NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders.
REMS are a particularly important issue for oncology and the National Comprehensive Cancer Network (NCCN). A disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders. REMS policies and processes within oncology may act as a model for other clinical areas. A breadth of experience and access to a wide knowledge base exists within oncology that will ensure appropriate development and consideration of the practical implications of REMS. NCCN is uniquely positioned to assume a leadership role in this process given its status as the arbiter of high-quality cancer care based on its world-leading institutions and clinicians. Notwithstanding the potential benefits, the successful design, implementation, and analysis of the FDA's recent requirement for REMS for some high-risk drugs and biologics will present significant challenges for stakeholders, including patients, providers, cancer centers, manufacturers, payors, health information technology vendors, and regulatory agencies. To provide guidance to these stakeholders regarding REMS challenges, the NCCN assembled a work group comprised of thought leaders from NCCN Member Institutions and other outside experts. The Work Group identified challenges across the REMS spectrum, including the areas of standardization, development and assessment of REMS programs, medication guides, provider knowledge and impact on prescribing, provider burden and compensation, and incorporation of REMS into clinical practice.
PharmD, BCOP, National Comprehensive Cancer Network, 275 Commerce Drive, Suite 300, Fort Washington, PA, USA.
Philip E
PE
Johnson
George
G
Dahlman
Kirby
K
Eng
Rekha
R
Garg
Scott
S
Gottlieb
James M
JM
Hoffman
Peyton
P
Howell
Mohammad
M
Jahanzeb
Shirley
S
Johnson
Emily
E
Mackler
Mark
M
Rubino
Brenda
B
Sarokhan
F
F
Marc Stewart
Tim
T
Tyler
Julie M
JM
Vose
Sharon
S
Weinstein
Edward C
EC
Li
Jessica
J
Demartino
D026683:Advisory Committees / Q000458:organization & administration; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001688:Biological Products / Q000627:therapeutic use; D004345:Drug Industry / Q000592:standards / Q000639:trends; D004348:Drug Labeling / Q000592:standards / Q000639:trends; D016903:Drug Monitoring / Q000592:standards / Q000639:trends; D004358:Drug Therapy / Q000379:methods / Q000592:standards* / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D015507:Drugs, Investigational / Q000627:therapeutic use; D005104:Expert Testimony; D019538:Health Care Surveys; D057220:Health Literacy; D006282:Health Personnel / Q000191:economics; D006801:Humans; D033183:Interdisciplinary Communication; D008495:Medical Oncology / Q000379:methods / Q000592:standards / Q000639:trends; D056687:Off-Label Use / Q000592:standards; D012051:Reimbursement Mechanisms; D018570:Risk Assessment / Q000379:methods / Q000592:standards / Q000639:trends; D017751:Safety Management / Q000379:methods / Q000592:standards / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D000970:Antineoplastic Agents; D001688:Biological Products; D015507:Drugs, Investigational