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 be a market worth more […]
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 market baskets, especially if multiple […]
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 HCPCS Coding Cycle documentation, CMS […]
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, and new modalities, including cell […]
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 party lines in the Senate […]
The End of the COVID-19 Public Health Emergency Is Inevitable. Here’s What That Could Mean for Health Plans

With the continuation of the COVID-19 pandemic and resulting policy changes, the health plan landscape is facing some complex challenges ahead. A key factor contributing to these challenges is the Public Health Emergency (PHE) that was declared in January 2020 and renewed on July 15. As a condition of receiving enhanced federal funds during the […]
Three Hot Topics at AHIP 2022

From drug pricing to health equity to digital therapeutics, the healthcare industry had a lot to talk about at this year’s America’s Health Insurance Plans (AHIP) conference, held June 21-23 in Las Vegas—the first in-person AHIP event since the start of the COVID-19 pandemic. While the keynote speakers, panel sessions and individual presentations covered a […]
Manufacturers and the Mental Health Crisis: How Data and Education Can Improve Patient Access

According to the National Institutes of Health (NIH), nearly one in five U.S. adults (approximately 52 million) live with some form of mental illness. Unfortunately, those struggling with a mental health disorder often aren’t getting the treatment they need, and when undertreated, can have considerable economic impact on national healthcare budgets due to the cost […]
PrEP Therapy Can End the HIV Epidemic, but Equitable Access Is Key

Amid a global pandemic that has been the foreground of thought and development in medicine the past two years, another epidemic has been lingering for decades: HIV and AIDS were first recorded in the early 1980s, and their presence has grown exponentially over the last 40 years. In that time, HIV has fostered significant innovations […]
FDA Updates to JAK Inhibitors: How Are Payers Reacting, and What Do Pharma Companies Need to Know?

After the FDA called for additional warning labels on anti-inflammatory drugs known as JAK inhibitors this September, pharma companies in the immunology space have been waiting with bated breath to see how payers will react to this news. Will insurers start requiring step-edits or prior authorization? Will payers alter their management strategies for rheumatoid arthritis […]