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As insurers continue to hold off on covering next-generation sequencing (NGS) tests for cancer tumors, pharmaceutical companies ranging from major players to smaller biotech companies are not only continuing to develop drugs that target specific tumors but also augmenting their NGS testing capabilities, through alliances and by enhancing their own genetic testing expertise. These initiatives aim to identify more patients who might respond to these specific drugs.
Genetic profiling of tumors is rare among patients with advanced cancer. As reported by Reuters, insurance companies are hesitant to reimburse for NGS tests. In their view, there’s not enough clinical evidence to justify the use of genetic tests on a broad scale. This has spurred companies with sufficient resources to build their gene testing infrastructures from within, including Eli Lilly and Co.’s Loxo Oncology and Bayer. These two companies have invested in a drug called Vitrakvi, which targets a rare genetic mutation and reverses late-stage cancer in patients who have exhausted other therapy options.
Bayer, which marketed the drug, “plans to spend $70 million to increase patient and physician awareness of testing for rare mutations and to encourage regulatory approval of more tests. They expect that budget to expand as Vitrakvi continues to win approval in other countries,” wrote Julie Steenhuysen and Ludwig Burger.
Bayer’s efforts, which include public awareness campaigns and hiring diagnostic experts in genomic testing, have proved fruitful so far. The number of clinical labs testing for the mutation that Vitrakvi targets has increased by twofold. In addition, average sequencing rates across tumors reached nearly 30% in 2018, according to company data.
Eli Lilly in the meantime is teaming up with Thermo Fisher Scientific to create a companion assay for LOXO-292, an investigational drug designed to treat patients harboring RET mutations. Such abnormalities are found in a small percentage of non-small cell lung and thyroid cancer tumors. Blueprint Medicines Corp., a small biotech firm, also offers a drug that targets RET mutations. Under this arrangement, these mutations would be added to Thermo’s Oncomine Dx Target Test, in the hopes of identifying more patients who could benefit from the drugs offered by Lilly and Blueprint.
Developing companion diagnostics for a drug that targets specific genetic mutations has become a trend among biopharma companies. Earlier this year, “QIAGEN and Inovio Pharmaceuticals partnered to co-develop a companion diagnostic to go along with Inovio’s DNA-based immunotherapy for cervical dysplasia caused by human papillomavirus (HPV),” according to another news report.
Such tests could save lives. In the case of Xin Zheng, a middle-aged woman with stage 4 lung cancer, a genetic test pointed her to a clinical trial for BLU-677, an experimental drug developed by Blueprint. According to Reuters, “Xin is nearly back to normal,” thanks to this drug.
Genetic tests have faced some challenges from the federal government, leading insurers to pause on reimbursing for them. Medicare recently offered to cover U.S. Food and Drug Administration-approved tests that simultaneously identify multiple genetic mutations for patients with advanced cancer, a measure that could have a domino effect on the private insurance industry. “But the final regulations dropped a requirement that test-makers prove the tests are cost-effective and improve patient care,” according to Steenhuysen and Burger.
This created a chilling effect among insurers that wanted additional proof that these tests would benefit patients, Jeff Schreier. of data analytics company Diaceutics PLC. told Reuters. Many payers view these tests as experimental and will only cover tests they deem medically necessary. In general, these tests are not easy for insurers to manage, medical geneticist Matthew Fickie, MD, FACMG, of Highmark Health in Pittsburgh, told Clinical Laboratory News earlier this year. The industry lacks genetic expertise and it’s difficult for insurers to assess which CPT codes to use for genetic tests.
Fickie recommended that insurers pursue innovative partnerships with clinical labs to share risk and information on genetic tests.
Loxo Oncology, purchased by Lilly in early 2019, is seeking to increase testing in local pathology labs as part of a campaign to “democratize” these tests nationwide, Anthony Sireci, Loxo’s senior medical director, told Reuters. The agreement with Thermo Fisher in particular will help expand access to needed genetic tests, he added.