Patients with certain forms of breast and ovarian cancer on Medicare will be able to receive coverage under the program for genomic sequencing tests, the agency in charge of the program said.
The Centers for Medicare and Medicaid Services said Monday that it would begin covering Food and Drug Administration-approved next-generation sequencing tests for inherited – also known as germline – ovarian or breast cancers. NGS is a term for a wide variety of genomic sequencing technologies that work much more quickly and cheaply than earlier forms. In recent years, it has enabled doctors to detect mutations in tumors that are amenable to highly targeted therapies, whether those that already have regulatory approval or are in clinical trials. Foundation Medicine, now part of Swiss drugmaker Roche, and Thermo-Fisher are among companies that make NGS systems.
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“We recognize that cancer patient shoulder a heavy burden, so we’re leaving no stone unturned in supporting women’s health and getting all patients the care they need,” CMS Administrator Seema Verma said in a statement. “NGS testing provides clinically valuable information to guide patients and physicians in developing a personalized treatment plan.”
Breast and ovarian cancers with germline BRCA mutations are a prominent example of inherited cancers in women, and CMS noted that such cancers have few treatments available. AstraZeneca’s Lynparza (olaparib) was the first PARP inhibitor to receive Food and Drug Administration approval for solid tumors with inherited BRCA genes and is indicated for ovarian and breast cancers. Pfizer’s Talzenna is also a PARP inhibitor, approved for breast cancer with germline BRCA mutations.
According to CMS’ memo, the coverage decision includes ovarian or breast cancer patients who have clinical indications for germline testing, risk factors for inherited cancers and who have not previously received the same NGS tests.
CMS originally issued a national coverage determination for NGS in March 2018, when it said that tests that have received FDA approval as companion diagnostics would automatically receive full coverage. The determination covered all solid tumors, as well as repeat testing if patients had new primary cancer diagnoses. Monday’s decision is meant to expand that coverage further by allowing more Medicare patients to have access to NGS in managing inherited cancers.
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