We spur your success in the U.S. Managed Markets: Driving impactful science with real world evidence analytics, payer strategy and the right commercial pull-through.

Have you planted the seeds for Managed Markets success?
To help you navigate the complex US access landscape, our consultants specialize in scientific value story development, pro-active policy and payer engagement, as well as multi-faceted go-to-market and distribution strategies.
The Most Reliable US Payer Panel
In all of our engagements, we can leverage Certara’s ‘Compass Expert Panel’, a leading proprietary database of formulary decision makers in health plans, PBMs, hospitals/IDNs and channels influencing access, incl. specialty pharmacy, GPOs. Established 25 years ago, it is updated in real time and has been leveraged across hundreds of strategic projects in life sciences.

Learn how we’ve helped clients in recent pricing and access projects: Download Case Study 1 


Every year, our teams are approached to conduct dozens of qualitative and quantitative studies to optimize go-to-market with pricing that maximizes reimbursement at launch, and across the lifecycle. Our research quantifies the value placed on key elements, share of preference and optimal price, and our models simulate how these values change under different market and access scenarios. We also maintain an in-house Center of Excellence in Gross-to-Net Modelling.
Innovative Contracting
You’ve heard it from payers and even PBMs, value based contracting has become a reality. Our unique platforms help you move performance contracts beyond pilots through decision-analytics and strategic scale. For guidance on developing innovative and outcomes-based agreements, read more in our recent series of whitepapers here.

Learn how we’ve helped clients in recent pricing and access projects: Download Case Study 2

 


We believe that 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.
Early Value Assessment
Certara works with healthcare innovators to strategically optimize their market value in the context of financing or partnering deals. Our services include:

In our work with small 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 commercial success. Our teams are experienced with meeting tight deal deadlines.

Due Diligence for Investors
At the heart of the commercial due diligence process, we seek to perform an independent validation of the target to inform the investment decision that gives clear guidance on the magnitude and sustainability of future value creation. Our teams customizes the commercial transaction support to a high degree based on the client’s scope and timing to secure the particular investment perspective at hand.

Usually, the engagement encompasses a rigorous:

  • Study of market dynamics, opportunities and risks;
  • Competitive benchmarking under various scenarios;
  • Validation of commercialization plans and revenue/ EBIDTA/ cashflow forecasts (including de-novo financial modelling, scenario analysis and valuation support);
  • Audit of target’s operational capabilities with respect to market entry;
  • Review of product placement, pricing, evidence generation and market access (TPP, both with payers and clinicians),
  • Integration of go-forward value enhancement options, upside opportunities under product life-cycle considerations.

Our process is fully integrated with an assessment of development, licensure, regulatory and manufacturing prospects, and concludes with a critical commercial appraisal of the investment case. The ultimate aim is to help clients discern and frame well-structured deal terms, capture potential upsides and create the underpinning of a successful exist later on.

Learn how we’ve helped clients in recent projects: Download Case Study 3


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 from others: Our focus on value demonstration and evidence development is driven by your product’s real world impact, not its clinical trial results. Our offering stands out as a unique marriage of analytics on the data in real world settings with prover payer strategy on how to best leverage that evidence for reimbursement success.

Leveraging our Industry-Leading Value Communication Platform
Our experts help develop your value stories, test key messages and leverage our market-leading BaseCase platform for proven US pull through. You work hand in hand with our joint team of expert payer consultants, data specialist and in-house app developers – guaranteeing faster, more reliable end-to-end strategy.

Learn how we’ve helped clients in recent projects: Download Case Study 4


Demands on the certainty of real world performance are increasing among all stakeholders, spurring a trend to employ structured frameworks to assess clinical and economic value of therapies. Our teams excel at evidence generation and modelling which is becoming increasingly important for US stakeholders. We conduct all types of standard economic and disease modeling, as well as very advanced Bayesian decision-modeling.

We also investigate value frameworks as tools to support a multi-dimensional assessment of technologies supporting transparent and participatory deliberations and decision making.

Institute for Clinical and Economic Review (ICER)
In preparing for ICER reviews where QUALY-based cost-effectiveness thresholds serve as benchmark for value, we strongly 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. We also lead the strategic preparation to showcase therapy value to those formulary decision-makers who may be considering ICER-based pricing recommendations with the goal to optimize impact on coverage negotiations.

Learn how we’ve helped clients in recent projects: Download Case Study 5


To allow for the optimal positioning of your product, portfolio or company, it is critical to understand the various forces that shape the US access landscape. Here are just a few trends we are monitoring on the evaluation of health systems:

  • Increasing volume control over prescribed therapies by commercial plans, MCO, PBM, VA
  • Narrower formulary and stricter utilization management
  • Provider incentives shifting away from volume, physicians’ flexibility to make Rx decisions
  • Increased patient exposure to out-of-pocket cost burden
  • Consolidation in the site-of-care landscape and payer cost shifting strategies
  • Rising complexity of reimbursement-relevant coding and billing procedures depending on setting/ site of administration
  • Growing payer ability to leverage biosimilar entrants and therapeutic alternatives across crowded drug classes

We’ve been track these and many other health system trends in the US over the last two decades, including the very latest transformative merger and acquisition activities. Our clients rely on tested playbooks to help them navigate complex and competitive market situations.

Policy Assessment and Legislative Tracking
In recent years, health policy pushes have seen an increasingly nuclear focus on drug costs and pricing processes.  We are witnessing regulatory moves at unforeseen speed towards combining volume control with regulations on pharmacy costs on the federal level. At the same time there is an escalation in various state legislatures to regulate drug pricing transparency, co-pay assistance, importation, rate setting, price gouging, spending targets, group purchasing and biosimilar substitution.

To enable decision-making in the face of ever more uncertainty, we offer clients a laser-focused assessment on the business implications of proposed and recent legislation, involving war-gaming and game theoretic strategies, to define critical success factors under multi-faceted scenarios.

Learn how we’ve helped clients in recent projects: Download Case Study 6

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Check out the Blog.



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Consulting
eva-bd@certara.com
(646) 887-6534

BaseCase
info@basecase.com
+49 30 2014 364 0

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eva-bd@certara.com 
(646) 887-6534


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