Coverage Policies

Use the index below to search for coverage information on specific medical conditions.

QualChoice reserves the right to alter, amend, change or supplement medical policies as needed. QualChoice reviews and authorizes services and substances. CPT and HCPCS codes are listed as a convenience and any absent, new or changed codes do not alter the intent of the policy.

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Future eligibility cannot be guaranteed and should be rechecked at time of service. Verify benefits by signing into My Account or calling Customer Service at 800.235.7111 or 501.228.7111.

QualChoice follows care guidelines published by MCG Health.

INDEX:

Effective Date: 08/03/2011

Title: Yervoy

Revision Date: 06/01/2019

Document: BI309:00

CPT Code(s): J9228

Public Statement

Effective Date:

a) This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1) Yervoy (Ipilimumab) requires prior authorization.

2) Yervoy (Ipilimumab) is used to treat unresectable or metastatic malignant melanoma, advanced renal-cell cancer, and metastatic colorectal cancer.

Medical Statement

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

Reference

1) Yervoy Product Information. Bristol-Myers Squibb. October 2015.

2) Hodi FS, O’Day SJ, McDermott DF, et al. Improved Survival with Ipilimumab in Patients with Metastatic Melanoma. N Engl J Med 2010; 363:711-723.

3) NCCN Drug Compendium Guidelines. Accessed online 04-25-2019

4) Motzer RJ, Tanner NM, et al. Nivolumab plus Ipilimumab versus sunitinib in Advanced Renal-Cell Cancer. N Engl J Med 2018; 378:1277-1290.

Application to Products

This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.

This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.