Short Term BCG Shortage in North America

[Jack Moon]

August 25, 2014
IMPORTANT BACKORDER INFORMATION
SUBJECT: Backorder of OncoTICE® (Bacillus Calmette-Guérin (BCG), Strain TICE®)
We want to inform you of the backorder of OncoTICE®.
• Merck is investigating a manufacturing issue at its Organon Teknika facility in Durham, NC related to the production of OncoTICE®.
• Pending an outcome of our investigation, product is not being released from the facility and back orders are expected to occur in Canada as inventory is depleted.
• The extent of the back order will be determined by the outcome of our investigation. Product may be available by the end of October 2014.
• All product currently on the market is unaffected and has met all quality and release tests.
• Merck has been working to increase supply of this important medicine and is committed to resolving the issue as quickly as possible.
OncoTICE® is indicated for treatment of primary or relapsing flat urothelial cell carcinoma in situ (CIS) of the urinary bladder, and as a adjuvant therapy after TUR of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage TA (grade 2 or 3) or T1 (grade 1, 2, or 3). It is only recommended for stage TA grade 1 papillary tumors, when there is judged to be a high risk of tumor recurrence.
OncoTICE® is not indicated for the treatment of invasive bladder cancer. It is not recommended for papillary tumors of stages higher than T1.
Sincerely yours,
Merck Canada Inc.
® Registered trademark of Merck Sharp & Dohme B.V. Used under license.

[Rick B]

Thanks for the heads up. This appears to a be Merck Canada Inc press release. Does BCC have access to more details on the cause, implications and when supply is expected back to normal in Canada.

Is there a concern, and to what extent, for people expecting BCG treatments over the near term?

[Jack Moon]

Hi Rick
The only information we have is the above letter from Merck Canada. The concern seems to be short term, and they are hoping to have the issue resolved in October. I will keep everyone posted as we receive further information. Yes there is a concern for patients expecting treatments over the near term. I recommend all patients scheduled for BCG treatments in the near future to contact their Uro and ask about supply available at the hospital where they receive their treatments.
Jack

[Rick B]

Met with my Uro today for a 3 month cysto which was “all clear” thank goodness. We chatted about the BCG shortage. He broached the subject saying they are down to just a few treatments left which are reserved for high priority cases. All Ta & T1 tumors are excluded.

We’ve seen suggested approaches such as reducing the dosage to 1/3 to achieve greater patient coverage but I wonder if that is common through the medical service providers or does each location have their own managment approach. Not a question to answer…I’m just saying.

We discussed the issue of having one location in North America that manufactures the product which in itself is problematic. Every product user knows that having one supplier is immediate cause for concern…what happens when the supplier cannot deliver which apparently is the case with Merck.

Not sure how this is addressed at the leadership level within BCC but is there any movement to put this on the agenda in the future…i.e. how can we plan for temporary interruption in supply…maybe we stock 5-10% over useage rate.

As we all have discussions with Urologists, Hospital Admin. from time to time, it might be a topic to get feedback on. There is no better way to get to alternative solutions than by asking those in the trenchs…in this case, the end administers.

Rick

[Greg]

Rick:
BCC has taken this up with the BCC medical advisory board and they have been very pro-active at not only getting the word out, but in dialoguing with specialists in many centres across the country. The UAC is also moving forward and our BCC chairman David Guttman has been front and centre on this with various levels of medical and political people. It’s a big deal and I am sure with the all interested parties collaborating on this an answer will be forthcoming for the future. Your concern is well placed and it’s good you were able to have such a good discussion with your own uro. Thanks from all of us.

[Rick B]

Thank you Jack.

I figured this would be front and centre at BCC and I am sure I speak for all when I say we truly appreciate what’s being done by all parties to press for an early resolution to the BCG shortage. It’s scary to think in this day and age, especially in North America, that we would not have sufficient medical supply to treat a treatable cancer.

Thank you again…hats off to you and your colleagues for the great work you do…and all on a voluntary basis.

Rick

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