Darzalex (Daratumumab) or
Darzalex Faspro is considered medically necessary for patients meeting the
following criteria:
A.
Multiple Myeloma (must meet all):
1)
Diagnosis of MM;
2)
Prescribed by or in
consultation with an oncologist or hematologist;
3)
Age ≥ 18 years;
4)
Darzalex or Darzalex
Faspro is prescribed in one of the following ways (a or b):
a.
Primary therapy (i or
ii):
i.
Ineligible for ASCT (1 or
2):
1.
In combination with
lenalidomide* and dexamethasone;
2.
In combination with
bortezomib*, melphalan, and prednisone;
ii.
Eligible for ASCT in
combination with bortezomib*, thalidomide*, and dexamethasone;
b.
Subsequent therapy (i or
ii):
i.
In combination with
dexamethasone and either lenalidomide*, bortezomib*,or carfilzomib* after ≥ 1
prior therapy (off-label for Darzalex Faspro**);
ii.
As monotherapy or in
combination with pomalidomide* and dexamethasone after ≥ 2 prior therapies
(off-label for Darzalex Faspro**), including both of the following (a and b):
1.
An immunomodulatory agent
(e.g., thalidomide*, lenalidomide*);
2.
A PI (e.g., ixazomib*,
bortezomib*, carfilzomib*);
5)
Request meets one of the
following (a or b):*
a.
Dose does not exceed the
FDA dosing limits.
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting evidence).
B. Systemic Light Chain Amyloidosis (must meet all):
1)
Diagnosis of systemic light chain amyloidosis;
2)
Prescribed by or in consultation with an oncologist or
hematologist;
3)
Age ≥ 18 years;
4)
Member meets one of the following (a or b):
a.
Darzalex Faspro is prescribed in combination with
bortezomib*, cyclophosphamide, and dexamethasone;
b.
Darzalex or Darzalex Faspro is prescribed for relapsed or
refractory disease after ≥ 1 prior therapy (e.g., bortezomib*, lenalidomide*)
(off-label**);
5)
5. Dose is within FDA maximum limit for any FDA-approved
indication or is supported by practice guidelines or peer-reviewed literature
for the relevant off-label use (prescriber must submit supporting evidence).*