How Drug Developers can
Navigate the Inflation Reduction
Act of 2022
Establish value of your health care innovation
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.
Certara’s 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.
Engage in Early Development
In early development, we help clients address key questions of value identification
- What are the unmet needs and value drivers from a payer and provider perspective?
- I have a product with many indications; which has the greatest commercial potential?
- How well does my target product profile and clinical trial stand up to provider and payer scrutiny?
- What endpoints will increase the pricing and access potential?
- What is the evidence to support price and access assumptions in forecasting or partnering discussions?
- What is the optimal launch sequence of global markets considering local pricing and reimbursement decision making processes?
- How does international reference pricing (IRP) affect the launch?
Reduce uncertainty with pricing and reimbursement (P&R) research
An evidence-based launch pricing strategy prepares product teams to achieve pricing and access objectives
- Qualitative and quantitative research methods ascertain optimal list and net prices that maximize revenue, access, or demand
- Segmentations aligning to the contracting strategy ensure judicious deployment of rebates and price concessions
- Assessing provider demand in the context of the anticipated access environment enables more accurate forecasting
- Patient level cost-sharing sensitivities help shape commercial strategy
Navigate the product's evolution
After launch, Certara helps clients navigate their category’s evolution, assessing and recommending strategies to:
- Defend market leaders from competitive entries
- Gracefully and optimally transition away from branded pricing approaches upon patent expiry
- Monitor the impact of price revisions and competitor changes on the overall international reference pricing web
Maximilian Vargas, PhD MBA, is a Senior Director, US Access Strategy and Account Management 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.
Pascaline Faivre (PharmD, Msc) is a Senior Director Market Access at Certara and brings 13 years of experience in Market Access and Health economics at pharmaceutical industries and consultancy groups. Pascaline has successful track record of reimbursement submissions in EU countries, product launches, and extensive knowledge of EU market Access challenges and payers requirements for drugs, medical devices and vaccines.
Maximilian Vargas, PhD MBA, is a Senior Director, US Access Strategy and Account Management 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.
Pascaline Faivre (PharmD, Msc) is a Senior Director Market Access at Certara and brings 13 years of experience in Market Access and Health economics at pharmaceutical industries and consultancy groups. Pascaline has successful track record of reimbursement submissions in EU countries, product launches, and extensive knowledge of EU market Access challenges and payers requirements for drugs, medical devices and vaccines.
