Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
Preliminary data indicates that 2023 may prove to be the most volatile year for health plan enrollment in a decade. The convergence of major market disruptions—namely the Inflation Reduction Act (IRA) and the end of the Public Health Emergency—is sparking tremendous shifts in the individual and public exchange market.
For health IT vendors, understanding these shifts is essential for identifying potential growth areas for their clients. Both payers and providers will need to improve the quality and variety of their services…
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 are placed in the highest cost-sharing tier, and intensive utilization management (UM) restrictions are common.
Rare disease manufacturers must take these factors into consideration when determining their market access strategy. Typically,…
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 for biosimilar manufacturers, it’s important to note that FDA approval will not guarantee automatic market access for these products. Given the various state regulations in play,…
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 identified payer coverage monitoring and ongoing analysis of payer responses as its most urgent priorities. The company selected MMIT Analytics to provide payer coverage and restriction data and MMIT Surveillance for…
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 these policies on their revenue stream, it’s become clear that real-world evidence will play a pivotal role in their strategy. Manufacturers will need to quickly conduct…
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 access teams can optimize access for their products by conducting market research that helps them better understand how therapy evaluation and coverage determinations are made. By making this research process valuable,…
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 exception for a non-covered therapy. As we’ve said previously, payers and PBMs often place a mandatory six-month block on new therapies, to allow for review by the P&T committee as final…
This article was originally published in BioPharma Dive.
Over the past few decades, pharma companies have perfected the art of using market access data to support product launches, negotiate payer discounts, and secure preferred status and positioning. Manufacturers typically track formulary and medical policy guidelines and restrictions—including prior authorization and step therapy requirements—for a product and its competitors, using this data to inform their market access strategy.
For the most part, this approach works. But in competitive therapeutic areas, like immunology and oncology, optimizing…
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 data supplier. Regardless of an organization’s data proficiency level, there are discrete steps all manufacturers can take to improve their partnerships with data vendors—and ultimately, to ensure commercial success.
Articulate your…
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 shortages include drugs used to treat ADHD, common over-the-counter children’s cold and flu medicine, and even a drug intended for diabetes treatment, which was used off-label to meet the tremendous demand…
