The Institute for Clinical and Economic Review (ICER) has published the protocol for its first annual “Launch Price and Access Report.” This essential drug pricing analysis evaluates launch prices and patient access to FDA-approved drugs from 2022 to 2024. The report will analyze list and net price trends of novel therapies, and it will also examine the relationship between drug characteristics and pricing. Also, it will assess affordability and access—including coverage restrictions and patient cost-sharing—and compare drug costs to ICER’s Health Benefit Price Benchmarks (HBPBs).

Rising Costs and Access Challenges

The protocol highlights that drug launch prices in the US have dramatically increased. Many new drugs are priced above $200,000 annually. Recent analyses reveal that median annual prices for new drugs have surged to $300,000 in 2023. This reflects a concerning 35% rise over the previous year. ICER emphasizes the disconnection between elevated launch prices and tangible clinical efficacy. It notes scant evidence that R&D expenses justify these high prices. This challenges the common industry narrative used by manufacturers.

High prices, delayed coverage, prior authorization requirements, and substantial out-of-pocket costs increasingly limit patient access. Nearly half of surveyed patients with chronic conditions report difficulties accessing prescription drugs. ICER also aims to quantify direct cost and access issues. It will consider broader opportunity costs, such as health outcomes sacrificed when overspending on drugs diminishes resources for other care options. The report’s framework benefits from contributions by a diverse working group. This includes clinicians, payers, patient advocates, and industry representatives. Their input ensures a comprehensive perspective that enhances policy relevance.

Impacts on Economic Evaluations and Drug Accessibility

• Advancements in Health Economics and Outcomes Research (HEOR): By systematically evaluating launch and net prices against value benchmarks and access barriers, the ICER report lays down an evidence-based groundwork. This is vital for determining whether new drugs provide adequate value for their costs—a key step towards enhancing resource allocation.
• Influencing Market Access and Reimbursement Policies: The findings may affect payer policies. This could lead to changes in coverage, formulary design, and patient cost-sharing that better align with value-based frameworks. Such changes would improve affordability and equity.
• Shifts in Pricing Strategies: The focus on opportunity costs and overall health impacts may propel demands for launch pricing that closely correlates with demonstrated clinical benefits. This could pressure pharmaceutical companies to adopt more transparent and value-oriented pricing models.
• Catalyst for Future Policy Changes: With bipartisan support accentuating the urgent need for greater drug affordability and transparency, ICER’s annual report could be a catalyst for further policy reforms. This would support initiatives aimed at curtailing excessive pricing and ensuring sustainable patient access.

Conclusion: Bridging Analysis and Accessibility

ICER’s initiative is particularly timely, as public and policy scrutiny intensifies regarding US drug pricing. By merging rigorous economic analysis with the realities of patient access, the upcoming Launch Price and Access Report is set to become a crucial resource. It will help stakeholders address the ongoing conflict between innovation, value and affordability in the pharmaceutical market.