BCAN and our Scientific Advisory Board have been advised by Merck & Co., Inc. that they anticipate a limited supply of Bacillus Calmette-Guerin (BCG) in the in the next year.
Due to increasing global demand for BCG treatment and as the only source of TICE BCG in many countries, Merck anticipates supply constraints beginning in the first quarter of 2019. Merck increased production of TICE BCG by more than 100 percent to enable it to be produced at the full extent of their manufacturing capacity. However, even with the increased production, an increasing global demand is leading to supply constraints. To minimize disruption to patient care, Merck will be proportionally allocating the medicine across countries, including the United States. This Merck allocation approach will enable TICE BCG availability in a manner that considers the needs of patients based on historical demand in each country.
BCAN’s Scientific Advisory Board is aware of this issue. If you have concerns about your BCG treatments, please speak with your physician. BCAN is continuing to monitor this and will update you as more information becomes available.
2/4/2019 Update from Merck:
Merck has moved into global allocation process for TICE BCG to enable proportional access to the medicine in all countries were we are the sole or primary supplier, including in the U.S. In the U.S., the medicine is being distributed to wholesalers on an allocated basis, and wholesalers are distributing on the same allocated basis to our customers or the oncologist or practice. Merck customers have all been notified of this new model and this is the only way the medicine can be distributed. TICE BCG is generally not purchased by or available through retail pharmacies.
As Merck receives questions from patients about this medicine, we are providing them with this information and directing them to speak with their physician. The prescribing physician would be in the best position to advise the patient about availability of the medicine and treatment. Clinics and providers should contact their supplier directly for current information on allocated quantities and timing of availability.
Learn more about how BCG is used to treat bladder cancer here.
BCAN Scientific Advisory Board member, Dr. Ashish Kamat from MD Anderson Cancer Center shared articles he wrote from the last BCG shortage in 2014-15. The content of those articles is still relevant in today’s shortage. Click the links below to read those articles.