Aetna considers aldesleukin (Proleukin) given intravenously medically necessary for metastatic renal cell carcinoma, cutaneous melanoma (as subsequent treatment of unresectable or metastatic disease given as high-dose single-agent therapy, or after an Amtagvi infusion for up to a maximum of 6 doses), chronic graft-versus-host disease that has not responded to first-line therapy, and neuroblastoma. Aetna considers all other indications experimental, investigational, or unproven, and considers subcutaneous IL-2 experimental for renal cell carcinoma and for all indications other than intralesional administration for melanoma. Continuation of therapy is medically necessary for renal cell carcinoma, single-agent subsequent cutaneous melanoma, chronic GVHD and neuroblastoma when the continuation criteria in the policy are met, and this policy applies to commercial medical plans.
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01Billing team: Bill aldesleukin under HCPCS J9015 (per single use vial) only when the selection criteria for a covered indication are met.
02Interleukin-2 requires inpatient intravenous administration or outpatient subcutaneous administration.
03If intravenous IL-2 therapy requires hospitalization, it is not medically necessary for the initial length of stay to exceed the number of days of IL-2 administration, typically 5 days or less.
04For continuation courses, the chart must show that the member was evaluated for response about 4 weeks after the last course and again before the next course, that there was some tumor shrinkage after the last course, and that retreatment is not contraindicated.
05Each course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.
06Therapy should be restricted to patients with normal cardiac and pulmonary function as defined by thallium stress testing and formal pulmonary function testing.
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