BCG Shortage is even worse today Bladder Cancer Drug Shortages and Price Gouging: The New Reality
Oct 2014 Forbes
The Presentation
Tom quit smoking as his second marriage started. The booze stopped as well. In his inimitable Yinzerbrogue he assured me he was “totally clean and n’at”. The light banter stopped when his wife interjected about seeing blood all over the toilet yesterday. Tom was in denial. His wife knew the score. Both started crying.
It didn’t take long to diagnose an aggressive bladder cancer in Tom. After a trip to the operating room to remove his bladder tumor we sat down to talk about the therapy he needed. For his disease I recommended a 30 year old drug called BCG that is directly instilled into his bladder through a catheter. But we had a problem. BCG was not available. Instead we would have to use a less effective and more expensive chemotherapeutic agent called mitomycin c. This agent has a lower response rate for his disease (or put another way – the chance of his bladder cancer recurring would be higher).
BCG Shortage Hits
Merck– the sole producer of BCG since Sanofi stopped production when the FDA found mold growing at its facilities in July 2012 – was in the throes of another production collapse. The wife looked at me blankly as if I was Merck’s agent. Tom was stoic and resigned. This was not the first time Merck had failed in its production of BCG for my patients. An elderly patient of mine 2 years ago – written about in my local paper – had been denied BCG treatments.
My exact prescient quote 2 years ago in the Pittsburgh Post-Gazette was “I have no confidence that we’re good in the long term”. It feels awful being right. 2 years later and Merck – now with a monopoly on BCG production – has failed miserably, tragically, and consistently.
Listen to Merck’s founder in this publicly available code of conduct file “We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been”.
But the people can not get the drug.
Drug shortages have been a subject long explored by academics, local papers, the FDA, and investigative journalists. In fact on July 9, 2012 new legislation addressing drug shortages became law. The “The Food and Drug Administration Safety and Innovation Act” (FDASIA) (Public Law 112-144) specifically called for pharmaceuticals to report to the FDA every 6 months prior to any anticipated shortages (posted to websites). The legislation also creates a user fee program that attempts to speed FDA approval of generic drugs. A subsequent Government Accountability Office report shows some decrease in new drug shortages but overall ongoing shortages have increased.
I spoke with a physician, Dr. Joe Eid , who is Head of Global Medical Affairs for Merck Oncology. Dr. Eid tried to explain Merck’s production problem by saying “there is no specific problem we can pinpoint”. He did say that batch production of the BCG drug was challenging. Batches of BCG take 3 months to mature and there is no way to tell if the production is bad during that time. He also added that Merck (or rather its legacy subsidiary from the Schering Plough merger) had increased it’s production by 100% since the Sanofi disaster. No doubt true but obviously inadequate.
The doctor was not aware that other strains of BCG appear to be more effective than Merck’s BCG strain. Here is some of the data from a recent paper in European Urology article. The more effective strain – called Connaught – is the one Sanofi is failing to make since the mold debacle.
Mitomycin C Drug Price Set to Skyrocket
The backup drug for BCG is called Mitomycin C. This drug is primarily made by two companies: a generic company called Accord Healthcare and Bedford labs a subsidiary of Boehringer. The emerging wholesale drug data is profoundly dispiriting. The average wholesale price (AWP) has risen sharply to over $800 per treatment from a historically stable price of around $350 price per treatment. This is being driven by a new price point set by Accord Healthcare’s new wholesale acquisition cost (WAC) of $724 dollars. Using a database of historical prices over the past 3 years, 40mg of mitomycin c has increased over a 100% over the past year. This price increase is in concert with the BCG shortage. Another illustration of increasing mitomycin C drug costs can be seen in the Boehringer data that I acquired from a national database. The AWP for mitomycin c from 2000 to 2013 ranged from $312 to $391. The last reported AWP was $535 on 9/2/14. Again, I can not find any reason – other than the ongoing BCG shortage – to justify the increase.
Conclusion
Clearly the market for bladder cancer therapeutics is suffering a crisis of consistency and reliability. The new FDA legislation initially touted as preventing this problem has had no effect. BCG is being made in a stuttering and unreliable pace while mitomycin c is being marked up for no obvious reason. I ended my conversation with Merck with a request to visit the factory in North Carolina that has been so sadly inconsistent over the years. Perhaps with a visit I can be convinced that Merck really just has a production problem and not an incentive problem – it will take some convincing. Does anybody think Keytruda will be on the drug shortage list?
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BCG Current update
BCG Vaccine Live Intravesical
[02 October 2015]
Products Affected - Description
TheraCys Intravesical Injection, Sanofi Pasteur
81 mg, vial, 1 count (NDC 49281-0880-03)
Reason for the Shortage
Sanofi Pasteur states the reason for the shortage is manufacturing delay.1
Merck states the reason for the shortage was manufacturing delay.2
Merck states Tice BCG vaccine percutaneous for tuberculosis (Merck, NDC 00052-0603-02) is also affected because this product is manufactured at the same facility.2
- See more at: https://www.ashp.org/menu/DrugShortages/CurrentShortages/bulletin.aspx?id=915#sthash.DAHgbyQE.dpuf