Cancer Policy Monitor: November 10, 2020
- Appropriations Update from Capitol Hill
- Supreme Court to Decide the Fate of the Patient Protection and Affordable Care Act
- Common Health Disparities Increase Risk for Both COVID-19 and Cancer
- New Study Shows HPV Vaccines Prevent Cervical Cancer
- Es Tiempo: Bringing Culturally Sensitive Cervical Cancer Awareness to Southern California
- Recording Now Available for the AACR Virtual Patient Advocate Forum: COVID-19 and Cancer
- Apply Today for the AACR 2021 Annual Meeting Scientist↔Survivor Program
- Oncology Approval Recap
Appropriations Update from Capitol Hill
-Marc Johnson, MPP
As a second wave of diagnosed cases of COVID-19 reached their highest rates since the summer and deaths due to COVID-19 have reached over 225,000 in the United States, negotiations between House Democrats, Senate Republicans, and the White House regarding COVID-19 emergency supplemental legislation and Fiscal Year 2021 (“FY 21”) appropriations, are in a state of paralysis.
Since the passage of the updated, $2.2. trillion HEROES Act on October 1, negotiations between House Democrats and the White House have been promising, although an agreement has not been reached. In a recent interview, Speaker Nancy Pelosi expressed hope that an agreement on coronavirus relief can be reached. “I’m optimistic. We put pen to paper and have been writing the bill based on what we hope will be the outcome of what they said they would get back to us on.” The White House has continued to push for a relief package ranging from $1.6 trillion to $1.9 trillion. Both offers are significantly higher than the $500 billion that Senate Republicans are putting forth. Senate Majority Leader Mitch McConnell and Senate Republicans are steadfast in their opposition to the House Democratic passed bill and are not enthusiastic about the White House counteroffer. Without an agreement, the chances of a relief package coming to fruition soon is nil. Speaker Pelosi has instructed members that she will recall the House for a vote if a deal is reached before the end of the calendar year.
The government is continuing to operate under a Continuing Resolution (“CR”) until December 11, as the status of FY 21 appropriations is uncertain. Although there is a chance that FY 21 appropriations can be finalized before the end of the calendar year, it is more likely that another CR will be passed, and finalization on FY 21 appropriations will not occur until the 117th Congress convenes in early-January 2021.
Supreme Court to Decide the Fate of the Patient Protection and Affordable Care Act
– Tod Guidry, PhD
On November 10, 2020, the Supreme Court hears oral arguments in the case of California v. Texas to determine the fate of the Patient Protection and Affordable Care Act (ACA). Signed into law in 2010, the ACA has improved access to and affordability of health care for cancer patients across the nation. Should the ACA ultimately be overturned, a replacement must be made that maintains the original law’s benefits for Americans affected by cancer.
The new case’s roots stretch back to 2012, when the Supreme Court ruled on the constitutionality of the law’s minimal essential coverage provision, better known as the individual mandate. In National Federation of Independent Business v. Sebelius, plaintiffs argued that the provision, which imposes a penalty paid to the Internal Revenue Service for failure to acquire minimum health insurance coverage, exceeded Congress’ authority to regulate interstate commerce. The court ruled that the individual mandate was constitutional, falling under Congress’ power to levy taxes.
President Trump’s signing of the Tax Cuts and Jobs Act in 2017, which included a provision setting the ACA individual mandate’s tax penalty at $0.00, has brought the ACA back into the courts. Eighteen states and two individuals argue that, because the individual mandate no longer provides revenue, it no longer falls under Congress’ power to tax and is, therefore, unconstitutional. If the Supreme Court decides that the individual mandate is now, indeed, unconstitutional, it will then determine whether the provision is severable from the rest of the law. If not, the entire ACA may be struck down. A final decision is expected by the summer of 2021.
The ACA has made major improvements to health care coverage and delivery for Americans affected by cancer. The law’s provision prohibiting denial of health insurance coverage based on pre-existing conditions has provided many of the millions of American cancer survivors access to coverage under individual market plans. The ACA provides a clear benefit to young cancer patients and survivors by allowing Americans under the age of 26 to remain under their parents’ insurance policies. In addition to improving coverage, the law prohibits limits on annual or lifetime benefits. Such caps would pose a particular hurdle for cancer patients, given the high costs of breakthrough cancer treatments like immunotherapy. The law also eliminates extra out-of-pocket costs for cancer screenings for patients with most types of insurance.
The ACA also gives states the option to expand eligibility for Medicaid, a critical source of affordable health care for low-income Americans. Over two million Americans under the age of 65 with a history of cancer depend on Medicaid to cover costs of their medical care. Medicaid expansion plus subsidized marketplace coverage under the ACA are responsible for cutting the uninsured rate for cancer survivors nearly in half. States that have expanded Medicaid show increased cancer screening rates compared to those that have not, and beneficiaries of the Medicaid expansion have experienced improved access to tobacco cessation services.
The ACA also improves oncology clinical trial participation by requiring coverage of costs of routine care (e.g., office visits, laboratory work, imaging) for privately insured patients enrolled in approved clinical trials. A study published in Clinical Cancer Research demonstrated a 10 percent increase in the approval rates of privately insured patients seeking enrollment in oncology clinical trials, as well as fewer delays in clearance for participation, at a major cancer center after enactment of the ACA.
The ACA has had a tremendous impact on the lives of Americans affected by cancer through provisions that: expand access to health insurance; mandate coverage of prevention, treatment, and survivorship services; control medical costs, and; facilitate clinical trial participation. Losing these provisions through an overturning of the law would have a clearly detrimental impact on cancer patients and survivors across the country. If the ACA is ultimately ruled unconstitutional, any replacement must include the original law’s vital benefits for Americans affected by cancer.
Common Health Disparities Increase Risk for Both COVID-19 and Cancer
– Tod Guidry, PhD
The COVID-19 pandemic has had a disproportionate impact on racial/ethnic communities already bearing an unequal share of the national cancer burden. The same systemic racial/ethnic inequities resulting in poorer cancer outcomes among minority populations have served to increase these populations’ risk of COVID-19 incidence, severity, and mortality. An article published in Clinical Cancer Research explores the shared root causes for disparities in COVID-19 and cancer outcomes. The authors also discuss the compounding impact of the pandemic on cancer health disparities, and the steps that need to be taken to minimize the disproportionate impact of both diseases on the health of minority populations.
Over half of the COVID-19 cases in the United States occur in African American and Latinx populations, which collectively make up only 30 percent of the population. The COVID-19 mortality rate is 50 percent higher among Latinx and Native American populations, and well over twice as high among African Americans, compared to Whites. The rate of severe COVID-19 disease requiring hospitalization is twice as high among African Americans compared to White Americans. Factors contributing to the disparate impact of COVID-19 on minority populations include: disproportionate representation among essential workers; concentration in areas with high residential housing densities, and; frequent use of public transportation.
On top of these risk factors unique to an infectious disease, the disparate effect of COVID-19 on minority populations is also a result of longstanding disadvantages that have similarly predisposed them to poorer cancer outcomes. The authors highlight the two-fold-higher poverty rate among African Americans compared to Whites and its link to impaired access to quality health care. African Americans make up a high proportion of the patient populations of safety net hospitals, due to barriers regarding household income and health insurance coverage. These public hospitals often cannot meet the financial requirements to conduct clinical trials, which are critical to improving treatment options for diseases and in which African Americans have historically been underrepresented. Furthermore, participation of African Americans in clinical research, and in medical care overall, is hampered by mistrust stemming from a long history of exploitation and exclusion, under-representation of African Americans in the physician workforce, and inequities in medical treatment delivery and health education. Housing disadvantages, residence in food deserts, and lack of access to recreational park spaces also leave African Americans with weak access to proper nutrition and exercise. The convergence of disadvantages experienced both within and beyond the health care setting have resulted in the disproportionate development of co-morbidities (e.g., obesity, diabetes) among African Americans. After a long history of contributing to cancer health disparities, these co-morbidities are now increasing the risk of severe COVID-19 disease and mortality as well.
While the disparities seen in outcomes for both COVID-19 and cancer have similar roots, the authors highlight the prospect of the pandemic exacerbating the disproportionate impact of cancer on African Americans. The impact of COVID-19 on the United States economy was more heavily felt by minority populations. Approximately 44 percent of African Americans and 61 percent of Latinx stated that they or a member of their household had lost a job or taken a pay cut due to the pandemic, compared to 38 percent of Whites. Between March and July 2020, African American unemployment was consistently higher than White unemployment, creating a disproportionate impact on loss of employment-based health insurance. An inability to handle the costs of COVID-19 care has brought safety net hospitals to the brink of bankruptcy, creating a devastating impact on health care delivery for their predominantly African American patient populations. The authors also highlight the impending challenges safety net hospitals will face when returning to pre-COVID-19 practices. Covering the COVID-19-induced backlogs of cancer screenings while arranging appointments to maintain social distancing poses a particular challenge.
To mitigate COVID-19 disparities as well as the impact of COVID-19 on downstream cancer care, the authors highlight: the importance of supporting the public hospitals serving medically-underserved communities that were disproportionately impacted by the pandemic; improving access to telehealth services to reach minority populations; aiding patients who have lost their health care coverage, and; leveraging established community engagement networks by cancer clinical trial teams to ensure diverse participation in COVID-19-related clinical trials. The authors also advocate for more long-term efforts to reverse the systemic and structural disadvantages faced by minority populations, including improved access to educational and professional opportunities and enhancing overall access to clinical trials. These efforts are critical to reducing overall disparities among minorities in outcomes for both COVID-19 and cancer.
New Study Shows HPV Vaccines Prevent Cervical Cancer
-Nicholas Warren, PhD
The Human Papilloma Virus (HPV) is very common among adults worldwide. HPV causes cancer in both men and women by disrupting processes that keep cellular growth in check. Worldwide, HPV causes over 500,000 cases of cervical cancer every year, resulting in over 300,000 deaths. Fortunately, several vaccines have been developed to prevent HPV infection and related cancers. Phase III clinical trials found HPV vaccines are effective at preventing infection and reduce incidence of pre-cancerous cervical lesions. Although much progress has been made, until now no large studies have demonstrated that HPV vaccination prevents invasive cervical cancer.
To date, a new study in the New England Journal of Medicine conducted by Lei, et al. is the largest prospective HPV vaccination study conducted. Researchers found significant protection from cervical cancer by following 1.67 million Swedish women and girls from 2006 to 2017 to analyze the effectiveness of HPV vaccination in preventing cervical cancer. Overall, women who received at least one dose of an HPV vaccine were 63 percent less likely to be diagnosed with cervical cancer than unvaccinated women. Furthermore, the authors stratified participants who received the vaccine before and after the age of 17 years; women who were vaccinated before the age of 17 years were 88 percent less likely to be diagnosed with cervical cancer compared to unvaccinated women. Conversely, women who were vaccinated after the age of 17 years were 53 percent less likely to be diagnosed with cervical cancer. This age disparity in effectiveness provides further evidence for public health recommendations that girls and boys be vaccinated against HPV before the age of 17 years.
It is unclear why some vaccinated women in the study were still diagnosed with cervical cancer. One possibility is that the vaccine used in this study only covered 4 strains of HPV and there are more strains of HPV that can cause cancer; this study did not analyze the strain of HPV that caused each cancer. The vaccine could also be only partially effective at preventing infection, particularly if only one dose was administered. Another possibility is that some women already had HPV infections at the time of vaccination and the vaccine is less effective at treating an existing infection. A major limitation of this study is that it only included patients from a single country and did not report race or ethnicity data. The AACR’s recently published Cancer Disparities Progress Report found that racial and ethnic minority women in the United States are more likely to be diagnosed with cervical cancer. Despite these caveats, this study provides strong evidence that HPV vaccination can significantly reduce the burden of HPV-related cancers globally.
Es Tiempo: Bringing Culturally Sensitive Cervical Cancer Awareness to Southern California
-Nicholas Warren, PhD
The Human Papillomavirus (HPV) causes over 35,000 cases of cancer in the United States every year. Additionally, 200,000 U.S. women are diagnosed with HPV-related pre-cervical cancer every year. However, HPV-related cancer disproportionately affects racial and ethnic minorities in the United States; Hispanic women are 50 percent more likely to be diagnosed with cervical cancer than White women. There are also disparities in cervical cancer screening rates, where only 78.6 percent of Hispanic women were up to date on cervical cancer screenings in 2015 compared to 83.7 percent of non-Hispanic White women. This disparity was worse for recent immigrants; only 67.3 percent of women who have lived in the United States for less than 10 years were up to date on screening compared to 84.5 percent of U.S.-born women. There are many intersecting causes that lead to health disparities in underserved Hispanic communities, such as lack of health insurance, proximity of health clinics, distrust of the health care system, and cultural beliefs about sexual health. These issues highlight the need for culturally sensitive outreach about HPV and cervical cancer screening in Hispanic communities.
This October, the American Association for Cancer Research (AACR) hosted the 13th conference on “The Science of Cancer Health Disparities ” that discussed the disproportionate burden of cancer faced by underserved minorities. The keynote presentation by Lourdes Baezconde-Garbanati, PhD, MPH, director of community outreach and education at the Institute for Health Promotion and Diseases Prevention Research at the University of Southern California, discussed efforts to address cervical cancer disparities in Los Angeles County, California. Dr. Baezconde-Garbanati described two evidence-based awareness campaigns: the Es Tiempo branding campaign, and the “Tamale Lesson” public service announcement.
Since 2015, the Es Tiempo campaign raises awareness of health clinics that provide cervical cancer screenings with images of the purple jacaranda tree. Additional advertisements on park benches and bill boards, as well as mailed postcards every spring coincide with the bloom of jacaranda trees to help provide annual screening reminders and share a phone number to call to schedule an appointment. The campaign was designed based on focus groups, which found many Hispanic women knew what cervical cancer screening entailed, but did not know where to go and wanted reminders to get screened. Dr. Baezconde-Garbanati found that women in neighborhoods with outdoor advertising and received postcards were almost twice as likely (65 vs 34 percent) to get a Pap test compared to women who only received postcards.
The Tamale Lesson video developed by Dr. Baezconde-Garbanati and colleagues shares culturally relevant information about HPV vaccines, Pap tests, and other women’s health issues. The video was developed based on a series of focus groups that found a narrative story of female family members would be most effective. This was partly because female family members were the most trusted source of health information for most Hispanic women in the focus groups. In a pilot study of 704 women, Dr. Baezconde-Garbanati, et al. found the Tamale Lesson video significantly increased knowledge and improved attitudes towards Pap tests compared to a non-narrative video. These successful outreach efforts serve as great models for culturally relevant health education to address health disparities in other underserved communities.
Recording Now Available for the AACR Virtual Patient Advocate Forum: COVID
Thanks to all who participated in October’s Forum, the first of a series of AACR advocacy forums. Special thanks to moderator Anna Barker, speakers Adam Hayden, Laura Esserman, Steven Libutti, Avrum Spira, and David Tuveson; and, featured voices Liza Bernstein, Jill Feldman, Ivy Elkins, and Emil Lou. Recording now available.
Apply Today for the AACR 2021 Annual Meeting Scientist↔Survivor Program
The AACR is now accepting applications for cancer survivors and patient advocates to enroll in the Scientist↔Survivor Program at the AACR 2021 Annual Meeting. This unique educational program provides an opportunity for survivors and patient advocates to learn and discuss the latest findings in cancer research, regulatory science, and health science policy.
The curriculum is designed to build enduring partnerships among the leaders of the scientific, survivor, regulatory, and patient advocacy communities. Participants are accepted through a competitive application process. Please note that participants accepted for the AACR 2020 Annual Meeting Scientist↔Survivor Program do not need to reapply. Learn more and access application materials.
Please share this announcement with survivors and patient advocates with an interest in cancer research and policy.
Oncology Approval Recap
Between September 26 and October 26, the U.S. Food and Drug Administration approved three indications for existing therapies, granted one regular approval for a drug that had previously received accelerated approval, and approved one companion diagnostic:
- The combination of nivolumab and ipilimumab was approved as first-line treatment for adult patients with unresectable malignant pleural mesothelioma.
- Pembrolizumab was approved for the following indications:
- adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
- pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
- Venetoclax was granted regular approval in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.
- The next-generation sequencing (NGS)-based FoundationOne CDx test was approved as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase (NTRK) genes, NTRK1, NTRK2, and NTRK3, in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with Larotrectinib.
Read more about FDA approvals on the AACR webpage and on the AACR Cancer Research Catalyst. To learn more about the approval of other cancer therapies, you can find more information on the FDA’s website and an AACR journal, Clinical Cancer Research, regularly publishes FDA approval summaries.