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
Coping With Drug Shortages: How Payers and Manufacturers Can Support Continued Patient Access
The COVID-19 pandemic illuminated a challenge to the U.S. healthcare system that continues to undermine effective patient care: medication shortages. A Senate report found that drug shortages increased nearly 30% last year, with a record five-year high of 295 active drug shortages by the end of 2022. Most recently, these
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
© 2024 MMIT
Weighing the Benefits: Are Payers Likely to Cover Weight Loss Drugs in 2023?
In 2021, Novo Nordisk’s Wegovy (semaglutide) gained FDA approval for chronic weight management in overweight or obese adults, hitting the market in June 2022 at a list price of $1,349 per 28-day supply. In clinical trials, patients achieved an astounding mean weight loss of nearly 15% after 68 weeks of
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.
© 2024 MMIT
Spotlight on Vaccines: The Path to Commercial Plan Coverage
Following a severe season of respiratory syncytial virus, or RSV, in the U.S., multiple companies have reported that they have promising vaccine candidates for various patient populations in the late-stage clinical trial pipeline. The FDA could approve some of them as early as this year, for what is estimated to
How Will the Launch of Humira Biosimilars Impact Patients, Payers and IDNs?
Across indications, biosimilar uptake is rapidly accelerating, with the number of biologics facing biosimilar competition more than doubling by 2026. This year’s impending launch of adalimumab biosimilars will serve as a case study for manufacturers, who will be studying the market’s response. Humira biosimilars have great potential to disrupt immunology
New HCPCS Codes for Generics: What Payers and Manufacturers Should Know to Ensure Accurate Reimbursement
As if medical billing and coding wasn’t challenging enough, 2023 brings a new layer of complexity: the establishment of unique HCPCS codes for generic drugs. Specifically, the new codes affect generics approved under the FDA’s 505(b)(2) new drug application (NDA) and biologics license application (BLA) pathways. In its Q3 2022
What’s Ahead for Market Access in 2023?
Despite the challenges of the pandemic, the pharma industry has enjoyed steady growth during the past two years, which is expected to continue in 2023. The global pharmaceutical market is forecast to expand at a CAGR of 5.7% between now and 2028. Hundreds of products are currently awaiting FDA approval,
What the Inflation Reduction Act Means for Manufacturers and Health Plans
Given the spotlight that COVID-19 has shone on the glaring holes within the U.S. healthcare system, it’s not surprising that the current Biden administration has placed considerable importance on addressing key issues head-on. The focus on solving these issues has manifested as the Inflation Reduction Act (IRA), which passed along