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 […]
What to Watch in Second Round of Medicare Drug Price Negotiations
Established by the Inflation Reduction Act in August 2022, the Medicare Drug Price Negotiation Program is still in its infancy, but is expected to impact a wide swath of stakeholders in the U.S. healthcare system. Last year, CMS negotiated prices for the first round of drugs, and in January, the agency revealed its second list […]
Mining the Hidden Gems in Unstructured EMR Data
This article was originally published in BioPharma Dive. Pharma companies are increasingly turning to real-world data to answer their commercial business questions, but not all realize that unstructured EMR data is the unsung hero of most queries. Whether a manufacturer is struggling to find a niche patient population, conduct unbiased outcomes research, or generate persuasive […]
How Copay Accumulators and Maximizers Affect Pharma PAPs
In a recent post on specialty carve-out mechanisms, we examined how payers’ use of specialty benefit managers and alternative funding programs can impact manufacturers’ patient assistance programs (PAPs). Today’s post takes a look at another managed care trend: the rise of copay accumulators and maximizers, also known as copay adjustment programs. In 2025, copay accumulator […]
GLP-1s and the Evolving Sleep Apnea Landscape
Obstructive sleep apnea (OSA) is a prevalent yet underdiagnosed condition affecting millions worldwide. People with OSA are subject to sudden drops in blood oxygenation levels that can lead to severe cardiovascular, metabolic, and cognitive consequences if the condition remains untreated. Traditionally, OSA has been managed through personal appliances that apply continuous positive airway pressure (CPAP). […]
How Unstructured EMR Data Helps Pharma Find Patients
As therapies have become more complex, pharma companies are now challenged to achieve precision targeting within a much tighter timeframe. While claims data is readily available, one of its key limitations is the lack of timeliness. Many manufacturers now rely on specialized lab data—from imaging results to genetic testing and genomics—to identify eligible patients and […]
Alzheimer’s Drugs Face Uncommon Market Access Challenges
Approximately 6.9 million Americans aged 65 and older have been diagnosed with Alzheimer’s disease (AD). By 2060, prevalence could reach 13.8 million if no therapies are approved to prevent or cure AD. For decades, Alzheimer’s treatment focused on symptom management, with stagnant progress in experimental breakthroughs. That changed recently with the development of beta-amyloid targeting […]
Promoting Your Brand: Six Steps for Success
Months and months of market access planning occur long before a new therapy is approved. Once that therapy is finally on the market, pharma companies must then turn their attention to the art of effective brand promotion. While the first step is identifying the right prescribing physicians, how manufacturers engage with these HCPs is equally […]
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 […]
Market Access Trends Impacting Your Patient Assistance Program
Payers tend to manage high-cost, high-complexity disease states quite differently than other indications. In recent years, payers’ growing reliance on managed care carveouts, in the form of specialty benefit managers (SBMs) and alternative funding programs (AFPs), has directly impacted pharma companies that offer patient assistance. This year, the downstream effects of the Inflation Reduction Act […]