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Effective Date: 04/01/2019 Title: Ultomiris
Revision Date: 10/01/2019 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 (ravulizumab) requires prior authorization.

2)    Ultomiris is used to treat paroxysmal nocturnal hemoglobinuria (PNH).

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

Medical Statement

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

1)    Patient is 18 years of age or older AND

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

3)    Diagnosis confirmed by flow cytometry evaluation of red blood cells and white blood cells with granulocyte or monocyte clone size of >5% AND

4)    Patient has been vaccinated for meningococcal disease per current ACIP guidelines (If vaccinated less than two weeks prior to ravulizumab initiation, must provide two weeks of antibacterial drug prophylaxis) AND

5)    Weight-based dosing per FDA label of one loading dose followed by (2 weeks later) every 8 hour maintenance dosing AND

6)    If switching from Soliris (exulizumab), loading dose will be administered 2 weeks after the last Soliris infusion AND

7)    Will not be used in combination with other complement-inhibitor therapy (i.e. Soliris)


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




Body Weight Range

Loading Dose (mg)

Maintenance Dose (mg)

>40kg - < 60kg



>60kg - <100kg






*Switch therapy from eculizumab: administer loading dose of Ultomiris 2 weeks after last infusion of eculizumab, and then administer maintenance doses every 8 weeks, starting 2 weeks after loading dose, as noted above.


1)    Ultomiris Prescribing Information. Alexion Pharmaceuticals, Inc. Boston, MA. December 2018.

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. 2019Feb7; 1336):540-549.

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.
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