Precision and Transformative Technology Solutions

What We DO

  • Publications

    Publication

    GBEMTI Perspectives - Is Managed Care Prepared for Regenerative Medicine? Early Landscape and Reimbursement Considerations. J Manag Care Med. 2017; 20(1):52-67. ABSTRACT

    Publication

    Developing Appropriate Evidence for Demonstrating the Value of Diagnostics: Where are We Now and What is Appropriate for the Future State? J Manag Care Med. 2016; 19(4):66-78. ABSTRACT

    Publication

    Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group. Value Health. 2016 Jul-Aug;19(5):577-87. doi: 10.1016/j.jval.2016.02.012. Epub 2016 May 11. ABSTRACT
    See More
  • Presentations

    ISPOR Forum

    F3: Generating Evidence of the Added Value of "Precision" Medicine

    ISPOR 19th Annual European Congress – 2016:

    Vienna, Austria
    29-Oct-2016

    Authors/Presenters: Shaya F, Payne K, Faulkner E, Siebert U, Holtorf AP, Sandhu G

    Year: 2016

    Issue Panel

    How to Improve the Integration of Precision Medicine and Multi-Biomarker Diagnostic Tests in Healthcare Systems

    World CDx – 2016:

    Boston, MA, USA
    18-Oct-2016

    Authors/Presenters: Whelan J, Pezalla E, Roth D, Mills Shaw K, Fiore L, Faulkner E

    Year: 2016

    Poster

    PMD3: Clinical Utility of Early Multigene Genetic Testing in Pediatric Patients with Suspected Seizure Disorders and Syndromic Epilepsies

    ISPOR 21st Annual International Meeting – 2016:

    Washington, DC, USA
    21-May-2016

    Authors/Presenters: Faulkner E, Spinner DS, Cardeiro D, Stanley CM, Foss TR, Zare AS, Boles RG, Le NM

    Year: 2016

    See More
  • Fact Sheets

    Fact Sheet

    A Global Leader in Regenerative and Advanced Therapies
    Download

A new generation of innovative health technologies are emerging with recent advances in science and technology. These “precision and transformative” technologies increase the precision of patient care, have the potential to fundamentally alter disease management, and by their very nature, have limited market precedent.

Precision and transformative life science technologies face unique challenges for value demonstration and access, requiring special expertise to optimize product potential.

Evidera recognizes that precision and transformative life science technologies are different. We therefore channel our considerable expertise in this area to provide solutions tailored to the specific needs of these kinds of products.

Having a Partner with Strong Innovative Health Technology Value Demonstration, Market Access, and Commercial Expertise Matters

  • We Understand Your Technology: Evidera has deep experience in the core transformative technology types and leverages solutions that fit your technology.
  • We’ve Been There Before: More than 20 years of experience helping anticipate hurdles and navigate innovative technologies into the global marketplace.
  • We Understand that Transformative Technologies Require Creative Solutions: Hands-on experience addressing value demonstration and market access challenges for technologies with little or no precedent.
  • We Span All Stages of Development: Experience ranging from new product planning, through all stages of evidence development, to market access and commercial strategy.
  • We’re Active in Key Transformative Technology Practice and Policy Issues: Recognized thought leaders active in the global precision and transformative technology practice and policy dialogue, including development of new methods and evaluative approaches built to address novel and complex value considerations associated with different technology types.

By integrating our deep innovative technology expertise across our business with our proven, world-class capabilities in health economics, outcomes research and market access, we are the partner of choice for successfully advancing cutting edge, precision, and transformative health technologies.

Offerings

Precision medicines

Successful commercialization of precision medicines extends beyond the strategies for conventional drug strategies. Knowing the unique implications of the diagnostic on precision medicine uptake and how each market handles precision medicines are examples of critical success factors. Evidera has expertise in all aspects of demonstrating the value of precision medicines, achieving market access, and developing commercial strategy. We have worked with all of the leading manufacturers for more than 20 years. Centers of Excellence and best practice models have been established to help companies address unique product value demonstration and differentiation opportunities.

Diagnostics, companion diagnostics, and next generation testing

Building the right clinical and economic value story can seem a moving target for diagnostics, with no agreement on “rules of the road” among decision makers. Our expert staff have partnered with test manufacturers for more than 20 years to develop value demonstration solutions and overcome specific reimbursement challenges facing stand-alone diagnostics, companion diagnostics, and next generation tests.

Cell, gene, and regenerative medicine therapies

Out-of-the-box thinking is required to successfully navigate regenerative therapies through global systems that have not anticipated these kinds of interventions. Regenerative medicines have limited precedent, challenging reimbursement “fit, ” in addition to requiring novel value considerations, such as the potential to cure disease. Evidera has significant expertise in value demonstration and reimbursement strategy for regenerative medicines. Our staff has supported more than 40 technologies in this emerging area, each with unique commercial challenges.

Orphan, rare disease, specialty treatments

Orphan, rare disease, and specialty treatments face special value demonstration challenges. These include uncertainty around supporting evidence, evolving Health Technology Assessment (HTA) scrutiny, and growing commercial and policy hurdles. Evidera has partnered with orphan drug manufacturers on more than 100 projects to optimize their value proposition. We have helped align access and commercial efforts to changing requirements for this growing category.

Immunotherapies, novel biologics, and therapeutic vaccines

Immunotherapies and advanced biologics offer great promise for improving outcomes by leveraging the body’s own capacity to heal. Unique attributes such as prolonged duration of therapeutic effect and novel administration regimens can also make their value demonstration more complex and stretch current reimbursement mechanisms. Evidera has significant experience in emerging immunotherapies and novel biologics. We understand that greater manufacturer diligence in market access and commercial planning is key for their success and have conducted approximately 200 projects for immuno-targeting biologicals, including novel cell-based approaches.

Medical devices and combination products

An important challenge facing devices is ensuring that value demonstration is aligned to optimize market access and return on investment, without being over-engineered. Evidera has more than 30 years of experience in health economics, outcomes research and market access for medical technology. Our staff have helped leading device manufacturers develop “first” value dossiers, creatively address common evidence gaps, and navigate global reimbursement challenges in a manner that “fits” medical devices.

E-connective technologies

A new wave of e-connective technologies is emerging that will transform how patient data is collected and used. These technologies range from “smart” technologies to advanced telemonitoring and patient media interfaces. Evidera has worked to align the “value add” of the e-connective technologies to conventional product attributes to craft a more holistic product value story. We can also leverage our pioneering approaches in new data channels to characterize unique aspects of the e-connective patient and physician experience.

What We DO

  • Publications

    Publication

    GBEMTI Perspectives - Is Managed Care Prepared for Regenerative Medicine? Early Landscape and Reimbursement Considerations. J Manag Care Med. 2017; 20(1):52-67. ABSTRACT

    Publication

    Developing Appropriate Evidence for Demonstrating the Value of Diagnostics: Where are We Now and What is Appropriate for the Future State? J Manag Care Med. 2016; 19(4):66-78. ABSTRACT

    Publication

    Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group. Value Health. 2016 Jul-Aug;19(5):577-87. doi: 10.1016/j.jval.2016.02.012. Epub 2016 May 11. ABSTRACT
    See More
  • Presentations

    ISPOR Forum

    F3: Generating Evidence of the Added Value of "Precision" Medicine

    ISPOR 19th Annual European Congress – 2016:

    Vienna, Austria
    29-Oct-2016

    Authors/Presenters: Shaya F, Payne K, Faulkner E, Siebert U, Holtorf AP, Sandhu G

    Year: 2016

    Issue Panel

    How to Improve the Integration of Precision Medicine and Multi-Biomarker Diagnostic Tests in Healthcare Systems

    World CDx – 2016:

    Boston, MA, USA
    18-Oct-2016

    Authors/Presenters: Whelan J, Pezalla E, Roth D, Mills Shaw K, Fiore L, Faulkner E

    Year: 2016

    Poster

    PMD3: Clinical Utility of Early Multigene Genetic Testing in Pediatric Patients with Suspected Seizure Disorders and Syndromic Epilepsies

    ISPOR 21st Annual International Meeting – 2016:

    Washington, DC, USA
    21-May-2016

    Authors/Presenters: Faulkner E, Spinner DS, Cardeiro D, Stanley CM, Foss TR, Zare AS, Boles RG, Le NM

    Year: 2016

    See More
  • Fact Sheets

    Fact Sheet

    A Global Leader in Regenerative and Advanced Therapies
    Download
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