Senior-businesswoman-explaining-strategy-with-colleagues-in-board-room

Thought Leadership

Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends

How Claims and Lab Data Helps Pharma Go to Market

By MMIT

When a manufacturer is at least a year out from a drug’s PDUFA date, the market access team begins to make informed decisions about what data is necessary for a successful launch. Many are using claims, lab, and other real-world data sets to access the right patient population at the right time to drive utilization of their therapies.

To explore why claims and lab data is so important for commercialization, we asked three clinical experts to explain the value of an integrated real-world and market access data asset. In the first of two blogs, we discuss how this data helps pharma companies launch their products.

What exactly is ‘real-world data’ in the pharmaceutical industry?

Ted Search, General Manager and CEO of RWD, Norstella: Honestly, real-world data can mean a lot of things to different people. It includes medical and pharmacy claims data, lab orders and test results, specialty pharmacy data, social determinants of health (SDoH) data—a whole multitude of data sets.

At Norstella, we think of it as the creation of a data asset that includes in-depth claims data, because that’s what anchors this longitudinal view of the patient. Integrated RWD can show you all the details of a patient’s journey: not just their diagnosis and medications, but also what they’re looking for—what they’re ultimately trying to treat.

Lance Wolkenbrod, Sr. Director of Commercial Solutions, MMIT: RWD can even encompass data that we don’t normally think about, like specific physician notes and other kinds of unstructured data. For example, a patient might not be given an ICD-10 code or a diagnosis on every visit, but there might be a pathology report or notes history that can help you better understand how their physician is treating them.

The difficult part, of course, is combining these disparate data sets together to give you a full, holistic view. Once it’s all tied together—not only with other real-world sources, but also with traditional market access data on payer policies and restrictions, plus all the clinical pathways data—you now have an integrated asset that you can query to solve specific use cases.

So why is it important that the data be integrated? 

Dr. Robert Petit, CMO/CSO of OS Therapies; EVP of Commercial Operations, RWD, Norstella: Well, real-world data comes from all kinds of disparate sources, and if you don’t integrate the data sets properly, you’re not using the same filters and denominators—it just doesn’t make sense. It’s got to be brought together in a cohesive way, so that it’s accurate and consistent as you move from one query to another, from understanding a particular lab index to identifying how providers will get reimbursed.

Ted Search: If a pharma company is independently sourcing single data sets, the data can be very large and dirty, and will need a lot of cleanup before it can become meaningful. But ultimately, it’s the linking and tokenization of multiple data sets that makes RWD so powerful.  There are petabytes of data out there, but they’re meaningless without context. It’s only recently that we’ve gained the capabilities to bridge that data to market access data and make it actionable. When it’s integrated, you can look across the whole patient life cycle to generate the evidence you need to solve access barriers for your patients.

Lance Wolkenbrod: The quality and integration of your data is key, but it’s also really important to bring in experts who have deep clinical knowledge about how patients are identified. Then you can start to ask really intelligent questions of the data, and you can write inclusion or exclusion criteria to tailor your queries to drive the specific insights you’re looking for.

How is claims data useful to companies developing a market access approach?

Lance Wolkenbrod: In the past, pharma companies used claims data mainly to identify which HCPs to target. Today, pharma companies are using real-world data from labs and claims to help them better understand how physicians identify, diagnose, and treat patients—and how that care might potentially be blocked.

This is especially useful now that therapies have advanced, and pharma companies have begun to stratify specific patient populations from a market access standpoint. For example, when payers put policies in place to ensure that certain biomarker testing occurs, are physicians actually identifying eligible patients at the right time for those tests? And is that testing appropriately reimbursed?

By understanding everything from referral patterns to payer restrictions to reauthorization criteria and out-of-pocket expense, you can see what the full gamut of access looks like for the patient.

Dr. Robert Petit: Before a product comes to market, you have to have a very precise understanding of what’s happening out there in the real world so that you can carve out your segment of the patient population. The question becomes, how are we going to subdivide the market?

And the answer relies on an integrated data set, that includes claims data, to document the patient journey. What have patients been treated with so far? How have they been doing with that treatment? What biomarkers are we seeing in the laboratory data? Are some patients more or less likely to respond to treatment based on a particular mutation?

The technical aspects of the patient’s medical journey and their particular physical condition at any point in time are becoming more critical to getting them the medications they need. Pharma companies have to generate real-world evidence that justifies payer coverage for these medications for patients who qualify. Integrated data is becoming almost logarithmically more essential for pharma companies to be successful in getting their medications to the right patients.

How is lab data useful to pharma companies in market access?

Lance Wolkenbrod: Unlike claims data, lab data is immediately available, which is immensely useful from a physician engagement standpoint. Lab results can become real-time trigger events for a pharma company’s sales reps, as you can determine when a patient is ready and eligible for your therapy. When you reach out to physicians at the exact right time—before they’ve made a prescribing decision, or even before they make a diagnosis—you can really move the needle on utilization.

Once you’ve figured out the patient cohort, you can use lab data to stratify the population and track disease progression over time. Lab data helps pharma companies understand how effective a treatment is at managing the specific disease for an individual patient. For manufacturers of second-line and third-line therapies, being able to see the deterioration of a patient’s condition and identify adverse events is really important.

Dr. Robert Petit: Pharma companies rely on assumptions about the patient’s disease and treatment, but those assumptions can be refined by a closer look at the patient’s journey. For every disease, there are average durations of time, from onset of symptoms to the time it typically takes to respond to treatment. There are averages, but there’s also a range, with patients on the very short or long end of that range.

Real-world data, and especially lab data, really gives you an idea of what that variability is, which means you can accurately target and time your outreach messaging to physicians and patients. If the data shows there are opportunities to move to a new treatment sooner, you can educate physicians about that, and drive higher utilization of your drug.

Learn how MMIT’s integrated claims, lab and market access data can help your team improve utilization and uptake.  

MMIT

MMIT

Related Posts

What-Pharma-Needs-From-RWD-featured-image
October 19

What Pharma Needs From RWD: Top 5 Trends

Read More
STAT-featured-image
September 14

Uncovering the Patient Journey: Four Ways that Real-World Data Offers Value

Read More
biopharma-oncology-patient
October 12

Using Real-World Data to Improve Patient Access to Oncology Therapies

Read More

GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND

Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today