Biocept’s NSCLC Liquid Biopsy Gains Coverage from Insurer Highmark

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ersonal Genome Diagnostics (PGDx) said today that its 500+ gene pan-cancer tumor profiling tissue assay is being used by Merck & Co. in a Phase II clinical trial designed to assess patient response to a dual biomarker-directed precision oncology combination therapy in patients with previously untreated advanced non-small cell lung cancer (NSCLC).

Molecular diagnostics developer Biocept announced today that it’s Target Selector liquid biopsy assay was approved for reimbursement for its use in the diagnosis and treatment of patients with non-small cell lung cancer (NSCLC) by Highmark, the U.S.’s fourth largest Blue Cross Blue Shield affiliate.

The coverage determination comes as a result or more than two years of the diagnostic’s evaluation to determine whether use of the liquid biopsy could more rapidly assess the molecular state of the disease to inform more targeted therapies and reduce overall costs of care performed at the Allegheny Health Network Cancer Institute. The evaluation of Target Selector was coordinated and managed by Highmark’s VITAL Innovation Platform that is designed to test innovative new healthcare technologies by tapping into claims and outcomes data from real-world clinical settings.

“The diagnosis, treatment and care of patients with cancer is among Highmark Health’s top priorities and a focus of the VITAL Innovation Platform,” said Anil C. Singh, M.D., Allegheny Health Network (AHN) system director of Pulmonary/Critical Care/Allergy-Immunology and Sleep Medicine, and medical advisor to VITAL.  “VITAL’s evaluation clearly demonstrates the value of using Biocept’s liquid biopsy test in making informed, first-line therapy decisions for patients with non-small cell lung cancer.  Additionally, using a simple blood sample reduced the number of invasive tissue biopsies, which can be challenging in patients with advanced NSCLC.”

With its coverage determinations, Highmark will reimburse testing with Biocept’s assay in health insurances across the company’s market areas of Pennsylvania, Delaware and West Virginia, where it serves 5.6 million members.

During the two-year study, the Target Selector liquid biopsy was used to profile both newly diagnosed, treatment-naïve advanced NSCLC patients, as well as NSCLC patients who were progressing after initial therapy, the evaluation of each patient also included the collection of tissue biopsies for evaluation.

According to said Gene G. Finley, M.D., deputy director of Allegheny Health Network Medical Oncology and lead investigator on the project, his team’s evaluation of assay provide accurate information about the state of NSCLC in the patients studied allowing for more effective treatment strategies that also lowered the costs of caring for those patients.

Finding easier and more effective ways to identify appropriate treatments for NSCLC patients is a focus of many liquid biopsy developers such as Biocept. The use of molecular profiling of these patients lag across the country for a number of reasons, but one major roadblock can be the access to a patient’s tumor tissue sample for evaluation, due to potential difficulties related to obtaining those samples. The simplicity of sample collection for a liquid biopsy—a standard blood draw—make it an attractive and viable option when a tissue sample is not available.

“The positive results from our collaboration under the VITAL program further solidifies Biocept’s role as a leader in the liquid biopsy field and represents an important movement towards improving care for cancer patients,” said Michael Nall, Biocept’s president and CEO in a press release.  “After several years of participating in the VITAL program, the fact that Highmark has made a positive coverage determination is a testament to the value we bring to patients with cancer and to the healthcare system.”

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