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 […]
Patient Access Barriers in 2025 and Beyond
The landscape of patient access has become increasingly complex, intensified by evolving channel dynamics, greater biosimilar investment, and legislative reform. As payers evolve their utilization management tactics, manufacturers must also become more sophisticated in their access strategies. To explore these topics, MMIT and The Dedham Group conducted the second annual State of Patient Access Survey […]
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 […]
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 […]
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 […]
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, […]
Solving Access Barriers in Biomarker Testing: 5 Tips for Manufacturers
Despite the rapid evolution of personalized medicine, access to genetic testing and next-generation sequencing (NGS) is a challenge—due in no small part to coverage confusion. Physicians struggle to navigate poorly defined testing coverage policies and a fragmentated payer and vendor ecosystem, resulting in delayed care for patients requiring precision therapies. While biomarker testing and NGS […]
Leaning into Real-World Evidence: Lessons from the IRA
Manufacturers are continuing to wrestle with the effects of the Inflation Reduction Act (IRA) on their business plans and revenue streams. Although some of the IRA’s impacts are still uncertain, real-world evidence (RWE) is an important tool for manufacturers navigating the road ahead, as it will help them demonstrate the value and comparative effectiveness of their treatments. […]
Four Trends That Are Shaping the Future of Market Access
In pharma, every year seems to bring forth even more change than the year before, but 2023 just might take the cake. Stakeholders have had to adjust to new developments in the healthcare ecosystem such as the Inflation Reduction Act, the rise of immunology biosimilars and insulin price changes impacting payer rebate economics, and the […]
How Much Does Medication Compliance Affect Site-of-Care Optimization?
In an effort to lower the cost of specialty drugs, many payers have initiated site-of-care optimization strategies. By encouraging patients to receive therapies in more cost-effective settings — such as physician offices, infusion clinics, or at home — payers can reduce unnecessary expenses while ensuring members receive clinically appropriate care. In addition to price concerns, […]