Yervoy is considered
medically necessary for patients who meet the following criteria as single agent
treatment or in combination with Opdivo:
·
Diagnosis
of unresectable or metastatic malignant melanoma (Stage III or IV);
·
Age >
12 years;
·
Life
expectancy of at least 4 months;
·
Eastern
Cooperative Oncology Group (ECOG) performance status of 0 or 1:
ECOG
PERFORMANCE STATUS* |
Grade |
ECOG |
0 |
Fully active,
able to carry on all pre-disease performance without restriction |
1 |
Restricted in
physically strenuous activity but ambulatory and able to carry out work
of a light or sedentary nature, e.g., light house work, office work |
2 |
Ambulatory and
capable of all self-care but unable to carry out any work activities. Up
and about more than 50% of waking hours |
3 |
Capable of only
limited self-care, confined to bed or chair more than 50% of waking
hours |
4 |
Completely
disabled. Cannot carry on any self-care. Totally confined to bed or
chair |
5 |
Dead |
* As published
in Am. J. Clin. Oncol: Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J.,
Davis, T.E., McFadden, E.T.,
Carbone,
P.P.: Toxicity and Response Criteria of the Eastern Cooperative Oncology Group.
Am J Clin Oncol
5:649-655,
1982.
·
Normal
hematologic, hepatic, and renal function;
·
No systemic
treatment in previous 28 days;
·
Approval
will be for maximum of 16 weeks (4 doses).
Yervoy (ipilimumab) is
considered medically necessary in patients 12 years of age or older in the
treatment of cutaneous melanoma with pathologic involvement of regional lymph
nodes.
Yervoy (ipilimumab) is
considered medically necessary for patients age 12 or older with advanced
renal-cell cancer as first line treatment in combination with Opdivo (nivolumab).
Yervoy (ipilimumab) is
considered medically necessary in patients age 12 or older for the treatment of
microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
metastatic colorectal cancer that has progressed with a fluoropyrimidine,
oxaliplatin, and irinotecan, in combination with Opdivo (nivolumab).
Yervoy (ipilimumab) is
considered medically necessary in patients 12 years of age or older for the
treatment of small cell lung cancer after failure of a platinum-containing
regiment (unless contraindicated or clinically significant adverse effects are
experienced) in combination with Opdivo (nivolumab).
Yervoy (ipilimumab) is considered medically necessary in patients 12 years of
age or older in the treatment of non-small cell lung cancer in combination with
Opdivo (nivolumab).
Codes
Used In This BI:
J9228 Ipilimumab Injection, 1mg