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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Contextualizing Artificial Intelligence for HEOR in 2023
ChatGPT marked an AI inflection point decades in the making—with implications for health economics and outcomes research.
ESRD Enrollment in MA Now Exceeds 30% of Dialysis Patients
New analysis finds that just over 40,000 Medicare FFS patients with end-stage renal disease (ESRD) elected to enroll in Medicare Advantage during the 2021 open enrollment period—the first time all ESRD patients had access to an MA plan. This enrollment shift increased the proportion of ESRD patients enrolled in MA from 23% to 30%.
CBO Considers Cost of Increasing Anti-Obesity Medication Use
Insurance coverage of anti-obesity medications is increasing, but patient access under Medicare remains uncertain.
Proposed Shifts in Oversight of Lab-Developed Tests
The FDA proposed to begin regulating LDTs as medical devices over the next 5 years. This has important implications for market dynamics and clinical care.
IRA Drug Price Negotiation Impact on Cardiovascular Drugs
A new Avalere white paper raises important considerations on potential added lifecycle pressures for sponsors of cardiovascular disease products.
HEOR Trends: Patient-Centricity
The patient perspective should be incorporated across the care spectrum, including clinical research and drug development, care decisions, outcomes measures, and how value is defined.
Part D Premiums Increasing Despite Stabilization Program
While the premium stabilization program under the IRA limits the growth of the base beneficiary premium, individual plan premiums vary.
Manufacturer Considerations for Rare-Disease Drug Development
The development and launch of rare disease therapies require tailored strategies that account for unique patient journeys and the broader evolving landscape.
How Will 340B Discounts Interact with Negotiated Drugs’ MFP?
The IRA requires covered entities to pay the lesser of a drug’s 340B ceiling price and MFP, presenting operational complications for manufacturers and providers.
Kidney Transplantation: Current Barriers and Evolving Policies
Longstanding barriers have limited rates of kidney transplantation, but recent changes in the policy landscape may signal changes for patients and providers.
Part D Premium Increases, Market Disruption Expected in 2024
Over 8 million enrollees in standalone PDPs could see an increase of more than 25% in their premium in 2024.
Influenza B Strain Removal Could Impact Future Flu Vaccines
WHO and VRBPAC recommendations to move back toward trivalent influenza vaccines may cause significant shifts in the global flu vaccine landscape.
Court Ruling Will Limit Accumulators
A district court’s decision to strike down the 2021 NBPP is the latest policy update on the use of copay adjustment programs, but questions persist.
Opportunities for Rare Disease Drug Manufacturers
Rare disease drug manufacturers can advance clinical development through FDA programs aimed at facilitating pipeline innovation.
How the Transitional Drug Add-On Payment Adjustment Works
The TDAPA supports payment and patient access to new therapies introduced to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). CMS has continued to refine the payment designation through rulemaking. Stakeholders should continue to monitor this payment-adjustment policy, as it has evolved since its introduction and may continue to change in future rulemaking cycles.
2023 Top Trends in Health Economics and Outcomes Research
Avalere identified the top trends in HEOR and key implications for life sciences companies to consider for their 2024 strategic plans.
Third Party to Assess Value of Digital Health Technology
As the US value assessment landscape evolves, a new third-party framework may standardize requirements and open reimbursement pathways for digital health.
Guide to Vaccine Coverage Policies
The IRA expanded vaccine access, but variations in federal policies governing vaccine coverage requirements and implementation remain
SNF 3-Day Waiver Use During the COVID-19 Pandemic
Use of the 3-day waiver was stable over the course of the pandemic, though shifts in admission sources were observed.
How Can Manufacturers Help Shape Medicare Negotiations?
Manufacturers should reevaluate CMS engagement strategies as soon as possible to maximize the opportunity to influence the IPAY 2026 Medicare negotiations.