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.