Forging the most promising paths to your success
Communication of the value of a product to key stakeholders is done through market shaping initiatives. Our teams utilize extensive experience to develop P&R strategies and commercially meaningful value arguments across a broad range of therapy areas.
What sets the Certara approach apart?
Our offering stands out as a unique marriage of analytics on the data in real world settings with proven payer strategy on how to best leverage that evidence for reimbursement success. Our focus on value demonstration and evidence development is driven by your product’s real world impact, not its clinical trial results.
In our work with small and large companies as well as for investors, we know that every step matters and that time is of the essence. As a strategic market access partner, we assess the most promising paths to your commercial success.
Early value assessment
Success in the life sciences marketplace is the result of objective, insightful, and accurate assessments of early-stage innovations, followed by comprehensive commercial planning and execution support.
Certara works with healthcare innovators to strategically optimize their market value in the context of financing or partnering deals. Our services include:
- Full asset valuation
- Target patient population selection
- Clinical development strategy
- Competitive landscape analysis
- Early revenue and pricing development
- Preparation and participation in investor and partner meetings
Value frameworks and ICER value assessments
Demands on the certainty of real world performance are increasing, spurring use of structured frameworks to assess clinical and economic value of therapies.
We conduct standard economic and disease modeling, as well as advanced Bayesian decision-modeling. We also investigate value frameworks to support a multi-dimensional assessment of technologies, supporting transparent and participatory deliberations and decision making.
In preparing for Institute for Clinical and Economic Review (ICER) reviews, we recommend a holistic and simultaneous evidence and value strategy. Our “ICER support” is rooted in superior modeling and data generation to highlight potential areas of scientific disagreement with the organizations’ approach and unveil more appropriate evidence capture.
Learn more about ICER and its impact on the pharmaceutical industry in this blog.
Literature reviews
Our systematic, targeted & rapid reviews are used to quantify clinical efficacy, safety and real world effectiveness, perform economic evaluations, assess unmet needs and disease burden, as well as provide thorough assessment of disease and target population epidemiology.
Your compelling Global Value Dossier (GVD)
Global Value Dossier is a single source compendium of information developed and gathered over the life cycle.
We use a structured approach to evaluate, synthesize, and translate evidence into a compelling value dossier underpinned by industry HTA standards and in-house methodologies derived from multi-criteria decision analysis.
Learn how Certara technology can help you create an interactive Global Value Dossier that enhances your drug’s value story.
HTA and Payer Engagement
The need for better alignment between evidence generation strategy and HTA bodies’ requirements calls for formal or informal early engagement, either nationally or across the EU through. Joint Scientific Consultation (JSC).
Along with that the upcoming Joint European HTA introduces a new way of cooperation on health aspects in the EU. Certara HTA expert team has an unmatched wealth of experience both with JSC and Joint Clinical Assessments (JCA) to prepare successfully for HTA and payer appraisals.
US and EU Experience
Market Specific Projects/Services that defy categories:
- Local submission (both US & EU, ICER, AMCP dossiers)
- Launch strategy and sequencing
- International referencing pricing (EU)
- Payer segmentation (US)
Our Global Value Strategy Team
Roman Casciano, MEng
SVP Evidence & Access
Lee Stern, MSc
Vice President, Global Head of Consulting Operations
Maximilian Vargas, PhD, MBA
Vice President, US Access Strategy
Elvira Müller, PhD, MPH
VP HTA and Evidence Development
Roman Casciano, MEng
SVP Evidence & Access
Lee Stern, MSc
Vice President, Global Head of Consulting Operations
Maximilian Vargas, PhD, MBA
Vice President, US Access Strategy
Elvira Müller, PhD, MPH
VP HTA and Evidence Development
Roman Casciano is Senior Vice President within Certara’s Evidence and Access Group. As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the international market access, HEOR and real world evidence context related to product value demonstration and has deep experience in both formal and informal exchanges with payers and HTA bodies.
Lee is responsible for all health economic and market access engagements for global clients. She also oversees the full operations of the New York office. Lee is a strategic and actionable leader managing highly qualified and scientifically robust cross-functional and geographically disparate teams.
Maximilian Vargas, PhD MBA, is a Vice President, US Access Strategy within Certara’s Evidence and Access Group since 2012. He brings both scientific training and experience in healthcare product development that are important for evidence-based value and access strategies for pipeline and marketed products.
Elvira is an expert in HTA engagements with substantial experience in health technology assessment, reimbursement strategy and early dialogues, both national and multi-HTA via the EUnetHTA collaboration.
Roman Casciano is Senior Vice President within Certara’s Evidence and Access Group. As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the international market access, HEOR and real world evidence context related to product value demonstration and has deep experience in both formal and informal exchanges with payers and HTA bodies.
Lee is responsible for all health economic and market access engagements for global clients. She also oversees the full operations of the New York office. Lee is a strategic and actionable leader managing highly qualified and scientifically robust cross-functional and geographically disparate teams.
Maximilian Vargas, PhD MBA, is a Vice President, US Access Strategy within Certara’s Evidence and Access Group since 2012. He brings both scientific training and experience in healthcare product development that are important for evidence-based value and access strategies for pipeline and marketed products.
Elvira is an expert in HTA engagements with substantial experience in health technology assessment, reimbursement strategy and early dialogues, both national and multi-HTA via the EUnetHTA collaboration.