Coverage Policies

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Current policies effective through April 30, 2024.

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QualChoice reserves the right to alter, amend, change or supplement medical policies as needed. QualChoice reviews and authorizes services and substances. CPT and HCPCS codes are listed as a convenience and any absent, new or changed codes do not alter the intent of the policy.


Effective Date: 04/01/2019 Title: Ultomiris
Revision Date: 02/01/2023 Document: BI613:00
CPT Code(s): C9052, J1303
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Ultomiris is used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, generalize myasthenia gravis.

2)    Ultomiris is a specialty drug covered under the medical benefit.

3)    Ultomiris (ravulizumab) requires prior authorization.

Medical Statement

Ultomiris (ravulizumab) is considered medically necessary for patients meeting the following conditions:

A. Paroxysmal Nocturnal Hemoglobinuria (must meet all):

1)    Patient is> 1 month;

2)    Patient has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH);

3)    Flow cytometry shows detectable glycosylphosphatidylinositol (GPI)-deficient hematopoietic clones or > 5% PNH cells;

4)    Member meets one of the following (a or b):

a.    History of > 1 red blood cell transfusion in the past 24 months and (I or ii):

                                          i.    Documentation of hemoglobin < 7 g/dL in members without anemia symptoms;

                                        ii.    Documentation of hemoglobin < 9g/dL in members with anemia symptoms;

b. History of thrombosis;

5)    Ultomiris is not prescribed concurrenty with Empaveli or Solliris


B. Atypical Hemolytic Uremic Syndrome (must meet all):

1)    Diagnosis of aHUS (i.e., complement-mediated HUS)

2)    Age ≥ 1 month;

3)    Member has signs of TMA as evidenced by all of the following (a, b, and c):

a.    Platelet count ≤ 150 x 109/L;

b.    Hemolysis such as an elevation in serum lactate dehydrogenase (LDH);

c.    Serum creatinine above the upper limits of normal or member requires dialysis;

4)    Documentation that member does not have either of the following:

a.    A disintegrin and metalloproteinase with thombospondin type 1 motif, member 13 (ADAMTS13) deficiency;

b.    STEC-HUS;

5)    Ultomiris is not prescribed concurrenty with Soliris;


C. Generalized Myasthenia Gravis (gMG)

  1)  Diagnosis of gMG;

  2) Prescribed by or in consultation with a neurologist;

  3) Age >18 years;

  4) Myasthenia Gravis Activities of Daily Living (MG-ADL) score > 6 at baseline;

  5) Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IV;

  6) Member has positive serological test for anti-AChR antibodies;

  7) Failure of corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;

  8) Failure of a cholinesterase inhibitor unless contraindicated or clinically significant adverse effects are experienced;

  9) Failure of two immunosuppressive therapies, unless clinically significant adverse effects are experienced;

 10) Ultomiris is not prescribed concurrently with Soliris or Vyvgart


Reauthorization Criteria:

·         Patient continues to meet the criteria identified in original authorization criteria; AND

·         Absence of unacceptable toxicity from the drug (e.g. serous meningococcal infections, thrombotic microangiopathy complications (TMA), etc.; AND

·         Disease response indicated by one or more of the following:

o   Decrease in serum LDH from pretreatment baseline;

o   Stabilization/improvement in hemoglobin level from pretreatment baseline;

o   Decrease in packed RBC transfusion requirement from pretreatment baseline;

o   Less fatigue;

o   Fewer thrombotic events;

o   Increased or stabilized platelet counts;

o   Improved or stabilized serum creatinine or estimated glomerular filtration rate (eGFR);

o   Reduced need for dialysis.


1)    Ultomiris Prescribing Information. Alexion Pharmaceuticals, Inc. Boston, MA. April 2022.

2)    Kulasekararaj AG, Hill A, Rottinghaus ST, et al. Raulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study. Blood. 2019 Feb7; 1336):540-549.

3)    Parker C, Omine M, Richards S, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood 2005; 106(12):3699-3709. doi:10.1182/blood-2005-04-1717.

4)    Loirat C, Fakhouri F, Ariceta G, et al. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. Pediatr Nephrol. 2016; 31:15-39.


1)    Effective 07-01-2019: Added C9052 to the policy.

2)    Effective 10/01/2019: Added J1303 to policy.

3)    Effective 06-01-2021:  Added Atypical Hemolytic Uremic Syndrome.

4)    Effective 09/01/2022: Added coverage criteria for Generalized Myasthenia Gravis.

5)    Effective 02/01/2023: Updated PNH criteria.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.