| Medical Guidelines |
Reason for Update |
| 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. |
| Buprenorphine Extended-Release (Sublocade®) |
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. |
| Canakinumab (Ilaris®) |
Medical record documentation required for trial and failure of conventional agents; removed criterion point regarding medication history indicating use of another biologic immunomodulator agent for the treatment of SJIA; minor updates to language and formatting for clarity. Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. |
| CAR-T Therapy |
Removed criteria points regarding requirement of no active infection including hepatitis B, hepatitis C, and HIV. 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. |
| 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. |
| Enzyme Replacement Therapy (ERT) for Lysosomal Storage Disorders |
Added age requirement for Fabrazyme and Vimizim per FDA label; site of care requirements applicable to all requested agents except Brinuera. 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. |
| 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 applicable HCPCS codes G2082 and G2083, and description of billing scenarios. 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 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®) |
Updated definition of virologic failure for clarity. 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®) |
Updated dosing in FDA Label Reference table. References added. 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: Medical record documentation required for trial and failure of conventional agents; removed criterion point regarding medication history indicating use of another biologic immunomodulator agent for the treatment of CD. 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 new indication for Tyvaso for pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability; separated criteria by requested product. 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®) |
Expanded PNH indication criteria and dosing table to age one month or older. 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 |
Medical record documentation required for trial and failure of preferred and conventional agents. 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. |
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