A Collection of Key Disruptive Trends That Shape U.S. Market Access
Certara has published a new series of whitepapers titled, “Disruptive Trends in U.S. Market Access 2020 – 2023” based on research with leading U.S. managed care stakeholders, representing a total of nearly 200 million U.S. lives. Findings from the white papers have been accepted for poster presentation at the Academy of Managed Care Pharmacy (AMCP) Nexus 2020 Virtual meeting. This poster was awarded the prestigious gold ribbon by AMCP.
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The Rise of Cost Effectiveness Considerations in the U.S.
In this analysis, Certara found there is a growing desire among payers to see the appraisal of pharmaceuticals based on quality adjusted life years (QALYs), like that of ICER, the nation’s self-proclaimed independent watchdog on drug pricing. To insurers, ICER offers limited value as a budgetary-decision framework as pricing recommendations are not easily translated into coverage. Most payers acknowledge the need to consider ICER reports during the drug evaluation process.
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The emergence of gene therapy and other transformative therapies has magnified concerns about affordability among payers, providers and patients. In this report, Certara analyzed milestone-based outcomes contracts for payment innovation, annuities payments/installment financing, reinsurance/stop loss, and subscription-based pricing. Despite heightened excitement around innovative financing models, managed care organizations (MCOs) see comparatively little to no current use.
The Escalating U.S. Policy Environment
In recent years, health policy pushes have seen an increasing focus on drug costs and pricing processes. Regulatory moves address issues such as volume control, drug pricing transparency, and importation. In this report, Certara examined congressional legislation such as the “Lower Drug Costs Now Act” and payer positions on drug pricing proposals. Except for large plans, payer representatives on average do not oppose government price setting or drug importation.
Key Trends in U.S. Specialty Pharmacy
In this report, Certara analyzed payer perspectives and identified developer strategies as they relate to the shifting landscape of specialty coverage, utilization management restrictions, and disruption of distribution channels. In 2019, approximately two-thirds of the 48 novel therapies approved by the U.S. FDA in 2019 were specialty drugs. About 60% of new molecular entities awaiting FDA approval through 2021 can be classified as specialty pharmaceuticals.
