirement for use of self-administered Vyvgart Hytrulo unless certain criteria are met. For Imaavy for treatment of gMG in patients ≥18 years old, added to initial and continuation criteria the requirement for trial of Vyvgart/Vyvgart Hytrulo or Rystiggo plus trial of Ultomiris for anti-AChR antibody positive patients, OR trial of Rystiggo for anti-MuSK antibody positive patients. For gMG: Updated list of drugs not to be used in combination for clarity. For CIDP: Updated electrodiagnostic requirements to align with guidelines. Added Site of Care medical necessity criteria. Policy notification given 11/1/2025 for effective date 1/1/2026. |
| Obinutuzumab (Gazyva®) “Notification” (PDF) | Original medical policy criteria issued for non-oncologic indications. Policy notification given 11/1/2025 for effective date 1/1/2026. |
| Pegcetacoplan (Empaveli®) “Notification” (PDF) | For PNH indication, added diagnostic criteria requiring flow cytometry and LDH level ≥ 1.5 times the upper limit of normal at baseline prior to starting complement inhibitor therapy. Added age requirement of 12 years or older for C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis indications according to FDA label. For C3G indication, removed requirement for reduced serum C3. For C3G and IC-MPGN indications, added age requirement according to FDA labeling. Policy notification given 11/1/2025 for effective date 1/1/2026. |
| Rituximab for the Treatment of Rheumatoid Arthritis “Notification” (PDF) | Changed requirement for trial and failure of preferred rituximab biosimilar products to include Riabni in addition to existing preferred Ruxience and Truxima; adjusted non-preferred rituximab products to include Rituxan. Adjusted verbiage for methotrexate trial option to indicate that inadequate response to methotrexate includes maximally tolerated dosing for at least 3-months. Listed examples of agents for trial option of other conventional agents used in the treatment of RA and added trial duration for at least 3-months. Added additional allowance within conventional trial verbiage for intolerance/hypersensitivity/contraindication to conventional agents used in the treatment of RA. Adjusted verbiage for required trial and failure of one or more TNF inhibitor to indicate at least one biologic immunomodulator FDA labeled or compendia supported for the treatment of RA for at least 3 months, and added allowance for intolerance/hypersensitivity to at least one biologic immunomodulator for treatment of RA. Added requirements to be prescribed by or in consultation with a specialist, no contraindication to the requested agent, and for hepatitis B screening. Other formatting changes made throughout policy and dosing reference table for clarity. Policy notification given 11/1/2025 for effective date 1/1/2026. |
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