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 25 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 has partnered with test manufacturers for more than 30 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 has 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.
Smart technologies, artificial intelligence and machine learning
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 approaches in new data channels to characterize unique aspects of the e-connective patient and physician experience.