We are at a pivotal time in health care in America. Biomedical discovery and innovation have the potential to revolutionize the way we diagnose and treat patients. At the same time, rapidly changing regulatory and market dynamics are shifting the ways we develop and pay for new technologies. Personalized medicine stands right at the center of this revolution, with the science enabling greater precision that not only can improve the lives of patients, but can also create efficiencies within the health care system by delivering the right treatment to the right patient at the right time.
New and innovative immunotherapy medicines developed by America’s biopharmaceutical research companies are transforming how we fight cancer and are providing newfound hope to patients.
Rather than killing cancer cells directly with traditional tools like radiation or chemotherapy, immunotherapy seeks to harness the immune system’s power to eliminate the cancer or slow its growth and ability to spread. Research shows immunotherapy is improving outcomes and survival rates for some patients, including kidney and lung cancer.
We’ve highlighted how the proposed Part B model lacks safeguards to protect patients from barriers and reduced quality of care.
Some stakeholders have suggested that the Part B proposal looks a lot like an “experiment on Medicare patients.” Here’s a look at how the proposal stacks up against a clinical trial.
Researchers sponsoring clinical trials (including biopharmaceutical companies) follow strict guidelines for review and approval to make sure patients are informed, risk is minimized and ongoing monitoring and evaluation are included.
Fact Check Friday – When it comes to communications between with payers, biopharmaceutical companies are often constrained in sharing safety and efficacy information about medicines in development. Read more about our recommended policy solutions regarding responsible communications with payers.
Topics: Week in Review
I had an opportunity to participate in the Stakeholders’ Event at the13th round of the Transatlantic Trade and Investment Partnership (TTIP) negotiations that took place in New York City earlier this week. The negotiations had a more urgent tone, as President Obama and European leaders strive to finalize the agreement this year. With only months remaining in his presidency, President Obama is focused on solidifying his legacy with the ratification of the Trans Pacific Partnership (TPP) and reaching an agreement with the EU on TTIP. Completing TTIP is important, but it is vital that any agreement reached provides the U.S. the strongest outcomes possible, to spur innovation and ensure the future health of the biopharmaceutical industry.
Today, we’re examining how and what biopharmaceutical companies communicate with payers about a medicine prior to its approval by the U.S. Food and Drug Administration (FDA).
MYTH: Biopharmaceutical companies can freely communicate with payers about a medicine ahead of the medicine’s approval by the FDA or about unapproved indications for approved medicines.
FACT: Outdated FDA regulations may inhibit biopharmaceutical companies from communicating scientifically sound, truthful and non-misleading information about medicines with payers prior to FDA approval.
Late last year, we highlighted a study published in in the New England Journal of Medicine that found many nonprofit hospitals were not complying with the charity care requirements laid out in the Affordable Care Act (ACA). Now, a new report released by the Alliance for Integrity and Reform of 340B (AIR340B)—of which PhRMA is a member—expands on this research and compares charity care compliance rates at 340B and non-340B hospitals. The report from the Berkeley Research Group (BRG) found 340B and non-340B hospitals had similar charity care compliance rates, even though in 2015 alone 340B hospitals received almost $4 billion in additional financial benefits through access to discounted medicines.
Clinical trials are the most effective way to find new, innovative treatments for illnesses patients may face. But misconceptions and lack of awareness about this important research often keep people from participating. In fact, two thirds of trials fail to enroll enough participants.
Next week, we celebrate Clinical Trials Awareness Week (May 2-6) to help people better understand clinical trials and feel empowered to get involved in the process.
Topics: Clinical Trials
In recent weeks, providers and stakeholders across the health care system have raised concerns that the Part B Drug Payment Model proposed by the Centers for Medicare & Medicaid Services (CMS) lacks needed safeguards to protect patients from access barriers and reduced quality of care. A new issue brief released by Discern Health last week builds on these concerns, finding CMS has not yet presented a monitoring and evaluation plan for the Part B Drug Payment Model to mitigate the risk of harm to Medicare beneficiary access and quality of care.
Today is World Intellectual Property Day, a celebration across the globe of the protections that allow creativity, risk-taking and innovation to thrive. America has long been the world’s innovation center – whether that is in manufacturing, technology or biopharmaceuticals. And it has been shown time and time again that strong protection of intellectual property (IP) is good for patients as it leads to the creation of innovative medicines and lifesaving cures.