New Treatments, Diagnostic Tests and Access Barriers in NSCLC
The oncology market is growing rapidly, driven by advancements in diagnostic technology, new biomarker testing, and a wealth of targeted therapies. The non-small cell lung cancer (NSCLC) space is especially crowded, which should be good news for the 226,000 patients diagnosed with this disease each year. Despite the new developments in NSCLC treatment, however, many […]
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
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 proof points, unstructured data can fill in the […]
Increased Competition Drives Biosimilar Market Shifts
For the past decade, biosimilar adoption in the U.S. has proceeded at a relatively slow pace, due in large part to limited financial rebates for payers and provider preferences for biologics. Recent research suggests that utilization is finally picking up steam as more health plans place both biosimilars and their reference biologics on preferred formulary […]
Expanding Molecular Testing: What Payers and Manufacturers Should Know
Medicine has been trending towards personalization for decades. The growth of individualized medicine and new diagnostic technologies has resulted in drugs that are tailored towards patients’ profile and condition—and are much more effective as a result. These therapies rely on the existence of molecular tests, including genetic testing, predictive and prognostic biomarkers, and companion diagnostics. […]
Changing Payer Management Dynamics at Play in Oncology
When it comes to the degree of payer management within a therapeutic area, pharma companies are becoming the victim of their own successes. One prime example is the rapid growth of competitive therapies across tumor types, pharmacological classes, and mechanisms of action in oncology. Payers have responded to the launch of more innovative and highly […]
Unlocking the Pathway Puzzle: How Biopharma Can Navigate the Clinical Pathways Landscape
In the realm of oncology, the advent of clinical pathways has gained substantial traction in the past two decades as the increasing cost and complexity of cancer care demanded structured, multidisciplinary, and cost-effective approaches. Pathways have become a critical strategy for both physicians and payers to streamline treatment decision-making, standardize evidence-based care, improve patient outcomes […]
What Pharma Needs From RWD: Top 5 Trends
The explosion of real-world data (RWD) now available to pharma companies can be overwhelming. While many larger manufacturers with their own teams of data analysts have been using RWD for years, smaller manufacturers are just beginning to incorporate RWD into their clinical development and market access strategies. Which data sets do they need, and how […]
Using Real-World Data to Improve Patient Access to Oncology Therapies
Many oncology manufacturers assume that a therapy’s inclusion on clinical pathways is more important than its coverage profile, but this isn’t always true. Across every oncology class, manufacturers need to know which organizations—IDNs, provider organizations, payers or PBMs—have the biggest positive and/or negative influence on their products’ utilization. Patient access can easily be blocked by […]