How to Mitigate Payer Pushback on Fast-Tracked Therapies
For pharma manufacturers, securing expedited approval for a drug in development is typically seen as a win, which will result in faster patient access as well as faster revenue recognition. However, the realities of market access mean that drugs approved by expedited pathways—most notably, the accelerated approval pathway—may face a much more difficult path to […]
Starting with the End in Mind: How Pharma Can Build a Smarter Path to Commercialization
This article was originally published in Drug Channels. To chart a clear path to commercialization, a manufacturer must begin with the end in mind. Early market research helps pharma companies understand which clinical endpoints and differentiators an asset will need to succeed at launch. Today, one-third of pharma companies start market access planning in Phase I, and […]
The Impact of Expedited Approvals on Payer Coverage
To speed patient access to potentially life-saving therapies, the FDA established expedited approval pathways for selected drugs that fill unmet needs or treat serious conditions. For patients in need, these pathways serve an essential purpose. But many payers and providers are concerned that expedited pathways do not require sufficient safety and efficacy data. Their concerns […]
Mapping the Patient Journey: Six Commercial Use Cases for RWD
For years, pharma commercialization strategies focused only on traditional market access data: payer policies and restrictions. While payer coverage is still essential information, this single-source approach cannot help manufacturers identify the many barriers to access. In the path to treatment, there are so many hurdles that can stand in the way of a patient receiving […]
Payers Prepare for 2025 Medicare Part D Changes
As of 2024, more than 54 million Medicare beneficiaries had prescription drug coverage through Medicare Part D. Of that total, 31 million had Part D coverage alongside a Medicare Advantage plan, and about 23 million had a Part D prescription drug plan. As a result of the Inflation Reduction Act (IRA), significant changes to the […]
How Physicians and Oncologists View AI Assistance
The progressive integration of AI within medicine is transforming the way physicians evaluate and monitor disease, enabling earlier detection and improving outcomes and quality of care. Medical practices are increasingly leveraging datasets, algorithms, and other machine learning techniques to identify subtle patterns that might not be discernable to physicians without this technology. These AI tools […]
Changing Site-of-Care Dynamics and the Growth of Self-Administered Therapies
Patients have expanding options for where to receive and take their medications. Both payers and manufacturers can capitalize on these options to improve patient access, adherence, and outcomes. Within many therapeutic areas (TAs), medications that were previously covered by the medical benefit are now covered by the pharmacy benefit. To accommodate the new benefit designs, […]
Growing Interest in Direct-to-Consumer Drug Programs
The past few years saw the launch of several direct-to-consumer (DTC) programs, including Amazon One Medical and Mark Cuban’s Cost Plus Drugs. In 2024, several manufacturer-designed DTC programs, such as LillyDirect and PfizerForAll, have been added to the mix, demonstrating pharma’s continuing shift toward an integrated model of patient care. While these programs can benefit […]
Meet Your Launch Goals with Payer and HCP Insights
The weeks preceding a pharma product’s launch date are a critical window for market access teams. The ability to pivot and adjust to last-minute shifts can make all the difference between a successful first year and a disappointing launch trajectory. While much of your market access research may have already been completed by the time […]
Payer Response to the Great Medicaid Unwinding
During the pandemic, the number of individuals in the U.S. enrolled in both fee-for-service and managed Medicaid programs increased dramatically. This increase was tied to a provision in the Families First Coronavirus Response Act, which boosted federal dollars to the states in exchange for keeping individuals covered through Medicaid, even if their eligibility changed since […]