Recent advances in modern medicine mean that a surprise diagnosis of advanced lung cancer is no longer an automatic death sentence. But when Medicare providers refuse to pay the cost of cutting-edge medicines, they prevent patients from receiving life-saving treatments and condemn them to the same fate. Attorney Janet Lowder and I just made it a little harder for Medicare Part D providers to do that.
Our client was living an otherwise active and healthy life when she was unexpectedly diagnosed with advanced lung cancer. She needed to act fast to get ahead of the disease. Her top-notch doctors prescribed the most effective treatment – one that could in fact save her life.
But there was a problem: the medicine her doctors wanted her to take [Tagrisso (osimertinib)] wasn’t yet approved as a first-line treatment by the FDA unless the patient had a very specific gene mutation. That will soon change: the FDA has put this breakthrough medicine on a “fast track,” and it is expected to be approved for use by patients like our client within months. But our client didn’t have months – she needed to start treatment immediately. Doctors told her that the medicine would not be as effective against her cancer if she waited to start taking it, or used it as a second-line treatment once another drug failed.
Unfortunately, because our client’s gene mutations are slightly different than those of the people for whom the drug was approved, her request to use the medicine was turned down. It didn’t matter that the FDA will soon approve the treatment for everyone. It didn’t matter that her doctors, national experts in lung cancer, recommended that medicine. It didn’t matter that cutting-edge research is confirming the effectiveness of Tagrisso. It didn’t matter that rejection could mean a death sentence for our client or that, given the exorbitant cost of the medicine out of pocket, most people would not be able to afford even a single treatment. In fact, the only thing that mattered for her Medicare provider was that the treatment had not been approved by the FDA for her specific condition.
Attorneys Lowder and I were asked to step into this case late in the game and quickly build a case to show why the Medicare Part D private drug company was obligated to provide coverage. They found that, even though medical knowledge and practice in this area changes weekly and even daily, the law comes down to two issues when treatments are “medically accepted,” but not yet approved by the FDA, whether use of the medication is supported in a recognized compendium (which is a recognized medical treatise on the use of a medicine), or whether it is supported by recognized peer-reviewed research literature.
Fortunately for our client, Attorneys Lowder and I were able to convince the Administrative Law Judge hearing the appeal that not only had the medicine been recently added to a recognized compendium, but also that very recent medical research supported its use. As a result, the ALJ issued a fully favorable ruling for our client, just in time for the holidays.
The ruling gave our client a new lease on life, one that is made possible by rapid advancements in medical science. But those advancements mean that others will face similar situations as our client: although it’s likely that others won’t be denied coverage for Tagrisso in the near future because it will have been approved, it’s just as likely that new, effective treatments will come out faster than the FDA can approve them. And when that happens, they’ll need experienced counsel to guide them through the appeal process.