Learn About ePI

An Introduction for Biopharma Manufacturers

Every drug, biologic, and medical device has a digital presence. This includes how it shows up in a doctor’s system, how pharmacies and insurance companies share pricing and coverage, and how hospitals use it in their treatment plans.

A product’s success depends on this digital presence, which we call the Electronic Product Identity, or “ePI.”

Each product’s ePI is made up of lots of information managed by different companies, systems, and people across healthcare. There is no single source of truth, so it’s up to the manufacturer to monitor these sources to ensure accuracy and consistency.

How does product information get into EHRs?

EHR appearance accounts for only a portion of a product’s ePI, but it’s often the top concern for manufacturers. That’s because a new product isn’t likely to be prescribed often until it shows up in an EHR. By understanding how pricing sources, EHR suppliers, health systems, and individual practices work, manufacturers can better prepare for a product launch and predict when the product will be available in the EHR.

A product’s information reaches doctors’ EHRs through a controlled process. It starts when the product gets approval from the FDA, is entered into drug information sources called “compendia,” and finally becomes available to doctors and other users.

Can we speed up the process?

Submitting clear and timely information to pricing compendia, in the format they each prefer, is the manufacturer’s best chance to influence their product listing. When a manufacturer follows each pricing source’s formatting guidelines and policies, it can save time for editors creating the new listing, which can impact the timing of publication.

However, manufacturers must understand that the timing of a product’s appearance depends on a system developed by the industry, and it cannot be reliably (or sometimes, even safely) “sped up”.

Be cautious of promises of quick fixes or shortcuts, as bypassing industry standards can cause major problems for launch products, including invalid prescriptions and increased patient safety risk.

So, what is a manufacturer’s role in managing a product’s ePI?

A manufacturer has direct control over only some parts of a product’s ePI, like the product labeling, compendia submissions, and marketing campaigns. The rest is controlled by other companies, associations, and publications.

That’s why it’s important to make the most of what you can control!

Manufacturers should focus on a few key activities:

The manufacturer’s goal is to make sure information about its products is easy to find, understand, differentiate, and use. That makes prescribing, dispensing, and reimbursement as smooth and easy as possible.

What sources, suppliers, and datasets influence a product’s ePI?

  • The product Prescribing Information (PI) and packaging provide the basic details needed to prescribe and use a product.

    The PI is written for humans, but it must be converted into structured data before it appears in healthcare provider software.

    Manufacturers should consider this conversion when writing the PI, as the FDA does not ensure it is optimized for digital translation.

  • It’s not just data from a drug’s clinical trials. Third-party studies, medical journals, and even clinical data from other drugs in the same class can affect a product’s ePI.

    It’s important to keep track of information in the entire therapeutic area to fully understand a drug’s ePI.

  • When respected organizations and agencies publish recommendations for a disease, these guidelines can greatly affect a product’s role in treatment within healthcare organizations and providers.

    Practice guidelines created by third parties may not always align with a product’s FDA-approved uses and indications.

  • Pricing compendia databases are no longer just for sharing a product’s price. They also provide the details needed to prescribe, dispense, and process claims for a drug (but don’t tell users when or how to use it).

    These compendia provide the drug information that makes a product appear in EHRs, pharmacy systems, and other platforms.

    In addition to industry standards, each compendium follows its own editorial policies.

  • Clinical compendia editors use a product’s labeling, along with other published studies, to create recommendations for its use.

    Although often accessed online, clinical compendia can also be accessed through some EHRs, giving prescribers direct access to these recommendations and clinical overviews.

  • Since the manufacturer has the most control over this part of the ePI, it’s important to create brand messaging that matches and supports the product’s digital appearance, making it easy to understand within the clinical workflow.

  • Decision makers, like payers and P&T committees, use product information to create their own datasets that guide product use.

    Payer Formulary & Benefit Files show coverage information to prescribers and pharmacists.

    Health system protocols and order sets can either encourage or limit the use of specific products.

  • EHRs use pricing compendia data to build their prescribing databases. Products with optimized listings are easier to find and prescribe.

    EHRs can also be used to apply and enforce local health system or practice policies, such as drug formularies.

  • The pharmacy is a key communication link between the prescriber and payer. Pharmacy software must be able to understand and translate prescription information to dispense the correct product and verify patient coverage.

    Payers also use compendia data to populate their reimbursement software and to assign drugs to therapeutic categories, which help determine therapeutic alternatives and substitution options.

What product features must be considered for successful ePI planning?

A product’s ePI describes features like its name, active ingredients, dosage form, strength, and route of administration. Its mechanism of action and approved uses also determine its therapeutic category and its competition. These details are usually decided before, and sometimes during, FDA label discussions. That’s why manufacturers should start ePI planning early, around late Phase 2 or early Phase 3, and continue it as the product moves from development to commercialization.

A manufacturer that is well-prepared for launch has already thought about key product features and aligned the language in the product label, and their downstream marketing tactics, with industry standards and compendia and EHR rules—so their product launches with a clear, consistent, and strong ePI.

Want to dive deeper?

If you’ve made it this far, we hope you have a better foundational understanding of Electronic Product Identity management. Now that you’ve scratched the surface, you probably realize that every product’s unique identity requires an individualized approach. We’d love to help you explore the specifics of your market situation and create an ePI Management Plan built on the unique opportunities and goals of your product.