I.  
Interferon Alpha
Interferon Alpha is 
considered medically necessary for the following indications:
1)   
AIDS-associated Kaposi`s sarcoma;
2)   
Basal cell 
carcinoma, when surgical intervention is contraindicated (interferon therapy in 
basal cell carcinoma is only considered medically necessary for those persons in 
which surgical intervention is contraindicated; surgical intervention is 
considered first-line therapy for basal cell carcinoma, and has been shown to 
have a 95% treatment success rate);
3)   
Carcinoid 
syndrome;
4)   
Cervical 
carcinoma, in persons who cannot tolerate, or whose tumor is resistant to, 
standard first-line therapy;
5)   
Chronic 
myelogenous leukemia;
6)   
Colorectal 
carcinoma, when used in conjunction with 5-FU;
7)   
Condylomata 
Acuminata (genital warts) (intralesional only);
8)   
Cutaneous 
T-cell lymphoma (including mycosis fungoides);
9)   
Desmoids 
tumors (fibromatosis), for unresectable disease or gross residual disease 
following surgery;
10)  
Essential 
Thrombocythemia;
11)  
Hairy cell 
leukemia; 
12)  
Hepatitis C 
(non-A, non-B hepatitis), in persons with compensated liver disease (Child-Pugh 
score less than or equal to 6 [class A]) (the safety and efficacy have not been 
established for treatment of persons with decompensated liver disease). 
Continued treatment with interferon alpha is considered not medically necessary 
for persons with HCV genotypes 1 and 4 through 6 who have failed to attain an 
early virologic response after 12 weeks of treatment (where early virologic 
response is indicated by achievement of at least a 100-fold (2 log10) decrease 
in serum HCV from pretreatment baseline). Up to a maximum of 24 weeks of 
interferon alpha is considered medically necessary for persons with HCV 
genotypes 2, 3, and 7 through 10; and up to a maximum of 48 weeks of interferon 
alpha is considered medically necessary for persons with HCV genotypes 1 and 4 
through 6. A course of standard interferon alpha in persons with hepatitis C who 
have failed to respond or relapsed after an adequate course of PEGylated 
interferon alpha or consensus interferon is considered experimental and 
investigational because of a lack of evidence on the effectiveness of standard 
interferon in these persons. Note: Upon medical review, extended 
treatment with interferon alpha beyond these limits may be considered medically 
necessary for persons with cryoglobulinemia and for liver transplant recipients 
with recurrent hepatitis C infection;
13)  
Hepatocellular carcinoma, for persons with hepatitis C and completely resected 
tumors;
14)  
Hyper-eosinophilic syndrome that is not adequately responsive to 
glucocorticoids;
15)  
Kasabach-Merritt syndrome;
16)  
Life-threatening hemangioma of infancy (intralesional) when member is intolerant 
of, or the hemangioma is resistant to, corticosteroid therapy;
17)  
Malignant 
melanoma; 
18)  
Meningioma, 
recurrent, surgically inaccessible; 
19)  
Malignant 
mesothelioma in persons who have relapsed following surgery and failed treatment 
with or cannot tolerate first-line chemotherapy;
20)  
Multiple 
myeloma, solitary plasmacytoma, or systemic light chain amyloidosis;
21)  
non-Hodgkin`s lymphoma (including adult T-cell lymphoma (chronic, smoldering or 
acute) and mycosis fungoides/Sezary syndrome);
22)  
Ocular 
herpes simplex (interferon alpha eye drops);
23)  
Ovarian 
carcinoma, in persons who cannot tolerate, or whose tumor is resistant to, 
standard first-line therapy;
24)  
Pancreatic 
islet cell carcinoma;
25)  
Persons 
with chronic hepatitis B who meet all of the following criteria:
a. 
Member has 
compensated liver disease (Child-Pugh score less than or equal to 6 
[class A]); and 
b. 
Serum 
aminotransferase (AST) greater than double the upper limit of normal range (AST 
normal range 0-35 u/l).
A 
course of standard interferon alpha in persons with hepatitis B who have failed 
an adequate course of PEGylated interferon alpha is considered experimental and 
investigational because of a lack of evidence on the effectiveness of standard 
interferon in these persons.
(The use of interferon 
alpha is considered contraindicated in the following persons with hepatitis B: 
those who are HIV positive; hepatitis B surface antigen (HBs Ag) positive 
persons undergoing liver transplantation; and those with a history of or 
currently active autoimmune hepatitis);
                    
26)  Persons with 
polycythemia vera who meet all of the following criteria:
·     
Oral 
therapy with hydroxyurea or other myelosuppressive agent is not effective, not 
tolerated, or is contraindicated; and
·     
Phlebotomy 
is not effective, not tolerated, or contraindicated.
Note: 
Failure of phlebotomy and/or myelosuppressive agents may be defined as any of 
the following:
o 
Lack of 
hematological control (e.g., hematocrit greater than 45 or platelet count 
greater than 600 x 109/L);
o 
Occurrence 
of intractable symptoms (e.g., headaches, pruritus);
o 
Occurrence 
of symptoms related to hepatosplenomegaly;
o 
Occurrence 
of thrombotic or hemorrhagic complications; or
o 
Phlebotomy 
required more often than once every two months.
27)  
Renal cell 
carcinoma; 
28)  
Respiratory 
papillomatosis; 
29)  
Superficial 
bladder cancer (carcinoma in situ of the bladder); 
30)  
Vulvar 
Vestibulitis, or
31)  
Waldenstrom`s Macroglobulinemia.
B. Interferon Alpha 
is considered medically necessary in some instances of the 
following conditions, and prepayment review will be routinely performed:
1)   
Ovarian 
carcinoma, in persons who cannot tolerate, or whose tumor is resistant to, 
standard first-line therapy; 
2)   
Chronic 
myelogenous leukemia (not in accelerated phase); 
3)   
Low-grade 
non-Hodgkin`s lymphoma (stage III/IV) especially follicular small cleaved cell 
lymphoma (nodular poorly differentiated types);
4)   
Colorectal 
carcinoma, when used in conjunction with 5-FU; 
5)   
Cervical 
carcinoma, in persons who cannot tolerate, or whose tumor is resistant to, 
standard first-line therapy; 
6)   
Superficial 
bladder cancer (carcinoma in situ of the bladder); 
7)   
Basal cell 
carcinoma, only when surgical intervention is contraindicated 
8)   
Life-threatening hemangioma of infancy (intralesional) when member is intolerant 
of, or the hemangioma is resistant to, corticosteroid therapy; 
C. Interferon Alpha 
is considered medically necessary in some instances of the 
following conditions; pre-authorization is required:
1)   
Persons 
with polycythemia vera who meet all of the following criteria: 
·     
Phlebotomy 
is not effective, not tolerated, or contraindicated; and 
·     
Oral 
therapy with hydroxyurea or other myelosuppressive agent is not effective, not 
tolerated, or is contraindicated. 
Failure of phlebotomy and/or myelosuppressive agents is defined as any of 
the following:
·     
Lack of 
hematological control (e.g., hematocrit greater than 45 or platelet count 
greater than 600 x 109/L); 
·     
Phlebotomy 
required more often than once every two months; 
·     
Occurrence 
of thrombotic or hemorrhagic complications; 
·     
Occurrence 
of intractable symptoms (e.g., headaches, pruritus); 
·     
Occurrence 
of symptoms related to hepatosplenomegaly. 
2)   
Malignant 
mesothelioma in persons who have relapsed following surgery and failed treatment 
with or cannot tolerate first-line chemotherapy; 
3)   
Hepatitis C 
(non-A, non-B hepatitis), in compensated liver disease manifest by the 
following:
·     
Laboratory 
parameters are all within the following ranges: 
a. 
bilirubin 
less than 2 mg/dL; 
b. 
albumin 
stable and within normal limits; 
c. 
INR less 
than 3; 
d. 
WBC greater 
than 3000/mm3; 
e. 
platelets 
greater than 70,000/mm3;
f.  
serum 
creatinine normal or near normal
·     
No history 
of hepatic encephalopathy, variceal bleeding, ascites, or other clinical signs 
of decompensation.
4)   
Persons 
with chronic hepatitis B who meet all of the following criteria: 
·     
Serum 
aminotransferase (AST) greater than double the upper limit of normal range (AST 
normal range 0-35 u/l); 
·     
Member has 
compensated liver disease manifest by the following:
a. 
Bilirubin 
less than 2mg/dL; 
b. 
Albumin 
stable and within normal limits; 
c. 
PT less 
than 3 seconds prolonged or INR less than 2; 
d. 
WBC greater 
than 3000/mm3; 
e. 
Platelets 
greater than 70,000/mm3; 
f.  
Serum 
creatinine normal or near normal). 
g. 
No history 
of hepatic encephalopathy, variceal bleeding, ascites, or other clinical signs 
of decompensation; 
II.  
PEGylated Interferon Alpha 
(requires pre-authorization)
A.  
Pegasys 
(PEGylated interferon alfa-2a) 
is considered medically necessary, either as monotherapy or in combination with 
ribavirin (Rebetol), for the treatment of chronic hepatitis C in persons who are 
interferon naïve or who have relapsed or failed to respond to prior 
non-PEGylated interferon therapy with compensated liver disease manifest by:
1)   
Bilirubin 
less than 2 mg/dL; 
2)   
Albumin 
stable and within normal limits; 
3)   
PT less 
than 3 seconds prolonged or INR less than 2; 
4)   
WBC greater 
than 3000/mm3; 
5)   
Platelets 
greater than 70,000/mm3; 
6)   
Serum 
creatinine normal or near normal
7)   
No history 
of hepatic encephalopathy, variceal bleeding, ascites, or other clinical signs 
of decompensation.
B.  Peginterferon alfa-2a 
(Pegasys) is 
considered medically necessary for the treatment of adult persons with HBeAg 
positive or HBeAg negative chronic hepatitis B who have compensated liver 
disease manifest by: 
1)   
Bilirubin 
less than 2mg/dL; 
2)   
Albumin 
stable and within normal limits; 
3)   
PT less 
than 3 seconds prolonged or INR less than 2; 
4)   
WBC greater 
than 3000/mm3; 
5)   
Platelets 
greater than 70,000/mm3; 
6)   
Serum 
creatinine concentrations less than 1.5 times upper limit of normal;
7)   
No history 
of hepatic encephalopathy, variceal bleeding, ascites, or other clinical signs 
of decompensation; 
8)   
Evidence of 
viral replication (HBV greater than 500,000 copies per ml for HBeAg positive and 
HBV greater than 100, 000 copies per ml for HBeAg negative) 
9)   
Liver 
inflammation (serum aminotransferase (AST) greater than the upper limit of 
normal range (AST normal range 0-35 u/l));
10)  
Who are 
interferon naïve or who have relapsed or failed to respond to prior 
non-PEGylated interferon therapy? 
C. Pegylated interferon 
alfa-2b is 
considered medically necessary for patients who meet the following criteria:
1)  Diagnosis of melanoma 
with microscopic or gross nodal involvement AND
2)  Medication will be 
used as adjuvant therapy within 84 days of definitive surgical resection AND
        3)  Patient does 
not have the following contraindications:
     a. Autoimmune hepatitis
     b. Hepatic decompensation (Child-Pugh score higher than 6 [class B or C]
III.  
Consensus Interferon (Interferon alfacon-1) 
(requires 
pre-authorization)
A.  
Consensus 
interferon (Infergen interferon alfacon-1) is considered medically necessary for treatment 
of chronic hepatitis C in persons with compensated liver disease who meet 
medical necessity criteria for interferon alpha. 
IV.    
 Interferon beta 
requires 
pre-authorization
Interferon beta-1a 
(Avonex, Rebif) or interferon beta-1b (Betaseron) are considered medically 
necessary for the treatment of relapsing/remitting multiple sclerosis in members 
who meet the following criteria for either clinically definite or laboratory 
supported definite MS:
1) 
Clinically 
definite MS is defined as either: 
·  
Two attacks 
and clinical evidence of two separate lesions; or 
·  
Two 
attacks; clinical evidence of one lesion and para-clinical evidence of another, 
separate lesion 
2) 
Laboratory-supported definite MS consists of demonstration of any of the 
following: 
·  
Two 
attacks; either clinical or para-clinical evidence of one lesion; and CSF OB/IgG*;
or 
·  
One attack; 
clinical evidence of two separate lesions; and CSF OB/IgG*; or 
·  
One attack; 
clinical evidence of one lesion and para-clinical evidence of another separate 
lesion; and CSF OB/IgG
§
CSF OB/IgG 
is defined as either:
·  
IgG 
oligoclonal band (OB) in the CSF (Oligoclonal bands must not be present in the 
member`s serum and the serum IgG level must be normal); or 
·  
Increased 
CNS synthesis of IgG (IgG is higher in CSF than in serum, and is increased in 
the CSF in the presence of a normal concentration of total protein). 
·  
Single 
attack with MRI evidence for Multiple Sclerosis (Clinically Isolated Syndrome).
See MS Policy
V.  
PEGylated Interferon Beta-1a
PEGylated Interferon Beta 
1-a (Plegridy) is considered medically necessary for the treatment of 
relapsing/remitting multiple sclerosis in members who meet the following 
criteria for either clinically definite or laboratory supported definite MS:
1) Clinically definite MS 
is defined as either: 
·  
Two attacks 
and clinical evidence of two separate lesions; or 
·  
Two 
attacks; clinical evidence of one lesion and para-clinical evidence of another, 
separate lesion 
2) Laboratory-supported 
definite MS consists of demonstration of any of the following: 
·  
Two 
attacks; either clinical or para-clinical evidence of one lesion; and CSF OB/IgG*;
or 
·  
One attack; 
clinical evidence of two separate lesions; and CSF OB/IgG*; or 
·  
One attack; 
clinical evidence of one lesion and para-clinical evidence of another separate 
lesion; and CSF OB/IgG
o 
CSF OB/IgG 
is defined as either:
·  
IgG 
oligoclonal band (OB) in the CSF(Oligoclonal bands must not be present in the 
member`s serum and the serum IgG level must be normal); or 
·  
Increased 
CNS synthesis of IgG (IgG is higher in CSF than in serum, and is increased in 
the CSF in the presence of a normal concentration of total protein). 
·  
Single 
attack with MRI evidence for Multiple Sclerosis (Clinically Isolated Syndrome).
See MS Policy
VI. 
Interferon Gamma 1-B
Interferon Gamma 1 
is considered medically necessary for the following indications (for these 
indications, no pre-authorization is required. For all other indications, 
payment will be denied): 
1)   
Chronic 
granulomatous disease, to reduce the frequency and severity of infections;
2)   
Chronic 
recalcitrant atopic dermatitis; 
3)   
Idiopathic 
pulmonary fibrosis;
4)   
Waldenstrom`s Macroglobulinemia.
Codes Used In This BI:
J1830   Interferon Beta-1B 0.25mg SC (Betaseron)
J9212   Interferon alfacon-1, 1 mcg (Infergen)
J9213   Interferon alpha-2A, 3 million units (Roferon-A)
J9214   Interferon alpha-2B, 1 million units (Intron A)
J9215   Interferon alfa-n3 inj
J9216   Interferon gamma 1-b inj
S0145   Peginterferon alpha-2A (Pegasys)
S0148   
Peginterferon alpha-2B (Pegintron)