Payer Medical Policies Can Promote Effective Use of Comprehensive Sequencing in Community Oncology Setting

Comprehensive genomic profiling (CGP) identifies clinically relevant genomic alterations that can be used to inform treatment decisions in community-based oncology practices, which benefits both patients and payers, according to a study in the Journal of Managed Care & Specialty Pharmacy. The authors say this real-world evidence supports covering CGP and integrating it into clinical practice, which provides ammunition to test makers and others calling on payers to cover CGP testing for cancer diagnosis and treatment.

The CGP Coverage Context

CGP uses next-generation sequencing (NGS) to detect genomic alterations, plus microsatellite instabilities and tumor mutational burden to guide treatment with targeted therapies. Despite emerging data demonstrating improved outcomes with targeted therapies, payers have been reluctant to cover CGP due to concerns about off-label drug use, test cost, and lack of

professional guidelines including testing. Thus, payers have designated many of these broad panel tests as experimental/investigational or medically unnecessary. In addition, tissue insufficiency commonly precludes conventional gene-by-gene testing. Participation in clinical trials also remains low outside of academic medical settings where CGP testing capabilities may be limited.

The Study

The researchers evaluated medical records of 96 patients undergoing testing with CGP assays (FoundationOne or FoundationOne Heme; Foundation Medicine, Cambridge, Mass.) at Cancer and Hematology Centers of West Michigan, a community oncology practice, from November 2013 to January 2017 after Grand Rapids, MI regional health plan, Priority Health, implemented a medical policy enabling coverage of CGP for patients with advanced solid or hematologic cancers meeting seven indications.

The researchers examined all previous and current molecular test results, matched therapy or clinical trial enrollment, and clinical outcomes (clinical benefit or disease progression), as well as potential cost diversion for patients who enrolled in clinical trials. (Two local programs enabled enrollment in clinical trials.)

The majority of patients (89.6 percent) had clinically relevant genomic alterations.

Testing occurred before completion of first-line therapy in 51 of 96 patients, while 34 patients had CGP testing following either first- or second-line treatment, and 11 patients had CGP testing following three or more lines of treatment.

The Findings

Of the 70 patients who were treated following receipt of CGP results, 15 received targeted therapy or immunotherapy, and six enrolled in clinical trials based on CGP results. In total, roughly one-third of patients (21 of 64) with actionable genomic alterations who continued treatment following CGP testing, had treatment informed by CGP. Among patients treated with CGP-matched targeted therapy or immunotherapy, 10 experienced clinical benefit, while five experienced disease progression.

Thirty-two patients previously underwent conventional testing (BRAF, EGFR, ERBB2, and KRAS), but for most (84 percent), CGP detected clinically relevant genomic alterations that conventional testing did not identify. A portion of these patients subsequently received treatment based on the CGP results.

Eighty of the 96 patients met the requirements stated in the health plan CGP medical policy. In the cost diversion analysis, 20 patients enrolled in phase 1 clinical trials, with an estimated $25,000 per-patient cost-benefit accrued to the payer (or $500,000 annually).

“The high proportion of tested patients who met the health plan’s medical policy clinical and disease requirements also suggests that CGP will be used in accordance with commercial payer medical policies if covered,” write the study authors led by Mitchell Reitsma from Priority Health.

Takeaway

The study comes at an opportune time for those trying to ensure Medicare and private payer coverage of GCP. “Given the recently released CMS National Coverage Decision for NGS in patients with advanced cancer (which includes coverage for tests used in this observational analysis), this observational analysis provides timely evidence of the utility of CGP in a real-world setting,” according to the study authors. “The results presented here may provide insight into the clinical utility of broad CGP coverage for a commercial payer whose policy is in alignment with Medicare coverage of CGP in patients with advanced cancer.”

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This article originally appeared in G2 Intelligence, Diagnostic Testing & Emerging Technologies, Feb. 2019