Slow and Steady Wins the Race: Why the Medical Device Approval Process Might be Better in the United States than in the European Union
At first glance, it appears that the new Veterans Affairs (VA) Center for Innovation for Care and Payment shares much in common with the Center for Medicare and Medicaid Innovation (CMMI). Both are charged with implementing payment and care models that address rising costs, while maintaining or improving quality of care.
Our health and social systems are ill-equipped to meet the needs of the growing population of older adults with chronic conditions and their family caregivers. We are living longer, but are we living better?
In 2017, people flocked to LDI in record numbers, with more than 470,000 page views on our website. If eyes (clicks) on the page are any indication, readers looked to LDI for nonpartisan information amidst hyperpartisan policy debates, for insight into the challenges we face in the opioid epidemic and health care reform, and for our research on how to deliver and pay for quality health care. They also celebrated with us as we marked LDI’s 50th Anniversary and honored our founders and leaders.
After the House passed the American Health Care Act (AHCA), I asked a few of our Senior Fellows to comment on the economic problems the AHCA is designed to fix, and the economic problems it might cause, all politics aside. Dan Polsky immediately pushed back on the premise of 'politics aside':
“Orphan drug” is a bit of misnomer, or at least verbal shorthand. It’s not the drug that’s “orphan” or rare; rather, the disease is the orphan, meaning that it might not affect enough people, and provide enough of a market, to incentivize a drug company to look for therapies. That’s the premise behind the 1983 Orphan Drug Act (ODA), which offers incentives for companies to develop therapies for diseases that affect less than 200,000 people in the United States.
“Just in case,” the oral surgeon said, as he prescribed the opioid hydrocodone for my 17-year-old son, who just had his wisdom teeth out. “But you might try Motrin first,” he added. Not knowing what the next hours, or days, would bring, we filled the prescription for 20 pills. We’d heard that the pain on the second day might be worse than the first.
Developing a value framework for cancer drugs can sound like an arcane exercise without much relevance to clinical care. Restate it as a question of how, and how much, to pay for cancer drugs, and you’ve got everyone’s attention.
It seems self-evident: one way to address the epidemic of opioid deaths is to make prescription opioids harder to misuse. OxyContin, for example, is especially dangerous when it is crushed for ingestion, inhalation, or injection. In 2010, the FDA approved a reformulated, abuse-deterrent version of OxyContin that made the pill difficult to crush or dissolve. The new version immediately replaced the old one, marking a substantial reduction in the supply of abusable prescription pain relievers.
Our colleagues at the Wharton Public Policy Initiative have released a new Issue Brief, The Economic Realities of Replacing the Affordable Care Act, by LDI Senior Fellow Hanming Fang, PhD. In it, Dr. Fang uses a new model of labor and health insurance market dynamics to simulate the long-run effects of the ACA's mechanisms, thus shedding some much-needed light on the repeal-and-replace debate.
“Pay more for drugs that do more.” Although few would argue with the concept of paying for value, the mechanism for doing so has thus far eluded our multi-payer, market-based system. The Gant Precision Cancer Medicine Consortium at the University of Pennsylvania looked past US borders to learn about mechanisms in other countries, in its quest to recommend sustainable frameworks for valuing precision cancer drugs.
We recently convened an expert roundtable to tackle how health systems, payers, and providers can spur the ‘de-adoption’ of medical practices and technologies no longer considered valuable. This got us thinking - while the process by which ineffective practices or technologies are abandoned is neither simple nor automatic, even the language used to describe it is not clear. And language matters. It often reflects an unstated focus on one mechanism or one level of decision-making. Here we review, and potentially clarify, the terminology.
As the latest jobs report shows, growth in employment in the health care sector continues to be, well, healthy. Others have pointed out that this may not be a good thing, especially if it crowds out jobs in other industries, taking up resources that would otherwise go to producing more valuable goods and services.