Medical Policy |
Revision |
Alemtuzumab (Lemtrada®) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Alpha 1-Antitrypsin Inhibitor Therapy |
Added requirement of non-smoker to continuation section; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Antisense Oligonucleotide Therapy for Duchenne Muscular Dystrophy |
Updated medical policy formatting. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Bezlotoxumab (Zinplava™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Bimatoprost Intracameral Implant (Durysta™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Brexanolone (Zulresso™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Burosumab-twza (Crysvita®) |
Added new indication for fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Buprenorphine Extended-Release (Sublocade®) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Canakinumab (Ilaris) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
CAR-T Therapy |
Removed specific weight dosing within Yescarta criteria based on updated FDA label; added requirement of documentation of planned dose; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Crizanlizumab-tmca (Adakveo®) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Denosumab (Prolia®, Xgeva®) |
Added trial and failure or contraindication/hypersensitivity to a bisphosphonate for patients with breast cancer or prostate cancer at high risk for fracture; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Eculizumab (Soliris®) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Edaravone (Radicava®) |
Added maximum units; added clarification of continued clinical benefit for continuation section; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Enzyme Replacement Therapy (ERT) for Lysosomal Storage Disorders |
Added baseline assessment parameters and expansion of age to less than 5 years and ≥16 months of age to Elaprase criteria; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Evinacumab-dgnb (Evkeeza™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Fosdenopterin (Nulibry™) |
Added maximum units; medical policy formatting change. Policy notification given4/16/2021 for effective date 6/16/2021. |
Emapalumab-lzsg (Gamifant™) |
Added requirement for TB testing prior to therapy initiation; added requirement to continuation section for concurrent dexamethasone; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Eptinezumab-jjmr (Vyepti™) |
Added maximum units and removed review of 300 mg strength in initial criteria; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Erythropoietin Stimulating Agents |
Added requirement of evaluation of patient’s transferrin saturation, serum ferritin, and hemoglobin; requirement of supplemental iron for low ferritin or transferrin; removal of Omontys; defined surgical candidate for reduce allogeneic transfusions as elective, noncardiac, nonvascular; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Esketamine (Spravato®) Nasal Spray |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Givosiran (Givlaari®) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Ibalizumab-uiyk (Trogarzo®) |
Added definition of clinically significant response in continuation section; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Immunoglobulin Therapy |
Added selective IgG subclass deficiency and specific antibody deficiency (SAD) under primary immunodeficiencies for IVIg and SCIg; added age requirement for bacterial infection prevention in HIV-infected children; added requirements for FDA labeled or compendia accepted indication with specific evidence level rating, no FDA labeled contraindications, and maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Inebilizumab-cdon (Uplizna™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Injectable Clostridial Collagenase for Fibroproliferative Disorders |
Added continuation criteria with no change to policy intent; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Letermovir (Prevymis™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Lumasiran (Oxlumo™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Luspatercept-aamt (Reblozyl®) |
Added specialist requirement and no use as substitution for RBC transfusions to continuation criteria; maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Natalizumab (Tysabri®) |
CD: Addition of criteria for history of use of another biologic immunomodulator agent for the same indication; added requirements to be prescribed by or in consultation with a specialist; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
New to Market Specialty Drug PPA Requirements |
Medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Nusinersen (Spinraza®) |
Added requirement for maximum units, dose, and dosing frequency; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Ocrelizumab (Ocrevus®) |
Added maximum units; medical policy formatting change with no change to policy intent. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Onasemnogene abeparvovec (Zolgensma®) |
Medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Patisiran (Onpattro®) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Pegloticase (Krystexxa®) |
Added requirements to continuation section of no concurrent use with an oral urate- lowering agent and no use for treatment of asymptomatic hyperuricemia; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Pulmonary Hypertension, Drug Management |
Added additional epoprostenol product (Veletri) to criteria; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Ravulizumab-cwvz (Ultomiris®) |
Added to continuation section no concurrent use with another complement inhibitor and revaccination requirement according to guidelines; PNH: defined symptom stabilization or improvement within continuation section; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Repository Corticotropin (Acthar® Gel) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Respiratory Syncytial Virus Prophylaxis |
Added maximum units; adjusted criteria for clarity; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Rituximab for the Treatment of Rheumatoid Arthritis |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Romiplostim (NPlate®) |
Added new indication for HSARS; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Romosozumab-aqqg (Evenity™) |
Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Teprotumumab-trbw (Tepezza™) |
Added diagnosis confirmation criteria for active, moderate to severe TED related to related to Graves’ disease; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Testosterone Pellet Implantation for Androgen Deficiency |
Added free serum testosterone for diagnosis confirmation; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Treatment of Hereditary Angioedema |
Changed diagnostic requirements; added no use for treatment of laryngeal HAE attacks for Ruconest; added no use with another anti- HAE medication used for prevention or treatment of HAE attacks; continuation criteria added; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
Voretigene neparvovec (Luxturna®) |
Updated age requirement to ≥ 12 months per FDA labeling; removed requirement for no pregnancy or breastfeeding; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |