Key Disruptive Trends That Shape U.S. Market Access

Based on research with leading U.S. managed care stakeholders, representing a total of nearly 200 million U.S. lives, Certara has published a new series of whitepapers titled, “Disruptive Trends in U.S. Market Access 2020 – 2023”.Findings from the white papers have been accepted for poster presentation at the Academy of Managed Care Pharmacy (AMCP) Nexus 2020 Virtual meeting to be held October 20 – 23, 2020. One poster was awarded the prestigious gold ribbon by AMCP. Certara will share these findings in a two-part webinar series, starting on October 8th at 11am ET. Register Here to join us.

Findings in the four reports were based on a qualitative research methodology, which included conducting online surveys among active voting members of Pharmacy & Therapeutics (P&T) committees through Certara’s Compass research network, in-depth interviews, and literature reviews.

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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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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 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.

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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.

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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.

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Join Us for the first of two live webinars. Hurry, space is limited:

To allow for the optimal positioning of your product, portfolio, or company, it is critical to understand the various forces that shape the US specialty access landscape. Certara’s teams have been tracking a wide range of critical market access developments in the US for over two decades. In this webinar, we will share some of the broader and more ubiquitous market trends we have recently uncovered.

Based on proprietary research with a panel of 31 payers representing over 198M lives, our experts will be looking at the increasing volume control over prescribed therapies by various payer types, present new data on tighter formularies and stricter utilization management, and current payer cost shifting strategies.

We will also be giving guidance on future policies, some of which offer a drastic redesign of the current landscape as we know it today.


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