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UnitedHealthcare Issues New Policy Expanding Coverage of Precision Oncology Diagnostics

NEW YORK – UnitedHealthcare has issued a new policy providing coverage for a variety of molecular tests used to personalize the care of cancer patients.

The medical policy, effective April 1, addresses multiple cancer types and test technologies, as well as a spectrum of early- to late-stage indications and clinical applications. However, the major changes from a prior policy made effective Jan. 1 center on multi-gene sequencing tests for molecular profiling of solid tumors.

UHC will continue to cover multi-gene tissue molecular profiling in lung cancer patients as long as individuals haven't already had one of these tests and the test is either under 50 genes or has approved companion diagnostic (CDx) status for which the patient meets criteria.

In addition, CDx-approved tumor tissue profiling tests will also be covered for lung cancer, as well as any solid tumor patients for whom a doctor is considering treatment with an agent with biomarker confirmation required per its US Food and Drug Administration-approved prescribing label.

The policy specifically lists Foundation Medicine's FoundationOne CDx assay as proven and medically necessary if certain criteria are met, including the patient having an unresectable or metastatic primary tumor for which an immune checkpoint inhibitor is being considered.

Patients also must have evidence of progression of disease and no satisfactory alternative treatment options. They can't have received prior testing with a comprehensive genomic profiling (CGP) assay.

UHC deemed repeat FoundationOne testing unproven and not medically necessary, and specifically excluded any other CGP test brands from coverage "due to insufficient evidence of efficacy."

The new policy also outlines coverage for liquid biopsy CGP tests under narrower criteria. In lung cancer, 50-gene-or-less tests are to be covered when patients haven't had prior multi-gene testing and biopsy and/or tumor tissue testing is not feasible.

Blood-based sequencing tests with CDx indications will also be covered when indicated by a drug's FDA label.

UHC wrote that this includes FoundationOne Liquid CDx in advanced or metastatic breast cancer, metastatic non-small cell lung cancer, metastatic castration-resistant prostate cancer or recurrent ovarian, fallopian tube, or primary peritoneal cancer as long as patients have not had previous CGP testing, are not fit for biopsy or tissue testing, and treatment with a CDx-labeled drug is being considered.

Additionally, the payor will cover Guardant Health's Guardant360 CDx when used in patients with recurrent, relapsed, refractory, metastatic, or advanced NCSLC under the same patient-criteria.

As with tissue, UHC stated that it views other liquid biopsy sequencing tests, as well as circulating tumor cell testing, to be unproven and not medically necessary.

Alongside the CGP update, UHC also added coverage for prostate cancer gene expression profiling, naming the Oncotype DX Prostate assay, as proven and medically necessary for patients with biopsy-proven, untreated, localized adenocarcinoma as long as the ordering urologist or oncologists intends to use the results to aid their treatment decision-making.

Tested patients must not have received prior treatment for prostate cancer and must be eligible for either active surveillance or definitive therapy. They also must have a life expectancy of at least 10 years and be characterized as either low-risk or favorable intermediate-risk.

UHC said it will also cover the use of the Decipher Prostate classifier post-prostatectomy in patients whose tumors show adverse features or who have persistent or recurrent elevated PSA.

Other molecular assays, including Exosome Diagnostics' ExoDx Prostate Test, LynxDx's My Prostate Score, and MDx Health's Confirm MDx and Select MDx, won't be covered.

The new policy also reiterates the payor's prior statements on early-stage breast cancer, uveal melanoma, and thyroid nodule testing, and clarifies the Jan. 1 policy's treatment of hematologic cancers.