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)