Focusing on Social Determinants of Health: How to Make an Impact
Consideration of patients’ social determinants of health (SDoH) has been a facet of healthcare delivery in the United States for decades. The CDC defines SDoH as the nonmedical factors that influence a patient’s health outcomes, such as access to care services and medication, housing and food stability, education levels, and employment. During the COVID-19 pandemic, […]
Leaning into Real-World Evidence: Lessons from the IRA
Manufacturers are continuing to wrestle with the effects of the Inflation Reduction Act (IRA) on their business plans and revenue streams. Although some of the IRA’s impacts are still uncertain, real-world evidence (RWE) is an important tool for manufacturers navigating the road ahead, as it will help them demonstrate the value and comparative effectiveness of their treatments. […]
What’s Ahead for Market Access in 2024?
Last year was a period of adjustment for the U.S. pharma industry, as the combination of increased financial pressures and the Inflation Reduction Act (IRA) meant adjustments to resource allocation. While concerns about macro trends like inflation and interest rates are still top of mind for manufacturers, we expect a renewed focus on efficient pipeline […]
How Are Payers Reacting to Insulin Price Caps?
This article was originally published in Drug Channels. Over the past two decades, skyrocketing list prices for insulin have threatened medication adherence for the estimated 7.4 million American diabetics who rely on insulin to manage their disease. According to the American Diabetes Association, nearly one in four insulin-dependent diabetics have decreased or skipped doses because they […]
What Pharma Wants to Know About the Medicare Drug Price Negotiation Program
Since the passing of the Inflation Reduction Act (IRA) last fall, pharma companies have been bracing for the impact of its provisions. The main healthcare-related IRA policies are the out-of-pocket spending cap, the Medicare Drug Price Negotiation Program, and the penalty for increasing drug prices faster than inflation. To get a better sense of what […]
10 Questions Oncology Manufacturers Should Be Asking About the Stark Law
Even though we knew it was coming, the end of the COVID public health emergency (PHE) on May 11, 2023, still took the healthcare industry by surprise. While the end of the PHE resulted in the rollback of many COVID-19 programs, it also changed the ways that Medicare patients can access oral therapies from community […]
Navigating the U.S. Patchwork of Biosimilar Laws
The FDA approved the first biosimilar more than eight years ago, and the agency continues to give the green light to multiple agents per year. In fact, 2023 could well be a landmark year in launches, spurred by multiple biosimilars of AbbVie’s Humira (adalimumab) entering the U.S. market. While the upcoming launches are a boon […]
Prepping for the Inflation Reduction Act: Why Manufacturers Need a Plan for Rapid RWE Generation
Since the passing of the Inflation Reduction Act (IRA) in August 2022, the healthcare industry has been bracing for the impact of several key provisions. Three of these policies—price negotiations, inflation-adjusted rebates, and the out-of-pocket spending cap—will be at least partially in place by the close of 2023. As manufacturers prepare for the effects of […]
Spotlight on Vaccines: The Inflation Reduction Act’s Impact on Coverage
While the Inflation Reduction Act (IRA) may best be known for mandating Medicare drug price negotiation, the act did much more than that. Among its other accomplishments are the elimination of cost sharing for vaccines under Medicare Part D, as well as improved access to adult vaccines for Medicaid and Children’s Health Insurance Program (CHIP) […]
Unintended Consequences of the IRA: Will the CPI Penalty Increase the Price of Drugs?
The Inflation Reduction Act (IRA), signed into law in August 2022, was intended in part to lower healthcare costs for families and small businesses. The IRA contains several provisions aimed at prescription drug costs which will roll out over the next few years, with the earliest taking effect this year. As of 2023, CMS will […]