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Cancer Policy Monitor: July 2021

APPROPRIATIONS UPDATE FROM CAPITOL HILL

-Marc B. Johnson, MPP

The House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) released its draft fiscal year (FY) 2022 spending bill ahead of the subcommittee markup on Monday, July 12th.  The bill would provide $49 billion for the National Institutes of Health (NIH), an increase of $6.5 billion.  This includes an increase of approximately $3.5 billion in NIH base funding and $3 billion for the establishment of an Advanced Research Projects Agency for Health (ARPA-H) proposed by the Biden Administration. Within the NIH, the National Cancer Institute (NCI) would receive approximately $7 billion, an increase of $432 million above FY 2021 levels. This includes $194 million for the Cancer Moonshot.

In addition, the bill would provide substantial increases to the Centers for Disease Control and Prevention (CDC), bringing its total funding to $10.6 billion, an increase of $2.7 billion.  The LHHS spending bill is scheduled for a full committee markup on Thursday, July 15th. The Senate has not yet scheduled markups for its appropriations bills.

AFFORDABLE CARE ACT UPHELD BY THE SUPREME COURT

–Tod Guidry, PhD

The Patient Protection and Affordable Care Act, which has provided crucial provisions facilitating access to healthcare for patients with cancer across the country, has survived its third major challenge in the Supreme Court.

The Court began hearing arguments in the case of California v. Texas in November 2020, in which plaintiffs claimed that the minimal essential coverage provision (also known as the individual mandate), which imposes a penalty for failure to obtain health care coverage, is unconstitutional. Eighteen states and two individuals argued that because the tax penalty under the mandate has been set to $0.00 through the 2017 Tax Cuts and Job Act, it no longer counts as a tax and is therefore unconstitutional. The plaintiffs further argued that the individual mandate is not severable from the rest of the law which should, therefore, be overturned.

Ultimately the Court voted 7-2 in favor of upholding the ACA, on the grounds that the plaintiffs did not suffer the sort of injury in the case that would give them standing to sue.

The ACA has had a tremendous impact on health care coverage and delivery for Americans affected by cancer, particularly its provisions protecting patients from being denied coverage due to pre-existing conditions, prohibiting caps on annual or lifetime benefits, and eliminating extra out-of-pocket costs for cancer screenings. The law has also given states the option to expand Medicaid eligibility, and its provisions requiring coverage of routine costs for privately insured clinical trial participants have led to increased oncology clinical trial enrollment.

Losing these vital provisions through an overturning of the law would have had a clearly detrimental impact on the Americans affected by cancer who rely on them.

Biden Administration, Congress Look to Advance ARPA-H Proposal

-Brandon Leonard, MA

The Biden Administration has released additional information on its proposal to create a new Advanced Research Projects Agency for Health (ARPA-H). On June 22 in a commentary published in Science, White House Office of Science and Technology Policy Director Eric S. Lander, PhD, National Institutes of Health Director Francis S. Collins, MD, PhD, and other leaders laid out their vision for ARPA-H. The administration also released a concept paper and a fact sheet with additional information on the proposed agency. In his FY 2022 budget proposal, President Biden has requested $6.5 billion to be spent over three years to fund ARPA-H, which would focus on accelerating biomedical innovation and bringing forth bold ideas that could revolutionize medicine and health care.

Biden and his scientific advisors have recommended that the new agency be placed under the NIH but operate with a similar culture and approach to the Defense Advanced Research Projects Agency (DARPA). This model would prioritize high-risk, high-reward research projects proposed and coordinated by term-limited program managers. Supporters have suggested that this model could bring forth revolutionary approaches to prevent, diagnose, and cure diseases such as cancer, Alzheimer’s, and diabetes and also highlighted the promotion of new technologies and platforms that could be applicable to addressing challenges across a wide a variety of diseases.

Also on June 22, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released a discussion draft and summary of their new 21st Century Cures 2.0 legislation. The draft includes a placeholder for language that would authorize the creation of ARPA-H. The two representatives, who led the development and passage of the original 21st Century Cures legislation in 2016, have also released a request for information to the public inviting responses on key questions related to the creation of ARPA-H.

In addition to creating ARPA-H, the 21st Century Cures 2.0 legislation seeks to build a national strategy to prepare for and mitigate the impact of future pandemics; improve Medicare coverage for new health care technologies; increase diversity in clinical trials; improve educational programs and training for caregivers; increase the use of real-world evidence in FDA decision-making; and increase access to telehealth services, among other provisions. The legislation also includes provisions from the RISE Act, which would provide a total of $25 billion, including $10 billion for the NIH, to offset the costs of disrupted research due to the COVID-19 pandemic. Reps. DeGette and Upton plan to introduce the legislation later this year after obtaining feedback on the draft bill from a wide variety of stakeholders.

Register for the 2021 Rally for Medical Research Virtual Hill Day!   

Registration is open for the ninth annual Rally for Medical Research, which will be held September 22-23, 2021, as an entirely virtual event. This format will allow as many people as possible to participate, and we look forward to making this the biggest Rally for Medical Research ever!

A virtual reception with exciting speakers from Congress and the NIH is being planned for Wednesday, September 22, while the virtual Hill Day meetings on Thursday, September 23 will be held with members of Congress and their staff via video and phone conference. We will hold a training session for all participants the week prior to the Hill Day on Friday, September 17. Please visit the Rally website for more information and to register!

AACR and AACI Host Joint Virtual Hill Day to Advocate for NIH and NCI Funding

-Brandon Leonard, MA

On June 9, the AACR partnered with the Association of American Cancer Institutes (AACI) to host its annual Joint Hill Day in support of federal funding for cancer research through the National Institutes of Health (NIH) and the National Cancer Institute (NCI). Nearly 100 participants including patient advocates, researchers, physicians, and cancer center leaders representing 26 states took part in the event, which was held in a virtual format due to the coronavirus pandemic.

Throughout the Hill Day, participants met via video or phone conference with more than 110 members of Congress or their staff and made three specific requests:

  • Continue to prioritize funding for medical research in the regular appropriations process and provide at least $46.1 billion (a $3.2 billion increase) for the NIH in FY 2022.
  • Provide at least $7.6 billion (a $1.1 billion increase) for the National Cancer Institute (NCI) in FY 2022, as supported by the NCI Director’s “professional judgement budget.”
  • Provide at least $10 billion for the NIH in emergency supplemental funding to restart research and clinical trials that have been impacted by the pandemic.

The AACR and AACI also organized a special virtual Hill Day program for participants which featured remarks from AACR President David A. Tuveson, MD, PhD, FAACR, and AACI President Caryn Lerman, PhD. During the program, the two organizations honored Rep. Gus Bilirakis (R-FL) and Rep. Brian Higgins (D-NY) with the 2021 Cancer Research Ally Award in recognition of their outstanding support for cancer research and patients living with cancer. Nicole Robinson, EdD, founder of the Hatz 4 Hearts Foundation; Heidi Nafman-Onda, MS and Pierre Onda, MD, MPH, co-founders of The White Ribbon Project; and Chris Draft, founder of The Chris Draft Family Foundation, all spoke about the importance of investing in cancer research from their perspectives as patient advocates.

Hill Day participants reported positive meetings with their representatives and senators, many of whom expressed strong support for medical research funding as a top priority. The AACR and AACI will continue to work together to advocate for NIH and NCI funding as we seek more progress against cancer.

FDA-AACR ONCOLOGY EDUCATIONAL FELLOWSHIP Application Period open

The FDA-AACR Oncology Educational Fellowship was initiated in 2020 through a partnership between the AACR and the FDA Oncology Center of Excellence (OCE) to provide early-career cancer researchers and fellows with a unique opportunity to learn more about oncology drug development and the regulatory review process. Fellows will engage in targeted educational activities and interactions with experts from the AACR and the OCE. Applications for the fellowship are being accepted now until August 14, 2021.

Eligible candidates must have an advanced degree (DO, MD, PhD, or MD/PhD), be within five years of starting their current academic position, and be or have applied to become AACR members. Neither U.S. citizenship nor residency are required to apply, but candidates must be proficient in English.

Fellows will participate in educational events on topics such as investigational new drugs (INDs), expedited approval pathways, clinical pharmacology, clinical trial design, companion diagnostics, and animal studies. These sessions will be a mix of didactic content presented by FDA OCE experts and group discussions. Fellows will also have the opportunity to participate in several networking sessions with OCE and AACR experts.

Previous participants including basic researchers and clinical fellows have attested to the value of the FDA-AACR Oncology Educational Fellowship in improving their understanding of oncology drug development and review, cultivating professional relationships, and serving their careers.

Learn more on the fellowship webpage or email Tod Guidry, PhD, AACR Science Policy Fellow, with questions.

ONCOLOGY APPROVAL RECAP

Between May 20 and June 24, the U.S. Food and Drug Administration approved three novel oncology therapies and new indications for two oncology drugs.

  • Avapritinib was approved for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
  • Infigratinib was granted accelerated approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
  • Sotorasib was granted accelerated approval for adult patients with KRAS G12C  mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
  • Amivantamab-vmjw was granted accelerated approval for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations that progressed on or after platinum-based chemotherapy.
  • Nivolumab was approved for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

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.