THE BUSINESS OF TESTING

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 that benefit both patients and payers, according to a study published in the Journal of Managed Care & Specialty Pharmacy. The authors say this real-world evidence supports covering CGP and integrating it into clinical practice.

“Given the recently released Centers for Medicare & Medicaid Services National Coverage Decision for next-generation sequencing 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,” write the authors led by Mitchell Reitsma, from Priority Health in Grand Rapids, Mich. “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.”

CGP uses next-generation sequencing to detect genomic alterations, plus microsatellite instabilities and tumor mutational burden in order 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, many of these broad panel tests have been designated as experimental/investigational or medically unnecessary. Tissue insufficiency commonly precludes conventional gene-by-gene testing. Additionally, participation in clinical trials remains low outside of academic medical settings where CGP testing capabilities may be limited.

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, after Priority Health, a regional health plan, implemented a medical policy that enabled coverage of CGP for patients with advanced solid or hematologic cancers (November 2013 to January 2017) 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.

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

Authors include employees of the health plan and Foundation Medicine.

Takeaway: This study, based on real-world data, indicates that CGP testing offers clinical benefits to patients and cost benefits for payers.

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