A complete guide to HEOR project costs

Every new treatment in healthcare requires evidence. From developing a novel drug to introducing a groundbreaking treatment for a rare disease, real-world evidence must support clinical trials, inform new distribution relationships, and help monitor post-market performance.

However, the cost of real-world evidence generation through health economics and outcomes research (HEOR) is ever-rising. There are many variables to consider when developing a new drug, and for many pharmaceutical companies, planning appropriately for observational HEOR costs can help increase the chances of the study’s success.

This blog covers the main HEOR project and cost variables to consider before starting a new study.

What is the goal of the research?

The research question posed can affect the overall cost of the study, and there are many questions research teams can ask themselves to solidify their focus area. For example:

• Is the research being conducted for observational research, commercial analytics, or clinical trial design?
• Is it a descriptive HEOR project question or does it include adjusted analysis or multiple outcomes of interest?
• Is the research focused on population health, such as a health equity or disease progression study?
• What are the conditions being studied?
• What data source or sources are needed to answer the research question?
• How long is the study expected to last?
• What time period will be used in the study?
• Is the study protocol driven?

The answers to these questions will help determine the complexity of the study design and the time needed to organize and analyze the data, and ultimately, influence the cost of the project

What condition is being studied?

HEOR studies can focus on more common therapeutic areas, specialty conditions, or rare diseases.

Common conditions are typically more cost-effective to research. There are usually more data available on these patient populations which can decrease the time (and investment) it takes to gather an appropriate amount of data for analysis.

On the other hand, the rarer the disease, the higher the cost to study based on the scarcity of available data. A specialty or rare disease category will have smaller patient populations which will take longer to generate sufficient data for analysis. A research consultant may also need to be identified for these studies to access data otherwise unavailable to the public.

What data sources are required?

Once the goal of the study is set, it’s time to gather the data for analysis. HEOR projects often use some combination of multiple data sources to establish a representative and comprehensive view of the population(s) in question.

Required data may include medical claims, Rx claims, electronic medical record (EMR) data, registry data, or population health data. The number and type of sources used can improve the validity of the research, though the more data typically means a higher study cost. Still, diversifying data is critical, as it helps make a study more applicable to the greater population.

Working with Inovalon makes it easy to access, standardize, and analyze large amounts of data for HEOR studies. Our industry-leading primary source dataset is a real-world database that includes medical and pharmacy claims from over 160 deidentified data sources. Our team of experts can also use and work with other data, including 100% of Medicare Part A and Part B FFS claims data (through a required data use agreement with CMS), long-term care, social drivers of health, laboratory result data, EMR data, and registries.

An effective study often necessitates multiple data sources. The more sources required, the higher the overall cost of the project.

Data linking for HEOR

Data from other sources can be linked to enhance study objectives and outcomes – and our team of research experts can help securely connect data via the Safe Harbor or Expert Determination method.

It is now possible to connect data between mothers and their newborns, enabling the evaluation of the maternal connection to their infants. Women’s health is gaining recognition across research fields, including pregnancy-focused and health equity studies. The ability to link mothers to their infants enhances the value of research data by providing deeper insights and connecting them to real-world outcomes.

Additionally, data linking through patient tokenization enables the integration of randomized controlled trials (RCTs) with real-world data (RWD). Tokenization involves converting sensitive patient information into encrypted tokens, allowing for secure and seamless linkage of diverse datasets. This innovative approach enhances patient privacy while enabling comprehensive insights into clinical and economic outcomes.

The integration of RCT and RWD data through tokenization supports enriched study designs, faster time-to-evidence cycles, and improved understanding of patient journeys, paving the way for more informed decision-making and equitable healthcare outcomes.

Determining the study lookback period

The further back a study intends to go, the more data there is to process and analyze – and the higher the total cost of the project.

How many years of longitudinally linked data does the project need to include to provide value? Some studies may get all the data they need with just a three-year data window, while others need to go back five years or more to establish a truly comprehensive and statistically representative view.

Additional HEOR project costs to consider

Will there be a need to develop an abstract or manuscript? Will the findings disseminate via a conference proceeding or publication?

The time and experience required to produce these deliverables will add to the total spend of the project, but the value of dedicated support at every point from study design through final deliverables often outweighs the cost. Additionally, conducting a study externally allows for more targeted expertise and frees up valuable time for companies by outsourcing.

HEOR costs vary, and the better that a team can identify exactly the kind of data they need, the data sources required, and who will be leading the study – the better off their cost (and timing!) expectations will be.

Answer your HEOR project questions with Inovalon Data Solutions

With over 350 years of combined healthcare data analysis experience¹ across HEOR, public health, outcomes research, epidemiology, clinical analytics, commercial analytics, biostatistics, our Data Solutions team is here to help answer your healthcare research questions