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FACT: Outdated FDA regulations may inhibit biopharmaceutical companies from communicating scientifically sound, truthful and non-misleading information about medicines with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.
The government is proposing dramatic changes to Medicare Part B, including possible cuts to physician reimbursement for many innovative treatments based on the government’s decisions about which treatments are most valuable for seniors. Unfortunately, these decisions would be based on average results across broad populations, ignoring individual patient needs.
These so-called market-based proposals are nothing more than a litany of new government regulations and mandates that would undermine the competitive market and empower government bureaucrats and insurance companies to make one-size-fits-all treatment decisions for patients.
Over the last two and a half decades the world’s life expectancy has grown from 65 to 71 years. This life-changing advance is due in no small part to the creation of new drugs, therapies and treatments that have mitigated and even cured a variety of diseases and conditions that once may have been chronic or even fatal. The development of new generations of treatments is, in part, a result of nations around the globe understanding the importance of supporting intellectual property policies that encourage innovation and risk-taking.