Policy

Policy

SITC is committed to taking a big tent approach involving all critical stakeholders in moving the field forward towards finding a cure for cancer. The US federal government is one of these critical stakeholders and impacts every aspect of the field of immunotherapy from basic research, regulatory approval, clinical care, and beyond. The SITC Policy Committee and Subcommittees are tasked with fostering SITC’s engagement with the federal government and establishing the Policy strategic priorities for the Society.

Federal Engagement

SITC has forged strategic relationships with government and regulatory entities from around the world to address key issues related to Immunotherapy. Included in these relationships are formal liaisons between SITC and the U.S. Food and Drug Administration (FDA) as well as National Cancer Institute (NCI).

Marc Theoret, MD

FDA CDER

Marc Theoret, MD
Deputy Center Director OCE

Peter Bross

FDA CBER

Peter Bross, MD
Chief, Oncology Branch, CBER OTAT

James L. Gulley, MD, PhD

NCI Intramural

James L. Gulley, MD, PhD
Co-Director, Center for Immuno-Oncology

Marc Ernstoff, MD

NCI Extramural

Marc Ernstoff, MD
Chief, Immuno-Oncology Branch

Quality Improvement

The development and stewardship of Immunotherapy specific quality measures is aimed at directly impacting day to day patient care, with the goal of improving outcomes and serving the field. Through multiple quality initiatives – including the identification of measure concepts – the development of quality measures and the stewardship of measures through CMS and other quality programs, SITC strives to make sure that each patient receives the highest quality of care, regardless of where they receive immunotherapy.

Published sitc quality measure concePTs

Defining current gaps in quality measures for cancer immunotherapy: consensus report from the Society for Immunotherapy of Cancer (SITC) 2019 Quality Summit

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Current SITC MIPS Measures

Quality ID #490: Appropriate Intervention of Immune-Related Diarrhea and/or Colitis in Patients Treated with Immune Checkpoint Inhibitors

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Current SITC Measures under review

Positive PD-L1 Biomarker Expression Test Result Prior to First-Line Immune Checkpoint Inhibitor Therapy


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Appropriations Language

SITC annually drafts report language for consideration by the U.S. House of Representatives and Senate Appropriations Committees to be incorporated into appropriations bills. Incorporation of report language helps advocate for funding of federal agencies supporting cancer immunotherapy research and regulation, including the U.S. Food and Drug Administration (FDA) and National Cancer Institute (NCI). Continue reading below to view past language submitted on behalf of the society to the FDA and NCI.

Past NCI Appropriations Language

SITC NCI Report Language for FY 2024


SITC NCI Report Language for FY 2023


SITC NCI Report Language for FY 2022


SITC NCI Report Language for FY 2021


SITC NCI Report Language for FY 2020


SITC NCI Report Language for FY 2019

Past FDA Appropriations Language

SITC FDA Report Language for FY 2024


SITC FDA Report Language for FY 2023


SITC FDA Report Language for FY 2022


SITC FDA Report Language for FY 2021


SITC FDA Report Language for FY 2020


SITC FDA Report Language for FY 2019

SITC Policy Committees

Policy & advocacy committee

Chair
Ryan J. Sullivan, MD
Harvard Medical School

About the Committee

The Policy and Advocacy Committee reviews and analyzes immunotherapy and oncology related policy issues to advise the Board of Directors on the broad policy, advocacy, regulatory and value priorities of the society. The committee serves at the pleasure of the Board of Directors, representing the society when requested and supporting the development of talking points for the board when asked. The committee works with relevant subcommittees to achieve its purpose.

Science and Research Subcommittee

Chair
Rimas J. Orentas, PhD
Caring Cross

Co-Chair
Ryan J. Sullivan, MD
Harvard Medical School

About the Committee

The Science and Research Subcommittee assists the Policy and Advocacy Committee in the articulation, development and dissemination of SITC’s recommended National Institutes of Health (NIH) and National Cancer Institute (NCI) appropriations and congressional report language. The subcommittee also supports the Policy and Advocacy Committee in the development of an engagement strategy and talking points to the NCI that incorporates key scientific priorities in immuno-oncology. The subcommittee represents the society to the NIH and NCI when requested.

Regulatory subcommittee

Chair
Emily Hopewell, PhD
Indiana University

Co-Chair
Shari A. Pilon-Thomas, PhD
H. Lee Moffitt Cancer Center & Research Institute

About the Committee

The Regulatory Subcommittee assists the Policy and Advocacy Committee in the articulation, development and dissemination of SITC’s recommended U.S. Food and Drug Administration (FDA) and appropriations and congressional report language. The subcommittee also reviews and analyzes immunotherapy and oncology policy issues related to clinical trial design, management of toxicity and adverse events reporting and other activities under the FDA Oncology Center of Excellence.

Quality Subcommittee

Chair
Sara Pai, MD, PhD
Massachusetts General Hospital/Harvard Medical School

About the Committee

The Quality Subcommittee assists the Policy and Advocacy Committee in the articulation, development and dissemination of a value framework for cancer immunotherapy and areas focused on patient access and delivery of care, data sharing and research, quality, and other activities under the Center for Medicare and Medicaid Services (CMS) including coverage, reimbursement and engagement with private payers.