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Ensuring access to injectable generic drugs--The case of intravesical BCG for bladder cancer

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A shortage of the bladder cancer drug bacille Calmette–Guérin (BCG) in 2014 and 2015 led to steep increases for mitomycin, the primary alternative to BCG for high-grade bladder cancer, according to new research.

A shortage of the bladder cancer drug bacille Calmette–Guérin (BCG) in 2014 and 2015 led to steep increases for mitomycin, the primary alternative to BCG for high-grade bladder cancer, according to new research. Following reports of BCG supply disruptions in August 2014, the average wholesale price (AWP) for mitomycin increased on August 26, 2014, from $436.80 to $869.59 for the 40-mg dose and from $67.20 to $165.60 for the 5-mg dose. While actual drug costs may differ from the AWP, the researchers note that Medicare data indicate these price increases were passed on to patients. From 2012 to 2015, annual Medicare Part B spending on mitomycin rose from $4.3 million to $15.8 million. In addition, out-of-pocket costs for the drug (substituted for BCG) for a patient covered by Medicare would have increased from about $49 annually to $155 during that period. The researchers call for more to be done to prevent drug shortages, particularly for generic injectable drugs, which often have few suppliers. They suggest that companies that maintain high-quality production capacity could be rewarded with priority review of future generic-drug applications, and that FDA could exercise its discretion to allow importation of BCG made outside the United States. Payment reforms could also help stabilize the market for generic injectable drugs, they note. "The experience with BCG highlights the vulnerability of the U.S. drug supply and suggests that disruptions in the production of an important generic drug can have a cascading effect, including price increases and shortages of alternative chemotherapeutic agents. Drug shortages and drug prices remain urgent public health crises in need of resolution," conclude the authors.

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http://www.nejm.org/doi/full/10.1056/NEJMp1615697

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