Tampa, FL [February 21st, 2023]– Angels for Change announced the release of white paper, "Implications of the National BCG Shortage", 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 incorporates hospital survey results illustrating the degree of patient impact; all respondents reported having to use at least one less alternate therapy in patient care because they were unable to obtain BCG and some reported receiving no BCG for any patients.
The white paper was initiated through a patient who contacted Angels for Change, the only patient advocacy organization for patients facing drug shortages. Angels for Change collaborated with the End Drug Shortages Alliance (EDSA) and Vizient, a healthcare performance improvement company that works with health systems across the country. Both are members of EDSA.
“This collaboration showcases the power of patient advocacy. Patients must have a place to go to gain information and request support. We are proud to advocate on behalf of patients and hospitals faced with a drug shortage crisis and thankful that through our champions in the supply chain we can work together to end these crises.” said Laura Bray, Chief Change Maker, Angels for Change.
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 in 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.
“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”, said Eric Tichy, PharmD, MBA, FCCP, division chair, pharmacy supply solutions for Mayo Clinic and EDSA chairperson.
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.
Angels for Change calls on pharmaceutical manufacturers to investigate increased manufacturing of BCG to end the shortage and ensure delivery of care and access of medicines to all patients facing bladder cancer.
Read our work shared on CNN here.
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About Angels for Change
Angels for Change is a volunteer supported, global, 501c3 organization started in Tampa, FL on a mission to end drug shortages through advocacy, awareness, and a resilient supply chain. Founder, Laura Bray, was driven to start Angels for Change after her own child faced 3 life-saving drug shortages in 9 months of pediatric cancer treatment. Each day Angels for Change advocates on behalf of any patient in a life-saving drug shortage, while building relationships with patients and members of the pharmaceutical supply chain to end all healthcare crises created by drug shortages. www.angelsforchange.org
About Vizient, Inc.
Vizient, Inc., the nation’s largest health care performance improvement company, serves more than 60% of the nation’s acute care providers, which includes 97% of the nation’s academic medical centers, and more than 20% of ambulatory care providers. Vizient provides expertise, analytics and advisory services, as well as a contract portfolio that represents more than $130 billion in annual purchasing volume. Vizient’s solutions and services improve the delivery of high-value care by aligning cost, quality and market performance. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com
About the End Drug Shortages Alliance
The End Drug Shortages Alliance is a collaboration of healthcare 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.