Orphan Drug Development Amid Regulatory Uncertainty
Policies within the IRA and at the FDA in response to recent litigation could influence commercialization decisions for orphan drugs and may need to be clarified by policymakers.
Policies within the IRA and at the FDA in response to recent litigation could influence commercialization decisions for orphan drugs and may need to be clarified by policymakers.
With higher plan liability under Part D benefit redesign, risk adjustment could play a larger role in how plans set formulary design and contracting strategies.
The Inflation Reduction Act (IRA) brings some of the biggest changes affecting the pharmaceutical industry in the last decade. Avalere expert Megan West discusses how these shifts will impact pharmaceutical organizations and how Avalere can support in developing strategies to mitigate risk and identify opportunities across the product lifecycle.
Avalere expert Rebecca Yip discussed plan and beneficiary responses to IRA policies during our 2023 Outlook webinar.
The IRA’s drug price negotiation policies, extended marketplace subsidies, and Part D redesign will impact investors’ current portfolios and investment strategy in the future.
An Avalere analysis finds that about 800,000 beneficiaries in 2024 and 200,000 in 2025 will have OOP costs that exceed 10% of their annual income.
Avalere identified 19 states that must change their Medicaid vaccine policies to comply with the IRA’s requirement that states cover all recommended vaccines without cost sharing.
IRA would lead to a minimum 47% add-on payment reduction on average for Medicare providers who furnish the Part B drugs initially targeted for negotiation.
Government price-setting provisions in the IRA have highlighted the diverse nature and interpretation of value across the US healthcare system.
The IRA will expand adult vaccine access by mandating coverage without cost sharing for all adult vaccines in Medicare Part D and Medicaid.
Join us for a live, expert discussion on life sciences industry trends to watch in Q4.
Understanding where federal agencies will make key determinations on details of the IRA’s policies will be crucial for stakeholders seeking to shape implementation and prepare for their impact.