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Payer-Pharma Perspectives on Outcomes-based Contracting

The adoption of outcomes based agreements (OBA) is growing given the urge among payers to reduce their exposure to risks of uncertain clinical value and budgetary impact, and the demand for drug manufacturers to demonstrate real world value to justify new, high-priced therapies and guarantee access to existing products exposed to increasing rebate levels. Prior to discussing practical considerations for the OBA implementation in this white paper, we’ve included the voices and rationales of two seasoned OBA pioneers and let you be party to their personal reflections.

Author(s): Ulrich Neumann, Emmanuel Coeytaux
Solution: Evidence and Access
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The Shifting Landscape for Outcomes-Based Contracting

As health systems are driven to accept increasing accountability, payers and providers are looking for the biopharmaceutical industry to share the risks around performance of their products. Outcomes-based agreements (OBA) can be seen as the next chapter of the pay-for-value trend wherein the reimbursement for the pharmaceutical product is tied to the measurable ‘real world’ value it provides in terms of predefined outcomes.

Author(s): Ulrich Neumann, Emmanuel Coeytaux
Solution: Evidence and Access
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The Six Stages to a Successful Value-Based Risk-Sharing Agreement

Outcome based agreements (OBAs) are a type of value-based risk sharing agreement between payers and drug manufacturers. OBAs are a useful tool for managing uncertainty regarding a drug’s real world clinical benefit, the economic impact to a payer’s budget, and market penetration. Read this white paper to learn about a six-stage process that will put you on the right path for attaining a successful OBA!

Author(s): Ulrich Neumann, Emmanuel Coeytaux
Solution: Evidence and Access
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Supporting the Approval of a Treatment for a Neglected Tropical Disease

Medicines Development for Global Health (MDGH), a not-for-profit biopharmaceutical company, needed integrated, model-informed drug development expertise to support developing a treatment for river blindness. Learn how Certara’s clinical pharmacology, pharmacometrics, and regulatory strategy expertise yielded a significant financial, scientific, and regulatory ROI to MDGH.

Solution: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease
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Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.

Author(s): Piet van der Graaf, Andrzej Kierzek
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
Therapeutic Area: Oncology/Hematology, Rare/Orphan Disease
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Managing Immunogenicity Using Quantitative Systems Pharmacology

Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.

Author(s): Piet van der Graaf, Andrzej Kierzek, Timothy Hickling
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
Therapeutic Area: Cardiovascular, Central Nervous System, Dermatology, Endocrinology, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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