Washington, D.C. (June 12, 2012) — Following Food and Drug Administration (FDA) approval of a new cancer medicine, it often takes years of additional research to fully understand the value of the medicine to patients, according to "Recognizing Value in Oncology Innovation," a new paper released by the Boston Healthcare Associates (BHA). Examining four separate cancer therapies, the paper identifies five key pathways through which additional clinical value is recognized over time. The paper also underscores the importance of policymakers to recognize how progress against cancer continues to evolve over time when considering policies that impact patient access to innovative treatments.
“Over the span of several decades, incredible advancements in cancer innovation have resulted in millions of patients’ lives being enhanced and even saved. And as we learn more about this complex disease, many generations of patients will continue to experience an evolution in the way they receive care, particularly as more targeted cancer therapies are discovered,” said John J. Castellani, president and CEO, Pharmaceutical Research and Manufacturers of America (PhRMA). “As we seek to move the science forward in the oncology field, it is important to keep our focus on the millions of patients awaiting better treatments, as well as those who have benefited from recent advances that have helped them beat cancer.”
The BHA report, “Recognizing Value in Oncology Innovation,” which was commissioned by PhRMA, provides a unique overview of the incremental benefits of specific cancer therapies currently available for patients in the U.S. and outlines the pathways by which new benefits have been realized with these treatments. For example, new cancer treatments typically must first be tested in the sickest of patients with few treatment options. Once a medicine is used at an earlier stage of the disease, the impact can be much greater.
“As each new cancer survival story is told, we can celebrate the fact that investments made in cancer research and discovery have forged a lengthy pathway forward. But in order for this path to remain a continued source of hope and survival for patients battling this devastating disease, it is critical that our elected officials support policies that foster advancements in biopharmaceutical innovation,” said Castellani.
The authors of the paper examined four individual cancer therapies – targeting lung, breast and colorectal cancer as well as myeloid leukemia – and found that in each case subsequent studies showed larger impacts than earlier research found. This evolution in progress is reflective in FDA label expansions for new indications and expanded patient populations. Based on extensive reviews of post-market clinical research, the authors conclude that additional clinical value is recognized through five different pathways after FDA approval:
- Use in the initial FDA-approved indication
- Use earlier in treatment line and earlier disease stage
- Use in different disease indications
- Use in combination with other agents
- Use in combination with specific biomarkers
Many of these points, including the fact that new medicines have accounted for 50 to 60 percent of the increase in cancer survival rates since 1975, will be discussed today at the Turning the Tide through Sustained Medical Innovation conference taking place in Washington, DC. Turning the Tide Against Cancer will be streamed live.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.5 billion in 2011 in discovering and developing new medicines.
Find PhRMA Online:
- Website – http://www.phrma.org
- Facebook – www.facebook.com/PhRMA
- Blog – www.phrma.org/catalyst
- Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress
- YouTube – www.youtube.com/PhRMApress
For information on how innovative medicines save lives, visit: http://www.innovation.org
For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org
For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org