Understanding Therapeutic Value of Cancer Drugs Increases after Initial FDA Approval
BOSTON, June 23, 2015 /PRNewswire/ — The full therapeutic value of a cancer therapy is typically realized long after the drug’s initial FDA approval, according to a report from Boston Healthcare. In the report, several industry examples demonstrate why FDA approval should be viewed as a starting point for additional research into a drug’s full therapeutic potential. The Value of Innovation in Oncology: Recognizing Emerging Benefits Over Time was commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) and examines the pathways by which additional benefits of cancer therapies are revealed over time through continuing research after initial FDA approval.
Progress in cancer survival rates and improved health outcomes are not typically driven by dramatic, single breakthroughs in science and medicine, but more commonly result from an accumulation of knowledge over time. The potential to derive greater benefit from cancer therapies increases as researchers and clinicians explore all aspects of how the medicine is used, how it affects patients, and as it is evaluated in new areas.
“This research shows our understanding of how the benefits and risks of cancer therapies evolve over time as additional evidence accumulates,” said Thomas F. Goss, PharmD, Senior Vice President of Boston Healthcare and co-author of the report. “The clinical value observed at the time of initial FDA approval is generally only a partial reflection of the evidence of clinical efficacy and safety that a new therapy provides to patients. Ongoing research and real-world clinical practice reveal important information about how to best use new therapies. This building process is central to the long-term realization of significant clinical gains for treating cancer and many other diseases.”
While the intrinsic “value” or clinical properties of a therapy do not change, the understanding of the benefits and risks of the therapy grows over time as clinical experience and knowledge accumulate. The report outlines how additional value is recognized through a number of different pathways, including use within a singular FDA-approved indication, use earlier in treatment line and in earlier disease stage, use in additional disease indications, use in combination with other agents, and use in combination with specific biomarkers.
About Boston Healthcare:
Boston Healthcare helps biopharmaceutical, medical device, and diagnostics companies unlock the value of innovation in the global health care marketplace. Boston Healthcare provides reimbursement and market access strategy services, health economics and outcomes research, market analytics and pricing strategy, and business development support to health care clients worldwide.
With offices in Boston, Berlin, and Shanghai, our unique approach, combining strategic consulting with a deep understanding of the evidence-driven value environment, gives clients a real-world edge in assessing and capturing global market and business development opportunities.
For more information, please visit www.bostonhealthcare.com.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $550 billion in the search for new treatments and cures, including an estimated $51.1 billion in 2013 alone.
For more information, please visit www.phrma.org.