Coverage is provided in the following conditions:
• Patient is at least 18 years of age (unless otherwise specified); AND
• Confirmation that patient does not have an unresolved serious Neisseria meningitidis infection prior to initiating therapy; AND
Universal Criteria 1
• Prescriber is enrolled in the Ultomiris and Soliris Risk Evaluation and Mitigation Strategy (REMS) program; AND
Patient must be vaccinated against meningococcal infection (serogroups A, C, W, Y and B) according to current ACIP recommendations at least two weeks prior to initiation of therapy and will continue to be revaccinated in accordance with ACIP recommendations (Note: If urgent Ultomiris therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible.); AND
Will not be used in combination with other immunomodulatory biologic therapies (e.g., efgartigimod, efgartigimod-hyaluronidase, eculizumab, pegcetacoplan, satralizumab, tocilizumab, inebilizumab, rozanolixizumab, rituximab, zilucoplan, pozelimab, etc.); AND
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Patient is at least 1 month of age; AND
Used as switch therapy; AND
Patient is currently receiving treatment with eculizumab and has shown a beneficial disease response and absence of unacceptable toxicity while on therapy; OR
Patient is complement inhibitor treatment-naïve; AND
Diagnosis must be confirmed by detection of PNH clones of at least 5% by flow cytometry testing; AND 
Patient has at least 2 different glycosylphosphatidylinositol (GPI) protein deficiencies (e.g., CD55, CD59, etc.) within at least 2 different cell lines (e.g., granulocytes, monocytes, erythrocytes); AND  Patient has laboratory evidence of significant intravascular hemolysis (i.e., LDH ≥1.5 x ULN) with symptomatic disease and at least one other indication for therapy from the following (regardless of transfusion dependence):
Patient has symptomatic anemia (i.e., hemoglobin < 7 g/dL or hemoglobin < 10 g/dL, in at least two independent measurements in a patient with cardiac symptoms) –
Presence of a thrombotic event related to PNH
Presence of organ damage secondary to chronic hemolysis (i.e., renal insufficiency, pulmonary insufficiency/hypertension) –
Patient is pregnant and potential benefit outweighs potential fetal risk –
Patient has disabling fatigue –
Patient has abdominal pain (requiring admission or opioid analgesia), dysphagia, or erectile dysfunction; AND
Documented baseline values for one or more of the following (necessary for renewal): serum lactate dehydrogenase (LDH), hemoglobin level, packed RBC transfusion requirement, and history of thrombotic events
Atypical Hemolytic Uremic Syndrome (aHUS)
Patient is at least 1 month of age; AND
o Used as switch therapy; AND
Patient is currently receiving treatment with eculizumab and has shown a beneficial disease response and absence of unacceptable toxicity while on therapy; OR
Patient is complement inhibitor treatment-naïve; AND
Patient shows signs of thrombotic microangiopathy (TMA) (e.g., changes in mental status, seizures, angina, dyspnea, thrombosis, increasing blood pressure, decreased platelet count, increased serum creatinine, increased LDH, etc.); AND
Thrombotic Thrombocytopenic Purpura (TTP) has been ruled out by evaluating ADAMTS13 level (ADAMTS13 activity level ≥ 10%); AND
Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS) has been ruled out; AND 
Other causes have been ruled out such as coexisting diseases or conditions (e.g., bone marrow transplantation, solid organ transplantation, malignancy, autoimmune disorder, drug-induced, malignant hypertension, HIV infection, Streptococcus pneumoniae sepsis or known genetic defect in cobalamin C metabolism, etc.); AND
Documented baseline values for one or more of the following (necessary for renewal): serum lactate dehydrogenase (LDH), serum creatinine/eGFR, platelet count, and plasma exchange/infusion requirement
Generalized Myasthenia Gravis (gMG)
Used as switch therapy; AND o
Patient is currently receiving treatment with eculizumab and has shown a beneficial disease response and absence of unacceptable toxicity while on therapy; OR •
Patient is complement inhibitor treatment-naïve; AND
Patient has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV disease§; AND o
Patient has a positive serologic test for anti-acetylcholine receptor (AChR) antibodies; AND o
Patient has had a thymectomy (Note: Applicable only to patients with thymomas OR non-thymomatous patients who are 50 years of age or younger); AND
Physician has assessed objective signs of neurological weakness and fatiguability on a baseline neurological examination (e.g., including, but not limited to, the Quantitative Myasthenia Gravis [QMG] score, etc.); AND
Patient has a baseline MG-Activities of Daily Living (MG-ADL) total score of ≥6; AND
Patient has had an inadequate response after a minimum one-year trial of concurrent use with two (2) or more immunosuppressive therapies (e.g., corticosteroids plus an immunosuppressant such as azathioprine, cyclosporine, mycophenolate, etc.); OR
Patient required chronic treatment with plasmapheresis or plasma exchange (PE) or intravenous immunoglobulin (IVIG) in addition to immunosuppressant therapy; AND
Patient will avoid or use with caution medications known to worsen or exacerbate symptoms of MG (e.g., certain antibiotics, beta-blockers, botulinum toxins, hydroxychloroquine, etc.)
