Health Policy

FDA Commissioner Outlines New Plan to Increase Biosimilars by “Balancing Innovation and Competition”

Eileen Koutnik-Fotopoulos

October 2018, Vol 9, No 3 - Health Policy

FDA Commissioner Scott Gottlieb, MD, discusses the recent release of the FDA’s 11-part action plan to boost biosimilar development, noting that biosimilar competition is “anemic because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the U.S. several years before they’ll be available to patients here.” [ Read More ]

The Impact of Policy and Politics on Health and Drug Pricing

Jessica Miller

December 2016, Vol 7, No 11 - Health Policy

Washington, DC—A panel discussion on health and drug politics took place at the Sixth Annual Conference of the Association for Value-Based Cancer Care. The expert panel included Kavita Patel, MD, Johns Hopkins Medicine, Baltimore; Dan Todd, Principal of Todd Strategy, Washington, DC; and Liz Fowler, Vice President, Global Health Policy, Johnson & Johnson. The panel discussed what is working in healthcare, what is not, and where cancer care fits into it all. [ Read More ]

FDA Streamlines Expanded Access Application for Patients to Get Investigational Drugs

Nick Bryant

July 2016, Vol 7, No 6 - Health Policy

The Individual Patient Expanded Access Application, which is designed to streamline the application procedure for individual patients who apply for expanded access to investigational therapeutics, including expanded access to drugs that are not in clinical trials, was recently updated by the FDA. Form FDA 3926 authorizes expanded access to investigational drugs for patients with serious or life-threatening conditions who have no therapeutic options. [ Read More ]

ASCO’s Annual Report: Major Advances in Oncology and the Challenge of Value-Based Care

Eileen Koutnik-Fotopoulos

April 2015, Vol 6, No 3 - Health Policy

Significant gains in cancer research and prevention have led to longer survival, improved quality of life, and decreased disease burden. The 2015 annual report on “Clinical Cancer Advances” from the American Society of Clinical Oncology (ASCO) outlines the biggest advances made in oncology, and for the first time designates one cancer as the Advance of the Year, as well as emphasizing the ongoing challenge of value-based care. [ Read More ]

High-Quality Cancer Care Focus of ASCO’s Medicaid Reform Recommendations

Rosemary Frei, MSc

March 2015, Vol 6, No 2 - Health Policy

Late last year, the American ­Society of Clinical Oncology (ASCO) issued a policy statement on Medicaid reform, with recommendations on ensuring quality of care for all patients with cancer, including the underserved population, while also improving provider reimbursement to ensure value-based care. ASCO’s poicy statement advocates for the expansion of Medicaid coverage to all Americans with cancer, an increase in Medicaid pay­­ment rates to reach those of Medicare, and a greater emphasis on rewarding providers for the delivery of quality care. [ Read More ]