White Papers’ Findings Accepted for Poster Presentation at AMCP Nexus 2020 Meeting
PRINCETON, N.J.—2020 年 10 月 6 日. Certara, a global leader in biosimulation, today announced that its Evidence & Access group has published a series of four white papers on key trends poised to shape U.S. market access. The series titled “Disruptive Trends in U.S. Market Access 2020 – 2023” was based on research with leading U.S. managed care stakeholders, representing a total of nearly 200 million U.S. lives.
Findings from the research have been chosen for a poster presentation at the Academy of Managed Care Pharmacy (AMCP) Nexus 2020 meeting to be held October 20 – 23, 2020. The lead poster was awarded the prestigious gold ribbon by AMCP earlier this year. Additionally, Certara Evidence & Access will share key findings in a two-part webinar series, with the first one on October 8th at 11 a.m. ET.
“COVID-19 has refocused the spotlight on access to care in the U.S.,” says Justin Edge, president of Regulatory and Access at Certara. “I am pleased that Certara is contributing a fact-based view of market access trends that can inform decision-making by manufacturers, payers, providers and policy makers.”
The white papers combine primary research with secondary evidence, drawing on literature reviews, surveys, and in-depth interviews with active voting members of Pharmacy & Therapeutics committees in U.S. managed care organizations.
“Current systems in place in the U.S. are not sufficient to manage the coming wave of transformative therapies,” said Roman Casciano, general manager of Certara’s Evidence and Access group. “It is therefore critical that innovators come with an objective assessment of their products’ value and fully understand alternative financing solutions available to address payer concerns.”
The new white paper series is available for download online. Below is a summary of topics covered.
The Rise of Cost Effectiveness Considerations in the U.S.
Certara finds a growing desire among payers to see the appraisal of pharmaceuticals based on cost-effectiveness analysis, like that of ICER, the nation’s self-proclaimed independent watchdog on drug value and pricing. Most payers acknowledge a need to consider ICER reports during their drug evaluation process and many are open to seeing an official U.S. agency conduct cost-effectiveness research.
Innovative Financing for Novel Therapies
The emergence of gene therapy and other transformative therapies has magnified concerns about affordability among payers, providers and patients. In this report, Certara assesses novel payment innovation such as performance contracts, annuities, reinsurance/stop loss, and subscription models.
The Escalating U.S. Policy Environment
In recent years, health policy pushes have seen an increasing focus on drug costs. Proposals have embraced concepts like price referencing, transparency requirements, and drug importation. In this report, Certara examines congressional legislation and commercial payer positions on these approaches. The data reveal little opposition to policies such as international reference pricing or drug importation.
Key Trends in U.S. Specialty Pharmacy
Certara analyzes payer perspectives and identified developer strategies as they relate to the shifting landscape of specialty drug coverage, utilization management restrictions, and the disruption of U.S. distribution channels. About 60% of new molecular entities awaiting FDA approval through 2021 can be classified as specialty pharmaceuticals.
Register here to attend the webinar on October 8th on payment pressures in the specialty access landscape.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
Elizabeth Tang, Ph.D. 212-715-1579