Delays in Cancer Screenings Exacerbate Health Disparities

Prior to the original Cancer Moonshot Initiative launch and throughout the COVID-19 pandemic, Avalere reviewed and analyzed aspects of the evolving oncology landscape, including adherence to cancer screening guidelines and recommendations. Diagnosis and treatment delays, including those related to this pandemic, have a domino effect on patient care, particularly in oncology. Review of post-pandemic levels of cancer screening, biopsy, and treatment from the Avalere 2022 Healthcare Industry Outlook show that screening rates continue to lag, and providers are concerned that the delay has led to more late-stage cancer diagnoses. In a review of Inovalon’s Provider Clearinghouse data, breast cancer screening in July–November 2021 was 34% lower than the same time in 2019, before the pandemic.

These cancer screening delays have exacerbated cancer disparities across social health risk factors, including race and ethnicity. An Avalere analysis of colorectal cancer among Medicare beneficiaries found that Black beneficiaries presented with advanced disease at about 1.4 times the rate of White beneficiaries in 2021. In collaboration with the Community Oncology Alliance, Avalere has released findings in the American Journal of Managed Care detailing disparities in breast cancer screening access and adherence segmented by social risk and insurance type during the COVID-19 public health emergency.

Later-stage diagnoses that result from delayed screenings also raise implications for value-based payment and financial risk, as providers will be caring for potentially more complex and sicker patients. These analyses offer government stakeholders important insights as they consider policies, education, and outreach strategies to reduce instances of delayed and deferred cancer care.

HPV Vaccine Research & Outcomes for Cervical Cancer Data

The relaunch of the 2022 Cancer Moonshot also includes the addition of vaccines to the arsenal of cancer prevention tools. As emphasized by President Biden’s Cancer Moonshot Initiative, human papillomavirus (HPV) vaccination is a tool in the prevention of cancers caused by 7 oncogenic strains of HPV. Roughly 79% of the 44,000 new HPV-attributed cancers diagnosed in the US annually could be prevented by HPV vaccination. A recent Avalere Health analysis comparing current routine vaccinations to pre-pandemic rates, found that adolescents and adults may have missed an estimated 37.1 million doses of recommended vaccines, including HPV, in January 2020–July 2021, which could result in even more preventable HPV cancer diagnoses.

Prior to the emerging success of mRNA vaccines providing protection against COVID-19, scientists researched mRNA vaccines for the prevention and treatment of pancreatic cancer, colorectal cancer, and melanoma. With greater customization capabilities, more targeted vaccine-induced immune responses, and rapid production and manufacturing timing, these investigational mRNA vaccines may more quickly fulfill unmet cancer prevention medical needs.

Changing Landscape of Cancer Care & Prevention

The 2016 National Cancer Moonshot Initiative increased collaboration among regulatory scientists and reviewers at the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) and expedited product development, particularly combination therapies and companion diagnostics used in the prevention, screening, diagnosis, and treatment of cancer.

Since the initial Cancer Moonshot, the OCE has been directly involved in advancing cancer care through initiatives like Project Orbis, a program that streamlined international approval of a combination therapy. Agencies are likely to continue utilizing collaborative approaches that improve science- and risk-based regulatory frameworks, advance evidence generation strategies, and expedite regulatory pathways as demonstrated by successes from the first Cancer Moonshot Initiative and during COVID-19.

Data gathered from regular cancer screenings can make the FDA’s expedited regulatory pathways, such as accelerated approval and priority review, more reliable in helping identify and bolster the evidentiary link between surrogate endpoints and final clinical outcomes. The expedited approval of products is frequently accompanied by regulatory and policy advisory meetings such as the FDA’s Vaccines and Relate Biological Product’s Advisory Committee and, especially in the case of vaccines, the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). With varying data and evidence needs related to vaccination approval and recommendation milestones, occasionally more time can elapse between FDA approval and ACIP recommendation for use among products approved via expedited approval pathways when compared with non-expedited approvals, underscoring the opportunity for improvement.

Greater cross-agency collaboration could play a role in eliminating excess lag time between an expedited FDA approval and a recommendation from the CDC for the use and implementation of these products. At the same time, equivalent paths for expedited review of medicines do not exist for guideline developers that publish recommendations on the clinical use of such products. Piloting these approaches now can increase the likelihood that bodies such as the ACIP have the tools and means necessary to make prompt recommendations for future products, including cancer-preventing vaccines. The Cancer Moonshot Initiative creates opportunity for greater harmonization of regulatory, policy, and medical practice reviews to increase access to and appropriate use of cancer treatments.

What’s Next?

President Biden’s 2022 Cancer Moonshot Initiative establishes a formal governing structure across White House leadership and a cross-agency “Cancer Cabinet.” As stakeholders await updates from the Biden administration, the core tenets of the 2016 Cancer Moonshot Initiative may help to inform the areas of prioritization for cancer care in 2022 and beyond. The pillars of this revitalized initiative underscore the role for the following:

• Increasing access to innovative technologies for cancer prevention: The last 10 years have seen immense technological advancements in cancer prevention and early detection tools. Stakeholders interested in the success of the federal cancer prevention strategy—as outlined in the 2022 Cancer Moonshot screening “Call to Action”—should consider how to support adequate coverage and reimbursement of these innovative technologies.
• Breaking down siloes for policies to support cancer survivorship: As new treatments continue to extend the life-expectancy of patients with cancer, survivorship support for patients and families remains a legislative priority for the Biden administration. Some stakeholders are considering the range of patient survivorship support activities that could assist in addressing patient barriers related to prevention, diagnosis, and treatment.
• Reducing the risk of cancer and increasing the incidence of earlier-stage diagnoses: Private sector stakeholders, in partnership with oncology guideline-making bodies, have an opportunity to bring innovative preventive products and services to market, thereby increasing cancer screening rates. This can provide clinical and financial benefits to all stakeholders, as late diagnosis of disease has been associated with worsening outcomes and higher healthcare costs.
• Increasing cross-collaborative systems proactively in anticipation of efficient approvals: Greater harmonization of regulations and policies for expedited approval of therapies and technologies to prevent, diagnose, and treat cancer requires cross-agency collaboration. Private sector stakeholders could consider how the coordination of federal oversight could help to ensure patients can access innovations in cancer care as they are approved.

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