The Catalyst

Outdated FDA Regulations Discourage Development and Dissemination of Healthcare Economic Data to Support Value-Based Healthcare

Posted by Randy Burkholder on July 2, 2015 at 12:00 PM

As demand for evidence about the clinical and economic benefits of new treatments continues to grow, Food and Drug Administration (FDA) regulations on communications by biopharmaceutical companies remain rooted in the past and limit companies’ ability to meet these needs.  A new Forbes op-ed by Dr. Scott Gottlieb highlights the negative consequences for patients and the health care market.

A range of efforts are underway to shift the U.S. healthcare system toward value-based care such as the new payment models being tested by the Center for Medicare and Medicaid Innovation to reduce spending and improve the quality of care, a framework for evaluating medical oncology treatments recently announced by the American Society of Clinical Oncology, and a Learning Action Network to inform payment reforms launched by Health and Human Services.

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Topics: FDA, Patients, HHS, ASCO

ICYMI: New Report on Benefits of Cancer Medicines That Emerge After FDA Approval

Posted by Emma Van Hook on July 1, 2015 at 9:00 AM

In case you missed it, Boston Healthcare Associates recently published a report examining how additional benefits of cancer medicines emerge over time through ongoing research after initial approval from the FDA.

To discuss the report and what it means for patient care, Tom Goss, one of the lead authors of the report, participated in a Q&A with BioSpace News.

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Topics: Value, Innovation, R&D, cancer, drug cost, Healthy Outlook

Lupus Foundation of America Event Calls for More Progress for Patients

Posted by Michelle Nyman on June 30, 2015 at 12:00 PM

Optimism and hope. That’s what NBC’s Chuck Todd took away from the Lupus Foundation of America’s National Advocacy Awards Dinner on June 16. Todd moderated a thoughtful discussion among health care leaders about initiatives aimed at accelerating new treatments and cures for lupus and many other diseases. 

PhRMA’s John Castellani was honored with an award for advocacy leadership and participated on the esteemed panel alongside Congressman Fred Upton (R-MI), Mary Woolley, president & CEO of Research!America, Francis Collins, M.D., Ph.D, director of the National Institutes of Health and Susan Manzi, MD, MPH, chair of the Department of Medicine at Allegheny Health Network.

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Topics: Patients, Lupus, NIH, patient advocacy

New Report: Innovation in the Biopharmaceutical R&D Process – Adapting to a Changing Environment

Posted by Anne McDonald Pritchett, PhD on June 30, 2015 at 9:00 AM

With the average cost of developing, testing and receiving approval for a new medicine at $2.6 billion and rising, biopharmaceutical companies are continuously looking at new ways to increase efficiencies in their research and development capabilities.

In a new report, “Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development," the Tufts Center for the Study of Drug Development found that biopharmaceutical companies are using a variety of innovative approaches to improve the efficiency and productivity of their research efforts.

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Topics: R&D, Drug Development, Clinical Trials, drug cost, clinical research

#MedicareMonday: What is CMMI?

Posted by Kelsey Lang on June 29, 2015 at 9:58 AM

This week Medicare Monday is looking at the Center for Medicare and Medicaid Innovation (CMMI) and why it matters to patients.

The Center for Medicare and Medicaid Innovation (CMMI) is a government body established by the Affordable Care Act (ACA) to test new models for paying for and delivering health care. The ACA gives CMMI significant flexibility to test and evaluate a wide range of these “alternative payment models” (APMs) – such as accountable care organizations, bundled payments and patient centered medical homes – both in Medicare and in the private sector. If an evaluation finds the APM reduces Medicare spending while preserving or enhancing quality of care, CMMI has the authority to expand the model, including nationwide implementation in the Medicare program. The work CMMI is doing now will shape how Medicare pays for health care in the future as it seeks to shift reimbursement to “value-based” models.

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Topics: ACA, HHS, Part D, Medicare, #MedicareMonday, Congress

Week in Review: The Latest from PhRMA

Posted by Priscilla VanderVeer on June 26, 2015 at 2:19 PM

Fighting High Cholesterol: The prevalence of high cholesterol among American adults underscores the importance of continued innovation. Take a look at the new infographic on fighting high cholesterol.

Burden on Patients: In the second of our Burden on Patients Q&A series, we spoke with Carl Schmid, deputy executive director for The AIDS Institute, about access to HIV/AIDS medicines in the 2015 health insurance exchanges. Be sure to check out the fact sheet as well.  

Value in Cancer Care: This week, the American Society of Clinical Oncology (ASCO) released its draft conceptual framework to assess the value of cancer treatment options. PhRMA has long supported patient-centric measures and provided recommendations for moving forward.

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Topics: cancer, The Aids Institute, HIV/AIDS, ASCO, high cholesterol

ICYMI: The Importance of Enrolling in Clinical Trials

Posted by Emma Van Hook on June 26, 2015 at 11:59 AM

Clinical trials are a crucial step in the long and costly process of researching and developing a new medicine to address substantial unmet medical needs in such areas as Alzheimer’s, cancer, and many rare diseases. At the center of the clinical trial process is the patient. In an Op Ed in the New York Times, Stan Collender reflects on his own experiences as a cancer patient and the importance of participating in clinical research.

However Collender notes that only 3% of all cancer patients participate in clinical trials, which is a huge problem – the lack of patients willing to participate leads to delays in the timely completion of trials, which in turn increases the time it takes to get medicines approved and available to patients more broadly.

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Topics: Innovation, Clinical Trials, NY Times, NYT

Fighting High Cholesterol

Posted by Holly Campbell on June 25, 2015 at 9:00 AM

High cholesterol itself is not a disease, but it can lead to disease. After all, every 40 seconds, an American adult dies from a heart attack, stroke, or related vascular disease. Despite being largely preventable, high cholesterol is a main risk factor in each of them.

According to the Centers for Disease Control and Prevention, two in three Americans with high cholesterol do not have it under control, and that has serious consequences for patients and society. Nearly 44 percent of Americans are likely to face some form of cardiovascular disease by 2030, and the cost of the disease is projected to reach $818 billion by 2030.

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Topics: Value, Innovation, drug cost, Cholesterol

Burden on Patients: 5 Questions on Access to HIV/AIDS Medicines in Health Exchange Plans

Posted by Allyson Funk on June 24, 2015 at 10:00 AM

Patients, especially those suffering from chronic conditions, deserve access to the medicines they need to live longer, healthier lives. Today, PhRMA released a new fact sheet on access to HIV/AIDS medicines in exchange plans in 2015 (2014 fact sheet is available here). The fact sheet highlights some of the potential barriers to accessing needed treatments. Learn more on, in our patient profiles and our other fact sheets.

This is the second post in our Burden on Patients Q&A series with patient advocates. To learn more, we talked with Carl Schmid, deputy executive director for The AIDS Institute

Question (Allyson Funk): What is the AIDS Institute and who do you represent?

Answer (Carl Schmid): We’re a national public policy and advocacy organization with a focus on HIV and hepatitis issues. We were founded in Florida and still maintain our presence there, and we have our national policy office in Washington, D.C. Our goal is to make sure people with HIV and hepatitis are given the proper care and treatment they need as well as prevent new infections.

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Topics: Access, ACA, health insurance, Burden on Patients, exchanges, Access Better Coverage, ABCs of Coverage

ASCO’s Framework: Value at the Crossroads

Posted by Randy Burkholder on June 23, 2015 at 5:34 PM

Yesterday the American Society of Clinical Oncology (ASCO) released its long-awaited draft conceptual framework to assess the value of cancer treatment options.

PhRMA has long supported the development and use of sound tools that enable informed decision-making by patients and providers, which is foundational for fostering efficient delivery of high-quality, patient-centered care. We also appreciate the challenges of developing sound tools – both in terms of conveying the right information at the right time, and making sure they are used to empower patient choices rather than limiting them.

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Topics: Value, cancer, ASCO

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