The market access and reimbursement team, Global Health Economics Outcomes Research and Epidemiology team, and medical communications team are three groups within ICON’s commercial solutions division that offer integrated solutions to pharma and biotech clients to demonstrate the value of their products for accelerated market access and product adoption.
“We show how companies can leverage and create efficiencies from the full scope of available data obtainable within each of its teams, whether medical affairs, market access, or GHEORE,” says Cherian.
Preparing for a product launch should start at least 24 months prior to the anticipated approval date as the amount of data to collect, navigate, and determine how to use, is enormous. According to Cherian, having cross-functional teams under one roof that focus on identifying the right data to collect and how to optimise its use can streamline and expedite processes.
Though the market access team, GHEORE team, and scientific data team are separate, they can work cross-functionally with one another and consult with each other for input or reach out for expertise as needed.
“Our groups can leverage one another. While each team has distinct skills and areas of expertise, [scientific, market access, and GHEORE teams], together we build a layered, effective story that leverages scientific, economic, and market research data to create access to therapy,” explains Cherian.
The collection of evidence, research that is performed and evaluated, and the materials created are equally valuable. Understanding which teams are critical at different time points pre-launch can help manufacturers understand how to optimise our capabilities to meet their needs.
Gathering scientific data is an essential first step in establishing a product’s potential impact, but the task of assessing and analysing all of that data can be arduous.
“Our pharma/biotech clients ask us to do all the analysis of what’s being said in scientific literature and pull it all together,” Brinsden says.
The information is then garnered, distilled, and communicated to internal stakeholders. “We are turning around our research and analysis very quickly to meet the incredibly fast pace of information that’s coming through,” explains Brinsden. “We arrange for the pharma/biotech stakeholders to meet, usually through WebEx or during a face-to-face meeting, and we help facilitate how they want to speak about the disease area, about the efficacy of their drug and the safety of their drug,”
The terminology and choice of words used to present a product to healthcare decision-makers can generate interest and determine how its target audience receives it. The language a company determines to use becomes what ICON calls the brand’s ‘scientific platform and lexicon’, which is updated regularly throughout the preparation process.
“As more and more data comes in, companies must fine-tune their lexicon – what they want to say and how they want to say it – as they get closer to launch,” Brinsden says. “Once you’ve got everybody’s approval of the scientific platform and lexicon, then the company uses all the information for everything they do in their organisation. This ensures that everyone is utilising the same language.”
Once the scientific platform and lexicon are established, there is a foundation for other teams critical to commercialisation such as market access and reimbursement and GHEORE to build upon.
As early as two years pre-launch, the market research and analytics team, along with US and global strategists at ICON Market Access and Reimbursement, are heavily involved in qualitative and quantitative research and analysis that is supported by secondary research conducted by a team of pharmacists. The main activities undertaken at this time are typically a landscape and analogue analysis, competitive assessment of target product profiles, as well as a payer segmentation and targeting analysis.
A landscape analysis provides deep understanding of key stakeholders, current and future competitive dynamics, and factors that heavily influence treatment decisions, such as clinical guidelines. These are foundational elements that are needed prior to other research activities.
Thereafter, identifying competitors and appropriate analogues and evaluating their coverage is critical to understanding the market landscape and factors that may influence US and global reimbursement decisions, as well as potential scenarios at launch.
The output of the analogue assessment is also essential for segmentation and targeting research, which will inform not only who the key targets are, but also attitudinal and behavioural variables that can inform future strategies, interactions, and tactics.
Two years pre-launch, the GHEORE team supports the development of health economics and outcomes research, patient-reported outcomes, Real World Evidence (RWE), and health technology assessment roadmaps aligned with global, regional, and local strategies.
Key opinion leader interviews and/or advisory boards would also allow for external validation of the relevant health economics, outcomes research and epidemiology (HEORE) roadmap. To develop the roadmap, the GHEORE team leverages an experienced and multi-skilled team, including statisticians, health economists, pharmacists, outcomes researchers, data scientists, and epidemiologists.
ICON’s GHEORE team conducts clinical, epidemiological, health-related quality of life (HRQoL), patient-reported outcomes, and economic systematic and targeted literature reviews to gather available evidence and identify data gaps.
The GHEORE team reviews a client product’s value evidence and develops a Global Value Dossier (GVD), which can be used at global, regional, and local levels. The GVD is a strategic tool that captures all clinical, safety, and economic information and plays a key role in communicating the product’s value externally.
To meet the increasing need of RWE, the GHEORE team would also identify any RWE gaps, review existing databases, and map the available data to ensure a robust RWE strategy. Experienced epidemiologists, data scientists and statisticians from the GHEORE team leverage rich secondary data sources around the globe to profile burden of illness, assess patterns of use, and understand prescriber and patient experiences.
The GHEORE team also assesses the feasibility of network meta-analysis to incorporate potential competitors in economic models. At this early pre-launch stage, pricing threshold analyses and early economic models are also conducted together with the development of a cost-effectiveness model.
These analyses are constantly updated to account for new data and will be refined for health technology assessment (HTA) submissions.
Twelve months ahead of launch, the goal of most undertakings is to bolster arguments for product coverage/reimbursement and successfully communicate a product’s value potential to stakeholders, typically with an understanding of target segments, key drivers, and pricing in the US and global markets.
At one year pre-launch, the market access and reimbursement team utilises earlier insights to inform additional research into how a company can incorporate pricing and demand considerations and best shape its product messaging to address unmet needs and ensure its product is well-placed within the market.
This research may take the form of surveys, advisory boards or Mock P&T meetings and incorporates phase III clinical data to identify pricing implications, key value messages, and the priority of these messages based on resonance. While value message testing is not unique to ICON, the team’s proprietary methodologies, experience, and ability to create the optimal story tailored to various stakeholders is unique.
She continues, “Working with a team of experts that understands the therapeutic space is crucial. Oncology is going to be very different than immunology, and it’s going to be very different than the cardiovascular space or metabolic space, for example.
“Because payers manage those categories entirely differently, understanding the process thoroughly, nuances in utilisation management, for example, and having the expertise within a group to help you navigate these considerations is important to ensure you are guided in the right direction.”
The team provides market access expertise while working cross-functionally with the GHEORE team to plan regional and local submissions.
The GHEORE team simultaneously manages HTA submissions around the globe and performs economic modelling. Network meta-analyses, patient-centred outcomes analyses, cost-effectiveness and budget impact models are adapted and tailored to meet local regulatory and HTA requirements.
These analyses are constantly being updated to account for any new data, such as the release of pivotal phase III trial’s data, new database lock clinical data, and RWE studies, which are then incorporated into the updated Global Value Dossier.
ICON’s teams have the capacity to answer any demand made by either regulatory or HTA bodies which can include undertaking early scientific advice, providing specific countries results from clinical trial data, and launching real world evidence studies.
After consolidating vast amounts of research and assessment, the companies then assemble a narrative around the product’s value within the marketplace, which is delivered through customised strategic and tactical solutions at launch.
The GHEORE team adapts all HEORE material, including cost-effectiveness models (CEM) and budget impact model (BIM) local adaptations, country-specific clinical data analyses (e.g. utility analyses), to further submissions. Together with ICON’s MAR team, the GHEORE team develops a value communication package for a successful launch with objection handler, payer toolkits, and direct payer communication.
At launch, the market access and reimbursement team works closely with the manufacturer’s market access marketing leads to deliver value stories formatted to the stakeholders of interest and aligned to the current environment.
As part of best practice, ICON creates training for field teams on the appropriate use and delivery of these messages, which it believes are equally important in ensuring the stakeholders receive the story in the most consistent and impactful way. Post launch, it is also critical to refine the value story as additional data becomes available to further support the clinical and economic value of the product and, ultimately, coverage/reimbursement decisions.
Beyond typical value/access tools, ICON’s market access team is experienced in the creation of HUB sites and related tools that can enhance the value of a product and create added differentiation for a product entering a competitive space.
Developing an end-to-end strategy that ensures a thorough evaluation of a product can maximise the uptake of a new treatment. With the right structure and strategies in place, companies can approach product launches with the confidence that the product story has been carefully planned.
For ICON, this concept encourages each team to work in harmony to develop a clear action plan. With all three groups working towards the same end goal, companies can be sure that they are creating an informed and impactful value story founded in clinical research, supported by expertise, and customized to the ever-changing market environment.
“There’s a distinction between the three teams, but all work to recommend and generate the strategy, insights, and tools, which are equally critical and complementary in communicating a compelling product value story in a competitive space,” Cherian states.
It is well accepted that an asset’s commercial success relies on approval, reimbursement, and adoption. ICON’s Commercial Solutions team advocates for an integrated approach to evidence-generation strategies to better demonstrate the value of therapies to all stakeholders, whether regulators, payers, or HCPs and patients.
Tanya Brinsden, MA, CMPP is senior vice president of Account and Scientific Operations at ICON. She has over 20 years pharmaceutical and healthcare communications experience and leads organisations and teams in developing of strategic, impactful and timely medical scientific content.
At ICON, Brinsden is the organisational lead for Global Medical Communications & Pubs Hub™ and responsible for overall project delivery and strategic direction of the practice. She is a medical communications industry thought leader and influencer active in International Society for Medical Publication Professionals (ISMPP). She has a broad range of therapeutic areas such as rare disease, oncology/immuno-oncology, infectious disease, and immunology. Brinsden holds a B. Appl. Sc. from Sydney University and MA from the Graduate School of Management, Macquarie University.
Jessica Cherian, PharmD, Rph is the vice president of Content and Strategic Services with ICON Market Access & Reimbursement. In this role, she leads a team of pharmacists, medical writers, promotional writers, and editors to execute the translation of market access objectives and strategies into compelling deliverables. Cherian has significant experience in providing strategic medical and content oversight for specialty and traditional medications across a wide range of therapeutic areas throughout the product lifecycle to engage stakeholders in the payer, hospital/health system, and organised customer spaces. Prior to her time at ICON, Cherian held roles in academia and community pharmacy.
Béranger Lueza, PhD, is a principal consultant with the Global Health Economics, Outcomes Research and Epidemiology (GHEORE). He has worked in statistics and economic consulting and academia for over 11 years, specialising in health economics and outcomes research.
At ICON, Lueza acts as Project Director on a range of HEOR project,s such as development of cost-effectiveness and budget impact models, survival and utility analyses, HTA submissions, network meta-analyses, KOL ad-boards, literature reviews, Delphi panels.
His recent therapeutic areas of expertise include oncology (lung cancer, breast cancer, colorectal cancer, melanoma, and lymphoma), inflammatory bowel disease, heart disease, diabetes, meningitis B, haemophilia and blood disorders. Béranger holds a MSc in Statistics with a major in Health Economics from the engineering school ENSAI, Rennes, France, and a PhD in Biostatistics from Paris-Saclay University.
ICON is a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. ICON’s focuses on the factors that are critical to clients – reducing time to market, reducing cost and increasing quality – and its global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards. With headquarters in Dublin, Ireland, ICON employs approximately 38,000 employees in 151 locations in 46 countries. Further information is available at www.iconplc.com.