Cancer Policy Monitor: December 13, 2022
- Appropriations Update
- AACR Hosts Workshops to Discuss FDA Guidance on Diversity in Clinical Trials with Industry Leaders
- Californians Vote to Ban Nearly All Flavored Tobacco Products
- AACR Virtual Patient Advocate Forums in 2022
- Apply Today for The AACR 2023 Annual Meeting Scientist↔Survivor Program
- DEADLINE EXTENDED: Patient Advocate Abstracts at AACR Annual Meeting Due
- Biden Administration Announces Extension of Public Health Emergency, Providing Benefits for Patients with Cancer
-Marc B. Johnson, MPP
House and Senate Appropriations Committee leaders are in negotiations to finalize a bipartisan agreement on top-line spending and program levels for Fiscal Year (FY) 2023. The federal government is currently operating under a continuing resolution (CR) which funds the government through December 16 at current funding levels. As negotiations are ongoing, it is possible Congress will need to pass another short-term CR to provide time to complete the enactment of the spending bills.
Due to the CR and budget uncertainty, the National Cancer Institute (NCI) has announced lower interim pay lines for issuing grants, including reducing the pay line for R01 grants for established and new investigators from the 11th percentile to the 10th percentile, and reducing grants for early-stage investigators from the 16th percentile to the 15th percentile. In addition, while the federal government is operating under a CR, NCI will pay most noncompeting grants at the 90 percent rate. The AACR continues to advocate for Congress to find agreement on FY 2023 spending bills as soon as possible to increase pay lines and funding levels for NCI.
AACR Hosts Workshops to Discuss FDA Guidance on Diversity in Clinical Trials with Industry Leaders
-Tristen Tellman, PhD
In April 2022, the FDA released draft guidance on diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials. In response to this guidance, the AACR invited leaders from across the oncology therapeutics space to participate in a series of three workshop sessions to share information, including discussing best practices to ensure that diversity plans are effectively integrated into their respective company’s overall clinical development plan. This three-part workshop kicked off with a brief introduction to the guidance by Lola Fashoyin-Aje, MD, MPH, who serves as the program lead for Project Equity, a project that is part of the FDA’s Oncology Center of Excellence (OCE). Participants shared insight into best practices on early integration of diversity plans as new therapies enter the clinical trials space. The three main topics for the workshop series were strategies and challenges for the development of clinical trial recruitment, considerations for operationalizing an effective diversity strategy, and deployment of operational strategies to clinical sites. The AACR is grateful to the industry leaders that participated and looks forward to the publication of a summary article describing the highlights of these meetings to serve as reference material for other members of industry to employ these practices.
Californians Vote to Ban Nearly All Flavored Tobacco Products
-Nicholas Warren, PhD
The science has been clear for decades that flavored tobacco products are the key driver of hooking youth on nicotine. For that reason, the Family Smoking Prevention and Tobacco Control Act prohibited flavors in cigarettes, except menthol, in 2009. While the U.S. Food and Drug Administration (FDA) is currently considering a ban on menthol cigarettes and flavored cigars, this effort could take years to implement. This November, voters in California sent a clear signal that flavored tobacco products should be prohibited by passing Proposition 31, which upheld a California state law that banned flavored tobacco products, such as flavored e-cigarettes, cigars, and menthol cigarettes. Ahead of the crucial vote, the chief executive officers of the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) published an opinion article in STAT news to support the ballot initiative.
The United States has made incredible strides to reduce youth and adult tobacco use since the 1960s. However, progress has been slower among people who use flavored tobacco products, especially with menthol’s effects that increase the addictiveness of nicotine. Additionally, electronic nicotine delivery systems (ENDS), such as e-cigarettes, have addicted a new generation of Americans to nicotine with a wide availability of appealing flavors.
ENDS use grew dramatically in the past ten years, peaking in 2019 among youth. While fewer middle and high school students used these products during the COVID-19 pandemic, they are once again rising in popularity. A new analysis of the 2022 National Youth Tobacco Survey (NYTS) estimated that more than three million high school and middle school students currently use tobacco products, which equates to 16.5 percent of high school students and 4.5 percent of middle school students. This represents nearly a 24 percent increase in tobacco use compared to 2021. ENDS were the most commonly used product, including among 2.1 million high school students, of whom 85 percent used flavored ENDS. Of these, fruit was the most popular flavor. This resurgence of tobacco use is worrisome as tobacco use remains the number one preventable cause of cancer, and the addictive levels of nicotine in ENDS increases the risk of smoking by approximately three-fold.
Flavors increase the appeal of tobacco products by masking the harsh taste of tobacco, altering perceptions of health risks, and in the case of menthol, reducing irritation from smoke. In fact, most youth who use tobacco products do so because they “come in flavors I like.” As detailed in the recent joint AACR-ASCO ENDS policy statement, prohibiting flavored tobacco products is a powerful strategy to decrease the appeal to youth and young adults who are unlikely to otherwise start using tobacco.
In addition, banning flavored tobacco products, menthol in particular, could have a significant impact on reducing cancer disparities. There is a great deal of evidence that the tobacco industry purposefully marketed flavored tobacco products to racial and ethnic minority communities in order to preserve market share as overall smoking rates declined. These predatory practices have resulted in a greater burden of tobacco-related illness, particularly among African American and Native American communities. It is estimated that 41 percent of premature deaths caused by menthol cigarettes between 1980 and 2018 were among African Americans, despite comprising 12 percent of the U.S. population. Importantly, flavor prohibitions could disproportionately improve the health of communities with high rates of flavored tobacco product use.
Proposition 31 serves as a powerful model for other states and the nation to decrease youth initiation of tobacco use and support cessation. The AACR will continue advocating for effective tobacco control policies to improve public health and decrease tobacco-related cancers.
AACR Virtual Patient Advocate Forums in 2022
Patient advocates from across the cancer community join these free virtual events to get the latest information on cancer research, new discoveries, and potential cancer treatments. Speakers include patient advocates, researchers, and clinicians. Watch the recording of the most recent forum, Revolution in Cancer Clinical Trials (conducted on November 29), view other 2022 recordings and stay updated on the upcoming forums of 2023.
Apply Today for The AACR 2023 Annual Meeting Scientist↔Survivor Program
The Annual Meeting Scientist↔Survivor Program® provides participants with the opportunity to attend numerous scientific sessions, present a poster, and network with leading cancer researchers. Participants are accepted through a competitive application process. The next program will be at the AACR Annual Meeting 2023. Applications are due January 11, 2023. Learn more and submit an application.
DEADLINE EXTENDED: Patient Advocate Abstracts at AACR Annual Meeting Due
The American Association for Cancer Research (AACR) invites patient advocates to submit abstracts for poster presentation at the AACR Annual Meeting 2023. Authors must submit abstracts using the AACR Abstract Submission System. The abstract submission deadline has been extended for patient advocates to January 12, 2023. Learn more.
Biden Administration Announces Extension of Public Health Emergency, Providing Benefits for Patients with Cancer
The Biden administration announced November 11 that the COVID-19 public health emergency (PHE) will be extended at least one more time through January 2023. The extension of the PHE ensures that temporary flexibilities on Medicaid coverage and telehealth reimbursement will continue.
The PHE was first declared in January 2020 and has been renewed every 90 days since. The most recent PHE extension came in October, when it was extended to January 11, 2023. The Department of Health and Human Services (HHS) had initially promised to provide 60 days’ notice before ending the PHE, and the November 11 announcement coincided with the 60-day deadline under the current PHE.
According to administration officials, HHS will extend the PHE to ensure the federal government can continue to pay for COVID-19 vaccines, tests, and treatments in anticipation of a possible surge in COVID-19 cases this winter. Administration officials additionally said the extension was necessary to provide stakeholders more time to prepare for a transition out of the PHE.
In the weeks leading up to the November 11 announcement, a growing number of stakeholders had been calling on the administration to extend the PHE at least once more after January 11. They argued that keeping the PHE in place for an additional 90 days would help avert Medicaid coverage disruptions by allowing states more time to prepare for the Medicaid redetermination process. More than 15 percent of new patients with cancer each year are Medicaid enrollees, and most Medicaid programs cover cancer screenings and treatments.
Additionally, stakeholders said that extending the PHE would ensure Medicare telehealth flexibilities continue for longer and give providers more opportunities to prepare for the eventual unwinding of popular Medicare telehealth flexibilities. At least 14 percent of Medicare beneficiaries have a cancer diagnosis, and countless beneficiaries have utilized telehealth for pretreatment visits, nontreatment visits, and follow-up visits since the start of the pandemic.
The AACR is acutely aware of the significant benefits that PHE-related flexibilities have provided for patients with cancer. In the Report on the Impact of COVID-19 on Cancer Research and Patient Care published in February 2022, the AACR urged Congress to expand Medicaid and deliver a permanent extension of Medicare-covered telehealth services.
Once the administration renews the PHE in January 2023, the new expiration date will be April 11, 2023. Any decision to subsequently extend the PHE could likely depend on public attitudes toward COVID-19, the pandemic’s impact on the health care system, and the status of legislation to address eventual termination of Medicare telehealth waivers.