(UroToday.com) The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between January 25th and 27th was host to a session addressing the shortage of drugs for urothelial carcinoma patients and, specifically, why practitioners struggle to get patients what they need and what can we do about this.
Rick Bangs, a bladder cancer patient advocate and Chair Emeritus of the Patient Advocate Committee, discussed the patient advocacy’s role as a catalyst for change during the current drug shortages.
A bladder cancer diagnosis has an immeasurable impact on patients and their families across many domains:
- Increased risk of death and poorer outcomes
- Increased anxiety, stress, and depression
- Logistical burdens related to treatment and follow-up thereafter
- Costs: “Consumers may incur increased costs in the form of higher out-of-pocket costs, higher insurance premiums, and adverse health outcomes as a result of a drug shortage.” – APE Report to Congress: Impact of Drug Shortages on Consumer Costs
Collectively, these are the ‘adverse events’ that are at stake and which advocacy groups and patients work hard to prevent and address. Advocacy groups succeed (or fail) by engaging with multiple stakeholder partners, including:
- Patients
- Clinicians
- Guideline panels
- FDA
- Clinical trialists
- Pharmacology industry
- Advocates
- Other advocacy groups
Mr. Bangs proposed the following ‘blueprint’ for action to empower advocacy groups, emphasizing the following four domains:
- Educate: Educate patients on existence and expected durations of shortage and how to best navigate, through actions and questions
- Convene: Convene and/or mobilize stakeholder partners to determine how best to handle and how to communicate
- Motivate: Motivate new and existing suppliers to:
- Expand supply
- Prevent dominoes (one drug shortage leading to another)
- Within existing clinical trials, work to ensure that supplies of standard of care agents in the control arm are protected, proactively address eligibility revisions, and seek alternatives to existing agents (e.g., SWOG S1602 comparing the Japanese BCG strain to TICE strain and examining the potential of immune priming)
- Partner: Partner with other impact advocacy groups across other disease sites that may have similar experiences and use overlapping systemic agents (“coalition”)
How has the Bladder Cancer Advocacy Network (BCAN) along with other groups applied this blueprint to address the recent BCG and platinum shortages? First, in conjunction with multiple organizations such as the AUA and SUO, the groups released a joint statement on BCG shortage that unified these organizations on this front.
Next, BCAN created web pages or central “hubs”, where information on the BCG and platinum shortages were readily available to patients. This hub provided links to educational information from other organizations, as well as giving patients access to BCAN’s own created content.
Webinars and podcasts were created in collaboration with many experts, giving patients advice on how to navigate these shortages.
Advocacy groups can also play a large role in government lobbying. Federal agencies are limited without Congressional directives in many cases. Recent legislation was presented that attempted to accomplish two tasks:
- Build protections against shortages
- Ease import restrictions during shortages
Advocacy groups have also engaged with guidelines stakeholders to adjust recommendations in light of drug availabilities and shortages that may arise. This has significant economic implications as payers rely on guidelines’ recommendations when making reimbursement and insurance coverage decisions.
He acknowledged the role ASCO has played during the drug shortages, whereby ASCO has established a Drug Shortages Advisory Group. Guidance from this advisory group can be found on ASCO’s website and includes clinical guidance and drug availability updates.
He concluded with the following:
- Advocates, advocacy groups, and their partners should know and use their power to prevent and navigate drug shortages by leveraging this proposed or another blueprint
- Strong partnerships (clinicians, FDA, pharma, guideline panels) are needed
- Guideline panels should proactively reflect drug shortages to align clinicians, payers, and patients
- Nimble and effective cross-advocacy group collaboratives will be needed in many cases
Presented by: Rick Bangs, PMP, MBA, Cancer Research Advocacy Leadership, SWOG Cancer Research Network, Pittsford, NY
Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, San Francisco, CA, January 25th – January 27th, 2024