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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ACNU Provides a New FDA Approval Pathway for Prescription-to-OTC Drugs
The ACNU final rule provides a new approval pathway for prescription drugs to also gain nonprescription marketing status.
White Paper: The Role of PBMs in the US Healthcare System
A new white paper describes the role of PBMs in the US healthcare system using evidence published in the literature to inform future discussions.
MFN EO Raises A Range of Potential Options for DTC Implementation
A DTC purchasing program could take various forms to enable patients to access MFN pricing.
White Paper: Provider Survey on Part B Step Therapy in Medicare Advantage
Step therapy is a form of utilization management increasingly used by health plans, including Medicare Advantage plans, with the stated intent to guide prescribing decisions toward cost-effective, evidence-based therapies.
Part D Cost Pressures May Shape Future Alzheimer’s Drug Management
As new Alzheimer’s drugs are developed, increased plan liability pressures may shape future Part D plan management strategies
Avalere Health Experts React to the Most-Favored Nation Executive Order
A new EO revives international reference pricing as a core Trump administration priority, with a focus on Most-Favored Nation pricing through direct-to-consumer models, regulatory action, and broader enforcement measures.
White Paper: The Cost of Opioid Use Disorder
Avalere Health finds opioid use disorder costs businesses, governments, and households almost $1 trillion per year, but treatment with medications can lower costs.
RWE Data Management Lessons Applicable to NIH Autism Database
The NIH recently announced plans to develop an RWE database to study autism spectrum disorders. In doing so, they can learn lessons encountered by life sciences companies developing data ecosystems for their products.
Manufacturers Must Adapt to Growing GLP-1 and GIP/GLP-1 RA Markets
As the GLP-1 product market continues to expand, manufacturers must find ways to differentiate their inline and pipeline assets with new evidence and strong value story.
New Clinical Trial Requirements Could Affect Vaccine Development
Reports that all new vaccines could require placebo-controlled testing are raising stakeholder concerns about the future of vaccine development, approval, and access.
Commercial Step Therapy May Include Steps Beyond FDA Label
Across three therapeutic areas, an Avalere Health analysis identified commercial plan coverage policies with more steps than indicated by drugs’ FDA labels.
Understanding the Scope of CIDRAP’s Vaccine Integrity Project
The Vaccine Integrity Project aims to maintain evidence-based US vaccination guidance amidst a dynamic federal policy landscape, although questions remain about the project’s role in the current immunization policy structure.
What the EPIC Act Could Mean for Generics and Medicare Spend
Delaying selection of small-molecule drugs for Medicare negotiation may support the generic market by preserving competition and maximizing long-term savings for payers and the federal government.
CMS Proposes Pay Bump for CAR-T in FY 2026
The inpatient rule proposes a 17% increase for CAR-T stays and several CGTs are under review for New Technology Add-on Payments.
White Paper: Medicaid Reforms’ Impact on Funding for Children’s Healthcare
Avalere Health estimated how three possible changes to federal Medicaid funding could impact national- and state-level funding in total and for children’s services.
Stakeholder Considerations for MFP Effectuation in Part B
Several pathways exist to effectuate the MFP for Part B negotiation with benefits and drawbacks for stakeholders across the drug supply chain.
World Vaccine Congress Highlights Dynamic Policy Environment
Avalere Health connected with other public health stakeholders and vaccine experts at World Vaccine Congress to discuss key policy, access, value, and evidence themes.
USPSTF at a Crossroads: Preventive Care Coverage Mandate at SCOTUS
The Supreme Court weighs a case that could reshape access to no-cost preventive services under the ACA and redefine USPSTF's legal authority
Site of Care Optimization Offers Savings for Specialty Services
Across physician specialties, Medicare utilization and reimbursement data shows that site-of-care optimization can reduce expenditures for certain healthcare services.
Early Enrollment Data Indicates More Beneficiaries Could Benefit from MPPP
Avalere Health’s analysis of early MPPP enrollment shows that only a small portion of beneficiaries who are likely to benefit from the program have enrolled.