The Future of Accelerated Approval: Evolving to Better Serve Cancer Patients

Tuesday, June 28th, 2:00 – 3:00 pm ET

Association for Value-Based Cancer Care (AVBCC) and Oncology Network for Change (ONC) are pleased to introduce a live webinar designed to facilitate a conversation on accelerated approval, a process that allows for the approval of promising therapies that are likely to provide a clinical benefit for patients with serious or life-threatening conditions. Since 1992, over 269 drugs have been authorized by the FDA’s accelerated approval program, with over 150 of those in oncology (85% of recent accelerated approvals across FDA). Currently, insurers cover these drugs in parity with drugs approved via standard approval pathways. Recent scrutiny of this approval pathway has focused on the validity of surrogate end points used, completion of post-marketing requirements, and the costs of these drugs to insurers.

Topics will include:

• An overview of accelerated approval and its use in oncology
• The impact of the approval process on patients and physicians
• A discussion of how to evolve the process to meet patients’ needs
• Identification of policy action that could benefit the cancer community

Discussions around changes to the accelerated approval process have already begun in preparation for the reauthorization and passage of PDUFA VII this summer.

“If Mike lived long enough, at some point he would progress.”
- Caren
Care Partner and wife to late husband Mike,
who was diagnosed with NSCLC Exon20i.

An Oncology Nurse Practitioner spoke to patients diagnosed with NSCLC Exon20i, like Mike, and said, “The need for new treatment options for this patient population…in what may sound like a small number of patients…is huge.”

Changes made to accelerated approval should strengthen the process and sustain early approval and access to therapies that treat patients with serious and life-threatening conditions.

“The first time you learn that you have cancer your world kind of crumbles because everyone has what they think life should be and you have goals, you have dreams, and when you do face that diagnosis it shatters whatever because it’s hard to see the future at that point...”
- Hans
Diagnosed with chronic myeloid leukemia (CML)

Speakers

Andrea Ferris, MBA

President and Chief Executive Officer
LUNGevity Foundation

Ryan Hohman, JD

Vice President - Public Affairs
Friends of Cancer Research

Paul Jeffrey, PharmD

Principal
Jeff℞ey Consulting
Retired, Sr. Director of Pharmacy
MassHealth

Robert Orlowski, MD, PhD

Chairman, Ad Interim, Director of Myeloma and Professor of Medicine
Department of Lymphoma/Myeloma and
Experimental Therapeutics
Division of Cancer Medicine
MD Anderson Cancer Center

Andrew Robertson, PhD, JD

VP, Head of Global Regulatory Policy and Innovation
Takeda

Moderators

Tracy Baroni-Allmon, BS Pharm, JD

Head, Global Oncology Access &
Reimbursement Policy
Takeda

Nicholas J. Sarlis, MD, PhD, FACP

Head of Medical Content
Amplity Health

About the Organizers

Association for Value-Based Cancer Care (AVBCC) is a nonprofit organization dedicated to the education and exchange of knowledge among all stakeholders in the cancer care ecosystem responsible for patient care to ensure optimal care is delivered to patients with cancer.

The mission of AVBCC is to provide a forum for payers, providers, and the entire oncology team to enter conversations and evaluate value in terms of impact, quality, and cost on patient care and outcomes.

Oncology Network for Change (ONC) is a working group of leading national patient organizations and Takeda focused on exploring key US federal and state issues important to cancer patients and caregivers through advocacy leadership.

Patient organizations represented in ONC include American Cancer Society Cancer Action Network, CancerCare, Cancer Support Community, Caregiver Action Network, Friends of Cancer Research, LUNGevity Foundation, National Patient Advocate Foundation, and Patients Rising.