October 2020 Announcement about BCG Production, Supply

For more than a year, the AUA has been actively monitoring the global shortage of bacillus Calmette Guerin (BCG), and providing updates to members about this important concern.

Last month we shared an update from Merck regarding their commitment to explore ways for improving the global supply of TICE BCG, as well as maximizing the output of their current facility in order to provide additional supply of BCG to patients.

As part of this commitment, earlier today Merck announced plans to construct a new TICE BCG manufacturing facility in the United States, specifically Durham, NC. This new facility will be a part of the existing Maurice R. Hilleman Center for Vaccine Manufacturing. Merck expects to break ground on the new facility next year and anticipates the build to take up to six years to complete. Once fully operational, Merck expects to triple its current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the foreseeable future.

Until the new facility is licensed, Merck has no plans to change the current dosing of BCG –or how they supply BCG to their manufacturing partners; they will continue to use a system to proportionally allocate TICE BCG based on historical demand within the United States and other countries where Merck is the sole supplier.

Read more about the new facility.

September 2020 Member Communication and Recommendations

September 4, 2020 Dear Members: Last year we shared a message regarding the global shortage of Merck’s TICE BCG due to an increasing global demand for the product. The American Urological Association (AUA), American Association of Clinical Urologists (AACU), Bladder Cancer Advocacy Network (BCAN), Society of Urologic Oncology (SUO), the Large Urology Group Practice Association (LUGPA) and the Urology Care Foundation (UCF) remain extremely concerned about this ongoing shortage and its effects on the care of bladder cancer patients. Efforts to engage the U.S. Food and Drug Administration to approve additional strains and supplies of BCG are continuing and all organizations noted above maintain communications with Merck for the most up-to-date information on this issue. In that regard, Merck has provided us with the following statement: Our commitment to TICE BCG, while other companies have stopped production, is at the core of Merck’s mission to save and improve lives. Our teams remain focused on maximizing the output and reliability of our current facility striving to provide additional supply of TICE BCG to patients. Additionally, we have been exploring additional ways in which to expand our current manufacturing capacity. Although any manufacturing expansion will take years to fully realize, we have recently confirmed that we have a path forward. More detailed information will be shared at the appropriate time. We are also assessing our current allocation process to look for additional ways to optimize the distribution of available supply in the U.S., to the best of our ability. The AUA recommends several management approaches to maintain high quality care for patients with Non-Muscle-Invasive Bladder Cancer (NMIBC). These recommendations may supersede the guideline statements found in the Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Joint Guideline (2020). As always, these recommendations are subject to physician judgment in individual cases: BCG should not be used for patients with low-risk disease. Intravesical chemotherapy should be used as the first-line option for patients with intermediate-risk NMIBC. Patients with recurrent/multifocal low-grade Ta lesions who require intravesical therapy should receive intravesical chemotherapy such as mitomycin, gemcitabine, epirubicin, or docetaxel instead of BCG. If BCG would be administered as second-line therapy for patients with intermediate-risk NMIBC, an alternative intravesical chemotherapy should be used rather than BCG in the setting of this BCG shortage. For patients with high-risk NMIBC, high-grade T1 and CIS patients receiving induction therapy, they should be prioritized for use of full-strength BCG. If not available, these patients and other high-risk patients may be given a reduced 1/2 to 1/3 dose, if feasible. If supply exists for maintenance therapy for patients with NMIBC, limit BCG dose to one year. In the event of BCG supply shortage, maintenance therapy should not be given and BCG naïve patients with high-risk disease should be prioritized for induction BCG. If BCG is not available, alternatives to BCG such as gemcitabine, epirubicin, docetaxel, valrubicin, mitomycin, or sequential gemcitabine/docetaxel or gemcitabine/mitomycin may also be considered with an induction and possible maintenance regimen. Patients with high-risk features (i.e., high-grade T1 with additional risk factors such as concomitant CIS, lymphovascular invasion, prostatic urethral involvement or variant histology) who are not willing to take any potential oncologic risks with alternative intravesical agents, should be offered initial radical cystectomy, if they are surgical candidates. ADDITIONAL NOTES: As always, it is important these decisions be made after an informed discussion with the individual patients regarding their treatment options in the context of the ongoing BCG shortage. It is further recognized that there are billing, consent, oncological, and administration concerns around split-vial dosing of BCG. The AUA suggests confirmation with any insurance company prior to splitting vials and appropriately consenting the patients, administering the doses consistent with the package insert, and providing appropriate safeguards against exposure risks. Sincerly, Scott K. Swanson, MD, FACS President, American Urological Association Scott B. Sellinger, MD, FACS President, American Association of Clinical Urologists Andrea Maddox-Smith CEO, Bladder Cancer Advocacy Network Richard G. Harris, MD President, LUGPA Michael S. Cookson, MD, MMHC, FACS President, Society of Urologic Oncology Harris M. Nagler, MD, FACS President, Urology Care Foundation

Frequently Asked Questions

We understand your patients may have questions regarding the BCG shortage. The following FAQs may help in answering these patient questions. Feel free to download and share these with your patients.
AUA BCG Shortage FAQs [pdf]

Q:  What is BCG?

A.   Bacille Calmette-Guérin (BCG) is an immunotherapy drug used to treat early-stage bladder cancer. BCG is placed in the bladder through a catheter and triggers the body’s immune system to stop or slow the growth of cancer cells. BCG is approved by the U.S. Food and Drug Administration (FDA) to treat patients in the United States. BCG is also used to treat bladder cancer patients in many other countries around the world.

Q:  Why is there a shortage of BCG?

A.   Merck & Co., Inc. is the sole maker and supplier of BCG to the United States. They are also the only source of BCG to many other countries around the world.

Although Merck has boosted its production of BCG by more than 100 percent and is producing the drug to the fullest extent of their manufacturing capacity, they are not able to sustain the increasing global demand of this product. This has led to supply constraints and a BCG shortage.

Q:  How long will the shortage last?

A.   Due to the increasing demand for BCG treatment in many countries, including the United States, Merck anticipates this shortage to continue throughout 2020.

Q:  Why can't Merck make more BCG?

A.   While Merck has many years of experience producing BCG, this medicine has a lengthy and complex manufacturing process. Merck continues to produce BCG at full capacity, but the demand for the drug is greater than what can be produced. Merck understands this is a challenge for patients and is working hard to improve production so they are able to get this medicine to patients as quickly as possible. On October 4, 2020, Merck announced plans to construct a new TICE BCG manufacturing facility in the United States. Merck expects to break ground in 2021 and anticipates the build to take up to six years to complete. Once fully operational, the company expects to triple its current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the forseeable future.

Q  Can I get BCG somewhere else?

A.   Merck is the sole maker and supplier of BCG to the United States. While the FDA is exploring opportunities to approve additional strains and supplies of BCG, Merck is still the only approved supplier at this time.

There are companies in Japan, Canada, and Europe working to develop their own strains of BCG. If the FDA ultimately approves them, they might be able to alleviate future shortages of the drug.

Q:  How is Merck determining how much BCG each country will receive during this shortage?

A.   For the existing quantity of the medicine, and as more of it becomes available, Merck will be allocating the quantity of available supply across countries based on historical demand.

Q:  How is Merck determining how much BCG each physician office in the United States will receive during this shortage?

A.   As the sole supplier of BCG to the United States, Merck is allocating the quantity of available supply across states based on historical demand.

To minimize disruption to patient care, in January, Merck announced an immediate change to their BCG distribution model, and began allocating BCG exclusively to wholesalers and distributors based on product supply and historical purchasing patterns of physicians and hospitals. Wholesalers and distributors in turn, began utilizing the same allocation model to fulfill physician and hospital orders directly.

Q:  Who can I call with more questions about the BCG shortage?

A.   We understand this situation may be stressful to those who rely on this drug, and we are sorry. Please understand that we are working with suppliers in order to provide the best possible care for our patients. We encourage you to talk to your provider about alternative treatment options to BCG while this shortage continues.

For further information about BCG, please feel free to reach out to Merck’s National Service Center at 1-800-444-2080.

BCG Phone Script for Member Offices (60 seconds)

May also be posted as a message on Member websites

Bacillus Calmette-Guérin, otherwise known as BCG, is a standard treatment option for non-muscle invasive bladder cancer.

Merck & Company is the only maker and supplier of BCG to the United States. They have informed us there is a global shortage of this product and they expect the shortage to continue through the end of 2020.

We understand this situation may be stressful to those who rely on this drug, and we are sorry. Please understand that we are working with suppliers in order to provide the best possible care for our patients. We encourage you to talk to your provider about alternative treatment options to BCG while this shortage continues. We will continue to keep you updated as more news becomes available.

Several national organizations, including the American Urological Association, are staying in close contact with the U.S. Food and Drug Administration who is working to identify and approve other sources of BCG.

For further information about BCG, please feel free to reach out to Merck’s National Service Center at 1-800-444-2080.