Value & Access Consulting

Our value and access teams provide comprehensive market access services in an integrated model. We combine strong technical capabilities in real world evidence development, health-economic analysis, and advanced analytic methods with our deep relationships in the payer/heath technology assessment (HTA) community.

Market Access Strategy

Comprehensive market access strategy powered by leading-edge research, data, evidence synthesis

An exponential rate of innovation, increased competition, and the growth of cost containment pressures create a greater need to comprehensively establish the value of health care interventions.

Our integrated approach allows global market access teams to optimize product value, positioning, and evidence synthesis across all stages of the reimbursement journey. Our combination of strong science as well as empathy with public health decision-makers’ challenges is the key to effective market access and the central philosophy of the Certara Value & Access consultants.

Assessing and optimizing therapeutic value are central to all our activities. Through our work with regulatory agencies, HTA organizations, payers, biopharma, med-tech and investment funds, we have developed an array of methods to assess the value of health interventions. This enables us to address the variety of situations and points of view faced by stakeholders of the healthcare systems.

Dossiers & Submissions

An unparalleled track record of impactful submissions across key markets

At Certara, we’ve prepared hundreds of dossiers and reimbursement submissions since the early 1990’s, drawing on thorough evidence synthesis, decades experience in health economics, industry-leading epidemiological resources, high level access to stakeholder insights. Each of our offices has extensive local and regional expertise. Our approach is aligned with EUNetHTA Guidelines, and we ensure the validity of our approach by regularly engaging vetted panels of payers, former payers and payer influencers.

Experience of reimbursement across key markets:

  • Europe: Germany (AMNOG); France (HAS); UK: NICE (England & Wales) & SMC (Scotland); Italy (AIFA, Lombardia, etc); Poland (AOTM), Spain; Belgium; The Netherlands; Finland; CEE (Romania, Hungary, Bulgaria, Czech Republic, Slovakia, Croatia, Serbia, Slovenia, Estonia, Latvia, Lithuania), CIS
  • North America: US: AMCP, Canada (CADTH; INESSS; pCODR); (Quebec, Ontario, British Columbia, Alberta, Sasketchewan, Manitoba, New Brunswick, Nova Scotia, Labrador & Newfoundland, Public Health Authority, NIHB);
  • Rest of the World: Turkey, Russia, South Korea, China, Taiwan, Singapore, Hong Kong

CORE HTA Methodology

The organization of health technology assessment and the setting in which HTA agencies operate varies considerably across and within countries. There is also a significant variability in the practical application of HTA-type approaches, and their linkage to the policy and reimbursement process. Our approach to dossiers—the CORE HTA—assembles, within a single document, the materials needed for developing local submissions. It includes formal descriptions of the evidence and strategic guidance as to how to use the evidence in submissions depending upon local circumstances.

The Global Value Dossier

Our Global Value Dossier (GVD) is a pragmatic, single source compendium of information gathered and developed over the life cycle of a product. The GVD provides functional access to everything needed to support market access globally. The GVD communicates evidence and strategies from global teams to local teams and enhances successful Reimbursement Submissions. 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 multicriteria decision analysis methodology.

Overview of Integrated GVD Framework

Systematic Reviews & Analyses

Dependable systematic reviews and analyses that are trusted by decision-makers globally

Systematic reviews are a commonly used tool in the Market Access and HTA areas. Certara gathers, summarizes and shapes unique insights through systematic data reviews and meta-analyses as well as targeted literature reviews to illustrate and strengthen your evidence-based messages. Our unbiased reviews are reliable sources of information for your decision-making purposes.

Services by our team:

  • Design and implementation of systematic/literature reviews
  • Standard and advanced meta-analyses
  • Mixed and indirect treatment comparisons
  • Meta-regressions
  • Bayesian meta-analyses

We offers a full range of Evidence Synthesis capabilities by matching the literature review approach and data synthesis method to your specific needs. Learn more here

Multicriteria Decision Analysis (MCDA)

MCDA has been used for decades in industrial, technical, social & political priority-setting. The HTA and market access field is increasing its use of this structured and transparent approach to identify and weigh criteria relevant to payer decision-making.

Certara leaders pioneered developing and implementing pragmatic MCDA for complex healthcare decision-making (the EVIDEM framework). Our teams work with clients to comprehensively and systematically consider the value of products. In each collaborative engagement, we combine our extensive experience in MCDA/HTA and scientific knowledge.

Payer Intelligence

Current and former payers who truly understand what matters to HTA bodies and payers

To help our clients engage payers, Certara creates formal and informal communications with HTA and payer stakeholders. The result? Integrated evaluation of expected value, clear and concise briefing materials, and a strategic approach.

We have developed a comprehensive and systematic framework to support HTA and payer appraisals. Our team of former payer executives has decades of experience with the criteria used in HTA and payer decision-making processes. We bring this knowledge into each client engagement.

We regularly work with:

  • Private US payers, managed care, HMOs, IDNs, ACOs, Medicare, Medicaid
  • European HTA bodies: EUnetHTA, NICE, SMC, HAS, G-BA, AIFA, AEMPS, AOTM, other CEE countries, Israel as well as regional decision-makers
  • CADTH (CDR and pCODR); INESSS, provincial formulary submissions and cancer agencies; private payers
  • Stakeholders in South Korea, Australia (PBAC), New Zealand (PHARMAC), and others

Regulatory Involvement

We extract the maximum value out of all forms of scientific engagement throughout the development process, in a way that can be integrated within core operating models. Our regulatory experience includes EMA, FDA, MHRA, ANSM, AEMPS, AIFA, HPB, CEE countries, Joint HTA-Regulatory advice as well as post-marketing commitments.

Innovative Pricing & Contracting

Trusted experience in innovative pricing and contracting, financial risk-sharing and outcomes-based agreements

Health care decision-makers around the world agree that value-based reimbursement marks an irreversible trend. Forced to accept increasing accountability, health systems and plans expect manufacturers to share risks around performance.

Certara partners with leading manufacturers who support the pay-for-value trend wherein reimbursement is tied to the measurable ‘real-world’ innovation the medicinal product provides. These include financially-based agreements on the population-level (eg, capitation of total reimbursement, free value-added services), patient-level agreements (eg, dose-dependent discount, capitation of use or patient co-pay, free days of supply), as well as outcome-based agreements (eg, population or patient-based, conditional treatment continuation, coverage with evidence development).

Our experience in innovative contracting includes:

  • Assessment of the financial impact of innovative contracting schemes for a treatment in multiple myeloma
  • Simulation of the outcomes of 15 performance plans across multiple disease areas for a leading Pharma Company
  • Evaluation of new price structures and financial risk-sharing scenarios for a treatment in multiple solid tumors
  • Scientific support including predictive modeling to guide study design and monitoring of real-world outcomes for a new lipid-lowering treatment
  • Measurement of real-world outcomes in the context of a coverage with evidence development programs for new treatments in schizophrenia and in asthma
  • Evaluation of the real-world risk of hospitalization for the implementation of an innovative contract in asthma

The proprietary HOPE technology for Performance-based Contracting

What if you could quantify the uncertainty in your next outcomes-based agreement?

Our HOPE technology lets you:

  • Optimize your plan design and inform payer negotiations and contracting
  • Know what outcome, comparator, and time horizon to select
  • Define the best methods to ensure performance and opt for the most appropriate payment mode

Learn more about HOPE for Outcomes Prediction here.

Early Value Assessment

Partner to early stage innovators in optimizing market value for financing/partnering deals

R&D investment decisions represent the largest risk taken by developers and biopharma investors. Amidst the massive uncertainties, we help companies identify the most attractive development option that will deliver the highest value in the real-world, with a reasonable cost and risk.

R&D challenges involve immense costs, substantial risks of failure, and high uncertainty around the value potential of the program. In addition, any decisions require the assessment and integration of multiple dimensions of analysis, including scientific, medical, commercial, financial data. Leveraging a unique team of senior industry executives and entrepreneurs, former HTA decision-makers, scientists, and seasoned strategy consultants, we’re bringing you innovative expert advice on:

  • Full asset valuation
  • Target patient population selection
  • Clinical trial design
  • Competitive landscape
  • Pricing studies
  • Preparation and participation to investor and partnering meetings

Investment options are compared and prioritized by our early value teams based on financial metrics of value and risk derived from real-world findings such as:

  • The disease significance and adjusted patient stratification
  • The predicted relative effectiveness of the intervention(s) in real-life
  • The evaluation of the price and reimbursement potential of the program(s)