ABSTRACT
Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.
Subject(s)
Antineoplastic Agents/therapeutic use , Biosimilar Pharmaceuticals/therapeutic use , Drug Approval/legislation & jurisprudence , Antineoplastic Agents/adverse effects , Antineoplastic Agents/economics , Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/economics , Drug Approval/organization & administration , Drugs, Generic/economics , Drugs, Generic/therapeutic use , Europe , Humans , Neoplasms/drug therapy , United States , World Health OrganizationABSTRACT
OBJECTIVES: To review the development of advocacy and its influence on health policy from the perspective of AIDS, the American Cancer Society, the Cancer Leadership Council, and the Patient Advocacy Foundation. DATA SOURCES: Published articles, news articles, books and personal experience. CONCLUSIONS: Advocacy on behalf of patients in the health care arena is a powerful force in modern life. Advocacy organizations have been influential in the development of health policy. IMPLICATIONS FOR NURSING PRACTICE: There are a variety of advocacy organizations in which nurses can commit their energies in the support of advocacy.
