Driving proficiency, collaboration, and productivity for data analysis that informs business and product strategy.
Professionals and team members with diverse backgrounds are often tossed into the market access arena with little context of how it actually works in a global manner. Knowing what matters in valuing a drug is the blueprint for gaining market access.
Whether working through direct access to the Market Access Platform (MAP) or collaborating on projects with our Analytical Services team, the Context Matters' data model delivers the highest quality data required for the multiple aspects of market access. Our solution supports a unified approach that applies evidence-driven decision making to drug development from early pipeline to product introduction and franchise expansion. Here are just a few ways the many forward-thinking biopharmaceutical teams use our solution.
DOSSIERS | SUBMISSIONS
- Using our application, you have access to the most important aspect of starting the dossier creation process – competitive intelligence. This is the critical information about how prior submissions for a similar drug or a drug for the same/similar disease condition have been and can be evaluated. Our application lets you view and understand the types of evidence, clinical criteria, and economic model considerations that lead to a positive or negative reimbursement decision.
CLINICAL TRIAL DESIGN
- Clinical Trial Design from a market access point of view, encompasses both pre- and post-market clinical trials. Pre-market trials are the pivotal trials in which selection of endpoints, population parameters, and comparators have a life beyond the trial. All will be used in a health technology assessment evaluation, which will determine market access in the future. Post-market trials add new data to the ongoing evaluation process. In addition to expanding indications and populations, the selection of endpoints, population parameters, and comparators must now include competitive considerations.
- Using our application, you have the capability to test your own assumptions about the comparator, endpoints, and population criteria to select or develop. And you have the ability to understand how other drugs fared in this process.
HEOR | HTA
Clinical Trial Design | HEOR | HTA |Market Access | R&D
Single Drug Narrative
- Single Drug Narrative is a robust, evidence-based synthesis of the market access timeline for a drug. It shows the entire launch journey of a drug. Specifically, the Single Drug Narrative begins with the pivotal clinical trial evidence submitted for regulatory approval and ends with the health technology assessments that lead to reimbursement. Single Drug Narrative also includes key insights on successes and barriers to the drug’s path to market access.
- Brand teams use Single Drug Narrative to monitor a competitive landscape, understand the appropriate comparators, and design more impactful, pivotal trials.
Disease Condition Narrative
Disease Condition Narrative allows you to gain a quick understanding of your drug in the context of a disease condition. For example, you may want to understand all second-line treatments for melanoma or understand what kinds of measures (e.g., patient-reported outcomes) are commonly (or rarely) used for a disease condition.
- Market Access, Health Economics Outcome Research (HEOR), and Brand teams use different types of narratives to gain a unique and thorough understanding of the disease condition.
Brand | HEOR | Market Access
When trying to understand the competition, most questions begin with a hypothesis about the disease condition, the way health technology assessment agencies have assessed competitor drugs, or how certain comparators may matter more than others.
Our application provides the capability to test hypotheses whether the grouping is a class of drugs, a disease condition, a specific indication, or even a single competitor drug.
- All teams (particularly R&D and Pricing) value this capability – it is the foundation of how to begin planning a trial or a strategy.
Market Access is a moving target as new drugs, new data, new criteria, and new methods of evaluation are constantly emerging:
Do agencies care more about subgroups in Hepatitis C?
What primary outcome is favored?
How are orphan drugs affecting reimbursement decisions?
Do agencies expect a risk-sharing agreement or a patient access scheme?
Understanding trends is critical to keeping up and getting ahead.
Market Access | Pricing | Reimbursement
Analogues are useful, particularly when there is no direct competitor for a drug. Analogue Search is an important capability for a Market Access or Health Economics Outcomes Research (HEOR) professional to:
Find drugs that have a similar regulatory and reimbursement path.
Search for molecules that have been deemed similar in terms of clinical trial endpoints and outcomes.
Find drugs that have faced similar evaluation challenges, but from different therapeutic areas or disease conditions.
Learn about similarities in evaluation approaches by individual health technology assessment agencies.
Find similarities across drugs that are matched along lines of therapies, additional indications, or even mechanisms of action.
- For example, you may be interested to understand how a first-to-market oral medication will be assessed by health technology assessment agencies in a disease condition where only injection products are approved. If you have the first-to-market oral medication, you need the capability to to search for analogues that may give you a better understanding of the different scenarios and show you a path forward.
The basis of health technology assessment begins with the selection of an appropriate comparator. In fact, this is the area of greatest contention and risk for a biopharmaceutical company, largely because the ultimate choice may not be within their control. Another challenge is that the selection of a comparator can rapidly change (i.e., new competitor drug launch).
You need the capability to understand the criteria that a comparator must meet and is expected to meet if that comparator is chosen by the agency, a competitor, or by you. Note that the selection of a comparator is often influenced by the current standard of care.
You also need the capability to distinguish between the appropriate clinical vs. the appropriate economic comparator, as your drug will be evaluated by both.
- Our application provides an understanding of the comparators that have been used for competitor drugs and also the frequency of use for a particular comparator. It lets you understand what the past comparators are and what the current comparators are. In the context of a competitive environment, knowing which comparator is critical.
BRAND | HEOR | MARKET ACCESS
Portfolio | Franchise Management
Many teams have a therapeutic franchise and they are responsible for ensuring optimal reimbursement. The market access challenge is greater than self-cannibalization. Rather, the choice of comparators can pit one drug in your portfolio against another. And the ramification is a zero-sum game whereby the market access for one of your drugs is gained at the expense of another of your drugs. In this brave new world, a first-to-market drug is not necessarily a good thing – at least not all the time.
- Tracking and understanding health technology assessment reimbursement decisions for your drugs is essential. Our application allows you to gain insights, at high and granular levels, into how the drugs in a class, new drugs, and/or a particular company’s drugs are faring within the paradigm of market access or health technology assessment evaluations. Managing your franchise portfolio requires that you understand the risks your drug faces in a health technology assessment evaluation in the context of your larger drug portfolio and the competition. But understanding single risks is not the end goal. Rather, it is understanding how these evaluations compare to one another along multiple dimensions and similar contexts that gives you the confidence to make the necessary trade-offs in both valuing and managing your therapeutic franchise.
Ensuring that your global team has the same information at the same time is never easy. Our application fosters communications and collaboration across your team as you solve for strategic pricing and reimbursement.
Share principles and tools are embedded throughout the application that allow you to easily develop and share tables, graphs, and searches with colleagues as far away as next door or across the globe.