Facing global shortage, Merck commits to meeting patient demand for crucial treatment option
We know how important it is to get medicines to the people who need them and providing those medicines is at the center of what we do
January 19, 2023
In 2012, Merck unexpectedly became the sole manufacturer of TICE® BCG BCG LIVE (for intravesical use). In many countries around the world, increasing global demand has outpaced our current maximum manufacturing capabilities. In recognition of the medical need for this product, Merck continues to operate at maximum production capacity. Due to the increasing global demand, Merck has been experiencing a supply shortage for TICE BCG.
In October 2020, we announced our plans to construct a new manufacturing facility in Durham, North Carolina, to significantly expand our production capacity for TICE BCG BCG LIVE. This investment reaffirms Merck’s longstanding commitment to producing this medicine, and all our medicines, for patients who need them.
If patients have questions regarding TICE BCG, they should speak with their physicians. Additional information related to the shortage, current allocation practices, and Merck’s efforts to increase supply, including construction of a new manufacturing site, is below.
FAQs: Supply & availability of TICE BCG
What is the cause of the shortages and backorders for TICE BCG?
Since 2012, when Merck unexpectedly became the sole manufacturer of TICE BCG in many countries around the world, increasing global demand has outpaced our current maximum manufacturing capabilities. While the company has many years of experience producing TICE BCG, this medicine has a lengthy and inherently complex manufacturing process.
Between 2012 and 2019, Merck increased production of TICE BCG by more than 200%. Merck’s maximum capacity at our current facility for global supply is between 600,000 to 870,000 vials of TICE BCG annually. Merck has been producing TICE BCG to the full extent of manufacturing capacity over the past several years. In recognition of the medical need for this product, Merck continues to operate at maximum production capacity.
Can you provide an update on the new facility?
In October 2020, Merck announced it will construct a new manufacturing facility to significantly expand its production capacity of TICE BCG. In that original announcement, we stated that construction of the new manufacturing facility may take approximately 5 to 6 years. Construction is well underway, and we believe that, barring any unforeseen circumstances, including pandemic-related supply chain and other issues, the new facility is on track to the previously announced timeline and will be completed in 3 to 4 years (late 2025 to late 2026), which includes time for all necessary regulatory approvals.
When construction is complete, and following regulatory reviews and approvals, supplies of TICE BCG will gradually increase over time. Once this new facility is fully operational, we expect to triple our current manufacturing capacity of TICE BCG. We anticipate that this will meet the needs of physicians and their patients for the foreseeable future. The investment in this new manufacturing facility reaffirms Merck’s longstanding commitment to producing this medicine for patients.
Can you please describe how the allocation process works?
In the U.S., Merck has been supplying TICE BCG consistently to our network of distributors and wholesalers since allocation began in 2019. Merck allocates available supply among its network of wholesalers and distributors based on historical purchasing. In turn, the wholesalers and distributors allocate their inventory of TICE BCG to their own customers, with guidance from Merck that the allocation should be based on each customer’s historical purchasing patterns. Merck does not directly determine the amount of supply to individual hospitals, hospital pharmacies or medical practices, and these customers cannot order product directly from Merck. This allocation process is designed to proportionally allocate TICE BCG to minimize disruption to patient care as much as possible.
Where can I find out more information about the availability of TICE BCG?
Patients:
Patients should reach out to their physician, as they are in the best position to answer questions about the availability of the medicine in their practice, and can inquire about the quantity and timing of product availability with their supplier.
Health care professionals:
Health care professionals with questions regarding allocation should contact their wholesaler or distributor.
