Insights & Analysis
There’s one constant in healthcare: change. Count on us to break down the trends so you can stay up to date. Follow our take on each piece of this deep, intertwined, and often perplexing industry to find opportunities and practical approaches to move healthcare forward.
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A Paradigm Shift in LDT Regulation
The FDA’s final rule to regulate LDTs as medical devices brings on numerous uncertainties for stakeholders.
Breast Cancer Screening Recommendations May Drive Inequities
New USPSTF breast cancer screening recommendations may not address the disparities experienced by Black women.
Health Plans 2030: Evolving Operational Approaches
The first installment of our Health Plans series explains how plans can evolve their approaches to provider contracting and utilization management for the future.
New Resource: State Statute Oncology Drug Coverage Report
A detailed Avalere report offers insights into state-specific statutes guiding commercial payer coverage for off-label use of oncology drugs/biologics.
Adult Seasonal Combination Respiratory Vaccines: Policy Considerations
In a new white paper, Avalere considers key questions related to strain selection, ACIP recommendation, and coverage and reimbursement of adult combination vaccines in development.
Five Data Strategy Questions Pharma Should Ask For 2025
When utilizing and acquiring data, life sciences companies should consider these top questions and key implications for their 2024–2025 strategic plans.
CMMI Quality Pathway Prioritizes Patient-Centered Value
Innovation models will prioritize improving quality and redefine how quality is measured.
Inequities in Medicare Beneficiaries’ Use of Accelerated Approval Products
An Avalere analysis shows the use of drugs approved under the Accelerated Approval pathway across historically underserved Medicare beneficiaries.
CGT Payment Changes Proposed in FY 2025 IPPS Proposed Rule
Medicare CAR-T payment remains stable; CMS proposed structural changes for New Technology Add-on Payments (NTAP).
CMS’s Interpretation of “Qualifying Single-Source Drugs” in Medicare Negotiation
CMS’s definition of a “qualifying single-source drug” in the Medicare Drug Price Negotiation Program may impact manufacturers’ investment strategies.
Key Policy and Access Themes from the World Vaccines Congress
The World Vaccine Congress addressed the changing landscape of infectious diseases and vaccine types, approvals, recommendations, and reimbursement pathways.
Opportunities to Prepare for Year 2 of Medicare Negotiation
Manufacturers anticipating potential selection or therapeutic impact for 2027 Medicare negotiations should begin preparations and align internal decision-making, applying learnings from Year 1.
Trends in Generic Tiering in Medicare Part D, 2011–2021
From 2011 to 2021, there was an increase in higher formulary tiering, patient out-of-pocket spending, and negotiated price for a cohort of generics.
Upper Payment Limits on Drugs Could Alter Patient Access
State approaches to PDABs and UPLs vary, but all approaches could impact patient access and affordability.
A More Complex Future Market for Diagnostics?
With regulatory changes on the horizon, diagnostics stakeholders should prepare for a new evidence development and commercialization environment.
Research Explores Health Plan Perceptions of PDABs and UPLs
Avalere assessed how health plans may view UPLs, including implementation considerations and impacts on providers and patients (e.g., plan benefit design).
2024: An Era of Innovation and Disruption in Kidney Care
A dynamic regulatory landscape, technological advancements, and investments in R&D offer new opportunities and challenges in kidney care.
Forthcoming Regulatory Changes for Lab-Developed Tests
This spring, the FDA will issue a rule to begin regulating LDTs as medical devices. A multi-faceted legislative, legal and market response is anticipated.
Payment Barriers Persist for Vaccinating Providers
Following policy changes addressing vaccine coverage gaps, stakeholders are focusing on provider financial and administrative barriers to vaccination.
A Collaborative Approach to Incorporating AI in RWE
Stakeholders can collaborate to ensure the safe, ethical, and effective use of AI-based tools to bolster RWE and improve patient outcomes.