Intellectual property drives and sustains research, development and delivery of valuable new treatments and cures for patients who need them around the world. America’s world-leading research-based biopharmaceutical industry supports 3.4 million good-paying jobs in all 50 states. With this in mind, PhRMA takes the annual opportunity to submit our comments to the Office of the U.S. Trade Representative’s (USTR) Special 301 Report– a regular review of trade barriers that exist with U.S. trading partners.
More than 1.7 million new cancer cases are expected to be diagnosed in the United States this year. Although that number is daunting, World Cancer Day reminds us that tremendous progress in the prevention and treatment of cancer has been made over the years, and researchers around the globe are working together to advance cancer care for patients.
We previously noted that it is counterintuitive that more hospitals would become eligible for the 340B discount program as the share of uninsured patients these hospitals serve declines due to the coverage expansions in the Affordable Care Act.
Now, new data reported by hospitals shows the recent declines in the uninsured are translating into less uncompensated care for hospitals. If the number of uninsured is declining and uncompensated care is declining, why is the 340B program continuing to grow? This raises important questions about whether the current hospital eligibility criteria for 340B are consistent with the program’s origins as a discount program to safety net facilities.
This week on Medicare Monday, we’re looking at how proposals to change the structure of Medicare Part D could actually limit – and hurt – beneficiary access.
As we’ve covered before, price negotiation already occurs effectively within the Medicare prescription drug program. Large, powerful Part D purchasers negotiate discounts and rebates directly with manufacturers, and according to the Government Accountability Office, this private negotiation helps keep costs low for both beneficiaries and taxpayers. In fact, the Medicare Trustees have reported rebates are substantial and have increased each year of the program.
Record number of new medicines in 2015: The FDA’s Center for Drug Evaluation and Research’s (CDER) fifth annual Novel New Drugs Summary approved a record 45 new medicines in 2015, marking the highest number of approvals in almost two decades. More than a third of the medicines approved were first-in-class treatment options - offering a completely new way to treat disease – and nearly half were for the treatment of rare disease. Learn more about how these and other new medicines are giving patients even greater hope for the future.
Topics: Week in Review
A couple of weeks ago, we talked about the success of the Medicare prescription drug program 10 years after its implementation, and over the coming weeks, we’ll continue to look at coverage before and after the program.
One example is how the implementation of Part D expanded coverage to millions of seniors who previously didn’t have access to comprehensive drug coverage.
2015 was a record year for personalized medicine approvals, according to a new analysis from the Personalized Medicine Coalition (PMC). This news confirms the growing role of personalized medicine as an approach to treatment that can improve outcomes for patients and also create important efficiencies in the health care system. Personalized medicine is an emerging field of medicine that uses diagnostic tools to identify specific biological markers to help assess which medical treatments and procedures will be best for each patient. Personalized medicine also takes into account patients’ medical history, circumstances and values in developing targeted treatment and prevention plans.
Biosimilars will continue to become more widely available to patients in 2016 and beyond. PhRMA supports science-based regulation of biosimilars by the Food and Drug Administration (FDA). However, critical guidance on how they should be labeled to ensure regulatory transparency and accurate prescribing has yet to be issued by the Agency.
Since its launch in 2005, the Partnership for Prescription Assistance – or PPA – has helped connect nearly 9.5 million people with public and private patient assistance programs. A nationwide effort sponsored by America’s biopharmaceutical research companies, PPA is a free service that helps uninsured or underinsured patients access programs that provide prescription medicines for free or nearly free.
Last week, the American Society for Clinical Oncology (ASCO) issued a policy statement calling for improvements in clinical pathway programs. The statement responds to the growing concern that clinical pathways are being developed and implemented in a way that could impede delivery of high-quality cancer care.