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.
Which Therapeutic Areas Are Likely to Be Affected by IRA Negotiation?
Sponsors with portfolio or pipeline assets within certain therapeutic areas can prepare for the downstream effects of price negotiation on the market.
Should Competitors of Negotiated Drugs Review Their Market Strategies?
Manufacturers of therapeutic alternatives to negotiation-eligible drugs should re-examine their commercialization strategies in response to market dynamics.
Assessing the MA Risk-Adjustment Model’s Accuracy Among Subpopulations
The accuracy of the CMS-HCC model differs by beneficiaries’ race and ethnicity.
MDRP Proposal Will Impact Vaccine and Novel Immunization Landscape
The proposed vaccine definition would have a significant market impact on novel immunizations such as preventive immunoglobulins and therapeutic vaccines.
Should Competitors of Negotiated Drugs Review Their Evidence Strategy?
Manufacturers of therapeutic alternatives to negotiation-eligible drugs should examine their value and evidence strategy in response to new dynamics.
Will the IRA Change Investment in Orphan Drug Pipelines?
IRA negotiation eligibility criteria may impact orphan drug investment, affecting long-term innovation and patient access.
ISPOR 2023 Presentation: The Future of Value and Evidence Strategy
Avalere’s expert presentations at ISPOR described the IRA’s impact on evidence strategy and highlighted a recent study to capture total disease burden.
Clinical and Market Differentiation of Combination Products
Combination products may offer differentiation but require consideration of unique decisions with regulatory and market access implications.
How Do IRA Drug Pricing Policies Interact with One Another?
Stakeholders should consider the interaction of inflation-based rebates, AMP cap removal, and Medicare price negotiation in pricing and contracting strategies.
Hospital at Home: Opportunities for Manufacturers and Digital Health
The COVID-19 public health emergency and advancements in digital health technologies accelerated the adoption of Hospital at Home, a promising acute-care delivery model.
Insights on IRA Policies and Business Impacts Presented at Asembia
Avalere’s expert presentations at the AXS23 Summit described IRA drug-pricing policies and the law’s impact on patient access and affordability.
EOM Payment Methodology Updated as Start Date Approaches
Amid stakeholder speculation for the future of the EOM, CMMI continues to plan for July 2023 implementation and released key payment methodology details.
US Supreme Court Will Hear Case Affecting Agency Power
The Supreme Court is expected to hear oral arguments in Loper Bright Enterprises v. Raimondo, which challenges Chevron deference.
CAR-T Reimbursement Updates Proposed for FY2024
Policy proposals for Medicare’s CAR-T inpatient reimbursement reflect additional cases and increase clinical trial payment.
Pipeline Transformative Therapies May Require Payment Model Innovation
Avalere’s assessment highlights a diverse set of over 200 products in development that could challenge payment models across care settings and payers.
What’s Next for Patient-Centered Value?
A significant push towards patient-centered value has occurred in recent years, yet a validated instrument to collect patient-centered data has not been established. The Patient Perspective Value Framework (PPVF) Initiative offers an approach for addressing this missing piece.
Digital Health Technology Access Requires Early FDA, Payer Engagement
As digital health technologies evolve, manufacturers seek clarity on regulatory pathways and access channels.
Do Drug Manufacturers Have the Evidence Needed for Price Negotiation?
Manufacturers may find significant gaps between their existing evidence and the negotiation data elements that CMS will evaluate during the negotiation process.
Operational Complexities of Providing Access to MFP for Part D Drugs
Stakeholders in the drug supply chain should consider operational complexities that will result from variable arrangements for accessing the MFP.
Braidwood Ruling’s Impact on Preventive Service Access
168 million individuals could lose access to $0 preventive services, creating pressure for healthcare stakeholders to address access and equity concerns.