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The Academy of Oncology Nurse & Patient Navigators (AONN+) Supports Patient Advocacy Language in Cures 2.0 Legislation

August 23, 2021

AONN+ joins numerous patient care organizations in writing to Representatives DeGette and Upton in support of patient advocacy language in the Cures 2.0 final legislation.

CRANBURY, NJ, August 20, 2021 – The Academy of Oncology Nurse & Patient Navigators (AONN+) joins more than 20 professional and advocacy organizations in a letter penned to the Honorable Diana DeGette and the Honorable Fred Upton in support of the newly proposed language in Title II, Section 204, Patient Experience Data (PED), Subsection (b), Collection, Submission, and Use of Data.

This new language emphasizes the importance of patient experience data, which goes beyond physical symptoms or side effects of a disease, therapy, or clinical investigation, to also address the psychosocial concerns, needs, and preferences of patients. Patient advocacy and patient empowerment are part of the core competencies of AONN+ as we work to provide oncology nurse and patient navigators with the tools and resources needed to ensure better patient care.

The AONN+ Policy and Advocacy Committee serves as the voice of AONN+ when reviewing legislature that involves patient advocacy and urges this new language on patient experience data to remain, in its entirety, in the final Cures 2.0 legislation.

The full letter can be viewed here:

Dear Representatives DeGette and Upton,

Thank you for the opportunity to comment on the 21st Century Cures 2.0 (Cures 2.0) discussion draft. The organizations below represent millions of patients confronting serious health conditions across multiple diseases that understand the importance of capturing and incorporating patients’ perspectives, preferences, and priorities in the development of safe and effective treatments. We applaud the newly proposed language included in Title II, Section 204, Patient Experience Data (PED), Subsection (b), Collection, Submission, and Use of Data and urge this language remain, in its entirety, in the final Cures 2.0 legislation.

Passage of the 21st Century Cures Act, as amended by the Food and Drug Administration Reauthorization Act of 2017 (FDARA) recognized and elevated the importance of patient experience data (PED), which goes beyond the physical symptoms or side effects of a disease, therapy, or clinical investigation, to also address the psychosocial concerns, needs, and preferences of patients. The Food and Drug Administration (FDA), too, acknowledges that patient experience data provide unique insights that contribute to important patient preference information for identifying relevant clinical trial endpoints to ultimately inform medical product development that best meet patients’ needs. Notwithstanding the consensus by Congress, the FDA, patient advocacy organizations, and other stakeholders on the importance of PED, there is no imperative to ensure that PED is consistently collected, submitted, and used in the drug development process as intended.

PED is defined in Title III, Section 3001 of the 21st Century Cures Act (Pub. L. 114-255), as amended by Section 605 of the 2017 FDARA (Pub. L. 115-52), as “data that: (1) are collected by any person (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and (2) are intended to provide information about patients’ experiences with a disease or condition including (A) the impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients’ lives, and (B) patient preferences with respect to treatment of such disease or condition.” The new subsection (b) of Title II, Section 204 in Cures 2.0 will help actualize the intent behind the 21st Century Cures Act and the 2017 FDARA. Specifically, the new subsection provides a clear and consistent mechanism to enable patient experience data to best inform the drug development process by:

  • requiring drug manufacturers/sponsors to collect and report on patient experience data as part of the clinical trial;
  • requiring FDA to fully consider all patient experience data collected during the clinical trial; and
  • requiring reporting of patient experience data in a transparent manner that is uniform, meaningful and informative to patients and providers.

Embracing required processes for the consistent collection, use, and sharing of meaningful PED will allow us to better understand and address the full range of patients’ needs and concerns which will, in turn, encourage increased participation in trials generally and enhance diversity among trial participants specifically, lead to greater trial adherence and retention, improve the shared decision-making process by better informing patients, caregivers, and providers about which treatment pathways may be best, and help inform future clinical trial design. The importance of collecting, using, and sharing PED that encompasses patients’ psychosocial well-being is illustrated by The Institute of Medicine concluding in 2008 that comprehensive cancer care must include psychosocial care.

On behalf of the patients and caregivers we represent, we express our full support for the new subsection (b) of Title II, Section 204, Patient Experience Data, and urge that this language be included in the Cures 2.0 final legislation. Should you have any questions, please reach out to Phylicia Woods, Executive Director, Cancer Policy Institute at the Cancer Support Community at This email address is being protected from spambots. You need JavaScript enabled to view it..

Sincerely,

Cancer Support Community

Academy of Oncology Nurse & Patient Navigators (AONN+)

American Kidney Fund

Arthritis Foundation

Brem

CancerCare

Cancer and Careers

Child Neurology Foundation

Children’s Cancer Cause

Colorectal Cancer Alliance

EveryLife Foundation for Rare Diseases

Fight Colorectal Cancer

GO2 Foundation for Lung Cancer

Hemophilia Federation of America

National Hemophilia Foundation

National Eczema Association

National Multiple Sclerosis Society

Ovarian Cancer Research Alliance (OCRA)

Sick Cells

Susan G. Komen

The AIDS Institute

UsAgainstAlzheimer’s

About the Academy of Oncology Nurse & Patient Navigators® (www.aonnonline.org)
The Academy of Oncology Nurse & Patient Navigators, Inc (AONN+), is the largest national specialty organization dedicated to improving patient care and quality of life by defining, enhancing, and promoting the role of oncology nurse and patient navigators. The organization, which has more than 8900 members, was founded in 2009 to provide a network for all professionals involved and interested in patient navigation and survivorship care services in order to better manage the complexities of the cancer treatment process.

About the Journal of Oncology Navigation & Survivorship: The Journal of Oncology Navigation & Survivorship (www.jons-online.com) is the official publication of AONN+. JONS seeks to strengthen the role of nurse and patient navigators in cancer care by serving as a platform for these professionals to disseminate original research findings, exchange best practices, and find support for their growing community.

About CONQUER: the patient voice magazine: CONQUER: the patient voice magazine (www.conquer-magazine.com) is the AONN+ premier forum for patients with cancer. CONQUER magazine features articles written by and for patients with cancer, survivors, nurse navigators, and other oncology team members. This magazine addresses the issues that patients, their family members, and caregivers face every day in an easy-to-read format. Issues include interviews with patients with cancer, information on access to care, and articles on lifestyle topics such as nutrition, stress management, personal finance, and legal and employer issues.

About The Lynx Group: The Lynx Group (TLG) is a premier medical communications and education company acutely focused on oncology and rare disease states. TLG specializes in market access to and with advanced practice providers, patients, and their caregivers. With more than 100 years of combined senior leadership experience, TLG continually creates award winning medical education and cultivates strong relationships within proprietary brands serving patients and their caregivers, physicians, payers, nurses, pharmacists, navigators, and practice managers.

TLG has broad and deep experience in crafting custom, award winning solutions for life science and biotech companies. Currently, TLG partners with more than 50 of the top pharma and biotech companies globally. TLG proudly serves as co-founder and association management company of the Academy of Oncology Nurse & Patient Navigators (AONN+) and the Association for Value-Based Cancer Care (AVBCC).

Last modified: August 23, 2021
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