End Drug Shortages Alliance Finds Care for Bladder Cancer Patients Impacted by Drug Shortage

The End Drug Shortages Alliance (EDSA) today released a white paper that describes the ongoing gap in supply and anticipated future demand of Bacillus Calmette-Guerin (BCG), an essential oncology medication used to treat patients with bladder cancer. The paper also incorporates hospital survey results illustrating the degree of patient impact by highlighting procurement challenges, including that all respondents reported having to use at least one less optimal alternate therapy in patient care because they were unable to obtain BCG. The paper can be downloaded here.

The white paper was initiated through a patient who contacted patient advocacy organization Angels for Change, which collaborated with Vizient, a healthcare performance improvement company that works with heath systems across the country. Both are members of EDSA.

Approximately 82,000 cases of bladder cancer are diagnosed in the U.S. every year, with approximately 17,000 deaths. The white paper reports that BCG has only one supplier globally and has been on shortage since 2019. Based on pre-shortage BCG sales data and the estimated growth rate of bladder cancer, the report finds that the current market is only producing 69% of the estimated BCG needed in the U.S. As the incidence of bladder cancer increases, the estimated annual growth rate for BCG utilization is anticipated to be 2.58% for the U.S. market through 2028.

The report’s projection model estimates this growth rate could result in a supply gap of greater than 150,000 vials annually. Under current treatment protocols, approximately 18 vials of BCG per patient may be utilized for full treatment and maintenance. Due to the current supply challenge, the paper estimates potentially 8,333 patients are currently not able to receive optimal care on an annual basis.

“The standard of care for bladder cancer patients is being compromised,” said Eric Tichy, PharmD, MBA, FCCP, division chair, pharmacy supply solutions for Mayo Clinic and EDSA chairperson. “Until additional suppliers enter the market, the shortage will continue to disrupt our ability to provide this potentially life-saving therapy for patients with bladder cancer.”

For this paper, Vizient conducted a survey of 20 academic medical centers, reflecting about 4,000 patients with new diagnoses of non-muscle invasive bladder cancer (NMIBC). The results highlight the implications of the shortage on patient care. Among other findings, all respondents reported having to provide at least one alternate therapy option to patients, and 20% reported not being able to provide any BCG to patients who were eligible for therapy.

Respondents reported employing the following less optimal treatment strategies based on the shortage:

• Switched to other agent such as gemcitabine, docetaxel or mitomycin
• Dose reduction
• Initiation therapy only
• Sterile splitting of vial and optimizing schedule for patients on the same day

Additionally, nearly 80% of respondents reported their institution does not have a drug mitigation protocol for the BCG shortage. The report lists strategies for healthcare organizations to use from the American Society of Health-System Pharmacists and National Comprehensive Cancer Network as well as from the American Urological Association, which includes:

• BCG should not be used for patients with low-risk disease.
• Intravesical chemotherapy should be used as the first-line option for patients with intermediate-risk NMIBC.
• If BCG would be administered as second-line therapy for patients with intermediate-risk NMIBC, an alternative intravesical chemotherapy should be used rather than BCG in the setting of this BCG shortage.

“If an organization doesn’t have an established drug mitigation strategy for BCG shortages, it could potentially lead to a faster decline in stock due to a lack of conservation and consistent practices in utilization. Both are key to optimizing supply and patient care during a disruption,” Tichy said.

The End Drug Shortages Alliance calls on pharmaceutical manufacturers to investigate increased manufacturing of BCG to end the shortage and ensure delivery of care to all bladder cancer patients.

About End Drug Shortages Alliance

The End Drug Shortages Alliance is a collaboration of health care industry stakeholders, including providers, group purchasing organizations, manufacturers, distributors and other industry thought leaders dedicated to solving the pharmaceutical supply challenges that disrupt access to essential medications in the U.S. We prioritize initiatives focused on transparency, quality, redundancy and production of additional supply to achieve undisrupted access to essential medications for health care providers and patients.

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