Policy changes needed for access to lung cancer research.

from The Hill

Advances in Lung Cancer Treatment

Advances in treatment have completely transformed the way that Americans are living with lung cancer, something that was unthinkable even ten years ago. Since 2015, the U.S. Food and Drug Administration (FDA) has approved 26 new drugs and treatment indications for lung cancer, including 17 biomarker-driven therapies. While Lung Cancer Awareness Month was an opportunity to recognize the great progress we have made in treating this deadly disease, now is an important moment to consider the additional steps that policymakers can take to ensure patient access to these revolutionary treatments.

One key to accessing potentially life-saving lung cancer therapies is biomarker testing, which helps identify which treatment options — including targeted therapies and immunotherapies — are best suited for each patient. We now know that lung cancer is not one disease, but a collection of different subtypes of the disease. Each of these subtypes require a personalized treatment option. Further, because cancers mutate and develop resistance to treatments, additional biomarker testing post-diagnosis can also be critical if lung cancer returns.

Progress through DNA Sequencing

In 1988, Congress allotted billions of dollars to mapping the human genome — an enormous feat. Twenty years later, lung cancer is one of the cancers that has been successfully mapped. In 2008, genome mapping identified 26 genes that are frequently mutated in the most common form of lung cancer — adenocarcinoma, a type of non-small cell cancer.

Lung Cancer’s huge public health impact

Every year in the U.S. nearly a quarter of a million Americans are diagnosed with lung cancer. Of those roughly 200,000 will have non-small cell lung cancer. Treatment of this subtype of lung cancer has been completely transformed since the mapping. We now have insights as to what’s driving the cancer and which patients are most likely to succeed on certain therapies including targeted therapies and immunotherapies. These drugs can be effective against specific types of lung cancer. People are living longer and better. The pace of scientific advancements is mind-boggling.

It is crucial that we increase access to these advancements, including comprehensive biomarker testing. Making biomarker tests a standard of care and ensuring that they are covered by insurance more than once in a patient’s lifetime is the first step toward personalized treatment.

The majority of people diagnosed with lung cancer are treated in community oncology clinics, rather than in large, academic research centers. If biomarker testing isn’t reimbursed by insurance or isn’t a standard of care, doctors who aren’t lung cancer specialists might not order it. Forcing patients to pay out-of-pocket for biomarker testing or to make uninformed treatment decisions will worsen health outcomes and exacerbate health disparities.

Insurance coverage for biomarker testing

In March 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination that covers diagnostic laboratory tests using FDA-approved Next Generation Sequencing (NGS) for patients with advanced cancer. While this step was critical to ensuring coverage and sets an excellent precedent for other payers, the CMS determination only pays for one next generation sequencing test in a person’s lifetime per cancer diagnosis. It does not account for the fact that patients and their physicians may need additional testing when their cancer develops resistance to their current therapies to help determine the best next treatment option.

Apart from helping patients access the right FDA-approved treatment, biomarker testing may also enable a patient to be matched to a biomarker-driven clinical trial. Not only does this ensure that a patient may access life-saving therapies before they get approved, but also helps drive innovation and research into new therapies that might save the lives of others in the future.

It used to be that chemotherapy was one of the only treatments available for lung and other cancers. But research has come so far in delivering more meaningful treatment based on a deeper understanding of biology of the cancer. We respectfully urge policymakers to take steps to ensure that patients can benefit from these new advancements. It is our responsibility, as a community, to ensure that patients have access to high-quality, comprehensive biomarker tests and the most appropriate treatments for their particular type of cancer — truly personalized medicine.

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