Other clinically supported indications
Rituximab (Rituxan) or a rituximab biosimilar may be considered medically necessary for
ANYof
the following off-label indications:
Autoimmune Hemolytic Anemia (AIHA)
-
Warm AIHA in glucocorticoid-refractory or glucocorticoid-dependent individuals;
or
-
Cold agglutination syndrome
;
or
Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis)
-
First-line treatment in combination with glucocorticoids for individuals with severe (organ-threatening) disease;
or
-
Add-on therapy for treatment-refractory disease
;
or
Epstein-Barr virus disease; Prophylaxis - Hemopoietic stem cell transplant
-
Prophylaxis for Epstein Barr virus infection in pediatric individuals undergoing hematopoietic stem cell transplant;
or
Evans syndrome (Pediatric only)
-
Treatment for Evans syndrome refractory to immunosuppressive therapy;
or
Hemophilia
- T
reatment of
individuals 18 years of age or older for
hemophilia with acquired inhibitors
in individuals
who are refractory to conventional first line treatments (i.e. immunosuppression with prednisone and cyclophosphamide)
;
or
Hepatitis C Virus‒Associated Cryoglobulinemic Vasculitis
-
As add-on therapy for individuals with hepatitis C virus‒associated cryoglobulinemic vasculitis who have:
-
Active disease resistant to antiviral drugs;
or
-
Severe or life-threatening cryoglobulinemic vasculitis;
or
Idiopathic Membranous Nephropathy
-
As treatment for idiopathic membranous nephropathy;
or
Immune thrombocytopenia, previously treated (Pediatric only)
- T
reatment for
pediatric individuals with
previously treated
primary and secondary
immune thrombocytopenia
;
or
Inflammatory Myopathy (Idiopathic)
-
Treatment for individuals 18 years of age or older who have failed to respond to, or are intolerant to, another immunosuppressant (e.g., methotrexate) with refractory idiopathic inflammatory myopathy;
or
Lupus Nephritis
-
As add-on therapy for lupus nephritis refractory to standard first-line treatment regimen;
or
Microscopic polyarteritis nodosa (Adult only)
-
Treatment for microscopic polyarteritis nodosa in combination with glucocorticoids;
or
Minimal change disease (Pediatric only)
- T
reatment for
remission induction and maintenance of remission in pediatric individuals who have
refractory, steroid-dependent or steroid-resistant minimal change disease
;
or
Multiple Sclerosis (Primary Progressive)
-
Treatment for individuals 18 years of age or older with primary progressive multiple sclerosis who have gadolinium brain lesions at baseline and have failed treatment with ocrelizumab;
or
Multiple Sclerosis(Relapsing Remitting)
- Treatment of relapsing remitting multiple sclerosis when the individuals
has experienced therapeutic failure, intolerance, or contraindication to two (2) alternative drug therapies indicated for the treatment of multiple sclerosis (e.g., Avonex, Aubagio, Gilenya, etc.)
;
or
Myasthenia Gravis
- T
reatment for
individuals 18 years of age or older with
myasthenia gravis
refractory to conventional therapy (e.g., azathioprine, corticosteroids, immunosuppressants, plasma exchange, IV immunoglobulin, thymectomy)
;
or
Myopathy, Idiopathic Inflammatory
-
Treatment for refractory idiopathic inflammatory myopathy in individuals who have failed to respond to, or are intolerant to, another immunosuppressant (e.g., methotrexate);
or
Neuromyelitis Optica
-
Treatment for neuromyelitis optica for relapse prevention;
or
Pemphigoid Diseases
-
Treatment for
ANY
of the following pemphigoid diseases in treatment-refractory individuals:
-
Bullous pemphigoid;
or
-
Mucous membrane pemphigoid, including ocular cicatricial pemphigoid;
or
-
Epidermolysis bullosa acquisita;
or
Pemphigus Diseases
-
Treatment for pemphigus diseases (i.e., pemphigus vulgaris, paraneoplastic pemphigus);
or
Pemphigus Foliaceus
-
Treatment for individuals 18 years of age or older with pemphigus foliaceus in combination with a tapering course of corticosteroids;
or
Sjogren's Syndrome (Primary)
-
Treatment for individuals 18 years of age or older with primary Sjogren's syndrome as a one (1) time course of treatment over 15 days;
or
Systemic Lupus Erythematosus
-
Treatment as add-on therapy for systemic lupus erythematosus refractory to immunosuppressive therapy;
or
Systemic Sclerosis (Scleroderma)
-
Treatment for systemic sclerosis (scleroderma) in individuals refractory to first-line treatment;
or
Thrombocytopenic purpura (Idiopathic)
-
Treatment for individuals 18 years of age or older with idiopathic thrombocytopenic purpura refractory to first-line therapy (e.g., corticosteroids, IV immune globulin, splenectomy, etc.) who are at risk of bleeding (grade 2C);
or
Thrombotic Thrombocytopenic Purpura
- Treatment in combination with steroids and plasma exchange in individuals 18 years of age or older with refractory thrombotic thrombocytopenic purpura (i.e., lack of response to plasma exchange therapy and glucocorticoids).
Reauthorization Criteria
Continuation of therapy with rituximab (Rituxan) or a rituximab biosimilar for non-oncologic indications may be considered medically necessary when the following criteria is met:
-
The individual has one of the above diagnoses;
and
- Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy.
The use of rituximab (Rituxan) or a rituximab biosimilar for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
