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Tice BCG, A Lifesaving Bladder Cancer Drug, Is Facing A Critical Shortage Across The Rochester-Finger Lakes Region & Upstate NY As Patients Are Routinely Denied Care

 Schumer Uncovers Major Inconsistency In Fed Regulations That Could Result In Unemptied Vials Of Essential Medication Being Thrown Away; Senator Launches Major Effort To Eliminate Misguided Policy

 Schumer To Feds: With Lives On The Line, Finger Lakes Patients Deserve To Have Every Drop Of BCG Used

Standing at the University of Rochester Medical Center’s (URMC) Wilmot Cancer Center, U.S. Senator Charles E. Schumer today revealed that the Rochester Finger Lakes Region and Upstate New York are facing a crippling shortage of the major bladder cancer drug, Tice BCG, and called on the federal government to snap into action to address the crisis rippling across the state. Schumer explained that after receiving calls from cancer-ridden patients located in the Finger Lakes Region scrambling to get the drug, he uncovered that demand for the drug has skyrocketed and manufacturing has not been able to keep up with patients’ needs. To address this crisis, Schumer urged the Centers for Medicare and Medicaid Services (CMS) to fix a policy that leads to the discarding of partial vials of Tice BCG, which could be otherwise used to treat patients. Second, Schumer urged the Food and Drug Administration (FDA) to identify any other options that can alleviate the drug shortage, whether that includes bringing in supplies of the drug from other countries if they have an excess, or fast-tracking approval for other strains of the drug that may also be used to treat bladder cancer. Lastly, he called on Merck to examine whether creating smaller dose vials could be a way to help more people access treatment.

“The shortage of BCG is already devastating to the above-average number of bladder cancer patients Upstate. Combined with the fact that because of misguided federal policy, Medicare is instructing doctors to throw reserves of the life-saving medication in the garbage, this crisis is made all the more severe,” said Senator Schumer. “That’s why I’m urging CMS to change this rule without wasting any time and calling on the FDA to examine all options and put everything possible on the table to address this crippling shortage, including bringing in supplies of the drug from other countries, or fast-tracking approval for other strains of the drug that may also be used to treat bladder cancer. We can’t afford to be discarding unemptied vials of BCG, not when lives are literally at stake.”

Schumer said that the Rochester-Finger Lakes Region has not been immune to the BCG crisis. Locally, health care professionals like those at the University of Rochester Medical Center (URMC) have several times been unable to acquire the BCG needed to treat bladder cancer patients. While some patients were able to receive alternate types of treatment, others are still in the midst of their treatment and are unsure if they’ll be able to receive the next lifesaving dose of BCG they need to help fend off their bladder cancer. For example, standing with Schumer today is Webster resident, Bill Burchell, who is currently being treated for bladder cancer at URMC. His doctors performed surgery to remove his tumor, after which URMC planned to follow-up by treating Bill with BCG to prevent a regrowth of tumors. However, URMC was out of BCG at the time, so they treated Bill with another medicine, which unfortunately was not effective. When his cancer eventually returned, URMC was still out of BCG, so he began searching far and wide for a hospital that did have stock of the lifesaving medication. Eventually, he found it in Michigan, but right before driving out to Michigan, was told by URMC that a new shipment was coming in. Bill is now meeting with his doctors to determine when he should receive the next treatment of BCG, but even still, URMC has a wait list and supplies are not guaranteed. Schumer argued that this dire situation proves that something must be done to address the major shortage of BCG, and quickly.

The bladder cancer drug, known as Tice BCG, is a live bacterium that is inserted into patients that have an early form of bladder cancer. The drug creates a low-grade infection in the bladder to trigger a reaction in the immune system which can prevent bladder cancer from forming. As it is a live bacterium, the manufacturing process is intensive and timely; it involves growing the bacterium on a specific form of potato for months before initiating a complex chemical mixing process. Schumer said that he has confirmed with multiple organizations that Merck, the pharmaceutical company that manufactures the drug, has ramped up production and is doing everything possible to produce more of it. However, with such an intensive and timely manufacturing process required, the company is simply not able to produce enough of the drug to fully meet demand.

However, Sen. Schumer revealed that the federal government could be doing more to stretch the limited supply available. Typically, the Medicare billing process reimburses for cancer drugs per vial used and instructs the doctor to discard any unused portion of the drug remaining in the vial. However, data shows that even giving partial doses of BCG is effective to treat a patient’s bladder cancer and some doctors and patients have pushed to be allowed to use partial doses. Schumer said that he has spoken to multiple experts who said that some patients require only partial doses and that doctors could safely and effectively treat multiple patients with a single vial of the drug on a single day. Splitting doses would increase the national supply of BCG even for hospitals like URMC, which do not now rely on split doses.

Therefore, in response to the demand for partial dose ability, On July 1st, CMS announced it would begin to reimburse physicians for using partial vials on multiple patients, an action that Schumer praised. However, the local entities that represent CMS with doctors have indicated that they will not reimburse for partial vials, or have not confirmed that they will reimburse for partial vials, and are also maintaining the unused portions of the drug should be discarded. This has led some doctors to say they are confused as to whether they can treat multiple patients with a single vial, and could be resulting in doctors discarding portions of the drug. Groups that represent bladder cancer physicians are imploring CMS to clarify and fix these conflicting policies as soon as possible. Schumer, today citing this conflicting federal policy, revealed that Medicare’s policy for BCG could be resulting in doctors discarding partial vials of the drug when it could be used on other patients, and said that the CMS must fix this problem immediately.

Today, Schumer also called on the FDA to look at any other options that might alleviate the shortage, whether that includes bringing in supplies of the drug from other countries if they have an excess, or fast-tracking approval for other strains of the drug that may also be used to treat bladder cancer. His push follows efforts by national groups like the Bladder Cancer Advocacy Network (BCAN), which are urging the FDA to fast-track BCG strains used safely in other countries—like Tokyo BCG and Danish BCG.

In 2019, the American Cancer Society expects a total of 80,470 new cases of bladder cancer, with 70% expected to be cases of Nonmuscle invasive bladder cancer (NMIBC), which is treated by BCG. According to the National Cancer Institute and the American Cancer Society, The Rochester-Finger Lakes Region and much of Upstate New York is unique in having a higher incidence rate of bladder cancer than the national average. Bladder cancer is the sixth most common cancer in the United States. 700,000 people are living with bladder cancer in the U.S. 

Bill Burchell, Webster resident and URMC Bladder Cancer patient said, “The nation-wide shortage of this lifesaving BCG drug is alarming to every bladder cancer patient, and their families, who have no idea if they will be able to get their next needed dose. I appreciate Senator Schumer’s attention to this and support any and all efforts to reduce the current BCG shortage so that bladder cancer patients can have peace of mind knowing that they will not have to go without BCG, which for decades has been the gold standard to treat bladder cancer and to prevent tumor recurrences.”

“We treat hundreds of people with bladder cancer every year, and giving them less effective medications or fewer or reduced doses of BCG is not acceptable,” said Edward Messing, M.D., FACS, professor of Urology at the University of Rochester Medical Center, who specializes in treating bladder cancer. “Increasing the supply of BCG is incredibly important for ensuring that patients have access to the best treatment, and we appreciate Sen. Schumer bringing attention to this issue.”

BCG, or Bacillus Calmette-Guérin, was originally developed as a tuberculosis vaccine more than a century ago at the Pasteur Institute in France. However, since the 1970s, BCG has become the gold-standard treatment for bladder cancer patients. BCG triggers an immune response in patients that stops the development of new bladder cancer tumors and is regularly used to stop bladder cancer from returning. How often and how long patients need BCG depends on their cancer. Usually, BCG is instilled weekly for 6 weeks, and then maintenance treatments are given weekly for 3 weeks every six months for 3 years.  Without BCG, U.S. physicians have been forced to treat patients with surgery, radiation therapy, or chemotherapy, which can all be less effective and have greater risk and undesirable side effects.