Driving Market Access for Rare Disease Therapies
In the past, rare disease manufacturers often assumed that any therapy they launched would automatically be covered by most health plans. But the rising cost of many rare disease drugs has increased payer sensitivity to the expense of these therapies, even those with orphan drug designation. Many rare disease treatments
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
Case Study: Using Real-Time Market Access Data to Build a Strong Commercialization Strategy
Developing the first and only FDA-approved treatment for a particular indication is no longer a guarantee of market access. Before the launch of its first commercial product, one small biotech company was concerned about restrictive utilization management policies. How would its sales team combat barriers to patient access? The company
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
Market Research Insights: How to Get the Data You Need from Payer Decision Makers
Market access research leverages the knowledge of influential members of payer organizations to illuminate existing and potential barriers to access. Payer decision makers can provide invaluable insights into a payer’s preferences, purchasing behaviors, and trends, as well as regulatory and policy issues that may need to be addressed. Manufacturers’ market
Market Access 101: Formulary and Medical Exceptions
Beginning with the basics, our Market Access 101 blog series has addressed how manufacturers can improve formulary placement for pharmacy benefit drugs, secure coverage and assess the need for contracting for medical benefit therapies. In this final post, we’ll explore what it means to request a formulary exception or medical
How Real-World Data Helps Manufacturers See the Complete Market Access Story
In competitive therapeutic areas, like immunology and oncology, optimizing market share depends on creating a more structured, holistic market access story. By augmenting traditional market access datasets with real-world data from claims and labs, manufacturers can follow patients’ progression along the care continuum—and uncover new opportunities to improve access. Understanding
How Can Pharma Use Data-Driven Frameworks to Ensure Commercial Success?
Biotech and pharma companies have a vast range of capabilities and data sophistication, from their data acquisition strategy down to the way they consume, curate and present data internally. In the last 10 years of my career, I’ve been involved in hundreds of data assessments on the side of the
Market Access 101: Key Factors in Medical Benefit Contracting
Welcome back to our Market Access 101 blog series, which began with the basics of market access and covered how to improve formulary placement and secure coverage under the medical benefit. In this post, we’ll dive deeper into the medical benefit, explaining how payer/PBM contracting works—and why it’s increasingly necessary.
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
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